Company News: ISA Pharmaceuticals and Scancell enter collaboration agreement for the manufacturing, development and commercialisation of Modi-1 / AMPLIVANT® combination


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

— Collaboration seeks to further leverage Moditope® platform

ISA Pharmaceuticals B.V. (‘ISA’), a clinical-stage immunotherapy company, and Scancell Holdings plc, (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, are pleased to announce that they have entered into a worldwide licensing and collaboration agreement to use ISA’s AMPLIVANT® adjuvant technology for the manufacturing, development and commercialisation of Scancell’s first Moditope® development candidate, Modi-1.

This partnership has the potential to provide a new treatment option for patients with triple negative breast cancer, ovarian cancer, sarcomas, and other solid tumours.

Under the terms of this agreement, ISA has granted Scancell an exclusive worldwide license to manufacture, develop and commercialise the AMPLIVANT®:Modi-1 conjugate therapy and will contribute know-how and expertise related to AMPLIVANT®. Clinical studies will be conducted by Scancell and are expected to commence in H1 2019.

In return, ISA will receive an upfront payment from Scancell and is entitled to milestone and royalty fees following achievement of certain criteria as defined in the agreement.  Financial details were not disclosed.

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 re-challenge.

ISA’s AMPLIVANT® technology can be applied to any type of targeted immunotherapy, significantly enhancing its efficacy.  It is based on a proprietary and synthetic small molecule TLR1/2 ligand with enhanced immunostimulatory activity that can be chemically coupled to the respective immunotherapeutic. AMPLIVANT® conjugates allow lower dosing with higher efficacy through better dendritic cell antigen processing and presentation, as well as enhanced T cell priming.

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.

“This collaboration is an important step to advance new adjuvant technologies such as AMPLIVANT® to clinical-stage programmes and bring patients better treatments,” said Ronald Loggers, CEO of ISA Pharmaceuticals.  “The partnership will further validate the power of AMPLIVANT® conjugates for use in therapeutic cancer vaccines that carry a variety of epitopes, including post-translationally modified epitopes such as Scancell’s Moditope® products.”

Cliff Holloway, CEO of Scancell, commented:  “This collaboration with ISA Pharmaceuticals is an important step in the continued development and commercialisation of our first Moditope® immunotherapy, Modi-1, which has the potential to treat patients with triple negative breast cancer, ovarian cancer and sarcoma who are resistant to other immunotherapies.  Our pre-clinical studies have demonstrated Modi-1 induces potent anti-tumour responses and significant improvements in survival.  We believe that combining Modi-1 with an enabling adjuvant technology such as AMPLIVANT® has the potential to significantly enhance its efficacy in patients and we are looking forward to moving this important and novel therapy into the clinic in the first half of 2019.”