Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces results for the year ended 30 April 2014.

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
  • Melanoma-specific immune response seen in all Part 2 patients
  • Continuing positive survival trend in Part 1 subjects
  • No serious adverse events reported
  • 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 preclinical and clinical development of Modi-1, lead vaccine from Moditope® platform underway
  • Provisionally positioned as a novel immunotherapeutic for the treatment of lung, triple-negative breast cancer, ovarian and endometrial cancers
  • 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 ImmunoBody®
  • Survival times are highly encouraging in both Part 1 and Part 2 patient groups
  • Melanoma-specific immune responses in 24 of 28 (86%) patients
  • Reduction in the number and size of multiple lung metastases in two patients
  • No serious adverse events reported

Richard Goodfellow, Joint CEO of Scancell, said: “The cumulative results emerging from our ongoing Phase 1/2 SCIB1 clinical trial, including the destruction of lung metastases in two patients and the apparent prolongation of survival, continues to add to the evidence that SCIB1 has the potential to extend lives without the burden of serious side effects. The rationale for combining SCIB1 and PD-1 blockade, confirmed in recent animal studies, is also compelling.

“Our ongoing Moditope® research continues to be productive as we continue to prepare Modi-1, our lead vaccine from this platform, for clinical trials which are on schedule to start in 2016.

“Cancer immunotherapy is emerging as one of most exciting areas of pharmaceutical research and development. Scancell now has two innovative technology platforms in this emerging field, both of which are expected to be of substantial interest to the increasing number of pharmaceutical companies establishing R&D programmes in the area. The Board remains dedicated to realising value for our shareholders as we continue to build upon the excellent data garnered to date.”

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For Further Information:

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 has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects.

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 T cells 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.

Combining SCIB1 with PD-1 blockade enhances tumour destruction and extends survival times

Scancell Holdings plc (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce new data demonstrating that animals treated with a combination of 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.

We have previously shown that administration of SCIB1 alone induced potent tumour-specific T cell responses associated with increased T cell infiltration into the tumour and enhanced proliferation of T cells within the tumour resulting in tumour rejection and long-term survival in 50% of animals. In our new study, PD-1 blockade, when used alone, resulted in tumour rejection and long-term survival in 55% of animals. However, the combination of PD-1 blockade with SCIB1 vaccination further enhanced T cell infiltration, resulting in tumour rejection and long-term survival in 85% of animals. These results highlight the potential benefits of combining SCIB1 with PD-1 blockade in the treatment of cancer.

Checkpoint inhibitors can enable the host immune system to recognise, attack and destroy cancer cells. However, checkpoint inhibitors cannot work on their own if the patient fails to mount an adequate immune response to the tumour. Taking the brake off immunosuppressive T cells with PD-1 blockade, whilst simultaneously pressing the accelerator with active immunotherapies such as SCIB1 is increasingly regarded as the logical next step towards overwhelming the disease and increasing efficacy. These data confirm for the first time that the combination of SCIB1 with PD-1 blockade enhances tumour destruction and prolongs survival in animal models.

Prof Lindy Durrant, Joint CEO of Scancell and Professor of Cancer Immunotherapy at Nottingham University, commented: “The rationale for combining SCIB1 and PD-1 blockade in the clinical setting is increasingly compelling. The high immune response rates demonstrated with our SCIB1 vaccine, teamed with the enhanced T cell infiltration using PD-1 blockade, prolongs survival and strongly supports the hypothesis that combining SCIB1 with checkpoint inhibitors will be even more effective in the treatment of cancer than when either treatment is used alone.”

For Further Information:

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 has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects.

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 T cells 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 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.” 

For Further Information:

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 Tlymphocyte 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 further encouraging results from its on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBody®. The updated data was presented in a poster at the 2014 American Society of Clinical Oncology (ASCO) meeting in Chicago on Sunday 1 June 2014.

The Phase 1/2 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. While the primary objective of the study is to access safety and tolerability, the secondary objectives are to evaluate cellular immune responses and to assess any tumour response.

