, , ,









Great little Company, looking like it is through its growing pain stage, onwards and upwards

********************************************************************

Scancell Hlds
Patent Approval
RNS Number : 0217Z
Scancell Holdings Plc
09 March 2012


9 March 2012





Scancell Holdings plc

("Scancell" or "the Company")

ImmunoBody® Patent Approved in US



Scancell Holdings plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that its protein ImmunoBody® vaccine patent has been approved in the United States. The patent, which has already been approved in Europe and Australia, will further strengthen Scancell's IP position around its proprietary ImmunoBody® vaccine platform.



Scancell's lead vaccine, SCIB1 is being developed for the treatment of melanoma and is currently in Phase I clinical trials. It is an innovative DNA vaccine being developed using Scancell's ImmunoBody® technology. Phase 2 trials are due to start in Q2 2012.



Dr. Richard Goodfellow, Joint Chief Executive of Scancell, commented:



"The USA remains the most important market in which to commercialise our ImmunoBody ® vaccines. The award of this US patent confirms the innovative nature of the ImmunoBody ® platform and provides a sound basis on which to commercialise the technology in the US. Scancell will continue building its growing portfolio of intellectual property in parallel with driving the clinical trial programme forward during 2012

*******************************************************************

Especially......
Dr. Richard Goodfellow, Joint Chief Executive of Scancell, commented:



"The USA remains the most important market in which to commercialise our ImmunoBody ® vaccines. The award of this US patent confirms the innovative nature of the ImmunoBody ® platform and provides a sound basis on which to commercialise the technology in the US. Scancell will continue building its growing portfolio of intellectual property in parallel with driving the clinical trial programme forward during 2012


This is why all the excitement here.

Courtesy of the poster brigadon on LSE.


Make That A Billion Dollars!

After years of developing the melanoma antigens TRP - 2 and gp100 at the National Cancer Institute in Bethesda, Maryland, the United States Department of Health and Human Services (HHS) has entrusted Scancell with their commercial development. These antigens now form key components in the company's lead vaccine to treat melanoma, SCIB1.

The US Public Health Service, a division of HHS is due royalty payments on these antigens from future sales of SCIB1 so, to help realise a speedy return on its investment, the US National Institutes of Health, an agency of the US Department of Health has made the clinical trials data for SCIB1 available on its website, an important port of call for large pharmaceutical companies looking for new drugs and drug development businesses to acquire. [Scancell's board has expressed the intention to seek a 'trade sale' of the business upon completion of Phase II clinical trials of its lead vaccine SCIB1.]

In a recent presentation to analysts and investors Scancell made the point that large pharmaceutical companies were prepared to pay up to a billion dollars for a clinical stage cancer vaccine firm, such as Scancell, which had shown evidence of patient recovery from terminal forms of the disease after treatment with its products. In May 2010 it was revealed that an earlier version of SCIB1, configured at the time to treat bone cancer had indeed appeared to have cured two young patients of a terminal form of this condition.

It is this pedigree of Scancell's curative success, the watertight protection of its patents and the influential backing of the US Department of Health that any potential bidder will be buying into. So even if we were to assume the price being offered for Scancell, was only half of what has been offered in similar circumstances this could still amount to to an offer price of around 162p per share! Whatever the final price, it will certainly amount to many multiples of today's market price. I am therefore maintaining my Strong BUY recommendation for this stock.

I got in last Thursday. Paid a little higher than should've doen but it's going to be peanuts compared to what this nice little earner could return! (imho)

Anyone else in ?

Skyhigh, you'd not be so pleased if you'd invested a year earlier...since then the Board has trashed the sp by a horendus subdivision and placing at 5p to raise sufficient funds so they can continue. As to a bid at 162p - bring it on . . . but one has to wonder why the US DoH entrusted a British Company to develop such a go-er (my words), when the US is full of folks willing to promote small co's start-ups and the like?
Somehow it doesn't ring right, - but am willing to listen.
Sp today abt 7p

However, to pay for their Trials it seems they've granted 7m Options to a US-Medico (DYOR) which can buy oodles of shares at 4.5p until c.2017 as I read it. This must be an anchor to the sp which has fallen massivly from £1 only a short while ago.

Moditope Vaccine Technology Platform

Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, today announces the development of a new platform technology (ModitopeÔ) that stimulates the production of killer CD4 T cells with powerful anti-tumour activity. The Directors believe that this new discovery could have a profound effect on the way that cancer vaccines are developed.

TRADE SALE STILL ON NEXT YEAR

Scancell (SCLP) has announced its new technology platform will not alter its intention to sell next year.

AIM-quoted cancer vaccine specialist Scancell Holdings (SCLP) has announced its development of a new platform technology - Moditope - that stimulates the production of killer CD4 cells with powerful anti tumour activity. Joint chief executive officer Lindy Durrant commented that this new discovery could have a 'profound effect' on cancer vaccine development in the future.

The new venture follows Scancell's successful ongoing clinical trial of SCIB1, another cancer vaccine, which was developed using the company's groundbreaking ImmunoBody technology platform. This vaccine is currently being developed for the treatment of melanoma and is in Phase 2 clinical trials.

What the company intends to do with its latest discovery is an interesting topic. Fellow chief executive Richard Goodfellow admitted the directors 'have to sit down with the shareholders' to discern what the best strategy is. He added that in no way was this 'chance finding' going to derail the company's intention to look for a buyer late next year.

Plans might include creating a separate company which is purely responsible for raising funds and driving through Moditope to trial. 'It's a nice problem to have' Mr Goodfellow concluded, but reinforced that the company was committed to finding the 'greatest value' for shareholders.

Over the last year Scancell's share price has spiked from a 52 week low of 4.5p to a high of 28.7p. They are currently trading at 25.88p.

Source:

http://www.growthcompany.co.uk/news/2116623/scancell-still-to-sell.thtml

Up another 30% today.

Hmmm....'chance finding'.....Viagra was a chance finding.

Rodders

20 August 2012

Scancell Holdings Plc

('Scancell')


Market Update


The Board of Scancell (AIM:SCLP) have noted the continuous raise in its share price over the last 10 days and in particular following the announcement on 15 August 2012 relating to the Moditope vaccine technology platform.

The Board is actively evaluating its strategic options for the Moditope platform and will be consulting with key shareholders in this regard. As regards SCIB1, the cancer vaccine being developed for the treatment of melanoma and the Company's DNA ImmunoBody(R) vaccine technology upon which it is based, the Board reiterates that its strategy will be to seek a buyer on completion of the Phase I/II clinical trial, which is expected in late 2013.

The Board will update the market in due course.

-ENDS-

Duplicate!

Well done to all in this one

Helium Special Situations Fund Limited from 6.88% to 5.87%.

Scancell Holdings a biopharmaceutical company focused on the cancer therapeutics market, and the third-most popular 'buy' by TD Direct Investing's retail clients this morning. The shares are up 10% as I write these words, with bulletin board traffic -- as opposed to hard news or company statements -- the apparent cause.

That said, the shares are up 750% (yes, you read that right) this year, so investors will need to be confident that enough upside remains. Me?

Well this has had a roller coaster of a day for sure...

Scancell's amazing rise continues - UPDATE
Mon 08 Oct 2012

SCLP - Scancell Holdings

Latest Prices
Name Price %
Scancell Holdings 53.25p +4.41%

FTSE AIM All-Share 702 -0.72%
Pharmaceuticals & Biotechnology 9,833 -0.56%

LONDON (SHARECAST) - Scancell, the developer of therapeutic cancer vaccines, continued its amazing price rise in early morning trade on Monday to become a 10-bagger in only a few months.

It has apparently been propelled by hopes its news technology platform for anti-cancer vaccines, called Moditope, will be able to successfully produce an anti-cancer vaccine that destroys tumours without toxicity.

David Lowery, equity analyst at Faraday Research told Digital Look that the development was “potentially ground-breaking” and that “If the discovery is as big as it sounds the shares are potentially worth several pounds.”

Canny investor David Newton, from the Helium Special Situations fund, has been a long term holder of the company and has a stake of 6.88%.

In mid-morning trade the shares stood at 59.5p, up 16.67% on the day. The share price is now 80% higher over the past month and up a whopping 1,000% over the last year.

Yeah...that good....:-)

Final Results

Highlights during the period:

· In July 2011, Scancell raised £1.58 million, net of expenses, by way of a placing of new shares

· New lung cancer vaccine, SCIB2 - latest anti-tumour results in animal models provide further validation of ImmunoBody® vaccine technology platform and its commercial potential

· In November 2011, received milestone payment from Arana Therapeutics of £2.49 million net of costs

· Completion of recruitment to Phase 1 of the clinical trial for SCIB1 in April 2012

· Profit for the year of £557,058 (2011:loss £1,649,225)

· Cash at year end £3,529,007 (2011: £1,110,630)

Post period highlights:
· On 15 August, 2012 Scancell announced the development of a new platform technology, ModitopeÔ, that stimulates the production of killer CD4 T cells with powerful anti-tumour activity.

