MaxiVAX SA, a Swiss biotech developing anti-cancer vaccines, and Minaris Regenerative Medicine GmbH, a CDMO for the cell and gene therapies, 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 manufacturing agreement includes process development for scale-up and technology transfer with the goal of supplying Phase 2 and 3 clinical studies in the EU and then in the U.S.
 
Minaris will provide GMP manufacturing, freezing and shipping of the MVX-ONCO-2 capsules from its site near Munich, Germany. The autologous patients’ tumor cells will be processed at the clinical sites.
 
The MVX-ONCO-2 consists of two components: biocompatible capsules, loaded with a genetically modified cell-line that secretes a strong immune-booster GM-CSF and irradiated autologous patients’ tumor cells, isolated from patients which serve as tumor antigens. To induce an efficient anti-tumor response, the encapsulated GM-CSF secreting cells are implanted subcutaneously at the site of tumor-cell vaccination.

“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.”
 
“We are confident that our partnership with Minaris will accelerate MaxiVAX’s breakthrough cancer immunotherapy development from clinical trial to market success,” said Ksenija Pavletic, an executive board member of MaxiVAX. “Minaris has the expertise and industry experience to enable the delivery of MaxiVAX’s innovative lead product MVX-ONCO-2 to the patients stringently and reliably.”