Highlights

• SCIB1 is safe and well-tolerated, with no dose-limiting or grade 4/5 toxicities observed
• Five of 11 patients in Part 1 receiving 2, 4 or 8mg doses have shown evidence of a clinical response
• Part 1 patients receiving 2mg/4mg doses of SCIB1 had 1-year and 2-year survival rates of 100% and 67%, respectively
• All five Part 1 patients receiving 8mg doses of SCIB1 remain alive
• All 14 Part 2 patients with resected tumours are still alive 16-24 months after study entry (median 21 months); only three patients have disease progression
• 24 of 28 (86%) evaluable patients developed melanoma-specific immune responses
• Survival times are highly encouraging; only 2 of 25 patients receiving at least three doses of 2-8mg of SCIB1 have died since the study started in 2010
• Eight patients are currently on long term treatment with SCIB1

Prof Lindy Durrant, Joint CEO of Scancell and Professor of Cancer Immunotherapy at Nottingham University, commented:  “As positive and consistent data continues to emerge from this study, our confidence grows that SCIB1 will play an important role in the management of melanoma.  While recognizing the limitations of this open label trial, the results nonetheless detail a high rate of immune responders and a strong immune response with a drug that is well-tolerated and safe. The observation of objective clinical responses and apparent prolongation of survival further add to the evidence that SCIB1 has the potential to dramatically extend lives without the burden of serious side effects in this setting.”

Prof Poulam Patel, Chief Investigator for the trial and Professor of Clinical Oncology at the University of Nottingham, added: “The whole field of cancer immunotherapy is undergoing a fundamental transformation. Although checkpoint inhibitors are continuing to deliver clinical results, the long-term benefits are seemingly only apparent in around a third of patients.  Taking the brake off T cells with checkpoint inhibitors and pressing the accelerator with active immunotherapies such as SCIB1 may be an effective way of overwhelming the disease and increasing efficacy even further.”  

Part 1 higher dose 8mg study interim results (Stage IV disease only)

• All five patients with Stage IV disease remain alive with a median survival time of 11 months from study entry (range 8-12 months)
• One patient in this cohort has shown a pronounced reduction in lung metastases following SCIB1 treatment, meeting the RECIST* criteria for a partial response by Week 9 of treatment and has started continuation treatment. This is the second patient in the study to show an objective clinical response
• A further patient with breast and lung lesions at study entry remained stable for 6 months and is continuing treatment with SCIB1Four of the five patients produced an immune response to SCIB1
• Immune responses to the 8mg dose, measured by Elispot, were up to 10-fold higher than those seen in the lower dose 4mg group; high frequencies of melanoma-specific T cells exceeding 2% of total blood lymphocytes were observed

Part 1 lower dose 2mg/4mg study update (Stage III/IV disease)

• The four patients (of six) who were alive at the time of the December 2012 Part 1 report remain alive
• One patient had multiple tumour lesions which disappeared or decreased in size except for one lesion which was resected; the patient, who is still alive, has subsequently developed another lesion which was also resected
• Two further patients have remained disease-free for 18 and 35 months respectively, having required regular treatment and resection of metastases prior to SCIB1 treatment
• Median survival time in Part 1 patients who received at least three treatments with the 2mg/4mg doses of SCIB1 is now 30 months from study entry and 49 months since diagnosis of metastatic disease
• Five of six patients receiving 2mg/4mg doses of SCIB1 produced an immune response

Part 2 study update (Stage III/IV patients with resected tumours)

• All 14 study patients produced an immune response to SCIB1 treatment
• All patients are still alive after being on the study for between 16 and 24 months
• Only three patients have any evidence of disease progression after 4, 14 and 18 months on the study
• Median survival time of all Part 2 patients since initiating treatment is currently 21 months and 26 months since diagnosis of metastatic disease

Overall survival

Based on clinical staging according to the American Joint Committee on Cancer (Balch et al., Journal of Clinical Oncology 2009: 27(36), 6199-206), the 12 patients receiving SCIB1 therapy who had tumour present at study entry fall into the following categories: patients with advanced, visceral stage M1c disease (n=4); patients with disease restricted to M1a (n=1) or M1b (n=6) metastases and one patient with no distant metastases (M0). The other 16 patients all had fully-resected metastatic disease (Stage III or IV prior to surgery).

