Proposed placing to raise up to £5.0 million

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION.

Scancell Holdings plc

(“Scancell” or the “Company”)

Proposed Placing to raise up to £5.0 million

Funds raised will be used to initiate the clinical development of Modi-1, the first product from the Moditope® platform, and to continue to support the ImmunoBody® platform pipeline

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, today announces a proposed placing of new Ordinary Shares in the Company (the “Placing Shares”) with existing and new institutional and professional investors to raise up to £5.0 million, before expenses, for the Company (the “Placing”).

The net proceeds of the Placing will be used to support the Company’s clinical development pipeline of novel cancer immunotherapies, in particular to initiate clinical development of the first product from the Moditope® platform, Modi-1, and to continue to support the pipeline arising from the ImmunoBody® platform. The Placing is within the Company’s existing allotment authorities granted at its prior annual general meeting.

The Chairman of the Company is expected to participate in the Placing with the intention to acquire approximately one million Placing Shares.

Dr Richard Goodfellow, Chief Executive Officer of Scancell, commented:

“We continue to make significant progress with both our ImmunoBody® and Moditope® platforms and believe that success in further clinical studies should add significant value to the Company."

“This proposed funding will principally allow us to begin clinical development of Modi-1, the lead product from our Moditope® platform. Compelling pre-clinical data suggests that Modi-1 should be effective in up to 90% of patients with triple negative breast cancer, up to 95% of patients with ovarian cancer and up to 100% of patients with sarcoma. We expect to begin a phase I/II study in sarcomas, breast and ovarian cancers in Q3 2018 with first efficacy and safety data expected in Q3 2019."

“Additionally, we will use funds for on-going support of SCIB1, the lead product from our Immunobody® platform, as we prepare to submit an Investigational New Drug application to the FDA in Q3 2017 ahead of our planned SCIB1 plus checkpoint inhibitor Phase II trial in Stage III/IV metastatic melanoma patients.”

The Placing will be conducted by way of an accelerated bookbuilding process (the “Bookbuild”) which will be launched immediately following this announcement in accordance with the Terms and Conditions set out in Appendix II. The Placing Shares are not being made available to the public. It is envisaged that the Bookbuild will be closed no later than 4.30 p.m. London time today, 11 May 2017.

Panmure Gordon (UK) Limited (“Panmure Gordon”) is acting as Financial Adviser, Nominated Adviser and sole Bookrunner to the Company in relation to the Placing.

Further information about the Company and the Placing is set out in Appendix I. Capitalised terms not otherwise defined in the text of this Announcement are defined in Appendix III.

The Market Abuse Regulation ("MAR") became effective from 3 July 2016. Market Soundings, as defined in MAR, were taken in respect of the proposed Placing with the result that certain persons became aware of inside information, as permitted by MAR. That inside information is set out in this announcement and has been disclosed as soon as possible in accordance with paragraph 7 of article 17 of MAR. Therefore, those persons that received inside information in a Market Sounding are no longer in possession of inside information relating to the Company and its securities. The person responsible for arranging the release of this announcement on behalf of the Company is Dr Richard Goodfellow, a director of the Company.

For further information, please contact:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley/Duncan Monteith (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)    
Mo Noonan/Simon Conway FTI Consulting +44 (0) 20 3727 1000

 

Read the full article here

Change of Registered Office

Scancell Holdings Plc

("Scancell" or the "Company")

Change of Registered Office

Scancell Holdings plc ('Scancell' or the 'Company'), the developer of novel immunotherapies for the treatment of cancer, announces that it has changed its registered office address.

The new registered office address for Scancell is:

John Eccles House
Robert Robinson Avenue
Oxford Science Park
Oxford OX4 4GP

For Further Information:

Scancell Holdings Plc

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon (UK) Limited +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)   +44 (0) 20 7886 2500
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.  Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects.  In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence. 

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. 

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.  Experimental data suggests that the high avidity T cells induced by ImmunoBody® vaccines increase expression of PDL-1 on the tumour cell surface, thereby making the tumours more sensitive to checkpoint inhibitor drugs.  Re-challenging animals with tumour cells after SCIB1 treatment resulted in 100% survival suggesting that ImmunoBody® induces a powerful memory response.  Such an effect has not been observed with checkpoint inhibitors. 

