BioNTech SE and Duality Biologics announced their global strategic partnership to accelerate the development of differentiated antibody-drug conjugate (ADC) therapeutics for cancer treatment.
It is designed to specifically target and eliminate cancer cells while minimising harm to healthy tissue.
ADCs: A Novel Class of Cancer Therapy
ADCs, which merge the specificity of antibodies with the cytotoxic effects of chemotherapy or other cancer treatments, have gained significant traction in the pharmaceutical industry. Mylotarg (gemtuzumab ozogamicin), the pioneer ADC, was granted approval in 2000 and has been followed by over a dozen others. The global market for ADCs is presently valued at approximately $6 billion.
ADCs are a potent class of cancer therapies. The therapy combines the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents. BioNTech’s collaboration with DualityBio allows them to develop, manufacture, and commercialise two ADC assets globally.
DB-1303: A Promising HER2-Targeting ADC
BioNTech will gain access to DualityBio’s lead candidate, DB-1303, a topoisomerase-1 inhibitor-based ADC targeting Human Epidermal Growth Factor Receptor 2 (HER2). HER2 is overexpressed in various cancers, contributing to aggressive growth and spread of cancer cells.
Antibody therapy targeting HER2 has shown effectiveness in treating HER2-expressing cancers. The DB-1303 program received Fast Track designation from the U.S. Food and Drug Administration (FDA) and is currently in a Phase 2 clinical trial for HER2-expressing advanced solid tumours.
DB-1311: A Second Topoisomerase-1 Inhibitor-Based ADC Candidate
In addition to DB-1303, BioNTech will also gain access to a second topoisomerase-1 inhibitor-based ADC candidate, DB-1311. This ADC comprises a humanised antibody and DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates (DITAC) linker-payload. It has shown potent antitumor activity in various tumour models and cancer types.
Who are BioNTech and DualityBio?
BioNTech is a next-generation immunotherapy company that pioneers novel therapies for cancer and other serious diseases. The company exploits various computational discovery and therapeutic drug platforms for rapid development of biopharmaceuticals.
BioNTech’s broad portfolio of oncology product candidates includes individualised and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies, and small molecules. The company has established relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, Regeneron, Genevant, Fosun Pharma, and Pfizer.
Duality Biologics (DualityBio) is a clinical-stage biotech company focusing on the discovery and development of next-generation antibody-drug conjugate (ADC) therapeutics to treat patients with cancer and autoimmune diseases. DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates (DITAC) platform forms the foundation for the development of their innovative ADC candidates, such as DB-1303 and DB-1311.
Changing the Face of Cancer Treatment?
The groundbreaking $1.5 billion collaboration between DualityBio and BioNTech has the potential to revolutionise cancer treatment, offering new hope to patients battling solid tumours. These two companies are poised to make significant advancements in the field of ADC therapeutics and precision medicine, ultimately improving the lives of cancer patients worldwide.