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MaxiVAX and Minaris strike immunotherapy manufacturing partnership deal

22 Feb 2021

The manufacturing agreement includes process development for scale-up and technology transfer with the goal of supplying Phase II and III clinical studies

MaxiVAX has tapped cell and gene specialist CDMO, Minaris Regenerative Medicine, to manufacture MVX-ONCO-2, the Swiss clinical-stage biotech's cell-based immunotherapy for the treatment of cancers such as chordoma, head and neck, and other solid tumours.

Operating from its European site in Ottobrunn near Munich, Germany, Minaris will be responsible for the GMP manufacturing, freezing and shipping of the MVX-ONCO-2 capsules, which will be delivered to clinical sites. The autologous patients’ tumour cells will be processed at the clinical sites.

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 US.

The cancer immunotherapy 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 irradiated autologous patients’ tumour cells, isolated from patients which serve as tumour antigens.

To induce an efficient anti-tumour response against the patients’ own tumour cells, the encapsulated GM-CSF secreting cells are implanted subcutaneously at the site of tumour-cell vaccination.

MaxiVAX said the transfer of manufacturing process to generate commercial grade MVX-ONCO-2, also fulfills the first milestone obligation of its European Commission H2020 funded project, MaxONCO, under which it 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.

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