2023-04-03 07:21:41 ET
BioNTech ( NASDAQ: BNTX ) signed a licensning agreement with Duality Biologics (Suzhou) (DualityBio) for two antibody-drug conjugate (ADC) assets for solid tumors.
Under the agreements, DualityBio will get $170M upfront for both asset licenses, and additional development, regulatory and commercial milestone payments for both assets, potentially worth $1.5B, plus royalties on net sales.
BioNTech will get access to DualityBio's lead candidate DB-1303 — a topoisomerase-1 inhibitor-based ADC directed against Human Epidermal Growth Factor Receptor 2 (HER2).
The German mRNA COVID vaccine maker said that the DB-1303 program has received the FDA's fast track designation and is currently in a phase 2 trial for HER2-expressing advanced solid tumors.
BioNTech will also get access to a second topoisomerase-1 inhibitor-based ADC product DB-1311.
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 these regions.
DualityBio has the right to exercise a co-development cost and profit/loss sharing option for DB-1311 for the U.S. market, and co-promotion option for the U.S. market, the companies added.
"The addition of these two ADCs to our portfolio strengthens our pipeline of immunotherapies and expands our capabilities with the aim to provide therapeutic benefits for patients with a range of solid tumors, along the entire patient journey," said BioNTech Co-Founder and CEO Ugur Sahin.
For further details see:
BioNTech to pay $170M upfront in license deal for 2 cancer drug assets