• Collaboration expands to include development of monospecific antibody candidates to address malignant solid tumors
  • Expanded collaboration leverages Genmab’s proprietary HexaBody® technology platform to develop novel monospecific antibodies
  • First monospecific antibody candidate GEN1053/BNT313 planned to enter clinical trials by the end of 2022
  • Genmab and BioNTech will continue to share costs and potential future profits on a 50:50 basis

COPENHAGEN, Denmark I August 05, 2022 IGenmab A/S (Nasdaq: GMAB) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced an expansion of their global strategic collaboration to develop and commercialize novel immunotherapies for the treatment of cancer patients. Under the expansion, Genmab and BioNTech will jointly work to research, develop, and commercialize novel monospecific antibody candidates for various cancer indications. Since 2015, the companies have been working on the joint development of bispecific cancer antibodies aimed at improving immunotherapy options for cancer patients.

“We are thrilled to expand our collaboration with BioNTech to include additional novel antibody therapies with the goal to deliver them to patients in need of innovative therapeutic options,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “Strategic partnerships, like our collaboration with BioNTech, are critical to developing differentiated antibody medicines ​with the aim of improving the lives of cancer patients.”

“The expansion of our collaboration with Genmab expands our antibody portfolio and will further strengthen our oncology pipeline in indications with high unmet medical needs,” said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. “We are committed to working together with our colleagues at Genmab to develop new treatments for people affected by cancer.”

Under the expanded collaboration, the companies will jointly develop and commercialize, subject to regulatory approval, monospecific antibodies leveraging Genmab’s proprietary HexaBody® technology platform. The first monospecific antibody candidate, GEN1053/BNT313, is expected to enter clinical trials by the end of 2022.

GEN1053/BNT313 is a CD27 antibody based on the HexaBody® technology, specifically engineered to form an antibody hexamer (a formation of six antibodies) upon binding its target on the cell membrane of the T cells. Under the terms of the agreement, the companies will equally share the development costs and potential future profit deriving from GEN1053/BNT313.

The companies currently have two jointly developed investigational medicines in clinical testing since 2019, fusing BioNTech’s proprietary immunomodulatory antibodies and Genmab’s DuoBody® technology platform: GEN1046/BNT311 (DuoBody-PD-L1x4-1BB) is being evaluated in phase 1/2 clinical trials for the treatment of advanced solid tumors (NCT04937153, NCT03917381), and in a phase 2 study of patients with non-small cell lung cancer (NSCLC) (NCT05117242). GEN1042/BNT312 (DuoBody-CD40x4-1BB) is being evaluated for the treatment of patients with metastatic or locally advanced solid tumors in a phase 1/2 study (NCT04083599).

About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of people with cancer. For more than 20 years, Genmab’s vision to transform cancer treatment has driven its passionate, innovative and collaborative teams to invent next-generation antibody technology platforms and leverage translational research and data sciences, fueling multiple differentiated cancer treatments that make an impact on people’s lives. To develop and deliver novel therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. Genmab’s proprietary pipeline includes bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.

Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab.

About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.

SOURCE: BioNTech