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 to present at the Immuno-Oncology Summit Europe 2017

Professor Lindy Durrant, Scancell’s CSO, to chair and present in a session entitled: “Combining Checkpoint Inhibitors with Other Modalities”

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces that it will be participating in the upcoming Inaugural Combination Immunotherapy meeting, part of the Second Annual Immuno-Oncology Summit Europe 2017, 20-24 March 2017 at the Hilton Canary Wharf, London, UK, alongside other industry leaders from Merck, Sharp and Dohme, Brystol-Myers Squibb and Cancer Research UK.

Prof. Lindy Durrant, Ph.D., Chief Scientific Officer of Scancell and Professor of Cancer Immunotherapy, University of Nottingham, will chair the session entitled: “Combining Checkpoint Inhibitors with Other Modalities” on Thursday 23 March 2017. Prof. Durrant is also featured as a presenter in this session and will deliver a presentation entitled: “Combinations of Novel Vaccines with Checkpoint Inhibitors”, scheduled to take place at 14.20 GMT.

During the presentation, Prof. Durrant will discuss progress made with Scancell’s two cancer immunotherapy platforms, ImmunoBody® and Moditope®.
ImmunoBody® utilises both cross- and direct-presentation to increase T-cell avidity by 100 fold. In Phase 1/2 trials, it induced T-cell responses, tumour regression and long term survival. In combination with checkpoint inhibitors, it induced 100% tumour regression in established models. Phase 2 trials of ImmunoBody® vaccines in combination with checkpoint inhibitors in melanoma and non-small cell lung cancer are being planned.

Moditope® stimulates powerful anti-tumour T-cell responses against neo-epitopes produced by enzymes induced by cellular stress. First-in-man clinical studies for breast cancer, ovarian cancer and osteosarcoma are anticipated to commence in 2018.

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)   +44 (0) 20 7886 2500
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. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

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.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone. Experimental data suggests that the high avidity T cells induced by ImmunoBody® vaccines increase expression of PDL-1 on the tumour cell surface, thereby making the tumours more sensitive to checkpoint inhibitor drugs. Re-challenging animals with tumour cells after SCIB1 treatment resulted in 100% survival suggesting that ImmunoBody® induces a powerful memory response. Such an effect has not been observed with checkpoint inhibitors.

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.

About Immuno-Oncology Summit Europe 2017
Following the success of our inaugural Cancer Biotherapeutics conference in London, we are pleased to announce the Immuno-Oncology Summit Europe 2017, to be held 20-24 March in the heart of London’s Canary Wharf Business District.

With an expanded three-track program, attendees can now experience a full week of cutting-edge science and discussion. The first track on Novel Approaches for Cancer focuses on advances in T-cell technology including next-generation CAR Ts, TCRs, and TILs. In addition it covers bispecifics: for T and NK cell engagement; in the clinic; and modelling for optimal affinity. The track also presents genetic engineering technologies for T cells, preclinical models, and production strategies, and focuses on specificity, off-target tox, and safety. The second track on Immunomodulatory Approaches will present advances with checkpoint inhibitors, agonistic receptor engagement, NK and macrophage activation, Fc-engineering technologies, and cytokine-based therapies, and address the challenge of tumours unresponsive to checkpoint blockade. It includes a keynote session on current understanding of the role of the immune system in cancer. Combination Immunotherapy will review the strategies and clinical trials for designing rational combination immunotherapies, provide case studies of immune modulator combinations, as well as combinations of checkpoint inhibitors with other modalities, and discuss biomarker- and mechanism-based selection of IO combinations.

ALCMI - Scancell Collaboration in Lung Cancer

Addario Lung Cancer Medical Institute and Scancell Holdings PLC Form Partnership to Advance Lung Cancer Vaccine Clinical Trials

Collaboration builds a world-class network to develop innovative treatment alternatives for lung cancer patients

(January 30, 2017) — The Addario Lung Cancer Medical Institute (“ALCMI”), the Bonnie J. Addario Lung Cancer Foundation (“ALCF”) and Scancell Holdings PLC (“Scancell”) today announce a collaboration to evaluate the use of Scancell’s second innovative cancer vaccine, SCIB2, from its ImmunoBody® platform to treat non-small cell lung cancer (“NSCLC”).

