Scancell Holdings Regulatory News (SCLP)

03 April 2018

The PolyPeptide Group appointed to manufacture Scancell's Modi-1-AMPLIVANT® conjugate

Modi-1-AMPLIVANT conjugate expected to enter clinic in H1 2019

Scancell Holdings plc, ('Scancell' or the 'Company'), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that it signed an agreement at the end of March 2018 with The PolyPeptide Group, one of the world's largest independent contract manufacturers of therapeutic peptides, for Good Manufacturing Practice (GMP) manufacture of its first Moditope® development candidate, Modi-1 - AMPLIVANT® conjugate.

As announced on 15 February 2018, ISA Pharmaceuticals B.V., The Netherlands, has granted Scancell an exclusive worldwide license to use AMPLIVANT® for the manufacture, development and commercialisation of the Modi-1-AMPLIVANT® conjugate therapy.

Scancell's Moditope® platform acts by stimulating the production of CD4+ T cells using citrullinated tumour-associated peptide epitopes. This technology overcomes the immune suppression induced by tumours themselves, allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system. Previous pre-clinical data demonstrated that conjugation of the Modi-1 peptides to AMPLIVANT® enhances anti-tumour immune responses 10-100 fold and resulted in highly efficient tumour eradication, including protection against tumour recurrence.

Scancell plans to commence a phase 1/2 clinical trial of Modi-1-AMPLIVANT® in H1 2019 in patients with triple negative breast cancer, ovarian cancer and sarcomas.

The PolyPeptide Group is a privately-held organisation which is estimated to manufacture over one third of all approved peptide drug substances and has an exclusive focus on pharmaceutical peptide manufacture.

Cliff Holloway, CEO of Scancell, commented: "We are delighted to sign a deal with The PolyPeptide Group to manufacture our Modi-1 vaccine. Commencing GMP manufacture is an important step in the development of our first Moditope® product and is key to moving this novel therapy into the clinic in the first half of 2019."

Jane Salik, CEO of The PolyPeptide Group, added: "We are very pleased to have been selected by Scancell to manufacture Modi-1-AMPLIVANT® as this recognises our capabilities and reputation as a world leading GMP-compliant manufacturer of therapeutic peptides."

For Further Information:

About The PolyPeptide Group

The PolyPeptide Group employs around 800 staff at sites in Belgium, France, India, Sweden and the USA and manufactures approximately a third of all synthetic peptide drug substances utilized in pharmaceutical products approved worldwide. It specializes in developing small- to large-scale production processes for proprietary peptides and has the capacity to deliver peptide drug substances for use in R&D, lead optimization, clinical trials and commercial applications.

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.

ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system. They can be used as monotherapy or in combination with checkpoint inhibitors. This platform has the potential to enhance tumour destruction, prevent disease recurrence and extend survival.

· SCIB1, the lead programme, is being developed for the treatment of melanoma. A phase 1/2 clinical trial has so far successfully demonstrated survival data of more than five years.

· SCIB2 is being developed for the treatment of non-small cell lung cancer and other solid tumours. Scancell has entered into a clinical development partnership with Cancer Research UK for SCIB2.

Moditope® represents a completely new class of potent and selective immunotherapy agents. It stimulates the production of killer CD4 T cells which overcome the immune suppression induced by tumours, allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system. Moditope® alone, or in combination with other agents, has the potential to treat of a wide variety of cancers.

· Modi-1 is being developed for the treatment of triple negative breast cancer, ovarian cancer and sarcomas.

For further details, please see our website: www.scancell.co.uk