To start the ball rolling, BioNTech will pay Duality Bio $170 million for rights, outside China, to the two candidates DB-1303 and DB-1311. The pair are expected to find application as a combination therapy to treat solid tumors.

DB-1303, a topoisomerase-1 inhibitor directed at HER2 by a conjugated antibody, is said to be more advanced than DB-1311. According to BioNTech, this candidate has a favorable safety profile and a potentially expanded therapeutic window.

The Mainz-based mRNA vaccine pioneer said the collaboration will add a “new class of precision medicine therapeutics” to its clinical-stage oncology portfolio, expanding the breadth of its immunotherapy toolkit with synergistic potential.

“Over the last years, the ADC field has made significant progress, overcoming several limitations and demonstrating its potential as a broadly applicable precision medicine drug class that might be an alternative to standard chemotherapy,” said BioNTech’s CEO and co-founder Ugur Sahin.

Future milestone payments could top $1.5 billion

In exchange for the cash injection, the Chinese firm will be eligible to receive from its European partner development, regulatory and commercial milestone payments potentially worth more than $1.5 billion, as well as single-digit to double-digit tiered royalties.

Under the agreement’s terms, DualityBio, which began a phase 1/2 clinical trial with DB-1303 in 2019, will retain commercial rights for Mainland China, the Hong Kong Special Administrative Region and the Macau Special Administrative Region, with BioNTech holding the rights in the rest of the world.

At the same time, the Shanghai biotech has an option to co-commercialize DB-1311 in the US, the companies said in a joint statement. This candidate has received Fast Track designation from the US Food and Drug Administration (FDA) and is currently in Phase 3 clinical trials.

Author: Dede Williams, Freelance Journalist