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.”

For Further Information:

Dr Richard Goodfellow, Joint CEO	Scancell Holdings Plc	+ 44 (0) 20 3727 1000
Professor Lindy Durrant, Joint CEO	Scancell Holdings Plc
Camilla Hume/Stephen Keys	Cenkos Securities plc	+ 44 (0) 20 7397 8900
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 3727 1000

 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.  Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial.  Data from the trial demonstrate that SCIB1 produced a melanoma-specific immune response and promising survival trend. 

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 that destroy tumours without toxicity.  The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

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.”

For Further Information:

Dr Richard Goodfellow, Joint CEO	Scancell Holdings Plc	+ 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO	Scancell Holdings Plc
Camilla Hume/Stephen Keys	Cenkos Securities plc	+ 44 (0) 20 7397 8900
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 7831 3113

 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.  Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated  in a Phase 1/2 clinical trial.  Data from the trial demonstrate that SCIB1 produced a melanoma-specific immune response and promising survival trend. 

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future. 

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 U.S., 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. ”

^1. www.fda.gov/forindustry/DevelopingProductsforrareDiseasesConditions/default.htm

For Further Information

Dr Richard Goodfellow, Joint CEO	Scancell Holdings Plc	+ 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO	Scancell Holdings Plc
Camilla Hume/Stephen Keys	Cenkos Securities plc	+ 44 (0) 20 7397 8900
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 7831 3113

About Scancell

 Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms. Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial. Data from the trial demonstrate that SCIB1 produced a melanoma-specific immune response and promising survival trend

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

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Scancell Holdings Plc, (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that it has received a Nottingham Technology Grant Fund (”N’Tech”) of £80,000 from Nottingham City Council. Funded by the Government’s Regional Growth Fund, the grants from N’Tech are awarded mainly to small and medium-sized companies to support business growth and expansion in the Greater Nottingham area. Scancell will use the funds to secure additional staff to develop its groundbreaking new Moditope® technology platform.

Richard Goodfellow, Joint CEO of Scancell, said: “We are delighted to receive this additional funding from Nottingham City Council. This funding will allow us to expand our skill base and boost our productivity at this important juncture in the Company’s history."

For Further Information:

Dr Richard Goodfellow, Joint CEO	Scancell Holdings Plc	+ 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO	Scancell Holdings Plc
Camilla Hume/Stephen Keys	Cenkos Securities plc	+ 44 (0) 20 7397 8900
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 7831 3113

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.  Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and has just completed Phase 1/2 clinical trials which demonstrated that SCIB1 produced a melanoma-specific immune response and promising survival trend.  A further higher dose study of SCIB1 will take place during 2014.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 that destroy tumours without toxicity.  The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

Scancell Holdings plc (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, notes Nottingham Trent University’s announcement that using Scancell’s Immunobody® technology, they have unlocked a protein that could pave the way for future prostate cancer vaccinations.  The full text of Nottingham Trent University’s announcement follows:

 SCIENTISTS UNLOCK PROSTATE CANCER PROTEIN IN MOVE WHICH COULD LEAD TO IMPROVED CANCER VACCINES

UK scientists have identified how a specific region of a prostate-related protein can be used to trigger the body’s immune response against prostate cancer. The study by scientists at Nottingham Trent University – and published in the European Journal of Immunology – could pave the way for new and improved vaccines for prostate cancer.

The work focused on the prostatic acid phosphatase (PAP) protein, which is present in more than 90% of prostate tumours. Scientists were able to develop a new prostate cancer vaccination strategy utilising a portion, or ‘epitope’ of this PAP protein – PAP 114 – which was capable of preventing and reducing tumour growth in pre-clinical trials.

The team believes the study could lead to the development of new vaccines which are able to generate a more specific, more efficient, faster and longer-lasting protective immune response against prostate cancer.

It might also mean that vaccines could be developed at a lower cost than currently, and with fewer potential side effects, say the scientists, who are based in the university's John van Geest Cancer Research Centre.

Prostate cancer is the most common cancer in men in the UK – each year more than 10,000 men will die as a result of prostate cancer and more than 40,000 will be diagnosed with the disease. Cases are rising among men over 50 and the average age for men to be diagnosed is between 70 and 74.

