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

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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

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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.

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."