German-Chinese ADC collaboration

Under the terms of the agreement, DualityBio (Shanghai) cashes in $170m upfront plus potential milestones of about $1.5bn. Additionally, 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 for all regions not covered by DualityBio’s target markets, which include China, Hong Kong and Macau region. As part of the agreement for the third generation HER2 blocker DB-1311, which exhibited potent anti-tumour activity in both HER2 positive and HER2 low tumour models with a favorable safety profile and a potentially expanded therapeutic window, DualityBio has the right to exercise a co-development cost and profit/loss sharing option for the US market, as well as a co-promotion option for the US market. 

HER2 is a target that is overexpressed in a variety of cancers, which contributes to the aggressive growth and spread of cancer cells. The DB-1303 program received the Fast Track designation from the US Food and Drug Administration (FDA) and is currently in Phase II clinicaldevelopment (NCT05150691) for HER2-expressing advanced solid tumours.

BioNTech also gains access to a second topoisomerase-1 inhibitor-based ADC candidate, DB-1311 comprising of a humanised antibody and DualityBio’s proprietary DITAC linker-payload. It has exhibited potent antitumor activity in a range of tumour models representing multiple cancer types and has been well-tolerated in preclinical studies, with a good pharmacokinetics profile and wide therapeutic window.