Scancell’s ImmunoBody® cancer vaccine platform is a novel immunotherapy treatment under development that stimulates the immune system to potentially treat and prevent cancer. The Company recently successfully completed a Phase 1/2 clinical trial with SCIB1 in patients with melanoma.

The Addario Advanced Collaboration Program brings patients into clinical trials from ALCMI’s extensive research consortium of international researchers and member institutions and ALCF’s patient support programs. ALCMI plans to assist Scancell in the design and development of a Phase 1/2 clinical trial with SCIB2 in patients with NSCLC which is planned to begin in 2018 and complete approximately 18 months later.

“This partnership enables us to access an important clinical program that could also accelerate the development of this groundbreaking immunotherapy technology,” said ALCMI President and COO Steven Young. “Combining our two foundations’ unique resources will increase patient engagement with the goal to bring new treatment options to non-small cell lung cancer patients,” added Bonnie J. Addario, a 12-year lung cancer survivor and founder and chair of ALCF and founder of ALCMI.

According to the Centers for Disease Control and Prevention, lung cancer accounts for 27 percent of all cancer deaths, more than breast, prostate and colon cancer combined. More than 228,000 people receive a cancer diagnosis in the United States alone and more than 160,000 will not survive. It remains one of the most difficult cancers to treat.

“Immunotherapy has dramatically improved many patients' outcomes across various cancer types. One of the next steps is how we can further enhance the immune response to cancer. Early clinical data on ImmunoBody® suggests it is extremely well tolerated and may significantly improve outcomes, which would be ideal. I'm excited to work with Scancell and hopeful that we will take another important step in the fight against lung cancer,” said Jacob M. Sands, MD, assistant professor, medical oncology, Lahey Hospital & Medical Center in Burlington, Massachusetts.

SCIB2 has the potential to complement existing treatments and has potential value where current treatments either do not work or are not available. By stimulating immune responses to specific lung cancer antigens, SCIB2 should assist the body in targeting and fighting NSCLC, leading to longer survival rates.

“We have generated preclinical data that suggests that SCIB2 could be the ideal complement to existing and emerging checkpoint inhibitor therapies to treat NSCLC and so provide an effective new potential treatment option for patients with this devastating disease,” said Scancell CEO Richard Goodfellow.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

Addario Lung Cancer Medical Institute

Julia Spiess Lewis Perry Communications Group +1 916-658-0144
[email protected]

 

Scancell Holdings Plc

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)   +44 (0) 20 7886 2500
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

 

About the Addario Lung Cancer Medical Institute (ALCMI)
The Addario Lung Cancer Medical Institute (ALCMI, voiced as “Alchemy”) was founded by advanced stage lung cancer survivor Bonnie J Addario in 2008 as a nonprofit organization. Working in tandem with our “partner” foundation the Bonnie J. Addario Lung Cancer Foundation (ALCF), ALCMI and ALCF contribute resources and join together to power collaborative, patient-centric initiatives in genetic (molecular) testing, therapeutic discoveries, targeted treatments and early detection. ALCMI overcomes barriers to collaboration via a world-class team of investigators from 25 institutions in the USA, UK and Europe, supported by dedicated research infrastructures such as centralized project management and biorepositories and data systems. ALCMI directly facilitates research by combining scientific expertise found at leading academic institutions with patient access through our network of community cancer centers – accelerating novel research advancements to lung cancer patients. Byproviding access to critical masses of patient stakeholders, academic, community and industry researchers, ALCMI, in partnership with the ALCF, is making progress towards its goal of transforming lung cancer into a chronically managed disease by 2023.

About the Addario Advanced Collaboration Program
The Addario Advances Collaboration Program accelerates novel therapeutic medical device and diagnostics into patient trials. The program incentivizes the collaboration of the non-profit community and emerging life science companies to reduce development times, improve clinical trial designs, reduce costs and, most critically, accelerates more effective diagnostics and therapies to lung cancer patients globally.