Share Nominees Ltd > 9%

SCIB1 Trial-Higher Dose Allowed in Phase 1/2 Trial

Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that the Gene Therapy Advisory Committee ('GTAC') and the Medicines and Healthcare products Regulatory Agency ('MHRA') Medicines Division have given their approval to dose an extra group of patients with a higher, 8 mg, dose of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma.

The new cohort will recruit up to six more patients and will be recruited in parallel with the patients being recruited into Part 2 of the study. Patients with metastatic tumour present may enter the new cohort so that their tumour response can be assessed, whereas patients who have had their tumours surgically removed may enter Part 2. In addition, Scancell's partner Ichor Medical Systems ('Ichor') has obtained the required parallel approval from the MHRA Devices Division for the use of Ichor's TriGrid™ electroporation delivery device to administer SCIB1 to this additional group of patients."

Scancell is planning to start treating patients with the 8mg dose in the new year.

Update on patient recruitment in clinical trial

Update on patient recruitment in the ongoing SCIB1 clinical trial


Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, today announces the recruitment and treatment of the final patient in the second part of its Phase 1/2 clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. This part of the trial is being conducted in five UK centres in patients with Stage III/IV disease to further assess the safety of treatment and to assess the cellular immune response induced by SCIB1. Patients are being treated with a 4mg dose of SCIB1 on five occasions over a period of 6 months.

In December 2012, Scancell released preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma. Also in December 2012, Scancell announced that the Gene Therapy Advisory Committee ('GTAC') and the Medicines and Healthcare products Regulatory Agency ('MHRA') Medicines Division had given their approval to dose an extra group of patients with a higher, 8 mg, dose of SCIB1. Scancell is planning to start treating patients with the 8mg dose shortly.

Half Yearly Report

Highlights

· Encouraging preliminary results from Part 1 of the Phase 1/2 clinical trial for SCIB1 announced in December 2012

· First evidence that the vaccine is producing an immune response in cancer patients which may also be associated with clinical benefit

· Approval received to dose an extra group of patients with a higher, 8mg, dose of SCIB1

· Recruitment and treatment of the final patient in the second part of its Phase 1/2 clinical trial of SCIB1

ImmunoBody® Patent Approved for Grant in Japan.

Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, is pleased to announce that a patent for its protein ImmunoBody® vaccine technology has been approved for grant in Japan. The patent has already been approved in the US, Europe and Australia.

SCANCELL CHALLENGES THE NINE HUNDRED

Currently there are around 900 cancer vaccines in various stages of clinical trials. These 900 candidates represent a series of diverse approaches to the production of therapeutic cancer vaccines. Some include genetically engineered oncolytic viruses. Some include entire immune system transplants. Some include cancer antigens extracted from patients' urine, purified and mixed with alum. Some try to get away with a single antigen to treat all types of cancer; the so called universal approach. And some mix cancer antigens with the pulverized cell walls of bacteria to spark an immune response that way. But it is widely acknowledged that the most effective therapeutic cancer vaccines so far have been those which get patients' dendritic cells to absorb or retain on their surface cancer antigens specific to the particular cancer being treated. Scancell makes these latter kind of vaccines, called dendritic cell vaccines.

To date a number of companies have demonstrated that they can target dendritic cells ex vivo (outside the patient's body; having extracted them from the patient first) but only Scancell has been able to produce vaccines capable of targeting dendritic cells in vivo (while they are still in the patient's body).

So far only one company's vaccine has been approved by the FDA for commercial use. This company is the Dendreon Corporation and their vaccine is of course a dendritic cell vaccine. But it has one severe limitation. It can only target dendritic cells ex vivo by extracting them from each patient, before treating the cells for reinfusing back into the same patient again; a process which is inconvenient and prohibitively expensive. Scancell's one batch treats all approach therefore poses a serious threat to Dendreon's dominance of the global therapeutic cancer vaccine market. Hence the remarkable growth of Scancell's share price.

This is what Scancell says about its technology:

"A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive."


Research link:
http://www.scancell.co.uk/Apps/Content/html/?fid=6

SCANCELL SPELLS OUT THE LIMITATIONS OF ITS RIVALS

Cancer vaccines represent a highly attractive approach to cancer therapy. In contrast to current treatments such as chemotherapy and radiotherapy, small non-toxic doses of a vaccine may be administered to a patient to stimulate an immune response. It is generally accepted that to be effective against cancer, a vaccine needs to target dendritic cells to stimulate both parts of the cellular immune system; the helper cell system (known as the CD4-mediated response) which stimulates inflammation at the tumour site; and the cytotoxic T-lymphocyte or CTL response (known as the CD8-mediated response) in which cells of the immune system are primed to recognise and kill specific cells.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive.

Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome the present limitations of cancer vaccines.

Research link:
http://www.scancell.co.uk/Apps/Content/html/?fid=6

SCANCELL'S SKIN CANCER VACCINE TRIAL RESULTS

Here is a useful and informative post from Alan Turing, a poster with a good scientific background who writes on LSE's Scancell Chat. He is commenting on the recent Phase 1 results for Scancell's lead vaccine to treat melanoma, SCIB1:


PHASE 1 PRELIMINARY RESULTS

Well they were pretty astonishing really. Firstly because they were only measuring a group of patients in a study to test for toxicity, so there were only a few patients who actually received the vaccine at full strength.

The key 'stand out' was the tumour shrinkage in the patient with lung metastases. Dendritic cell vaccines have never before shrunk tumours without a toxic additive. Gp100 for instance was the first dendritic cell vaccine that was said, with much fanfare, to shrink tumours but only with the addition of the highly toxic Interleukin 2 (which defeats the purpose of using a non-toxic dendritic cell vaccine in my book). But previously without this additive Gp100 showed no signs of being able to shrink tumours. This is the most important achievement so far by SCIB1. It now has to repeat this in the proposed 8mg dose trial. If this tumour shrinking capability is confirmed then SCIB1 will have outdone all previous dendritic cell vaccines.

This extra power may be a result of its DNA delivery. The ImmunoBody vaccine consists of strands of DNA which are like a computer program. This DNA program is processed by the patient's healthy cells very much like a computer. Tens of thousands of antibodies are produced by the patient as instructed by Scancell's DNA program. Each antibody is shaped like a Y and on one of the arms of the Y is a 'pretend' cancer chemical unique to the cancer being treated. These antibodies, which in SCIB1's case, 'smell' like melanoma, stick to the surface of the immune system's sentinel cells (dendritic cells). They go crazy. To them they are covered in a foreign material that should definitely not be there. They then charge in their thousands to warn the immune system that something foreign has entered the body that needs to be searched for and destroyed. The immune system's army of T cells is dispatched. First the sappers, the Helper T-cells. They find the tumours and mark out a killing zone and change the blood chemistry inside this zone to make the tumours easier to kill. Then come the commandos, the Killer T-Cells to burst and destroy the tumours there.

This is so far ahead of what Dendreon does, Scancell's main competitor, that I suppose its no wonder that it achieved these promising results, albeit in just one particular patient. All eyes should be on the upcoming 8mg tumour trial, because so far, apart from its non-patient specific capability, the ability to shrink and eradicate tumours unaided is Scancell's most thrilling achievement. They have the pharmaceutical industry's attention for sure. Now they must show that they can repeat this success. I'm looking forward to the next instalment.

The market potential for dendritic cell vaccines is considerable. Scancell's vaccine is the only DNA (non-patient specific) version that has been shown to elicit an immune response. So if I was a buyer for a large pharmaceutical company looking for a dendritic cell vaccine to enter that sector of the market I would definitely choose Scancell's product first. The ability to shrink tumours is a unique one among this class of therapuetics so whatever this vaccine achieves on that front would be a bonus.

Bullrunner - thanks for the above post.

I looked at DNDN last summer before deciding to opt for SCLP - the former are also on a bit of a run recently and are ISA'ble.

SCANCELL'S RISE IS DENDREON'S DOOM!

The Dendreon Corporation is the one and only global leader in therapeutic cancer vaccines. The technology they use requires extracting immune system alarm cells (dendritic cells) from the patient's blood, pulsing them with cancer antigens and injecting them back into that same patient. This has proved prohibitively expensive. Scancell therefore designed an alternative solution and has provided the industry and the regulatory authorities with a more commercially viable product: a DNA dendtritic cell vaccine which coats the alarm cells with epitopes of cancer antigens while those alarm cells are still in the patient's body. This provides a solution with no rejection problems and can therefore be given to any number of patients without having to manufacture a fresh batch.

Dendreon's Provenge, to treat prostate cancer, is the first and only therapeutic cancer vaccine commercially approved to date but the business model behind it is fatally flawed and the industry knows it. The treatment is simply unaffordable. So as Dendreon's stock has plummeted, Scancell's stock has risen, making Scancell London's best performing stock of 2012. Without doubt Scancell remains the most significant ongoing threat to Dendreon's dominance.

