BNT324/DB-1311 FDA Fast Track
This is a BNT324 news story, published by BioNTech, that relates primarily to DualityBio news.
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metastatic prostate cancerBioNTech
•BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer | BioNTech
89% Informative
BNT324 /DB-1311 is a next-generation antibody-drug conjugate (“ADC”) candidate targeting the transmembrane glycoprotein B7-H3 , an immune checkpoint protein.
The candidate is currently being evaluated in an ongoing Phase 1/2 study (NCT05914116) in patients with advanced solid tumors.
The lead candidate in the collaboration of BioNTech’s and Duality Biologics ( Suzhou) Co., Ltd. ( DualityBio ) received Fast Track designation.
BNT324 /DB-1311 is a next-generation topoisomerase-I-inhibitor-based ADC candidate targeting the immune checkpoint protein B7-H3 .
DualityBio is a clinical-stage company focusing on the discovery and development of the next generation ADC therapeutics for cancer and autoimmune diseases.
The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events.
They are neither promises nor guarantees.
They involve known and unknown risks, uncertainties, and other factors, including the possibility of unfavorable new preclinical, clinical or safety data.
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