Advancing Development of Personalized Antibody-Drug Conjugate Therapies for Solid Tumors

BioNTech and DualityBio, a clinical-stage biotech company, have signed exclusive license and collaboration agreements for two next generation antibody-drug conjugate (ADC) assets that can treat patients with cancer and autoimmune diseases to develop, manufacture, and commercialize the two assets globally. ADCs are a class of potent cancer therapies that combine the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents. As part of the collaboration, BioNTech will gain access to DualityBio’s lead candidate, DB-1303, as well as to DB-1311.

Under the terms of the agreements, DualityBio will receive upfront payments for both asset licenses totaling $170 million, and additional development, regulatory, and commercial milestone payments for both assets, potentially totaling over $1.5 billion. DualityBio will be eligible to receive single-digit to double-digit tiered royalties on net 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 option 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.

DB-1303 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. Targeting HER2 with antibody therapy has been shown to be an effective treatment strategy for HER2-expressing cancers. DB-1303 received the Fast Track designation from the U.S. Food and Drug Administration (FDA) and is currently in a Phase 2 clinical trial (NCT05150691) for HER2-expressing advanced solid tumors.

DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates (DITAC) platform forms the basis of the DB-1303 program. DB-1303 has shown potent antitumor activity in both HER2 positive and HER2 low tumor models with a favorable safety profile and a potentially expanded therapeutic window. Both preclinical and preliminary clinical data from DB-1303 suggest that it has the potential to address unmet medical needs in various HER2 expressing cancers.

DB-1311 is an ADC comprised of a humanized antibody and DualityBio’s proprietary DITAC linker-payload. DB-1311 has shown potent antitumor activity in a range of tumor models representing multiple cancer types and has been well tolerated in preclinical studies, with a good pharmacokinetics profile. The wide therapeutic window demonstrated by preclinical antitumor activity and its safety profile support the potential of DB-1311 to address unmet medical needs across a broad range of cancers.