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. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

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.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone. Experimental data suggests that the high avidity T cells induced by ImmunoBody® vaccines increase expression of PDL-1 on the tumour cell surface, thereby making the tumours more sensitive to checkpoint inhibitor drugs. Re-challenging animals with tumour cells after SCIB1 treatment resulted in 100% survival suggesting that ImmunoBody® induces a powerful memory response. Such an effect has not been observed with checkpoint inhibitors.

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.

SCIB1 Clinical Study Report

Report confirms robust survival in late stage melanoma patients

SCIB1 Phase 2 combination study on track; IND expected to be filed in H1 2017

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, today announces that the Clinical Study Report (CSR) on the SCIB1 Phase 1/2 clinical trial in patients with Stage III/IV malignant melanoma has been completed on schedule.

The Clinical Study Report includes safety, immunology and clinical data from all patients with Stage 3/4 melanoma up to 29 October 2015, the date of the last patient’s final dose in the main study. The main conclusions of the CSR are:

  • SCIB1 was safe and well tolerated over a dose range of 0.4 to 8mg with no serious adverse events related to SCIB1.
  • There was clear evidence of an immune response in most patients receiving SCIB1. There were significantly stronger responses to the 8mg dose than to the 2/4mg doses, indicating that this is the appropriate dose for future studies.
  • Immune responses were stronger in patients without tumour present at study entry than in patients with detectable tumour; SCIB1 may therefore be particularly effective as monotherapy in early stage patients with a low tumour burden. Continued and broader responses were seen for up to two years of treatment with SCIB1, suggesting that patients may derive benefit from long term administration.
  • In the nine patients with tumour present at screening who received either a 4mg or 8mg dose of SCIB1, there was evidence of clinical activity in two patients; one had a partial response by RECIST and a second patient had a greater than 30% reduction in tumour size in target lesions but progression in a non-target lesion.
  • In the 20 patients with no detectable tumour at screening, disease-free survival was much higher than expected based on historical comparisons.

Updated survival and disease recurrence data are as follows:

  • Currently 19 of the 20 patients with resected tumours at study entry remain alive
  • Of the 16 resected patients who received 2/4mg doses of SCIB1;
  • Median observation time since entry is 52 months and 58 months since first diagnosis of metastatic disease
  • Only five patients have progressed and one has died
  • One patient in this group has now reached their 5-year post-treatment survival time point;
  • Of the four resected patients who received 8mg doses of SCIB1 (recruited after lower dose cohorts)
  • Median observation time since entry is 21 months and 27 months since first diagnosis of metastatic disease
  • All patients are alive
  • Two of these patients experienced recurrence of their melanoma in Q4 2016 following early termination of their treatment in June 2016 pending manufacture of new SCIB1 supplies. One patient had received only one further dose of SCIB1 and the other had received two doses after the end of the main study period. Immune analysis from the patients recruited earlier suggests that patients may benefit from up to two years continuous treatment to effectively delay or prevent recurrence.

The Clinical Study Report will support the Company’s Investigational New Drug (IND) Application for SCIB1 which is anticipated to be filed with Food and Drug Administration (FDA) in H1 2017 subject to the outcome of the pre-IND meeting planned for Q1 2017. Scancell is expecting to conduct a Phase 2 checkpoint inhibitor combination study with SCIB1 in melanoma in 2017, led by Principal Investigator Dr Keith Flaherty, Director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital and Associate Professor at Harvard Medical School. A key objective of this important study will be to evaluate safety and response rates in melanoma patients administered SCIB1 in addition to a checkpoint inhibitor compared to the checkpoint inhibitor alone.

Dr Richard Goodfellow, CEO of Scancell, said: “We are pleased that the Clinical Study Report on our SCIB1 Phase 1/2 clinical trial in patients with melanoma has now been finalised, and will be able to support our US IND submission. We are very encouraged by the compelling survival data generated in this study which now demonstrates a median observation time since trial entry of more than four years for the 16 patients with resected tumours and receiving 2/4 mg doses of drug. This is supported by our long-term immune analysis that suggests continued dosing of SCIB1 may control disease in resected patients."

