Genentech, part of Roche, has formed a worldwide strategic collaboration with BioNTech AG, a Mainz, Germany-based biotechnology company developing personalized cancer immunotherapies, to develop, manufacture, and commercialize messenger RNA (mRNA)-based, individualized cancer vaccines. The collaboration will combine Genentech’s cancer immunotherapy portfolio and research program with BioNTech’s mRNA cancer vaccine technology platform and personalized medicine expertise. Together, the two companies will develop individually tailored immunotherapies against a broad range of cancers.

Under the agreement, Genentech will pay BioNTech $310 million in upfront and near-term milestone payments. The two companies will equally share all development costs and any potential profits for certain programs under the agreement. BioNTech has the right to co-promote certain products that arise from the agreement in the US and certain countries, including Germany and other major European markets.

Under certain circumstances, BioNTech may have sole commercialization rights for other products that Genentech elects not to commercialize. BioNTech will manufacture mRNA cancer vaccines for clinical studies. Genentech will manufacture mRNA cancer vaccines for commercial supply, and BioNTech will have the right to manufacture commercial products as part of the global supply network. The completion of the agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to occur in the fourth quarter of 2016.

The collaboration will focus on developing mRNA cancer vaccines targeting neoantigens, based upon BioNTech’s Individualized Vaccines Against Cancer Mutanome clinical platform for the potential treatment of multiple cancers. This technology involves sequencing a patient’s cancer genome to define a spectrum of mutations known as “neoantigens” or “neoepitopes” present in a particular patient’s tumor (the “mutanome”). An mRNA vaccine encoding selected neoepitopes can be manufactured for each individual tumor’s mutanome signature. BioNTech will continue to develop its non-neoepitope mRNA cancer vaccines outside of the collaboration.

Source: BioNTech