Research link:
Scancell's ImmunoBody® Vaccines

SELLING THE KEYS TO THE KINGDOM

Scancell has a very simple strategy. Produce a better cancer vaccine than the global leader and sell Scancell on to the highest bidder by the end of the year.

So far only one company has had a therapeutic cancer vaccine approved for commercial use by the FDA. The Dendreon Corporation. Dendreon is therefore the one and only global leader in therapeutic cancer vaccines. But each treatment uses the blood of the patient to prepare it, so because of rejection, can only be given to one person at a time. This is inordinately expensive. So Dendreon's business model has proved to be fatally flawed with each course of treatment costing more than $90,000!

Scancell has found a way round this. It has patented a technology capable of providing the same treatment without having to extract the patient's blood first. Scancell's DNA vaccine can be given to any number of patients from the same batch so is therefore more cost effective, leaving plenty of room for profit.

In other words Scancell has found a short cut to becoming 'King of the Hill.' Whoever buys Scancell and brings its vaccines to market will become straight away the global leader of the cancer vaccine market. That's what's on offer. The keys to the kingdom. And in the expected bidding war to come, that's what will be fought over.

The Intellectual Property of Scancell's skin cancer vaccine, SCIB1, alone has been valued at a billion dollars! But Scancell's DNA vaccine technology allows its vaccines to be reprogrammed to treat different cancers. In fact, any kind of cancer. Indeed its already started the ball rolling for whoever buys Scancell by pre-preparing a second vaccine to treat lung cancer.

The industry will pay at least £12 a share (around $4 billion) for Scancell's existing vaccines in combination with its reprogrammable vaccine platform. They wont be able to resist it. If a company doesn't buy Scancell they hand over to the competition the top global position in cancer vaccines for a generation. A wise person will know that no pharmaceutical company can stand by and let that happen! Four billion dollars will prevent such a disaster. For they will fight like dogs to get Scancell. And as they do, its shares will rise and rise. In the end they could climb even higher than £12.



Research link:
Scancell's ImmunoBody® Vaccines

Scancell reveals plan to target rival's lead vaccine

Its no secret that Scancell has rival manufacturer Dendreon firmly in its sights. Dendreon holds the coveted position as leader of the therapeutic cancer vaccine market but not for long if Scancell has its way.

Dendreon has been a true trail blazer and its founders were the brains behind the only type of therapeutic cancer vaccine to get commercial approval by the FDA, the dendritic cell vaccine. Non-toxic and cleverly marshalling the patient's own immune system to fight off the disease, they thought they had it made when their first vaccine to treat prostate cancer entered the market place. Their science which used the immune system's sentinels, the dendritic cells, to alert the immune system to the presence of cancer was truly ground breaking but the technology they devised to produce their vaccine was simply uneconomic. Patients had to have their blood collected and sent off to Dendreon so their dendritic cells could be extracted, primed with cancer proteins to allow the immune system to identify and hunt down the cancer and returned for re-infusing back into the patient again. So every batch had to be 'tailor made' for just one patient! It cost the proverbial arm and a leg. $93,000 for a course of treatment that never really worked at its best because of the damage the patient's dendritic cells suffered in the process.

But the real nightmare for Dendreon began when Scancell came up with an alternative dendritic cell vaccine that didn't need patients' blood to make it. In fact Scancell's vaccine actually coated a patient's dendritic cells with cancer proteins while they were still in the patient's body; outdoing Dendreon's expensive 'one patient at a time' vaccine with one that could be mass produced to treat millions of patients from a single batch!

Scancell has achieved this by designing a DNA cancer vaccine called ImmunoBody that instructs the patient's own cells to produce special antibodies which mimic cancer proteins and stick to the surfaces of the patient's dendritic cells. The alarm is raised and the immune system seeks out and destroys the cancer these special antibodies are mimicking. Scancell's vaccine is also re-programmable, enabling it to target any kind of cancer by simply altering its DNA program to cause the production of antibodies that mimic the proteins of a different type of cancer.


The conference that time forgot
As far as most commentators knew Scancell was working on just two ImmunoBody vaccines, SCIB1 to treat melanoma, which is currently in Phase 2 clinical trials and SCIB2 to treat lung cancer which is now ready for trialling. So until last weekend, Dendreon could have comforted itself with the notion that Scancell was swimming in its neighbours' pools. But owing to the diligent research and dogged inquiry of a poster on London South East Scancell Share Chat, Inanaco, Scancell has revealed that they are working on a new ImmunoBody vaccine to treat prostate cancer as well! This has to be Dendreon's worst nightmare.

This astonishing news was initially 'leaked,' but went largely unreported, in a 15 minute presentation at the 12th International Conference on Progress in Vaccination Against Cancer (PIVAC) on Wednesday 12th September 2012. The paper entitled, "Development of new prostate cancer vaccine strategies using PAP as target antigen," described a collaborative project between Scancell and researchers at Nottingham Trent University.

The paper doesn't mince its words. It makes it abundantly clear that the intention is to use Scancell's ImmunoBody DNA vaccine technology to make a mass market successor to Dendreon's only commercial product, its prostate cancer vaccine Provenge. SCIB3, as it will no doubt be called, will encode epitopes from the same antigen used in Provenge. But even more alarmingly for any of Scancell's competitors in the prostate cancer field, Scancell seems to be preparing a prophylactic prostate cancer vaccine as well, intended to prevent the disease developing in the first place. And if you don't think that Scancell are serious about this just take a look at what Professor Lindy Durrant said about Scancell's SCIB 1 vaccine as long ago as May 2010:

"In the short term, this could cure some patients with the disease, and in the long term it could be used to prevent people developing it in the first place."


A weekend of revelations
Having come across the above research in PIVAC's conference program, Inanaco sent an email to Scancell seeking clarification of their apparent intentions to develop a vaccine to treat prostate cancer. These intentions were then confirmed in an email from the company which was then posted by Inanaco on London South East's Scancell Chat last Sunday afternoon at 16:10. It read:


Hi *****

You certainly are diligent in your research!! This is early stage research on a possible new ImmunoBody for prostate cancer. We also have several others in development but do not normally make any announcements until we have developed the vaccine to the point where it is sufficiently advanced to be considered a candidate already ready for clinical development (such as SCIB2)

Kind regards

Richard


So Dendreon, you have been warned, but there is precious little you can do about it anyway. Scancell is technologically so far in advance of any other company producing dendritic cell vaccines that its competition might be best advised to prepare for the inevitable. What's that I hear, "Scancell's just a tiny British company with a few million dollars in the bank?" Think again, at the end of this year Scancell is going to be offered up for sale to the highest bidder. The directors have already told the press that they have been approached by suitors so its only a matter of time until the big boys get hold of Scancell's breakthrough DNA technology. Then it really will be curtains for Dendreon.







Research link:

Latest interview by ceo richard goodfellow on 27th feb 2013 at the frankfurt stock exchange, uploaded 7th march 2013.

http://www.youtube.com/watch?v=E-J5J7bBQDs

Scancell welcomes new study in The Journal of Clinical Investigation suggesting that melanoma switches off the immune system


Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, would like to alert shareholders to the recent article "IgG4 subclass antibodies impair antitumor immunity in melanoma" in the peer reviewed cancer journal: The Journal of Clinical Investigation, published on 1 March 2013.

The new study published in The Journal of Clinical Investigation supports earlier studies by King's College London that indicate that patients with the cancer, malignant melanoma, appear to elicit a weak antibody response to the tumour cells which appears to be relatively ineffective in combating the cancer and which may in effect switch off the immune system.

This study indicates that patients with malignant melanoma initiate a B cell immune response to produce an antibody called IgG4. IgG4 is considered a "weak" subclass of antibody and is thought to inhibit the production of other stronger antibodies such as IgG1, actually protecting the tumour cells from a more effective and aggressive attack from the patients' immune system.

Scancell's melanoma cancer vaccine SCIB1, which is currently in Part 2 of a Phase I/II clinical trial, works by activating the immune system through T cells rather than B cells. The Board believes that T cell activation is a more effective approach to treating patients with an immune system compromised in the manner found in those with malignant melanoma.

Dr Richard Goodfellow, joint Chief Executive Officer of Scancell, comments: "We believe that The Journal of Clinical Investigation paper supports Scancell's approach to fighting cancers, such as malignant melanoma, where T cell activation appears to be the more effective route of combating this often fatal disease. Results from our Phase I/II clinical trial are expected at the end of this year."


-ENDS-

Appoints Peter Allen as Non-Executive Director

Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines, today announces that Peter Allen, ACA, has been appointed to the Board as Non-Executive Director, with immediate effect.