Although cancer vaccines can be formulated in a number of different ways, the approach devised by the scientists for this PAP vaccine would involve a series of injections. 

Dr Stephanie McArdle, lead researcher based in Nottingham Trent University’s John van Geest Cancer Research Centre, said: “Unfortunately for most cancers, the specific targets against which vaccination strategies can be based are sometimes weak and relatively poor at inducing robust, protective anti-tumour immune responses.

“Developing cancer vaccines that can overcome the capacity of tumours to ‘evade’ the immune system and induce protective anti-tumour immunity is therefore essential for the development of new immunotherapies for aggressive disease.

"Our findings demonstrate that PAP-114 is a promising candidate for further development of PAP-based anti-cancer vaccine strategies. It induces characteristics that are consistent with anti-tumour protection; capable of triggering an immune attack against prostate cancer cells and protecting against established prostate tumours."

The epitopes of the PAP protein were delivered to the immune system using Scancell’s proprietary ImmunoBody® technology. 

ENDS

Notes for editors: 

Nottingham Trent University’s John van Geest Cancer Research Centre is a unique purpose-built scientific facility. Its aim is to save lives and speed recovery by improving the early diagnosis and treatment of cancer.

The centre focuses on two key approaches to the treatment of patients with cancer:

• Improving the diagnosis and management of breast and prostate cancers
• Developing effective vaccines and immunotherapies that will significantly improve the survival rates and quality of life for cancer sufferers.

Visit the John van Geest Cancer Research Centre website to find out more about its work, or to make a donation towards its vital scientific research.

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms. Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is in Phase 1/2 clinical trials. 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 was released in December 2012.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

The paper in the European Journal of Immunology can be accessed here.

Press enquiries please contact Dave Rogers, Senior Press Officer, on telephone +44 (0)115 848 8782 or via email, or Therese Easom, Press and Internal Communications Manager, on telephone +44 (0)115 848 8774 or via email.

For Further Information:

Dr Richard Goodfellow, Joint CEO	Scancell Holdings Plc	+ 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO	Scancell Holdings Plc
Camilla Hume/Stephen Keys	Cenkos Securities plc	+ 44 (0) 20 7397 8900
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 7831 3113

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.”

For Further Information:

Dr Richard Goodfellow, Joint CEO	Scancell Holdings Plc	+ 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO	Scancell Holdings Plc
Camilla Hume/Stephen Keys	Cenkos Securities plc	+ 44 (0) 20 7397 8900
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 7831 3113

 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.  Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and has just completed Phase 1/2 clinical trials which demonstrated that SCIB1 produced a melanoma-specific immune response and promising survival trend.  A further higher dose study of SCIB1 will take place during 2014.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 that destroy tumours without toxicity.  The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future. 

Scancell, the developer of novel immunotherapies for the treatment of cancer, announces that further to the announcement of the results from Part 2 of its on-going Phase 1/2 clinical trial on 9 December 2013, share options were granted on 10 December 2013 to the Executive Directors. Prof Lindy Durrant and Dr Richard Goodfellow, Joint Chief Executive Officers, have each been granted options over 3,500,000 ordinary shares (the “Options”) in the Company under an Unapproved Share Option Scheme.

The Options, which will vest over a period of three years in three equal tranches, are subject to the achievement of performance criteria including scientific and commercials milestones as specified by the Remuneration Committee. The exercise price of the options is 33.2p (being the average closing price of Scancell shares since 1 August 2013 up to and including 9 December 2013).

Details of the total shares and options held by the executive team following the issue of the Options are set out in the table below:

	Share Options	Shares held under Joint Share Ownership Plan	Shares held in own name	Total
Professor Lindy Durrant	7,350,000	8,773,960	1,606,960	17,730,920
Dr Richard Goodfellow	6,380,000	6,343,840	200,000	12,923,840

 

For Further Information:

Dr Richard Goodfellow, Joint CEO	Scancell Holdings Plc	+ 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO	Scancell Holdings Plc
Camilla Hume/Stephen Keys	Cenkos Securities Plc	+44 (0) 20 7397 8900
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 7831 3113

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms. Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is in Phase 1/2 clinical trials. 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 was released in December 2012.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

 

Scancell Holdings plc (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce encouraging results from Part 2 of its on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBody® as well as an update from patients in Part 1 of the study.

