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Scancell to collaborate with BioNTech to investigate T cell receptor based therapeutics for the treatment of cancer 

Agreement expands potential therapeutic utility of Moditope® to adoptive T cell therapy 

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that it has entered into a research collaboration with BioNTech for the potential development of innovative, T cell receptor based therapeutics for the treatment of cancer. This research collaboration combines Scancell’s Moditope® immunotherapy platform and BioNTech’s platform technology for high-throughput cloning and characterisation of naturally selected T cell receptors. 

Moditope® represents a completely new class of potent and selective immunotherapy agents which could have a profound effect on the way that cancer immunotherapies are developed. It acts by stimulating the production of CD4+ T cells using citrullinated tumour-associated peptide epitopes which overcome self-tolerance and destroy tumour cells. The technology overcomes the immune suppression induced by tumours themselves without the need for checkpoint blockade inhibitors, thereby allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system.

Under the terms of the agreement, Scancell and BioNTech will enter into an initial research collaboration to discover and characterise T cell receptors specific for citrullinated epitopes from vimentin and enolase. These epitopes form the basis of Scancell’s first Moditope® development candidate, Modi-1. Upon completion of these studies, BioNTech will have the exclusive option to enter into a licence agreement for the development of cell receptor based therapeutics that are specific to Modi-1 epitopes. 

Prof Lindy Durrant, Chief Scientific Officer of Scancell, commented: “We are delighted to be working with BioNTech, one of Europe’s new immuno-oncology power-houses, to investigate the development of targeted immunotherapies for the treatment of cancer. Pre-clinical data from our Moditope® platform has shown unprecedented anti-tumour effects can be delivered without the need for checkpoint inhibition. We believe that this, combined with BioNTech’s engineered T cells specific to Moditope® epitopes, could have great potential as a novel immunotherapy.”

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

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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. 

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours with minimal 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 BioNTech

BioNTech is Europe’s largest privately held biopharmaceutical company pioneering the development of individualized therapies for cancer and other diseases. The company combines all building blocks for individualized immunotherapy under one roof – from diagnostics and drug development to manufacturing. Its cutting-edge technologies range from individualized mRNA-based medicines through innovative chimeric antigen receptors and T-cell receptor-based products to novel checkpoint immunomodulators and small molecules. BioNTech’s approach is validated by five top-tier corporate partnerships with Genentech, Genmab, Eli Lilly and Company, Sanofi and Bayer Animal Health. Founded in 2008, BioNTech’s financial shareholders include the Struengmann Family Office as majority shareholder, MIG Fonds, Salvia, Redmile Group, Janus Henderson Investors, Invus, Fidelity Management & Research Company and several European family offices.

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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 were duly passed.

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. 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.

 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.

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Landmark five year survival achieved in resected SCIB1 patients

Emerging pipeline of three products across five cancer

Scancell Holdings plc, (‘Group’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces results for the year ended 30 April 2017.

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Highlights

• Strong survival data for patients with Stage III/IV malignant melanoma on SCIB1 Phase 1/2 clinical trial
  •  8 of 20 patients with resected disease remain alive, survival well beyond established norms
  •  Of the 16 resected patients who received a 2-4mg dose of SCIB1, seven patients have now survived for five years since starting treatment and only six patients have had recurrence of their disease, of whom, two have died
  •  Final Clinical Study Report completed in December 2016 which included safety, immunology and clinical data from patients with Stage III/IV melanoma up to 29 October 2015
• Investigational New Drug (IND) application for SCIB1 Phase 2 checkpoint inhibitor combination study expected to be submitted in early 2018, with patient enrolment planned for 2018
• Continued good progress in development of Modi-1, our lead product from the Moditope® platform
  • Ultra-efficient linked adjuvant identified that works at up to 100-fold lower doses than could be achieved previously
  • Aiming to file a Clinical Trial Application (CTA) in the UK for the planned Phase 1/2 clinical trial in breast cancer, ovarian cancer and sarcoma in 2018
  • Early feedback from the European Patent Office suggests that broad patent claims for the Moditope® platform may be allowable
• Opening of new offices in San Diego to support the Company’s US growth plans, and in Oxford for its UK corporate and development activities
• Loss for year of £3.5m (2016: loss £2.6m)
• Group cash balance at 30 April 2017 was £2.7m (30 April 2016: £6.5m)

Post Period Highlights:

• Raised £4.7m in a placing of new ordinary shares
  • Funds to be used to initiate the clinical development of Modi-1 and to continue to support the ImmunoBody® platform pipeline
• Patent granted in Europe for Scancell’s DNA ImmunoBody® technology
  • Counterparts to this patent have already been granted in the US, Australia and Japan

Dr Richard Goodfellow, CEO of Scancell, said:

“We have made further significant progress during the course of the past year on the development of our ImmunoBody® and Moditope® platforms.  We continue to report strong survival data in patients with Stage III/IV melanoma from our SCIB1 Phase 1/2 clinical trial, with survival times now exceeding five years in resected patients.

Moditope® is also progressing well with the identification of a new linked adjuvant for the first Modi-1 clinical trial in the UK in patients with breast cancer, ovarian cancer and sarcoma which is expected to increase the potency of the product up to 100-fold. We are continuing to explore a number of funding options to ensure that we have the resources to progress these programmes through their next phase and the Board believes that this funding could be best achieved following the execution of one or more partnerships on the ImmunoBody® or Moditope® platforms, on which significant progress has been made since the year end.”

For Further Information:

Scancell Holdings Plc

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.

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.

To download Press Release click here

CRI Moditope Poster 1

CRI Moditope Poster 2