Peter has had a distinguished career in the life sciences industry. A chartered accountant by profession, he has held key senior positions in a number of companies, playing a significant role in their development. His experience extends to overseeing and orchestrating fundraisings, restructurings, acquisitions and IPOs. Peter has also had extensive M&A experience including the acquisitions of Chiroscience, Medeva and Oxford Glycosciences during his 12 year tenure at Celltech as CFO and Deputy CEO, which concluded in its £1.5 billion sale to UCB in 2004. More recently, as Chairman at Proximagen, Peter played a fundamental role in its acquisition by Upsher-Smith Laboratories for £357 million in 2012 and whilst Chairman and interim CEO of Prostrakan, he oversaw the sale of the Company to Kyowa Hakko Kirin for £292 million in 2011.

Peter is currently Chairman of Clinigen PLC, Chroma Therapeutics Limited, ProStrakan plc and Future plc and a non-executive Director of Oxford Nanopore Technologies Limited.

Strong today on reasonable volume.

Are we already in play??????

Posted by Puritas on a competitors bb....

Although Scancell plans to sell to the highest bidder in six months time will bidders wait that long?

When my cupboards bare I go out to the supermarket to stock up, no messing!

Big Pharma's out of patented stock and they ain't messing either!

Two Scancell sized companies have been snaffled up in the space of six days! On June 11th AstraZeneca nabbed Pearl, for its obstructive lung disease inhaler, fresh out of Phase II. Then on June 17th Johnson & Johnson acquired Aragon Pharmaceuticals for its lead drug to treat prostate cancer still in Phase I/II.

Pearl got a $1.15 billion deal for a single drug to treat just one type of lung disease and Aragon got its billion dollar deal for its androgen receptor inhibitor that's no further along the line than Scancell's SCIB1 vaccine is now!

Clearly the big boys don't wait for an invite to come knocking. And when time is such serious money for big pharma, six long months of lost future sales may be a spur to immediate action.

Alls peaceful, as tactics are discussed at Scancell manor.
Then an ear shattering, "RAT TAT TAT TAT!"

Yes, that Scancell sized company on next week's shopping list might very well be Scancell itself. And Scancell has a darn sight more product to fill up big pharma's trolley than either Pearl or Aragon could offer!

Rodders

Trying to stay above 50p having hit 6 month+ highs.

Final Results

Highlights during the period:

· Successful completion of Part 1 of the SCIB1 Phase 1/2 clinical trial
· Part 2 of the SCIB1 Phase 1/2 clinical trial fully recruited and on track for completion by the end of 2013
· Additional 8mg dose study underway, also expected to be completed by the end of 2013
· Development of new Moditope™ platform
· Strengthened IP with patents awarded in the US and Japan for protein Immunobody® technology platform
· Peter Allen appointed as a Director

Post period highlights:

· Placing and Open offer up to £6.5 million (announced today)

Proposed Firm Placing and Open Offer

oopps sp down 43%, yet another bio stock going down the drain.

h, I think it's because of the placing of new shares at a heavily discounted price (22.5p).

"Scancell Holdings plc (AIM:SCLP), the AIM-quoted developer of novel immunotherapies for the treatment of cancer, is pleased to announce a conditional Firm Placing and Open Offer to raise up to £6.5 million (before expenses) to enable the Company to commence work on the pre-clinical development of the first Moditope™ immunotherapy product, provide working capital for the completion of the Phase 1/2 SCIB1 clinical trial and for the recruitment of a further ten patients on the 8mg dose. As previously announced the Company expects to announce the preliminary results of the Phase 1/2 trial (excluding the patients on the 8mg dose) by the end of 2013.

The Company announces a conditional Firm Placing of 20,000,000 new Ordinary Shares at 22.5 pence each to raise gross funds of approximately £4.5 million by a means of a Firm Placing with investors in various EIS and VCT funds managed by Calculus Capital. In addition, and in order to provide Qualifying Shareholders with an opportunity to subscribe for new Ordinary Shares at the same price, the Company announces a proposed Open Offer to raise up to a further £2.0 million (before expenses)."

Its in the link in post 35.

Yes, that's where I got the info from, but not great news for existing shareholders, though may be worth a punt for new investors as the sp drops towards the placing price, if you consider that SCLP usually trades around the 35-50p range.
I don't usually invest in biotech Co's as the sp rise or fall will be totally dependent on the results of the various trial stages. A bit like investing in wildcat oil exploration!

Sorry Harry - I missed the from my post above.

The big thing is that it had been intimated that the company would be sold as early as the end of the year - that is obviously now delayed/not going to happen.

So another one in the SIPP bottom drawer!

But may be worth buying more at 22.5p?

For existing holders (me), its only a 1 for 22 held, I think 1 for 10 would have been about right.

I'm hoping to buy a few below 22p or maybe not at all - there is now (for me) uncertainty.

Research Update


SCIB1 8mg Study Update


Scancell Holdings plc, ('Scancell' or the 'Company') the developer of novel immunotherapies for the treatment of cancer, was informed on 11 July 2013 that one of the three patients recruited into the higher 8mg dose study of SCIB1 will no longer be eligible for evaluation due to delivery of an incomplete dose of SCIB1 following a fault with the electroporation device for that patient. Scancell will recruit a replacement patient as soon as possible in order to complete the initial phase of the 8mg study which is to assess the safety and immune response produced by the 8mg dose prior to expanding the study to include a further ten patients as planned. The initial part of the study is now expected to be completed early next year.

The higher 8mg dose SCIB1 study has been implemented for two reasons:

· Firstly, one of the goals of Part 1 of the Phase 1/2 study was to establish a "maximally tolerated dose" of SCIB1 for use in Part 2. As there were no drug related side effects observed at 4mg, a maximally tolerated dose was not reached and a higher dose could improve the immune response even further.

· Secondly, we were pleased to see a significant effect on tumour burden in one late stage patient in the Part 1 study. The Part 2 study, however, is primarily designed to assess immune response in resected Stage 3 patients and although we will be monitoring the time to disease progression, we will not be able to measure an effect on tumour size. The extended study using the 8mg dose will be in patients with tumour load and will therefore provide the opportunity to assess whether we can reproduce the valuable data reported from Part 1 in an additional group of patients and at a higher dose.

Listen - Scancell Holdings - Company update

AUDIO INTERVIEW WITH SCANCELL HOLDINGS

Director Shareholding

Result of Open Offer

The Open Offer has now closed in accordance with its terms and Scancell is pleased to announce that the Open Offer was oversubscribed. The Company has received valid acceptances from Qualifying Shareholders in respect of 8,888,888 Open Offer Shares, representing 100 per cent. of the Open Offer Shares available under the Open Offer. In accordance with the terms and conditions of the Open Offer all applications made pursuant to the Open Offer (other than Excess Shares applied for under the Excess Application Facility) have been met in full and a scaling back exercise has been undertaken in respect of applications for Excess Shares. The Company has therefore raised gross proceeds of approximately £2 million through the Open Offer.

Reyker Nominees Limited (Calculus Capital Limited a/c EIS Fund) Investec Structured Products Calculus VCT plc > 18%

Looks like @60% allocation.

Inclusion on Frankfurt Stock Exchange

Scancell Holdings plc, ('Scancell' or the 'Company') the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that the Company's ordinary shares have been included on the Quotation Board of the Open Market of the Frankfurt Stock Exchange with effect from today. Scancell has appointed ACON Actienbank AG as Listing Coordinator for providing the quote on the Borse Frankfurt (Frankfurt Stock Exchange) under the symbol "SCP".

The compliance listing is in addition to Scancell's existing listing on the AIM market of The London Stock Exchange.

DNA ImmunoBody® Patent Granted in first market

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that a patent for its DNA ImmunoBody® technology has been granted in Australia. This is the first jurisdiction to approve the DNA patent and is a key landmark on the road to comprehensively protecting Scancell's DNA ImmunoBody® platform technology.

The patent, which covers the DNA ImmunoBody® platform technology and is of importance for the protection of Scancell's entire pipeline of ImmunoBody® vaccines, has also been filed in the US, Europe and other major markets. The composition of matter patent for SCIB1, Scancell's ImmunoBody® vaccine for the treatment of melanoma, has already been granted in Europe, Turkey and South Africa.

Scancell's protein ImmunoBody® patent has been approved in the US, Europe, Japan and Australia.

Dr. Richard Goodfellow, Joint Chief Executive of Scancell, commented:

"Our lead ImmunoBody® for melanoma, SCIB1, currently in Phase I/II clinical trials is based on the DNA approach. The approval of this DNA patent is therefore a very important step in the development and commercialisation of our ImmunoBody® platform. Scancell continues to build its growing portfolio of intellectual property in parallel with advancing the clinical trial programme on SCIB1."


