BioNTech’s deal with China's DualityBio comes just weeks after Pfizer’s $43bn acquisition of ADC tech pioneer Seagen, with both the German biotech and the US pharma giant eying up the potential of ADCs (antibody drug conjugates) against cancer.
In the agreement announced this morning, BioNTech will gain access to DualityBio’s lead candidate, DB-1303, which is a topoisomerase-1 inhibitor-based ADC directed against Human Epidermal Growth Factor Receptor 2 (HER2), a target that is overexpressed in a variety of cancers, which contributes 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 the Fast Track designation from the US FDA and is currently in a Phase 2 clinical trial for HER2-expressing advanced solid tumors.
BioNTech will also gain access to a second topoisomerase-1 inhibitor-based ADC candidate, DB-1311.
Widening portfolio
While it rocketed onto the market with its mRNA COVID-19 vaccine, BioNTech's core mission is developing 'an immunotherapy powerhouse'.
It now has a wide portfolio of mRNA candidates as well as candidates in other areas such as engineered cell therapies, antibodies and small molecule immunomodulators.
The German biotech now adds ADCs to its portfolio: highlighting the potential of the technology against cancer.
ADCs are a class of potent cancer therapies combining the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents.
“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 Prof. Ugur Sahin, M.D., CEO and co-founder of BioNTech.
“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.”
Under the terms of the agreements, DualityBio will receive upfront payments for both asset licenses totaling $170m, and additional development, regulatory and commercial milestone payments for both assets, potentially totaling over $1.5bn.
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 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 DB-1311, DualityBio has the right to exercise a co-development cost and profit/loss sharing option for DB-1311 for the US market, as well as a co-promotion option for the US market.
Headquartered in Shanghai, DualityBio is a clinical-stage company focusing on the discovery and development of the next generation ADC therapeutics for patients with cancer and autoimmune diseases.
It has established a number of next generation ADC technology platforms with global intellectual property rights. It has advanced four assets into global clinical studies, and developed more than 10 product candidates which are currently in preclinical stage.
Additionally, DualityBio is continuing evolving its novel protein engineering and ADC technology platforms for the next wave of “super ADC” molecules including diverse payload classes, bispecific ADCs and dual payload ADCs.