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

These results confirm that Scancell’s SCIB1 ImmunoBody® therapy is producing a melanoma-specific immune response in patients with Stage III/IV melanoma. This is particularly evident in patients with resected disease. Together with the immunological and clinical data from Part 1 of the study, the results suggest that these induced immune responses might also be contributing to the control of tumour in these patients.

Prof Lindy Durrant, Joint CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented: “These results exceeded our highest expectations confirming that SCIB1 induces a consistent melanoma-specific immune response in Stage III/IV melanoma patients, especially in those with resected disease. Whilst the numbers are still small, it suggests that SCIB1 may be contributing to prolonged survival by controlling tumour growth and supports our belief that the highly targeted ImmunoBody® approach generates potent and specific T cells that can control malignant disease.”

Prof Poulam Patel, the principal investigator in the trial and Prof of Clinical Oncology at the University of Nottingham, added: “This promising new data further supports our hypothesis that SCIB1 can harness the body’s own immune system to control metastatic melanoma in a safe and effective way. More generally it also adds to the growing belief that training T cells to target and control tumour growth is one of the most promising new ways of treating cancer. In patients with more extensive metastases, it is feasible that combining SCIB1 with the latest checkpoint inhibitor drugs, which allow T cells to work better within the tumour environment, may offer further patient benefit.”

Study Design

The first part of this single arm, open label, Phase 1/2 clinical trial was conducted in five UK centres in 11 patients, ten with Stage IV and one with Stage III malignant melanoma. Patients were to be given five doses of 0.4mg, 2mg or 4mg of SCIB1, delivered by Ichor Medical Systems’ TriGrid™ electroporation delivery device, over a period of six months. One patient in the 0.4mg dose group and one in the 4mg dose group who received only a single dose of SCIB1 were withdrawn from the study due to progressive disease shortly after study entry and were replaced to ensure that at least three patients in each dose cohort could be fully evaluated for immune response. During the course of the study, regulatory approval was granted to increase the SCIB1 dose from 2mg to 4mg in patients in the 2mg cohort, if the treatment was well tolerated. Two patients in this group received two 4mg doses of SCIB1 and one patient received a single 4mg dose. Regulatory approval was subsequently obtained for treating a cohort of patients with 8mg of drug. Dosing of these patients is currently on-going.

In Part 2 of the study, 14 patients with resected Stage III/IV melanoma (eight with Stage III and six with Stage IV) entered the study. One patient was only able to tolerate three doses of 2mg and withdrew from the study. Of the remaining patients, 12 received a full 4mg dose of SCIB1 on five occasions over a period of 6 months and one received four doses of 4mg and one dose of 2mg.

During the course of the study, regulatory approval was granted to continue treating eligible patients for a period of up to 5 years from the formal end of the study. During this period patients can receive a 4mg dose of SCIB1 every 3-6 months.

Clinical response

Part 1

Four out of the six patients in the 2mg/4mg cohorts who received at least three doses of SCIB1 are still alive and one remains disease-free more than 2 years after starting treatment. All of the patients in the 0.4mg dose group have died from melanoma progression. The median survival time for the six evaluable patients in the 2mg/4mg cohorts is currently 25 months. 

One patient in the 4mg dose group with multiple tumour lesions present at the start of treatment showed a “differential response” pattern in which all of her lung lesions decreased in size or disappeared completely following six months of treatment with SCIB1 whereas one abdominal wall tumour nodule grew and was resected. Staining of tissue taken from the resected nodule showed it had lost expression of one of the target melanoma antigens, gp100, but had high levels of PD-1 protein, which is known to attenuate high avidity T cell responses; this suggests that combining SCIB1 treatment with anti-PD-1 monoclonal antibodies may be an effective therapeutic approach. The patient continued on extended treatment with SCIB1 until she was subsequently found to have recurrent melanoma in her intestines; this tumour was also excised and treatment was discontinued.