-ENDS-

Investor Update

They are obviously investing a lot of time in explaining to investors what it is they're doing. Nice to see that Investor Day interview with CEO

Re Agreement with Ichor

Extension to Ichor Commercial Option and Issue of Equity


Scancell Holdings plc, ('Scancell' or the 'Company') the developer of novel immunotherapies for the treatment of cancer is pleased to announce that it has been granted an extension of its option to commercialise Ichor's proprietary Trigrid™ electroporation delivery system with SCIB1, Scancell's ImmunoBody® vaccine for the treatment of melanoma. Under the terms of the extension, Scancell's option, which had been due to expire in July 2014, will be extended until July 2016. In exchange, Scancell has agreed to waive the two year lock period following the exercise of Tranche 1 share options (over 1,592,310 shares).

The agreement with Ichor, signed in July 2009, provides for the supply and use of the TriGrid™ device for Scancell's pre-clinical and clinical studies with SCIB1 and gives Scancell an option (the "Option") to license TriGrid™ for commercial use on payment of certain undisclosed milestones and royalties. The Option could be exercised at any time up to July 2014. In return, Ichor was granted share options to subscribe for Scancell shares at a subscription price of 4.5p as follows: on regulatory approval to start clinical trials in the UK, 1,592,310 share options ("Tranche 1); on starting the first Phase II clinical trial, 3,184,620 share options ("Tranche 2); and on completing the first Phase II clinical trial, 3,184,620 share options ("Tranche 3"). Tranches 1 and 2 have already vested.

On 15 November 2013 Ichor exercised Tranche 1 of the share options. Following this exercise the Company has applied for 1,592,310 ordinary shares to be admitted to trading on AIM ("Admission"). It is expected that Admission will become effective and that dealings will commence in these Ordinary Shares at 21 November 2013.

Following admission of the 1,592,310 new ordinary shares the Company's share capital will consist of 224,950,683 voting ordinary shares.

The above figure (224,950,683) may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, Scancell under the FCA's Disclosure and Transparency Rules.

Richard Goodfellow, Joint CEO of Scancell, said:

"Ichor's proprietary TriGrid electroporation delivery system is central to our current studies on SCIB1. We are delighted to have extended the option agreement to commercialise the technology with the Company beyond July 2014. It enables us to continue to evaluate its potential to effectively deliver our vaccine now that we have decided to expand the Phase1/2 clinical trial on SCIB1 to include a further 13 patients on an 8mg dose and the need to continue treating patients being placed on long term maintenance therapy."

SUNDAY TIMES LEAKS TRIAL SUCCESS

A new article published in today's Sunday Times leaks the success of Scancell's SCIB1 vaccine trials ahead of Phase 2 results expected this week. The author, Mathew Goodman, suggests that Scancell, on the back of these results, may either seek to license the vaccine to big pharma to fund its further development or sell the company outright to allow the buyer to take the product forward.


BOFFINS IN SKIN CANCER SUCCESS:

hxxp://www.thesundaytimes.co.uk/sto/business/Tech_and_Media/article1349860.ece

Half Yearly Report

Highlights during the period:
· Recruitment of 8mg dose patient cohort continues as part of the previously announced extension to Part 1 of the Phase1/2 study of ImmunoBody® vaccine, SCIB1 in patients with advanced melanoma
o Data anticipated by 2014 calendar year end
· Planning for preclinical and clinical development of Modi-1, lead pipeline vaccine from Moditope® platform underway
o Provisionally positioned as a novel immunotherapeutic for the treatment of triple-negative breast cancer, ovarian and endometrial cancers
o First in-man clinical studies are scheduled to start in 2016
· Australia becomes first jurisdiction to grant DNA ImmunoBody® technology patent. Counterpart pending in major territories around the globe
· Operating loss for the period, £1.31m (2012: loss of £0.99m). Net loss £ 1.19m (2012: loss £0.92m)
· Cash at bank at 31 October 2013 was £6.40m (30 April 2013: £1.49m), following a Placing and Open Offer of shares in August that raised £6.09 million (net of expenses)

Post period highlights:
· Important positive data from Part 2 as well as an update from Part 1 of the on-going Phase 1/2 clinical trial with SCIB1 in patients with Stage III/IV melanoma were announced today (see separate announcement)
o Melanoma-specific immune response seen in all Part 2 patients
o Continuing positive survival trend in Part 1 subjects, although patient numbers are small
o No serious adverse events reported
· Scancell granted an extension of the Option to commercialise Ichor's proprietary Trigrid™ electroporation delivery system with SCIB1

New data for SCIB1 in metastatic melanoma

Highlights

Part 2 study results
· All 14 study patients produced a melanoma-specific T-cell response to treatment
· All patients are still alive; only three patients have any evidence of disease progression
· Median survival time of Part 2 patients since initiating treatment is currently 15 months; 21 months since diagnosis of metastatic disease
· Six patients are continuing on extended, long-term treatment with SCIB1
· SCIB1 therapy was well tolerated with no reports of serious drug-related side effects in line with results reported from Part 1 of the study

Part 1 study update
· The four patients who were alive at the time of the initial Part 1 report (December 2012) remain alive
· Median survival time in Part 1 patients who received at least three treatments with the 2mg/4mg doses of SCIB1 is now 25 months

LISTEN: Scancell Holdings (SCLP) - Compelling new immune response data

Click here

DNA ImmunoBody® Patent Granted in Japan

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that a patent for its DNA ImmunoBody® technology has been granted in Japan. This key patent follows approval in Australia earlier this year and adds to Scancell's growing body of intellectual property for its ImmunoBody® platform. Scancell's protein ImmunoBody® patent has already been approved in the US, Europe, Japan and Australia.

Dr. Richard Goodfellow, Joint Chief Executive of Scancell, commented:

"This Japanese approval is an important addition as we continue to build a comprehensive IP portfolio for our ImmunoBody® platforms. With the positive results from our SCIB1 study announced earlier this week and the progress we are making on our Moditope® programme, IP plays an increasingly important role in the value ascribed to Scancell's technology. We look forward to building on the momentum of Scancell's progress in 2014."

SCIB1 Granted FDA Orphan Drug Status

Scancell Holdings Plc, (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that the United States Food and Drug Administration ('FDA') has granted orphan drug designation to its SCIB1 ImmunoBody® ('SCIB1') for the treatment of metastatic melanoma.

Orphan drug status in the United States qualifies the development of SCIB1 for a 50% tax credit for clinical trials, a waiver of the prescription drug user fee for the drug approval procedure and a period of seven years of market exclusivity following drug approval by the FDA. During the orphan market exclusivity period, the FDA cannot approve a NDA (new drug application) or a generic drug application for the same product including the principal molecular structure features of the drug and for the same rare disease indication.

The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the US, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.1

Richard Goodfellow, Joint CEO of Scancell, said: "The grant of orphan drug status gives SCIB1 further protection in our key US market in addition to our patent portfolio. We also welcome the financial incentives afforded by such a designation. Following encouraging data from Part 2 of our SCIB1 Phase I/II trial announced in December, development work continues apace and we look forward to disclosing data from additional patients receiving the 8mg dose in due course. "

Publication of Moditope® Patent

Scancell Holdings Plc, (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce the publication of the patent application underpinning the Company's Moditope® platform. When granted, this patent will protect the platform to at least 2033.

The patent application, describes how the Moditope® immunotherapy platform harnesses CD4+ T cells to eradicate tumours. Moditope® deploys certain tumour-associated peptide epitopes as immunotherapeutic agents to overcome self-tolerance and eradicate tumour cells, with no requirement for blockade inhibitors. Planning is underway for the manufacture, preclinical testing and first-in-man clinical development of the Modi-1, the first Moditope® immunotherapeutic. The PCT patent application which has a priority date of 7 August 2012 was published on 13 February 2014 as WO2014/023957.

Prof. Lindy Durrant Professor of Cancer Immunotherapy at the University of Nottingham and Joint CEO of Scancell, said: "The publication of the patent application is another important milestone in the development of a range of novel immunotherapeutics from the Moditope® platform. Recent data suggests that Modi-1 may exhibit potent anti-tumour effects even against established aggressive tumours, dramatically improving survival rates. We look forward to a busy and exciting year in which we continue to prepare Modi-1 for clinical trials which are on schedule to start in early 2016."

8mg Higher Dose SCIB1 Study On Track

8mg Higher Dose SCIB1 Study On Track


Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce completion of patient dosing with 8mg of SCIB1 ImmunoBody® ('SCIB1') in Part 1 of its on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma.

Following preliminary evidence from Part 1 of the study showing that a 4mg dose of SCIB1 produced an immune response that might be associated with clinical benefit in patients with malignant melanoma, regulatory approval was obtained for treating a cohort of up to six patients with a higher, 8mg dose of SCIB1. Five patients with metastatic tumour present have been recruited and dosed, with no reported drug or device-related serious adverse events. Immunology and clinical responses in this higher dose cohort of patients are currently being analysed and will be reported by the end of Q2 2014.

Regulatory approval to expand Part 2 of the study to include up to 13 patients receiving the 8mg dose was obtained in October 2013. With the absence of any serious toxicity in the 8mg Part 1 cohort, enrolment into this cohort has now been closed and new patients will be now be recruited into the expanded 8mg Part 2 cohort. The first such patient was dosed with SCIB1 earlier this week.

