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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.

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

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