“We continue to expect to file our IND for SCIB1 in the first half of 2017, and to start our US clinical study of SCIB1 in combination with a checkpoint inhibitor next year. We look forward to updating the market further on these plans in due course.”

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO    
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)    
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. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

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.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone. Experimental data suggests that the high avidity T cells induced by ImmunoBody vaccines increase expression of PDL-1 on the tumour cell surface, thereby making the tumours more sensitive to checkpoint inhibitor drugs. Re-challenging animals with tumour cells after SCIB1 treatment resulted in 100% survival suggesting that ImmunoBody induces a powerful memory response. Such an effect has not been observed with checkpoint inhibitors.

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.

Research Update - Amendment

This replaces the announcement number 0710T made on 3 January 2017 at 7:00am GMT due to the following amendment:

  • In the quote by Dr Richard Goodfellow, "next year" is replaced by "in the second half of the year".

All other details remain unchanged. The full amended text is shown below.

3 January 2017

Scancell Holdings Plc

("Scancell" or the "Company")

Final SCIB1 Phase 1/2 Clinical Study Report completed on schedule

Report confirms robust survival in late stage melanoma patients

SCIB1 Phase 2 combination study on track; IND expected to be filed in H1 2017

Scancell Holdings plc, ('Scancell' or the 'Company') the developer of novel immunotherapies for the treatment of cancer, today announces that the Clinical Study Report (CSR) on the SCIB1 Phase 1/2 clinical trial in patients with Stage III/IV malignant melanoma has been completed on schedule.

The Clinical Study Report includes safety, immunology and clinical data from all patients with Stage III/IV melanoma up to 29 October 2015, the date of the last patient's final dose in the main study.  The main conclusions of the CSR are:

  • SCIB1 was safe and well tolerated over a dose range of 0.4 to 8mg with no serious adverse events related to SCIB1.
  • There was clear evidence of an immune response in most patients receiving SCIB1.  There were significantly stronger responses to the 8mg dose than to the 2/4mg doses, indicating that this is the appropriate dose for future studies.
  • Immune responses were stronger in patients without tumour present at study entry than in patients with detectable tumour; SCIB1 may therefore be particularly effective as monotherapy in early stage patients with a low tumour burden.  Continued and broader responses were seen for up to two years of treatment with SCIB1, suggesting that patients may derive benefit from long term administration.
  • In the nine patients with tumour present at screening who received either a 4mg or 8mg dose of SCIB1, there was evidence of clinical activity in two patients; one had a partial response by RECIST and a second patient had a greater than 30% reduction in tumour size in target lesions but progression in a non-target lesion.
  • In the 20 patients with no detectable tumour at screening, disease-free survival was much higher than expected based on historical comparisons.

Updated survival and disease recurrence data are as follows:

  • Currently 19 of the 20 patients with resected tumours at study entry remain alive
  • Of the 16 resected patients who received 2/4mg doses of SCIB1
    • Median observation time since entry is 52 months and 58 months since first diagnosis of metastatic disease
    • Only five patients have progressed and one has died
    • One patient in this group has now reached their 5-year post-treatment survival time point
  • Of the four resected patients who received 8mg doses of SCIB1 (recruited after lower dose cohorts)
    •  Median observation time since entry is 21 months and 27 months since first diagnosis of metastatic disease
    •  All patients are alive
    • Two of these patients experienced recurrence of their melanoma in Q4 2016 following early termination of their treatment in June 2016 pending manufacture of new SCIB1 supplies.  One patient had received only one further dose of SCIB1 and the other had received two doses after the end of the main study period.  Immune analysis from the patients recruited earlier suggests that patients may benefit from up to two years continuous treatment to effectively delay or prevent recurrence

The Clinical Study Report will support the Company's Investigational New Drug (IND) Application for SCIB1 which is anticipated to be filed with Food and Drug Administration (FDA) in H1 2017 subject to the outcome of the pre-IND meeting planned for Q1 2017.  Scancell is expecting to conduct a Phase 2 checkpoint inhibitor combination study with SCIB1 in melanoma in 2017, led by Principal Investigator Dr Keith Flaherty, Director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital and Associate Professor at Harvard Medical School.  A key objective of this important study will be to evaluate safety and response rates in melanoma patients administered SCIB1 in addition to a checkpoint inhibitor compared to the checkpoint inhibitor alone.