Richard Goodfellow, Joint CEO of Scancell, said: "Our higher dose 8mg SCIB1 study is progressing well. In view of the continued safety profile of SCIB1 at the higher dose, we are now recruiting for Part 2 of this cohort, which will assess the immune and clinical response to SCIB1 in a larger number of patients with Stage III/IV melanoma. We look forward to reporting the results from Part 1 of the study later this year."

Dr Sally Adams to Join Scancell as Development Director


Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce the appointment of Dr Sally Adams to the Board as Development Director with immediate effect.

Sally Elizabeth Adams, 53, has worked as a consultant alongside Scancell since 2008 providing guidance through the drug development process. With 25 years' industry experience, Sally has brought to Scancell her expertise in most aspects of drug discovery, including preparation and execution of clinical development plans from research to the clinic, scientific writing, implementation of quality control and documentation systems plus management of the SCIB1 clinical trial itself. She has worked on a number projects in recent years including anti-infective vaccines, cancer immunotherapies and an innovative stem cell treatment for visual dysfunction. Previously, Sally was Head of Neurology & Virology at British Biotech and Development Director at Neures Limited. She has an MA in Genetics from the University of Cambridge and a PhD in Microbiology from Imperial College London.

Richard Goodfellow, Joint CEO of Scancell, said: "Sally has already worked closely with the Scancell team for several years. She has played a key role in the planning and execution of our successful clinical trial of SCIB1 in patients with metastatic melanoma and we are delighted that Sally will be joining our Board at such a pivotal juncture in the Company's history. With her industry, scientific and drug development knowledge, Sally will continue to play an important role in the development of our ImmunoBody® and Moditope® platforms."

Presents latest SCIB1 data at ASCO

Scancell to present latest SCIB1 data at ASCO Annual Meeting

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, today announces that the latest data from the ongoing Phase 1/2 clinical trial of SCIB1 ImmunoBody® ('SCIB1') in patients with Stage III/IV melanoma will be presented in a poster at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 30-June 3, 2014.

SCIB1 is being developed for the treatment of melanoma and is in Phase 1/2 clinical trials. The trial is an open label, non-randomised study to determine the safety and tolerability of four dose levels of SCIB1 administered intramuscularly using an electroporation device (TDS-IM, manufactured by Ichor Medical Systems, USA). The study will also assess immune effects and anti-tumour activity in patients with melanoma.

An earlier submitted abstract of the poster can be accessed through the ASCO website at: http://abstracts2.asco.org/.

DNA ImmunoBody Patent Granted in United States

Scancell Holdings plc ('Scancell' or the 'Company'), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that a patent for its DNA ImmunoBody® technology has been granted in the United States.

The patent, number 8,742,088, has been granted by The United States Patent and Trademark Office (USPTO) and covers Scancell's DNA ImmunoBody® platform technology. This patent is key for the protection of the Company's pipeline of ImmunoBody® vaccines and follows the grant of counterparts in Australia, China and Japan.

Scancell's protein ImmunoBody® patent has already been granted in Australia, Canada, Europe, Japan and the United States.

Dr. Richard Goodfellow, Joint Chief Executive of Scancell, commented:

"We are delighted to have further strengthened our IP portfolio around our proprietary ImmunoBody® platform technology. The United States is a key market for us and this, alongside the recent positive results from the Phase 1/2 trial for our SCIB1 ImmunoBody® in melanoma, demonstrates the strong progress Scancell is making. We look forward to continuing development of our ImmunoBody® platform and advancing our SCIB1 clinical trial, bringing patients one step closer to a new treatment for melanoma."

Listen:Dr Richard Goodfellow, Scancell Holdings (SCLP) - DNA ImmunoBody patent granted in United States

Click here to listen

Synergy of SCIB1 with checkpoint inhibitors

Scancell Holdings plc ('Scancell' or the 'Company'), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce new data demonstrating that animals treated with a combination of SCIB1, Scancell's ImmunoBody® vaccine in development for the treatment of melanoma, and checkpoint inhibition (blockade of the PD-1 immune checkpoint pathway), showed enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

more..

Final Results

Highlights during the period:

· Orphan drug designation granted by FDA for SCIB1 ImmunoBody® for the treatment of metastatic melanoma

· Positive data from Part 2 and an update from Part 1 of the on-going Phase 1/2 clinical trial with SCIB1 ImmunoBody® in patients with Stage III/IV melanoma
o Melanoma-specific immune response seen in all Part 2 patients
o Continuing positive survival trend in Part 1 subjects
o No serious adverse events reported
o Completion of patient dosing with 8mg of SCIB1 in Part 1 of on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma

· Planning for pre-clinical and clinical development of Modi-1, lead vaccine from Moditope® platform underway
o Provisionally positioned as a novel immunotherapeutic for the treatment of lung, triple-negative breast cancer, ovarian and endometrial cancers
o Continue to expect first-in-man clinical studies to start in 2016

· Publication of patent application underpinning the Company's Moditope® platform

· Scancell granted an extension of the Option to commercialise Ichor's proprietary Trigrid™ electroporation delivery system with SCIB1

· Loss for the year of £2,222,954 (2013: loss: £1,901,944)

· Group cash balance at 30 April 2014 was £5,566,234 (30 April 2013: £1,491,320). This increase in cash is attributable to the placing and open offer earlier in the financial year which raised £6.1m, net


Post period highlights:

· New data demonstrates that a combination of SCIB1 and checkpoint inhibition showed enhanced tumour destruction and significantly longer survival times than when either treatment was used alone

· Patent granted in the United States for Scancell's DNA ImmunoBody® platform technology, following the grant of counterparts in Australia, China and Japan

· Further positive results from the on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBodyÒ
o Survival times are highly encouraging in both Part 1 and Part 2 patient groups
o Melanoma-specific immune responses in 24 of 28 (86%) patients
o Reduction in the number and size of multiple lung metastases in two patients
o No serious adverse events reported

Scancell Holdings plc ('Scancell' or the 'Company'), the developer of novel immunotherapies for the treatment of cancer, will host its Annual General Meeting on Tuesday 14 October 2014.

Note.....''Scancell now has two innovative technology platforms in this emerging field, both of which are currently being evaluated by a number of pharmaceutical companies under a CDA.''



