By Chris Wack

 

Biopharmaceutical companies BioNTech SE and Duality Biologics (Suzhou) Co. Ltd. have entered into exclusive license and collaboration agreements to develop, manufacture and commercialize two antibody-drug conjugate assets (ADCs) globally, excluding mainland China, Hong Kong and Macau.

Germany-based BioNTech said that with the collaboration, ADCs would become an additional drug class in its oncology portfolio. BioNTech would gain access to Shanghai-based DualityBio's lead candidate, DB-1303, a topoisomerase-1 inhibitor-based ADC directed against Human Epidermal Growth Factor Receptor 2, as well as a second topoisomerase-1 inhibitor-based ADC candidate, DB-1311.

ADCs are a class of potent cancer therapies combining the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents.

The DB-1303 program has received a Fast Track designation from the U.S. Food and Drug Administration and is currently in a Phase 2 clinical trial for treatment of HER2-expressing advanced solid tumors.

For both assets, DualityBio would receive single-digit to double-digit tiered royalties on net sales, upfront licensing payments totaling $170 million, and additional development, regulatory and commercial milestone payments potentially totaling over $1.5 billion.

BioNTech would hold commercial rights globally, while DualityBio would retain commercial rights for mainland China, Hong Kong and Macau. For DB-1311, DualityBio also has the right to exercise a co-promotion option and a co-development cost and profit-loss sharing option.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

April 03, 2023 07:34 ET (11:34 GMT)

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