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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.

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.