BioNTech SE and Duality Biologics (Suzhou) Co. Ltd. has entered into exclusive licensing and collaboration agreements for two drug-antibody conjugation (ADC) assets to develop, manufacture and commercialize the two assets globally, excluding mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region.
With this collaboration, ADC will become an additional drug class in BioNTech’s oncology portfolio with the aim of further supporting BioNTech’s mission of developing efficacious therapies for cancer patients at every stage of disease.
ADCs are a class of potent cancer therapies that combine antibody selectivity with the cell killing properties of chemotherapy or other anticancer agents.
As part of the collaboration, BioNTech will gain access to DualityBio’s lead candidate, DB-1303, a topoisomerase-1 inhibitor-based ADC aimed at human epidermal growth factor receptor 2 (HER2). HER2 is an overexpressed target in various types of cancer, contributing to the aggressive growth and spread of cancer cells.
Antibody therapy targeting HER2 has been shown to be an effective treatment strategy for HER2-expressing cancers. The DB-1303 program received Fast Track designation from the US Food and Drug Administration (FDA) and is currently in phase 2 clinical trials for advanced solid tumors expressing HER2.
BioNTech will also gain access to a second topoisomerase-1 inhibitor-based ADC candidate, DB-1311.
BioNTech Bet on ADC
“Over the past few years, the field of ADC has made significant progress, overcoming several limitations and demonstrating its potential as a widely applicable class of precision-medicine drug that may be an alternative to standard chemotherapy,” said Ugur Sahin, chief executive officer and co-founder. from BioNTech.
“The addition of these two ADCs to our portfolio strengthens our immunotherapy pipeline and expands our capabilities with the aim of providing therapeutic benefit to patients with a range of solid tumors, throughout the patient journey.”
John Zhu, founder and CEO of DualityBio, said: “This is recognition not only for DualityBio’s next-generation ADC platform, but also for its internal discovery and development capabilities. With this strategic partnership, we are committed to working together to advance the development of innovative therapies for the benefit of patients worldwide.”
Under the terms of the agreement, DualityBio will receive up-front 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 is entitled to receive a single-digit to double-digit tiered royalty 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 the DB-1311, DualityBio is entitled to exercise the co-development cost and profit/loss-sharing option for the DB-1311 for the US market, as well as the co-promotion option for the US market.