BioNTech SE and Duality Biologics (Suzhou) Co. Ltd., a clinical-stage biotech company developing next generation antibody-drug conjugate (ADC) therapeutics to treat cancer and autoimmune diseases, entered into exclusive license and collaboration agreements for two ADC assets to develop, manufacture and commercialize the two assets globally, excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region.

ADCs will become an additional drug class in BioNTech’s oncology portfolio with the aim to further support its mission to develop highly efficacious therapies for cancer at every stage of disease.

As part of the collaboration, BioNTech will gain access to DualityBio’s lead candidate, DB-1303, which is a topoisomerase-1 inhibitor-based ADC directed against Human Epidermal Growth Factor Receptor 2 (HER2), a target that is overexpressed in a variety of cancers, which contributes to the aggressive growth and spread of cancer cells.

In a statement, BioNTech said that antibody therapy targeting HER2 has been shown to be an effective treatment strategy for HER2-expressing cancers. The DB-1303 program received the Fast Track designation from the U.S. FDA and is currently in a Phase 2 clinical trial (NCT05150691) for HER2-expressing advanced solid tumors.

BioNTech will also gain access to a second topoisomerase-1 inhibitor-based ADC candidate, DB-1311.

DualityBio will receive upfront payments for both asset licenses totaling $170 million, and additional development, regulatory and commercial milestones for both assets, potentially totaling over $1.5 billion. DualityBio will be eligible to receive royalties on sales for both ADC assets.

BioNTech will hold commercial rights globally (excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region), while DualityBio will retain commercial rights for Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region. As part of the agreement for DB-1311, DualityBio has the right to exercise a co-development cost and profit/loss sharing option for DB-1311 for the U.S. market, as well as a co-promotion option for the U.S. market.