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Genentech, BioNTech Partner on Personal Cancer Therapies

RNA molecule illustration

RNA molecule illustration (Nicolle Rager Fuller, National Science Foundation)

21 September 2016. Biotechnology company BioNTech AG is licensing its messenger RNA technology and collaborating with biopharmaceutical company Genentech to develop personalized cancer immunotherapies. The deal is expected to bring BioNTech, in Mainz, Germany at least $310 million in the early stages of the partnership. Genentech is a division of the Roche Group in South San Francisco, California.

BioNTech is an 8-year old company spun off from Johannes-Gutenberg University in Mainz developing immunotherapies from synthetic forms of messenger RNA, a nucleic acid related to DNA used by cells to produce the amino acids in proteins for carrying out functions in the body. An objective of the partnership is to adapt BioNTech’s messenger RNA technology to Genentech’s work in cancer immunotherapies to design treatments reflecting a cancer patient’s individual tumor composition. Another goal, say the companies, is to apply this therapeutic approach to a wide range of cancers.

Genentech researchers led by cancer immunologist Lélia Delamarre published a study in 2014 showing in lab animals the feasibility of cancer immunotherapies attacking precise targets identified through genomic sequencing. Delamarre notes in a Genentech essay that identifying targets for cancer vaccines is more difficult than vaccines for infectious diseases. “Vaccines work by exposing the immune system to ‘non-self’ proteins known as antigens,” says Delamarre, “priming it to recognize and eliminate the invaders. But in the case of cancer cells, most proteins are the same as those on healthy cells. This makes it hard to identify which antigen to use in a vaccine.”

One of BioNTech’s initiatives aims to address this issue through its Individualized Vaccines Against Cancer or Ivacs, that target unique mutations in a patient’s cancer genes identified through high-throughput genomic sequencing. Algorithms go through the sequencing results to compare healthy to cancerous cells, identifying the mutanome, the unique set of cancer-related mutations for each patient. Ivac vaccines encode the precise targets, called neoantigens, in synthetic messenger RNA, highlighting the epitopes, or precise binding locations for T-cells in the immune system to attack cancer cells. The vaccine then stimulates T-cells to attack only the cancer cells programmed in the messenger RNA, and ignoring healthy cells and tissue.

BioNTech is testing Ivac-mutanome vaccines in early-stage clinical trials with patients having breast cancer and melanoma, or advanced skin cancer. The collaboration is expected to broaden that portfolio to a wider variety of cancer types.

The agreement calls for Genetech and BioNTech to share all development costs and profits from designated therapy programs. BioNTech will manufacture vaccines for clinical trials, while Genentech will be responsible for manufacturing vaccines once commercialized, with BioNTech maintaining an option to manufacture vaccines for the worldwide supply chain.

Genentech will pay BioNTech $310 million in initial licensing fees and meeting early developmental milestones. In addition, BioNTech will have rights to co-promote certain products in the United States and major European countries, including Germany.

In the following video, Genentech tells more about this individualized approach to cancer immunotherapies.

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