MaxiVAX and Minaris Regenerative Medicine have entered into a manufacturing agreement for MVX-ONCO-2, a cell-based immunotherapy for the treatment of cancers such as chordoma, head and neck, and other solid tumors.
The treatment consists of two components: biocompatible capsules, loaded with a genetically modified cell-line that secretes an immune-booster GM-CSF (granulocyte-macrophage stimulating factor) and irradiated autologous patients’ tumour cells, isolated from patients which serve as tumor antigens. To induce an 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.
Minaris will be responsible for the 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 United States. Services will be performed at Minaris’ European site in Ottobrunn near Munich, Germany.
“We are excited to support MaxiVAX with their innovative product,” said Dusan Kosijer, CEO of the European operations of Minaris. “Their unique approach on cancer immunotherapies addresses a significant unmet medical need for patients with difficult-to-treat tumors.”
“Our mission is to develop life changing therapies. It can only be achieved if we manage to effectively deliver such therapies to our patients. In Minaris, we have found a partner that will not only help us in this aspect, but also in developing integrated manufacturing solutions and provide the appropriate infrastructure to support our future commercial production both in the US and in Europe,” added Julien Grogg, VP Technology of MaxiVAX.
The transfer of manufacturing process to a CMO to generate commercial grade MVX-ONCO-2 also fulfills the first milestone obligation of MaxiVAX’s European Commission H2020 funded project, MaxONCO.