Part 2

All of the resected Stage III/IV patients treated with SCIB1 in Part 2 remain alive and only three have had progressive disease to date. One patient had their lesion excised in January 2013 and has no further disease progression to date. The other two patients have progressed within the last month. The median survival time for Part 2 patients is currently 15 months from study entry and 21 months from diagnosis of metastatic disease. 

Immune response

Immune response was measured by peptide-specific proliferation. A positive response required at least twice the background control at each time point and at least twice the pre-treatment control value on two or more of the six time points measured. In addition, responses were assessed using an enzyme-linked immunosorbent (ELISPOT) assay after T cell expansion in vitro, where a positive response was more than three standard deviations above the pre-treatment control value on two or more of the six time points measured. Fresh samples were analysed in both assays, except for one patient where the controls for the fresh proliferation assay were not validated and the assay was repeated using frozen samples.

Part 1

One patient in the 0.4mg cohort, all three patients in the 2mg/4mg dose cohort and two patients in the 4mg dose cohort mounted a measurable proliferation response to the melanoma-specific epitopes in SCIB1. In addition, the patient with the differential clinical response was assessed using the ELISPOT assay and made a strong response to the melanoma TRP-2 antigen.

Part 2

All 14 patients responded to treatment in either the proliferation or ELISPOT assay. Twelve patients were immune responders in the proliferation assay, 13 patients responded in the ELISPOT assay and 11 patients responded in both assays, including the patient who only received three doses of 2mg of SCIB1. Broad, high frequency responses were seen against both the two CD8+ T cell epitopes and against the two CD4+ T cell epitopes. Six patients responded to all four epitopes, five patients responded to three epitopes and three patients responded to two epitopes. Statistically significant responses (p>0.0001) were seen after three, four or five immunisations but not after two, indicating that at least three doses are required for a strong immune response to develop.

Due to these encouraging results six patients are continuing on extended, long-term treatment with SCIB1. 

Tolerability and Safety

The SCIB1 immunotherapy produced very few side effects, none of which were serious, with no new or unexpected issues found over those reported with the results from Part 1 of the study where no systemic doselimiting toxicities were observed. The most commonly reported adverse events were injection site reactions and cold- and flu-like symptoms. The electroporation procedure itself was less well-tolerated in some patients and, in certain cases, required pre-treatment sedation. However, only one patient has withdrawn from the study for this reason and seven chose to continue treatment in Part 2 of the study (one has since discontinued).

For Further Information:

Dr Richard Goodfellow, Joint CEO	Scancell Holdings Plc	+ 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO	Scancell Holdings Plc
Camilla Hume/Stephen Keys	Cenkos Securities plc	+ 44 (0) 20 7397 8900
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 7831 3113

 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms. Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is in Phase 1/2 clinical trials. 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 was released in December 2012.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces results for the six months ended 31 October 2013.

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
• Planning for preclinical and clinical development of Modi-1, lead pipeline vaccine from Moditope® platform underway
• 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) 
  • Data anticipated by 2014 calendar year end
  • Provisionally positioned as a novel immunotherapeutic for the treatment of triple-negative breast cancer, ovarian and endometrial cancers
  • First in-man clinical studies are scheduled to start in 2016

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)
• Scancell granted an extension of the Option to commercialise Ichor’s proprietary Trigrid™ electroporation delivery system with SCIB1 
  • Melanoma-specific immune response seen in all Part 2 patients
  • Continuing positive survival trend in Part 1 subjects, although patient numbers are small
  • No serious adverse events reported

Richard Goodfellow, Joint CEO of Scancell, said:

“We are delighted with the results and progress generated from both our ImmunoBody® and Moditope® platform technologies during the period.  In particular, the immune response data released today from our lead programme, the SCIB1 ImmunoBody® vaccine for advanced melanoma, has exceeded our highest expectations.  We anticipate reporting data from the high dose 8mg arm of this Phase 1/2 trial by 2014 calendar year end.  While treated patient numbers are small, we believe our results to date add to the growing body of evidence that suggests that training T cells to target and control tumour growth could be one of the most promising new ways of treating cancer.  With that in mind, the discovery of the Moditope® platform technology could add a new dimension to cancer immunotherapy and form the basis of a completely new class of immuno-oncology treatments.  We are actively planning the preclinical and clinical development for Modi-1, our lead vaccine arising from this platform, as an immunotherapeutic provisionally for the treatment of triple-negative breast cancer, ovarian and endometrial cancers.

