BioNTech will broaden its pipeline into antibody-drug conjugates (ADCs) and deepen its presence in oncology via an up-to-$1.67 billion collaboration with Duality Biologics (DualityBio), the businesses stated at present.
By means of the collaboration, BioNTech has licensed rights for 2 ADC candidates designed to combat stable tumors in DualityBio’s pipeline—its lead candidate, the Part II DB-1303; and the preclinical-phase DB-1311. Each are topoisomerase-1 inhibitors, with DB-1303 disclosed as focusing on Human Epidermal Progress Issue Receptor 2 (HER2).
DB-1303 is a 3rd era HER2 ADC molecule created via DualityBio’s Duality Immune Toxin Antibody Conjugates (DITAC) platform. DB-1303 has proven what the businesses say is potent antitumor exercise in each HER2 constructive and HER2 low tumor mannequin, with a positive security profile and a probably expanded therapeutic window.
DB-1303—which has obtained the FDA’s Quick Observe designation—is below research within the Part II portion of a dose-escalation and dose-expansion Part I/IIa trial (NCT05150691) designed to evaluate its security and tolerability in sufferers with superior stable tumors that specific HER2. The estimated main completion date for that research is June 2025.
DB-1311 is an ADC comprised of a humanized antibody and DualityBio’s proprietary DITAC linker-payload. It has exhibited potent antitumor exercise in a spread of tumor fashions representing a number of most cancers varieties and has been effectively tolerated in preclinical research,
BioNTech has inked unique license and collaboration agreements to develop, manufacture and commercialize the 2 candidates worldwide besides in Mainland China, Hong Kong, and Macau, the place Shanghai-based DualityBio will retain rights.
Nonetheless, the settlement for DB-1311 additionally grants DualityBio the fitting to train a co-development value and revenue/loss sharing choice, in addition to a co-promotion choice, for the U.S. market.
“During the last years, the ADC discipline has made important progress, overcoming a number of limitations and demonstrating its potential as a broadly relevant precision drugs drug class that may be a substitute for customary chemotherapy,” Prof. Ugur Sahin, MD, BioNTech CEO and Co-Founder, stated in a press release. “The addition of those two ADCs to our portfolio strengthens our pipeline of immunotherapies and expands our capabilities with the purpose to offer therapeutic advantages for sufferers with a spread of stable tumors, alongside the complete affected person journey.”
Past mRNA, COVID-19
BioNTech’s 38-program pipeline is now dominated by some two dozen applications of its messenger RNA-based candidates, the most effective recognized of which is its COVID-19 vaccine BNT162b2, co-developed with Pfizer. The unique vaccine obtained FDA emergency approval in 2020, earlier than profitable full company approval a yr later, and has since been included into two bivalent remedies for variants of the virus.
BioNTech has instructed buyers it sees “development potential for COVID-19 franchise from 2025” because it shifts its market focus from authorities to industrial avenues, and because it probably introduces next-generation vaccines and novel combos by then.
Over the previous yr, nonetheless, gross sales of the COVID-19 vaccine—BioNTech’s sole marketed product—have fallen off with demand. BioNTech completed 2022 with €17.611 billion ($19.173 billion) industrial revenues, down 7% from €18.977 billion ($20.656 billion). Worse for BioNTech, the corporate has issued investor steerage estimating it can solely generate €5 billion ($5.442 billion) in COVID-19 vaccine income this yr.
Most cancers indications account for twenty-four of the 38 applications listed on BioNTech’s pipeline. BioNTech has utilized its mRNA expertise to develop a customized most cancers vaccine. Final yr the corporate reported constructive follow-up Part I/II information for its wholly-owned novel chimeric antigen receptor T-cell remedy (CAR-T) candidate BNT211 in sufferers with relapsed or refractory superior stable tumors—however noticed no corresponding rise in its inventory consequently.
BNT211 is being studied alone and together with a CAR-T cell Amplifying RNA Vaccine (CARVac) encoding CLDN6. The CARVac is meant to drive in vivo enlargement of transferred CAR-T cells to extend their persistence and efficacy. Later this yr, BioNTech has stated, it expects to offer a knowledge replace on an ongoing Part I/II dose escalation and enlargement research evaluating CLDN6 CAR-T cells with or with out CLDN6 CARVac in sufferers with CLDN6-positive relapsed or refractory superior stable tumors.
In 2024, BioNTech expects to start a Part II research of BNT211 in sufferers with second-line plus platinum resistant testicular most cancers.
BioNTech has agreed to pay DualityBio $170 million upfront and as much as $1.5 billion in funds tied to attaining improvement, regulatory, and industrial milestones. DualityBio will even be eligible to obtain single-digit to double-digit tiered royalties on web gross sales for each ADCs.
“This can be a recognition of not solely DualityBio’s next-generation ADC platform, but additionally its inner discovery and improvement capabilities,” said John Zhu, PhD, DualityBio’s founder and CEO. “With this strategic partnership, we’re dedicated to working collectively to advance the event of progressive therapies for the advantage of sufferers worldwide.”