Press Release

BioNTech to enter into worldwide strategic collaboration with Genentech to develop individualized mRNA cancer therapies

21 September 2016

Supporting Materials:

Mainz, Germany, September 21, 2016 BioNTech AG, a fully integrated private biotechnology company developing personalized cancer immunotherapies, today announced that it will enter into a worldwide strategic collaboration with Genentech, a member of the Roche Group, to develop, manufacture and commercialize novel messenger RNA (mRNA)-based, individualized cancer vaccines. The collaboration will combine Genentech’s leading cancer immunotherapy portfolio and research program with BioNTech’s proprietary mRNA cancer vaccine technology platform, and personalized medicine expertise. Together, the two companies will develop individually tailored cancer immunotherapies against a broad range of cancers to potentially provide a new treatment paradigm for cancer patients.

The collaboration will focus on the development of mRNA cancer vaccines targeting neoantigens, based upon BioNTech’s Individualized Vaccines Against Cancer (IVAC®) MUTANOME clinical platform for the potential treatment of multiple cancers. A patient’s cancer genome can be rapidly sequenced with next generation technology to define a spectrum of unique 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, which may trigger an immune response highly specific to the tumor resulting in precisely targeted cancer cell death.

Initial clinical development will focus on combination studies using IVAC® MUTANOME in a variety of cancer types.

Under the terms of 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 United States 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 product as part of the global supply network.

Professor Dr. Ugur Sahin, CEO of BioNTech AG commented: “We are delighted to collaborate with a leading cancer immunotherapy company such as Genentech. Supported by its extensive tumor immunology understanding, BioNTech has been building clinical experience with its proprietary mRNA vaccines in a number of cancer types over several years. Combining BioNTech’s broad proprietary capabilities in the design, formulation, manufacturing and clinical testing of individualized neoantigen-based mRNA vaccines with Genentech’s eminent cancer immunotherapy, diagnostic, manufacturing and commercial expertise, will allow us, on a global scale, to drive forward the development of individualized vaccines to the market to treat a broad range of cancers. ”

Sean Marett, COO of BioNTech added: ”This alliance underpins BioNTech’s strategy of collaborating with companies that are committed to developing truly disruptive immunotherapies and its long term ambitions of bringing its own products to market .”

“Unlike any medicine we have ever developed, virtually all cancer patients may potentially benefit from a custom built cancer vaccine,” said James Sabry, M.D., Ph.D., Senior Vice President and Global Head of Genentech Partnering. “By collaborating with BioNTech on this cutting edge approach, we hope to truly advance cancer treatments by using a common molecular backbone – mRNA – that is uniquely tailored to an individual patient.”

BioNTech will continue to develop its non-neoepitope mRNA cancer vaccines outside of the collaboration.

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.

You can find Genentech´s editorial about the agreement and an explanatory video here.