“As previously indicated at the time of our investor update in October, in view of the short to medium term licensing and partnership potential that both the Moditope® and ImmunoBody® programmes now bring to the Company, our strategy requires a more flexible approach.  Whilst we are still fully focused on securing a sale of the business at the earliest opportunity, we will also consider technology validating and revenue generating deals on each platform in order to enhance the value of the Company when it is eventually sold.”

For Further Information:

Dr Richard Goodfellow, Joint CEO	Scancell Holdings Plc	+ 44 (0) 20 7831 3113
Professor Lindy Durrant, Joint CEO	Scancell Holdings Plc
Camilla Hume/Stephen Keys	Cenkos Securities Plc	+44 (0) 20 7397 8900
Mo Noonan/Simon Conway	FTI Consulting	+ 44 (0) 20 7831 3113

 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms. Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is in Phase 1/2 clinical trials. 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 was released in December 2012.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

CHAIRMAN’S STATEMENT

I am pleased to report the Company’s interim results for the six month period ended 31st October, 2013. During this period the Group has continued progress with the SCIB1 clinical trials and in August 2013 raised £6.1m (net proceeds) in additional investment through a placing and open offer of shares. These funds will enable the Company to commence work on the pre-clinical development of the first Moditope® immunotherapy product and will provide working capital for the completion of the existing SCIB1 clinical trials as well as enable the Company to recruit the further ten patients for the 8mg cohort of the Phase 1/2 trial.

We have also announced today (see separate release) the extremely encouraging new results from the ongoing Phase 1/2 clinical trial in patients with advanced melanoma. This data from Part 2 of the trial shows that all 14 patients produced a melanoma-specific immune response to treatment and all are still alive. Only three patients have any evidence of disease progression to date. In addition, the four patients from Part 1 of the study who were still alive at the time of the Part 1 report (December 2012) are still alive with a median survival time since treatment commenced of 25 months. Furthermore no serious drug related adverse events have been reported.

Financial

Profit and Loss Account

The Group made an overall operating loss for the six month period to 31st October 2013 of £1,306,556 (2012: loss of £989,981).

Overall the loss for the six month period was £1,187,574 (2012: loss £923,020).

Balance Sheet

The cash at bank at 31 October 2013 was £6,395,927 (30 April 2013: £1,491,320) and net assets amounted to £10,006,318 (30th April, 2013: £5,092,145)

SCIB1 melanoma vaccine

Clinical Trial

Additional encouraging results from the on-going Phase 1/2 clinical trial with SCIB1 in patients with Stage III/IV melanoma were announced today (see separate announcement).

In Part 1 of the study, 5/6 patients allocated to the 2mg and 4mg dose cohorts and who received at least three doses of SCIB1 produced a melanoma-specific immune response to treatment and 4/6 are still alive. In one of these patients all of the lung metastases showed partial or complete regression during treatment. All four surviving patients from Part 1 are still alive after a further 12 months on study. The median survival time from study entry in these two higher dose groups is now 25 months, although in three of these patients there is evidence of disease progression.

Part 2 of the study was conducted in 14 patients with resected Stage III/IV disease. All 14 patients (100%) produced a melanoma-specific SCIB1-induced T cell response to treatment. Only three patients have experienced progressive disease to date and all patients are still alive. The median survival time since initiating treatment with SCIB1 in Part 2 is currently 15 months and 21 months from diagnosis of metastatic disease. Six of these patients are continuing on extended, long-term treatment with SCIB1.

There have been no serious drug-related adverse events to date.

