Genmab and BioNTech Expand Global Collaboration To Include Development Of Monospecific Antibody Candidates To Address Malignant Solid Tumors

Collaboration expands to include development of monospecific antibody candidates to address malignant solid tumors Expanded collaboration leverages Genmab's proprietary HexaBody® technology platform to
  • 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

BNTX, &quot, BioNTech&quot, ))))) 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 (NCT04937153NCT03917381), 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).

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