14 October 2014
Scancell Holdings Plc
('Scancell')
AGM research and development update highlights progress in both SCIB1 clinical trial and
Moditope(R) platform
Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, will today provide a research and development update following the Company's AGM. Dr Richard Goodfellow and Prof Lindy Durrant, Scancell's joint CEOs, will present an update on progress with the new ModitopeÒ platform as well as the ongoing SCIB1 Phase 1/2 clinical trial in malignant melanoma, the lead programme from the Company's ImmunoBodyÒ platform.
Highlights
-- Encouraging survival and safety data from Phase 1/2 clinical trial suggests that SCIB1 has the potential to become the first effective stand-alone treatment for adjuvant melanoma. All 16 patients with fully resected disease are still alive with a median survival of 26 months after starting treatment and only four have shown disease progression
-- Adjuvant melanoma represents a significant new market opportunity for SCIB1. -- Combining SCIB1 and PD-1 blockade in animals enhances tumour destruction and extends survival times supporting the use of the combination for later stage disease
-- Modi-1 on schedule to be ready for clinical trials in 2016
-- Two new Moditope(R) protein targets identified Dr Lindy Durrant, Joint CEO of Scancell, comments: "Modi-1 remains on track for start of first-in man clinical trials in 2016. The identification of new targets suggests that Moditope has significant potential as a platform for generating multiple cancer immunotherapeutics. In addition to the reported positive data from SCIB1, our Immunobody(R) platform continues to make good progress with a second vaccine target for lung cancer and the potential to take the platform into chronic infectious diseases."
Dr Richard Goodfellow, Joint CEO of Scancell, adds: "Cancer immunotherapy is emerging as one of the most exciting areas of pharmaceutical research and development. Scancell now has two innovative technology platforms in this emerging field, both of which are currently being evaluated by a number of pharmaceutical companies under a CDA. The encouraging survival data on SCIB1, especially in patients with resected disease, offers an even greater market opportunity for SCIB1 and our pipeline of ImmunoBody(R) vaccines than was originally envisaged."
Research and Development Update
SCIB1
We are pleased to announce further encouraging data from the on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with SCIB1. To date, 32 patients have been treated with SCIB1, including seven at the higher 8mg dose. Six patients are currently on long-term treatment and have received between 4 and 6 further doses of SCIB1 every 3-6 months. Although recruitment of patients with advanced disease remains challenging it is expected that enrolment for the study will be completed during 2Q15. A new clinical centre has been established at the Royal Surrey County Hospital in Guildford to accelerate recruitment. SCIB1 continues to be a safe and well tolerated treatment with no withdrawals from the study due to adverse events.
Overall, only five of the 27 patients who have received at least three doses of 2-8mg SCIB1 since commencement of the study in 2010 have died. Median survival time in Part 1 patients who received at least three treatments with the 2mg/4mg doses of SCIB1 is now 34 months since study entry. This group of patients had 1-year, 2-year and 3-year survival rates of 100%, 67% and 50%, respectively. For the Part 1 8mg cohort of patients, who were recruited later, the median survival time is currently 13 months since study entry. The median survival time since initiating treatment with SCIB1 in Part 2 patients with resected disease (and receiving 4mg doses of SCIB1) is currently 25 months.
Importantly, all 16 patients (two in Part 1 and 14 in Part 2) with fully-resected metastatic disease (nine Stage III and seven Stage IV) are still alive with a median survival time of 26 months since study entry (range 20-39 months) and only four have shown evidence of disease progression. The Stage III patients have a median survival time of 26 months since study entry and two (22%) have progressed. This compares extremely favourably with results from a peptide vaccine trial (Slingluff et al., 2011) where 52% of fully-resected Stage III patients had progressed and 33% had died two years after the start of treatment. The Stage IV patients treated with SCIB1 have a median survival time of 24 months since study entry and two of these patients (22%) have also progressed. In the Slingluff study, 50% of the fully-resected Stage IV patients had progressed and 19% had died after two years of treatment.
These results in patients with resected disease suggest that SCIB1 may have an important role to play as first line treatment in adjuvant melanoma. These are patients who no longer have measurable disease (following surgery) and are often generally quite well. However, they are at a high risk of recurrence and currently have very few, if any, effective treatment options. This represents a significant and as yet untapped market opportunity, including some 360,000 patients in the US alone, of whom around 45% have the MHC antigen HLA-A2 and are therefore suitable for SCIB1 treatment.
Animal data supporting the synergistic effect of combining SCIB1 with PD-1 blockade was announced in August. Any patients that progress following SCIB1 monotherapy, or indeed any patient with more advanced disease, may therefore benefit from the combination of SCIB1 with a checkpoint inhibitor.
ImmunoBody(R) platform
Scancell's Immunobody(R) immunotherapy platform enhances the uptake and presentation of cancer antigens to harness the high avidity T cell responses that destroy tumours. The platform has been validated both in animals and in the clinic with SCIB1 but many opportunities also exist for the development of a pipeline of ImmunoBody(R) vaccines, both for cancer and chronic infectious diseases.
A second ImmunoBody(R) vaccine targeting the lung cancer antigen NY-ESO-1 (SCIB2) has been developed to the point at which the product is fully defined and ready for further preclinical development as a potential immunotherapy for any tumour that expresses the NY-ESO-1 antigen such as lung, oesophageal, gastric, ovarian and bladder cancers. During the past 12 months research on other ImmunoBody(R) vaccines for prostate, liver and colorectal cancer have also been further advanced.
In addition, Scancell has conducted proof of concept studies with ImmunoBody(R) constructs expressing antigens from influenza and Epstein Barr virus and is in early discussions with potential partners for the co-development of ImmunoBody(R) vaccines for the treatment or prophylaxis of infectious diseases.
Modi-1
Scancell's Moditope(R) immunotherapy platform is based on exploiting the normal immune response to stressed cells, which is largely mediated by CD4+ T cells, and harnessing this mechanism to eradicate cancer cells. Scancell's first target for Moditope(R) is vimentin - a major cytoskeletal protein found in mesenchymal cells. Many epithelial tumours switch from expression of cytokeratin to vimentin during metastasis in a process known as epithelial mesenchymal transition (EMT); this change in phenotype enables the cell to become mobile and metastasize to new locations in the body.
Scancell has now selected two modified vimentin peptides in which the arginine residues have been substituted by citrulline to form the basis of its first Moditope(R) development candidate, Modi-1. The inclusion of additional modified peptides from other Moditope(R) target proteins into Modi-1 is currently under review. Animal studies have shown that the two vimentin peptides stimulate potent anti-tumour responses and leads to significant improvements in survival, suggesting that the Modi-1 product could have outstanding potential as a novel immunotherapy. Immune response studies with cells isolated from cancer patients have confirmed that T cell responses were stimulated by both modified vimentin peptides.
Optimisation studies have identified the adjuvant, dose and administration route for testing Modi-1 in the First in Man study. In animal studies, an aggressive tumour cell line confirmed that the two vimentin peptides eradicate tumour cells in a therapeutic, and therefore clinically relevant, setting. Remarkably, these responses were evident when tumours had reached a late stage of development.
Moditope vaccines have the potential to treat a wide variety of cancers. Scancell is currently further evaluating the initial indications for the first clinical trial with Modi-1 in terms of clinical need and market opportunity and based upon the possible addition of other peptide targets into the product.
Scancell is considering options for conducting the initial Modi-1 study in both Europe and the US and is designing the development and regulatory strategy to allow for either approach. The development programme will include manufacture plus toxicology and stability testing of the final formulated product. This data will form the basis of a clinical trial application, which is anticipated to be ready for submission in the first half of 2016.
Moditope(R) platform
Having exemplified the Moditope(R) platform with modified vimentin peptides, Scancell has been expanding the platform to other citrullinated tumour proteins that could be incorporated into Modi-1 or developed into a pipeline of other multiple-cancer immunotherapeutics. We are therefore pleased to announce today the identification of two further Moditope(R) protein targets, alpha-enolase and ING4.
Human alpha-enolase is a glycolytic enzyme that is overexpressed by lung, liver and other cancers. We have identified a citrullinated peptide within human alpha-enolase that induces a powerful and specific immune response and that elicits both increased survival and decreased tumour volume compared to control groups in animal models. Analysis of blood samples from donors has indicated that humans have a T cell repertoire that is able to recognise citrullinated alpha-enolase.
The tumour suppressor protein encoded by the ING4 gene plays a role in many cancer related processes. Two citrullinated peptides from human ING4 have been shown to induce specific T cell responses. Further studies are ongoing to evaluate the effect of these citrullinated peptides on tumour volume and survival. Both alpha-enolase and ING4 are believed to offer excellent prospects for future Moditope(R) immunotherapies.
-ENDS-

Half Yearly report

Highlights:

· Data from the on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBodyÒ shows highly encouraging survival times in both Part 1 and Part 2 patient groups

· Pre-clinical data demonstrates that a combination of SCIB1 and checkpoint inhibition (PD-1 blockade) produced enhanced tumour destruction and longer survival times than when either treatment was used alone, supporting use of the combination for later stage disease

· Adjuvant melanoma* represents a significant new market opportunity for SCIB1

· SCIB2 vaccine ready for further pre-clinical development as a potential immunotherapy for any tumour expressing the NY-ESO-1 antigen

· Patent granted in the US for Scancell's DNA ImmunoBody® platform technology, following the grant of counterparts in Australia, China and Japan

· Modi-1, lead vaccine from Moditope® platform, is on schedule for clinical trials in 2016

· Two new Moditope® protein targets identified

· Loss for the six month period of £1,339,915 (2013: loss: £1,187,574)

· Group cash balance at 31 October 2014 was £4,302,052 (30 April 2014: £5,566,234)

http://www.shareprophets.com/views/9745/nigel-somerville-s-2015-share-tips-of-the-year-no-1-scancell

Rodders

Positive SCIB1 Phase 1/2 clinical trial update

Scancell to provide positive SCIB1 Phase 1/2 clinical trial update during corporate presentations 12-15 January, San Francisco

Part 2 patients have median survival time of 28 months since study entry
All resected patients are still alive with median survival time of 30 months and 27 months for Stage III and IV patients, respectively

Scancell Holdings plc, ('Scancell' or the 'Company') the developer of novel immunotherapies for the treatment of cancer, announces that Joint CEOs Dr Richard Goodfellow and Professor Lindy Durrant will be making corporate presentations 12-15 January 2015, coincident with JP Morgan's 33rd Annual Healthcare Conference, San Francisco, CA, USA.

A very encouraging update on clinical outcomes in the Company's on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBody® will be given as part of these presentations. It will be reported that the overall median survival of Part 1 patients with tumour present at trial entry and who received at least three doses of 2-8mg of SCIB1 is 24 months. This compares favourably with first line untreated Stage IV disease where patients with no visceral disease had a median survival of 11 months and patients with visceral disease had a median survival of six months (Sosman et al., 2011 Cancer 117:4740-4706). The status of the patients with resected tumours at study entry is equally promising. The 14 patients in Part 2 of the trial have been on study for 23-32 months (median 28 months) and only three have evidence of disease progression. Of particular note, all resected patients (n=16; two from Part 1 and 14 from Part 2) are still alive and only four have progressed. The median recurrence-free survival (when 50% of patients have died) has not been reached; these resected patients have a median survival time of 30 months for Stage III patients (n=9) and 27 months for Stage IV patients (n=7). This compares very favourably with reported data from a peptide vaccine trial following two years of treatment, in which 50% of Stage III patients had disease progression and 19% had died; while 52% of Stage IV patients had disease progression and 33% had died (Slingluff et al., 2011 J Clin Oncol 29:2924-2932).

