BioNTech and Medigene Link Up for Solid Tumor T-Cell Treatments

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BioNTech and Medigene announced a global agreement to develop T-cell immunotherapies against cancer. The three-year collaboration will focus on multiple solid tumor targets. 

Medigene, a clinical-stage immuno-oncology company, will receive an upfront payment of EUR 26 million, followed by research funding throughout the collaboration and possible milestone payments “up to a triple-digit million EUR amount” for sales on products developed as a result of the collaboration.  

As part of the collaboration, BioNTech will acquire Medigene's preclinical TCR programs, including a program called MDG10XX that uses Medigene’s proprietary PD1-41BB switch receptor technology, as well as its extensive switch receptor and precision pairing library. Also on the table is the company's entire TCR discovery pipeline, which will be beneficial to BioNTech’s cell therapy programs.  

The deal is a win for both Mainz, Germany-based companies, as well as for patients. The research from the collaboration will focus on solid tumors, which represent about 90% of all cancers in adults. Solid tumors are especially good candidates for T-cell receptor (TCR) therapy, a process where T immune cells are reprogrammed to attack specific antigens on tumor cells. This allows the patient’s own immune system to fight the cancer without damaging other tissues in the body.  

BioNTech chose to partner with Medigene because of its impressive track record with immunology research, especially with TCR therapy. In 2019, Medigene won a license agreement with Helmholtz Zentrum München for chimeric co-stimulatory receptor research for TCR therapies and dendritic cell vaccines. This novel approach reverses a negative checkpoint mechanism on T-cells to stimulate T-cell attaches on tumor cells. Medigene’s resume also includes a publication on pioneering dendritic vaccines to stimulate T-cell responses and treat acute myeloid leukemia.  

These discoveries were possible because of the company's automated, high-throughput TCR discovery platform. The platform, which was designed to isolate and assess TCRs, can screen TCRs to find which ones will be most effective in fighting a specific type of cancer. This is especially beneficial because isolated TCRs are natural and do not need any kind of genetic engineering to be effective at targeting tumors.  

From BioNTech’s side, the deal is also beneficial. The biotech giant has an impressive cell therapy portfolio and has worked extensively on TCR therapies in the past. BioNTech has been very busy during the pandemic making COVID-19 vaccines, but in the background, it has continued its immuno-oncological research. 

In November 2021, BioNTech received a Fast Track Designation from the U.S. Food and Drug Administration for an investigational immunotherapy for melanoma, an aggressive skin cancer. The month before, in October 2021, BioNTech again made headlines with a Phase II trial enrollment for an mRNA-based colorectal cancer vaccine.  

Now that BioNTech has global licensing rights to any TCR therapies created with Medigene’s platform, the potential for treating previously unmet clinical needs has increased, and the two companies have big plans for the collaboration and its outcomes, even beyond solid tumor treatments.  

“The sale and licensing deal with BioNTech is an important validation from a global leading biotech company of our proprietary technologies to discover and characterize highly specific TCRs and empower resulting TCR-T cells to fight solid tumors,” said Prof. Dolores Schendel, CEO and SCO at Medigene. "This partnership provides Medigene with meaningful financial resources to fuel our next-generation development programs targeting potentially novel tumor-specific ‘dark matter’ antigens, further tools to enhance T-cell-based immunotherapies, as well as additional potential strategic deals with future milestone payments and royalties.”