MaxiVAX and Minaris Regenerative Medicine ink contract

Under the contract, Minaris will be responsible for the GMP manufacturing, freezing and shipping of MVX-ONCO-2, a cell-based immunotherapy for the treatment of cancersm to the clinical sites of a Phase II study in patients with chordoma. There, the autologous patients’ tumour cells will be processed 

MVX-ONCO-2 consists of two components: biocompatible capsules, loaded with a genetically modified cell-line that secretes a strong immune-booster GM-CSF (granulocyte-macrophage stimulating factor) and secondly, irradiated autologous patients’ tumour cells, which flag tumour antigens. To induce an efficient anti-tumour response against the patients’ own tumor cells, the encapsulated GM-CSF secreting cells are implanted subcutaneously at the site of tumor-cell vaccination.

The scope of the manufacturing agreement includes process development for scale-up and technology transfer with the goal of supplying Phase II and III clinical studies initially in the EU and eventually in the United States. Services will be performed at Minaris’ European site near Munich, Germany.

The process transfer fulfills the first milestone obligation of MaxiVAX’s European Commission H2020 funded project – “MaxONCO”. In January 2020, MaxiVAX initiated a two- and half-year project under the SME Instrument Phase 2 H2020 Programme, for which MaxiVAX was awarded € 2,785,300. The SME Instrument supports high-potential small and medium-sized enterprises to help them develop and bring onto the market new innovative products, services and business models that could drive economic growth.