Richard Goodfellow, Joint CEO of Scancell, said: "The maturing clinical data from our lead ImmunoBody®, SCIB1, continues to enhance our confidence in the clinical value of SCIB1 as monotherapy, especially in the adjuvant setting, a huge and relatively untapped market."

-ENDS-

Hmmmm.

Not a pretty chart!!

SCIB2 synergy with checkpoint inhibitor blockade

SCIB2 also shown to synergise with checkpoint inhibitor blockade

Combining SCIB2 with CTLA-4 blockade enhances tumour destruction and extends survival times


Scancell Holdings plc ('Scancell' or the 'Company'), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce new data demonstrating that animals treated with a combination of SCIB2, Scancell's ImmunoBody® vaccine in development for the treatment of lung, oesophageal, prostate and other epithelial cancers, and checkpoint inhibition (blockade of the CTLA-4 immune checkpoint pathway), showed enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

The data confirming the therapeutic effect of SCIB2 with this second checkpoint pathway follows our previous announcement on 12 August 2014 of SCIB1's synergy with PD-1 blockade in animal models.

In earlier pre-clinical studies, we have shown that administration of SCIB2 alone induced potent tumour-specific T cell responses associated with increased T cell infiltration into the tumour and enhanced proliferation of T cells within the tumour resulting in tumour rejection and long term survival. In our new study where higher doses of tumour cells were used, the combination of CTLA-4 blockade with SCIB2 vaccination resulted in a significant survival advantage over the individual treatments. Although patients with a relatively low tumour burden may benefit from SCIB2 alone, these results highlight the potential benefits of combining SCIB2 with CTLA-4 blockade, such as ipilimumab, for the treatment of patients with advanced disease.

more....

Panmure Gordon Buy 24.38 24.38 79.00 79.00 Reiterates

SCIB1 data update in resected melanoma patients

Highlights

· All 16 patients with resected disease (two in Part 1 and 14 in Part 2) are still alive.

· Survival times are very encouraging: median survival time for Stage III patients (n=9) and Stage IV patients (n=7) is 34 and 31 months, respectively.

· Only five patients (31%) have had a recurrence of the disease; all other patients have been disease-free for between 27 and 46 months since study entry* (median follow-up of 34 months).

· The median for disease-free survival and overall survival (when 50% of patients have progressed or died, respectively) have therefore not yet been reached.

· All 16 patients showed melanoma-specific immune responses.

· All patients who continued treatment showed strong T cell memory responses following three monthly boosts with SCIB1.

· SCIB1 was safe and well-tolerated, with no grade 4/5 toxicities observed other than those related to disease progression and one case of pneumonia.

more....

An interesting read from the Times - A cancer breakthrough worthy of the name

Scancell - Update on SCIB1 data

click here

Patient recruitment completed for SCIB1 Phase 1/2 clinical trial

Collaboration with ImmunID

Scancell - General update and collaboration with ImmunID

click here to listen

US Phase II combination study with SCIB1

Scancell to conduct Phase II checkpoint inhibitor combination study with SCIB1 with leading US melanoma specialists

Harvard, MD Anderson, Memorial Sloan Kettering, University of Colorado clinical team to lead checkpoint inhibitor combination trial with SCIB1

Aim of study will be to improve objective response to anti-PD-1 monotherapy without additional toxicity

Scancell Holdings Plc, (AIM:SCLP), today announced formation of its core US investigator team to lead a Phase II checkpoint inhibitor combination study with Scancell's lead cancer vaccine SCIB1. Dr Keith Flaherty, M.D., Director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital and Associate Professor at Harvard Medical School has been named the Principal Investigator. Joining Dr Flaherty are Dr Jennifer Wargo of the Department of Surgical Oncology at MD Anderson, Dr Michael Davies of the Department of Melanoma Oncology at MD Anderson, Dr Paul Chapman in the Melanoma/Sarcoma Service at Memorial Sloan Kettering and Dr Rene Gonzalez of the Division of Medical Oncology at University of Colorado.

Dr Keith Flaherty, Associate Professor, Medicine, Harvard Medical School and Director of Developmental Therapeutics, Henri and Belinda Termeer Center for Targeted Therapies, Massachusetts General Hospital said: "Based on the scientific and translational research behind SCIB1, I believe there is a compelling case for further investigation in both the metastatic and adjuvant melanoma settings. Despite meaningful recent advances in the treatment of this disease there still remains a significant unmet medical need. I am very excited to be working with Scancell and my other colleagues in the investigator team to bring this innovative treatment to patients."

Dr Paul Chapman, Dept. of Medicine, Memorial Sloan Kettering Cancer Center added: "SCIB1 represents a potentially important complement to checkpoint inhibitor therapy. Despite the unquestionable clinical utility of anti-PD-1 drugs, only around 30% of patients respond to treatment. Available data supports testing the hypothesis that the use of SCIB1 in combination with these agents may increase the number of patients responding to treatment and prolong progression free survival without the additional burden of significant further side effects."

Dr Richard Goodfellow, Joint CEO of Scancell, said: "The latest data on SCIB1, both in terms of the unprecedented survival of Stage 3/4 melanoma patients with resected disease, combined with anti-tumour responses in late stage patients and compelling animal data showing the potential value of a SCIB1/checkpoint inhibitor combination regimen sets the stage for an expanded clinical trial programme. We are delighted to have secured the help and support of such a prestigious group of US specialists, led by Dr Flaherty."

The clinical study will assess the impact of adding SCIB1 to a checkpoint inhibitor in patients with late stage melanoma. The aim will be to improve the objective response rates of anti-PD-1 ("checkpoint inhibitor") monotherapy without adding additional toxicity. It is expected that the trial will enrol approximately 80 Stage 3/4 metastatic melanoma patients and commence in the second half of 2016, ending around 18 months later.

Hmmm - something afoot!

I'm only down @50% now.

Final Results

Highlights:

· Strong survival data for patients with Stage III/IV malignant melanoma on SCIB1 Phase 1/2 clinical trial
o 18 of 20 patients with resected disease remain alive, survival well beyond established norms
o Of the 16 resected patients who received a 2-4mg dose of SCIB1, seven patients have now survived for five years since starting treatment and only six patients have had recurrence of their disease, of whom, two have died
o Final Clinical Study Report completed in December 2016 which included safety, immunology and clinical data from patients with Stage III/IV melanoma up to 29 October 2015

· Investigational New Drug (IND) application for SCIB1 Phase 2 checkpoint inhibitor combination study expected to be submitted in early 2018, with patient enrolment planned for 2018

· Continued good progress in development of Modi-1, our lead product from the Moditope® platform
o Ultra-efficient linked adjuvant identified that works at up to 100-fold lower doses than could be achieved previously
o Aiming to file a Clinical Trial Application (CTA) in the UK for the planned Phase 1/2 clinical trial in breast cancer, ovarian cancer and sarcoma in 2018
o Early feedback from the European Patent Office suggests that broad patent claims for the Moditope® platform may be allowable

· Opening of new offices in San Diego to support the Company's US growth plans, and in Oxford for its UK corporate and development activities

· Loss for year of £3.5m (2016: loss £2.6m)

· Group cash balance at 30 April 2017 was £2.7m (30 April 2016: £6.5m)

Post Period Highlights:

· Raised £4.7m in a placing of new ordinary shares
o Funds to be used to initiate the clinical development of Modi-1 and to continue to support the ImmunoBody® platform pipeline

· Patent granted in Europe for Scancell's DNA ImmunoBody® technology
o Counterparts to this patent have already been granted in the US, Australia and Japan

Dr Richard Goodfellow, CEO of Scancell, said:

"We have made further significant progress during the course of the past year on the development of our ImmunoBody® and Moditope® platforms. We continue to report strong survival data in patients with Stage III/IV melanoma from our SCIB1 Phase 1/2 clinical trial, with survival times now exceeding five years in resected patients.

Moditope® is also progressing well with the identification of a new linked adjuvant for the first Modi-1 clinical trial in the UK in patients with breast cancer, ovarian cancer and sarcoma which is expected to increase the potency of the product up to 100-fold.

We are continuing to explore a number of funding options to ensure that we have the resources to progress these programmes through their next phase and the Board believes that this funding could be best achieved following the execution of one or more partnerships on the ImmunoBody® or Moditope® platforms, on which significant progress has been made since the year end."

sp=10.2 doesn't inspire.
I guess their treatments are a long way from profitability. "Funding Options" means "Dilution" so as usual retail shareholders are being taken for mugs.. . . but I guess that's almost always the case for Bio's

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, will announce its financial results for the year ended 30 April 2018 on Tuesday, 25 September 2018.