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September 21, 2016

Genentech, BioNTech to Partner on mRNA Cancer Vaccines

  • Genentech, a member of the Roche Group, will partner with BioNTech to develop, manufacture, and commercialize novel messenger RNA (mRNA)-based, individualized cancer vaccines, through a collaboration that could generate $310 million-plus for BioNTech.

    BioNTech said today the collaboration is aimed at developing mRNA vaccines to treat multiple cancer types by targeting neoantigens, applying the company’s Individualized Vaccines Against Cancer (IVAC®) MUTANOME clinical platform as well as Genentech’s cancer immunotherapy portfolio and research program.

    The companies reason that mRNA vaccines encoding selected neoepitopes can be manufactured for each individual tumor's mutanome signature, resulting in targeted cancer cell death by triggering tumor-specific immune responses.

    Genentech agreed to pay BioNTech $310 million in upfront and “near-term” payments tied to achieving unspecified milestones. The companies also agreed to share equally all development costs and any potential profits for certain programs.

    The companies’ collaboration agreement gives BioNTech rights to co-promote some products that arise from the agreement in the U.S. and certain countries, including Germany and other major European markets. For other products that Genentech opts not to commercialize, BioNTech said, it may have sole commercialization rights under certain circumstances.

    BioNTech agreed to manufacture mRNA cancer vaccines for clinical studies, and Genentech will manufacture for commercial supply. BioNTech said it will have the right to manufacture commercial product as part of the global supply network.

    The companies expect to complete their collaboration agreement in the fourth quarter, subject to customary closing conditions that include clearance under the Hart–Scott–Rodino Antitrust Improvements Act.

    The collaboration with Roche comes nearly a year after BioNTech inked an up-to-$1.5 billion alliance with Sanofi to discover and develop up to five mRNA cancer immunotherapies—a deal large enough to be included in GEN’s list of Top 15 Immuno-Oncology Collaborations, published earlier this month.

    BioNTech in June joined translational research partner TRON in publishing results in the journal Nature from a study of what they said was the first example worldwide of a clinically relevant and systemic mRNA cancer immunotherapy. The company is one of several developers scrambling to develop mRNA-based personalized cancer immunotherapies. At the end of June, Merck & Co. and Moderna Therapeutics launched a $200 million-plus partnership toward that goal, while CureVac is in Phase II development of its lead RNActive® candidate CV9104 for prostate cancer.

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