As a result of the positive results and minimal side effects seen with the 4mg dose, Scancell commenced evaluating an 8mg dose in parallel with Part 2 of the Phase 1/2 study. 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 III/IV 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 Part 1 study using the 8mg dose is 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. Data from this cohort of patients is expected in by 2014 calendar year end.

Moditope® vaccine technology platform

The Company has developed a new platform technology, Moditope® which has been used to develop the lead product, which will henceforth be described as Modi-1. Planning is underway for the preclinical and clinical development of Modi-1 as an immunotherapeutic, provisionally for the treatment of triple-negative breast cancer, ovarian and endometrial cancers. First in-man clinical studies are scheduled to start in 2016. Moditope® harnesses CD4+ cells to eradicate tumours and represents a new class of immunotherapeutic agents. The platform deploys citrullinated tumour-associated peptide epitopes to overcome self-tolerance and destroy tumour cells, with no requirement for blockade inhibitors (for example CTLA4 antibodies and PD-1 inhibitors). It can potentially be expanded to develop multiple immunotherapeutic agents for different cancers.

The ImmunoBody® platform induces a high avidity CD8+ T cell response to tumour associated antigens. As the Moditope® platform stimulates a potent CD4+ T cell response to modified self-antigens both platforms are complementary relying on a response by different classes of T cell for their therapeutic effect. Thus, in principle, a combination of ImmunoBody® and Moditope® derived therapeutics may be a powerful approach to the treatment of both early and late stage cancers.

Patents

A patent for Scancell’s 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 also been approved in the US, Europe, Japan and Australia.

A broad patent for Scancell’s Moditope® has been filed to protect this platform and covers the use of multiple tumour-associated modified epitopes for the treatment of cancer.

Ichor

Scancell signed an agreement with Ichor in July 2009 which 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 including an option over 1,592,310 shares upon regulatory approval to start clinical trials being granted in the UK.

Since the end of the period, Scancell has been granted an extension of The 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 agreed to waive the two year lock-in period following the exercise of Ichor’s options over 1,592,310 shares at 4.5p which have been subsequently placed on the market.

Share Capital – Placing and Open Offer

On 1st August 2013 the shareholders of the Company approved resolutions for; (i) the placing of 20,000,000 ordinary 0.1p shares at a price of 22.5p and (ii) an open offer to qualifying shareholders, who had not taken part in the placing, to subscribe for 8,888,888 ordinary 0.1p shares at a price of 22.5p. Following the approval of these resolutions the company raised £6.1m, net of costs.

Outlook

The results released today from Part 2 of the Phase 1/2 study with the SCIB1 vaccine in advanced melanoma support the encouraging results from Part 1 of the study reported last year. Importantly, we have confirmed that SCIB1 induces a consistent melanoma-specific immune response in Stage III/IV melanoma patients, especially in those with resected disease. Whilst the numbers are still small, the results suggest that SCIB1 may be contributing to prolonged survival by controlling tumour growth. We remain confident that, as further long-term data is generated, both in these patients and those treated with the higher 8mg dose, the clinical and commercial potential of Scancell’s ImmunoBody® vaccine approach will be fully apparent. The results from this trial to date have exceeded our highest expectations and support our belief that the highly targeted ImmunoBody® approach is delivering potent T cells that can control malignant disease and adds to the growing body of evidence that suggests that training T cells to target and control tumour growth could be of the most promising new ways of treating cancer. Furthermore, in patients with more extensive metastases, it is feasible that combining SCIB1 with the latest checkpoint inhibitor drugs, which allow T cells to work better within the tumour environment, may offer further patient benefit.

The discovery of the Moditope® platform technology and its ability to induce potent CD4+ T cells against tumour associated epitopes could add a new dimension to cancer immunotherapy and form the basis of a completely new class of immune-oncology treatments.

As previously indicated at the time of our investor update in October, in view of the short to medium term licensing and partnership potential that both the Moditope® and ImmunoBody® programmes now bring to the Company, our strategy requires a more flexible approach. Whilst we are still fully focused on securing a sale of the business at the earliest opportunity, we will also consider technology validating and revenue generating deals on each platform in order to enhance the value of the Company when it is sold.