Scancell Holdings plc, (Scancell), the developer of novel immunotherapies for the treatment of cancer, announced that it has 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 and it is expected to enter clinic in H1 2019.
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.”