Dr Richard Goodfellow, CEO of Scancell, said:  "We are pleased that the Clinical Study Report on our SCIB1 Phase 1/2 clinical trial in patients with melanoma has now been finalised, and will be able to support our US IND submission.  We are very encouraged by the compelling survival data generated in this study which now demonstrates a median observation time since trial entry of more than four years for the 16 patients with resected tumours and receiving 2/4 mg doses of drug.  This is supported by our long-term immune analysis that suggests continued dosing of SCIB1 may control disease in resected patients."

"We continue to expect to file our IND for SCIB1 in the first half of 2017, and to start our US clinical study of SCIB1 in combination with a checkpoint inhibitor in the second half of the year.  We look forward to updating the market further on these plans in due course."

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)   +44 (0) 20 7886 2500
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.  Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects.  In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

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.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.  Experimental data suggests that the high avidity T cells induced by ImmunoBody® vaccines increase expression of PDL-1 on the tumour cell surface, thereby making the tumours more sensitive to checkpoint inhibitor drugs.  Re-challenging animals with tumour cells after SCIB1 treatment resulted in 100% survival suggesting that ImmunoBody® induces a powerful memory response.  Such an effect has not been observed with checkpoint inhibitors.

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 to present at the World Immunotherapy Congress in Basel and at the Biotech and Money Inv€$tival Showcase in London

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces that it will be presenting at the World Immunotherapy Congress being held on 14-16 November 2016 in Basel, Switzerland and at the Biotech and Money Inv€$tival Showcase on 18 November 2016 in London, UK.

At the World Immunotherapy Congress, Professor Lindy Durrant, Chief Scientific Officer of Scancell, will be presenting: “SCIB1, SCIB2 and Moditope novel cancer vaccines” at 11:25am on 16 November 2016 as part of the Cancer Vaccines segment.

At the Biotech and Money Inv€$tival Showcase, Dr Richard Goodfellow, Chief Executive Officer of Scancell, will be presenting an overview of the Company at 10:45am on 18 November 2016. Dr Richard Goodfellow will also be available to participate in one-on-one meetings with investors who are registered to attend the conference.

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)


 

+44 (0) 20 7886 2500
Mo Noonan/Simon Conway FTI Consulting +44 (0) 20 3727 1000

 

About The World Immunotherapy Congress
Immunotherapy currently offers the brightest hope for cancer treatment. New developments with checkpoint inhibitors and co-stimulatory targets have enabled some stunning breakthroughs and high optimism for the
sector. Recently, there have been some incredibly exciting new therapies in the field.

Our vision is to bring together the full community and provide a single meeting point for the whole value chain. It is where science meets business to make immunotherapy the cornerstone of the fight against
cancer.

The event is new, though the ideas and relationships are not. The event comes out of our discussions with leading clinicians, pharmaceutical companies, biotechs and research institutes held every year at the
successful European Antibody Congress, now in its twelfth successful year.


About The Biotech and Money Inv€$tival Showcase
Biotech and Money connects corporates to capital, and we have partnered with Jefferies for Inv€$tival to showcase the latest investable private and public life science opportunities.

Presenting companies will range from the latest start-ups through to growing public companies, delivering succinct powerful presentations to an audience of global investors and pharma. All companies will also have
their presentations recorded and a corporate interview video produced, forming a full corporate profile on the exclusive Biotech and Money Investor Portal.

For investors, Inv€$tival will help uncover and identify investable opportunities. And all of this in collaboration and with backing from the global investment bank Jefferies, co-located with their annual London Healthcare Conference.

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. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour
load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

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.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer
survival times than when either treatment was used alone.
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.

Results of AGM

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, announces that all resolutions proposed at the Annual General Meeting held today were duly passed.
For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)   +44 (0) 20 7886 2500
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. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

Scancell’s ImmunoBody® treatments 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+ 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.