• Two M1c patients treated with 0.4mg of SCIB1 had rapidly progressing disease and died after 7 months on study - as expected for patients with visceral metastatic disease. The two other M1c patients received at least 4mg doses of SCIB1; one patient died after 13 months and the other is still alive 11 months after study entry
• The single M1a patient received 2mg/4mg doses and is still alive 38 months after study entry. One M1b patient treated with 0.4 mg of SCIB1 died 16 months after study entry. Of the other five M1b patients, one received 4 mg doses and four received 8 mg doses: they all remain alive. The current median survival time for the M1b patients is 12 months from study entry (range 8-28 months)
• Sixteen patients with fully-resected metastatic disease received either 2mg or 4mg doses of SCIB1 and all remain alive with a current median survival of 22 months (range 16-35) from trial entry. The nine Stage III patients have survived for a median of 26 months since their last resection prior to study entry and two patients have experienced a recurrence (22%). The seven Stage IV patients have survived for a median time of 24 months since their last resection prior to study entry, with two patients showing evidence of disease progression 18 and 20 months post-surgery; this compares extremely favourably with a SouthWest Oncology Group prospective study of resection in Stage IV melanoma patients in which the median overall survival (i.e., when 50% of the patients had died) was 21 months and the median recurrence-free survival was 5 months from the time of surgery (Sosman et al., Cancer 2011: 117(20), 4740-46)

Safety

• SCIB1 therapy was well tolerated in all patient groups with no reports of serious drug-related side effects

In conclusion, while this is a Phase 1/2 clinical study and patient numbers are relatively small, there is consistent evidence emerging from this trial that Scancell’s SCIB1 ImmunoBody® therapy can produce a reduction in tumour load as well as inducing a powerful immune response in late-stage melanoma patients. When taken together with the apparent delay in disease progression and increasingly extended survival data, these results are highly encouraging and clearly warrant the continued development of SCIB1 ImmunoBody® as a potentially powerful new addition for the treatment of this disease.

* RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments.

For Further Information:

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 Tlymphocyte 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, 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/.

The title, timing and location of the poster presentation is as follows:

For Further Information:

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 Tlymphocyte 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 plc is delighted to announce that Prof. Lindy Durrant, Joint CEO of the Company, will be presenting a paper entitled “Phase I/II trial of a novel antibody DNA immunotherapy, SCIB1 ImmunoBody which targets CD64, in the treatment of Melanoma” at SMi’s 3rd Annual Cancer Vaccine conference, 15-16 September 2014, in London. The paper will describe interim results, as at December 2013, from the Company’s ongoing Phase I/II trial. Of the 25 patients recruited at that time, 23 were treated with SCIB1 per protocol. Of these, 20 patients were considered to have shown an immune response

For further detail on the conference see: http://www.smi-online.co.uk/pharmaceuticals/uk/conference/cancer-vaccines

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.”

Schedule Two information:

Sally was a director of Winetraders (UK) Limited until December 2013.

There is no further information required to be disclosed pursuant to paragraph (g) of Schedule To of the AIM Rules for Companies.

 For Further Information:

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, today announces that interim data from its Immunobody® (SCIB1) Phase I/II clinical trial in patients with Stage III/IV melanoma will be presented at the upcoming American Association for Cancer Research annual meeting (AACR) in San Diego, California, 5-9 April 2014.

Dr Lindy Durrant, Joint CEO of Scancell, will present results from the clinical study in the AACR Conference Session CT331 “Immunotherapeutic Trials, Immune Response to Targeted Agents, and Prevention” which is scheduled to be held between 1pm and 3pm PDT on Tuesday, 8 April 2014.

AACR is the premier cancer research event with about 18,000 researchers, patient advocates, and other professionals in the cancer field from around the world scheduled to be in attendance. It provides a unique opportunity for members of the worldwide cancer research community to learn about cutting-edge advances, obtain feedback on their own research, and make connections that will foster future collaborations. The theme for this year’s meeting, “Harnessing Breakthroughs – Targeting Cures,” reflects the fact that the translation of basic science into clinical advances for the benefit of cancer patients is occurring at an increasing pace and more seamlessly than ever before.

All abstracts and details on timings can be accessed through the AACR website: http://www.aacr.org/home/scientists/meetings--workshops/aacr-annual-meeting-2014.aspx

The title, timing and location of the poster presentations are as follows:

For Further Information:

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 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:

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

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.