LUND, SE / ACCESS Newswire / March 20, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX) today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to HLX22 (AC101), an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.
The FDA's ODD provides incentives such as tax credits for clinical trials, waiver of certain regulatory fees, and market exclusivity upon approval, supporting the continued development of HLX22 as a potential treatment for HER2-positive metastatic gastric and gastroesophageal junction (GEJ) cancer.
Henlius is conducting a Phase 3 clinical trial (HLX22-GC-301) to evaluate HLX22/AC101 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive metastatic gastric and GEJ cancer. The global study is enrolling patients across the U.S., China, Japan, and Australia.
Søren Bregenholt, CEO of Alligator, commented: "The FDA's recognition of HLX22/AC101's potential with Orphan Drug Designation is a notable recognition. While Alligator's is not directly involved in the development of HLX22/AC101, we continue to follow its progress as it potentially represents future income to Alligator."
Under the terms of the license agreement, Alligator is entitled to 35% of AbClon's revenue from its sublicense agreement with Henlius.
For further information, please contact:
Søren Bregenholt, CEO
E-mail: soren.bregenholt@alligatorbioscience.com
Phone: +46 (0) 46 540 82 00
The information was submitted for publication, through the agency of the contact person set out above, at 3:00 p.m. CET on 20 March 2025.
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Alligator Bioscience Announces FDA Orphan Drug Designation for HLX22/AC101 in Gastric Cancer
SOURCE: Alligator Bioscience
