Germany-based BioNTech SE (NASDAQ: BNTX) and China-headquartered Duality Biologics (Suzhou) Co., Ltd have announced that they have entered into exclusive license and collaboration agreements focused on two of Duality’s antibody-drug conjugate (ADC) assets. BioNTech is set to acquire all development, manufacturing, and commercialization rights to these two assets globally, excluding mainland China, Hong Kong, and Macau.
Financial Terms and Milestones of the Agreement
Under the deal terms, Duality will receive upfront payments for both assets totaling USD 170 million, with the potential to receive additional development, regulatory, and commercial milestone payments for both assets, which could exceed USD 1.5 billion. Additionally, DualityBio will receive single- to double-digit tiered royalties on net sales for both assets.
Commercial Rights and Collaboration Details
DualityBio retains commercial rights for mainland China, Hong Kong, and Macau. 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 in the US market, as well as a co-promotion option for the US market.
DB-1303 and DB-1311: Potent ADC Molecules with Broad Therapeutic Potential
DB-1303 is a third-generation HER2 ADC molecule built from DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates (DITAC) platform. The molecule has shown potent antitumor activity in both HER2-positive and HER2-low tumor models with a favorable safety profile and a potentially broad therapeutic window. Both preclinical data and preliminary clinical data from DB-1303 suggest the drug’s potential to address unmet medical needs in various HER2-expressing cancers.
DB-1311 is an ADC comprised of a humanized antibody (target not disclosed) and DualityBio’s proprietary DITAC linker-payload. It has exhibited 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 supports the potential of DB-1311 to address unmet medical needs across a broad range of cancers.-Fineline Info & Tech
