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Henlius Biotech receives FDA IND Clearance for Phase 3 Initiation
Alligator Bioscience’s has announced that Shanghai Henlius Biotech has received Investigational New Drug (IND) clearance from the FDA to initiate a Phase 3 study to evaluate HLX22 in combination with trastuzumab and chemotherapy in 1st line HER2-positive advanced gastric cancer patients.
HLX22 (AC101) is a monoclonal anti-HER2-antibody, which was out-licensed by Alligator to the South Korean company AbClon, Inc. in 2016, who sub-licensed the drug candidate to Henlius Biotech for clinical and commercial development in China. Alligator retains an ownership interest entitling the company to 35% of AbClon’s income from the agreement with Henlius Biotech.
HLX22 (AC101) is a monoclonal anti-HER2-antibody, which was out-licensed by Alligator to the South Korean company AbClon, Inc. in 2016, who sub-licensed the drug candidate to Henlius Biotech for clinical and commercial development in China.
“We are very pleased to see the highly encouraging progress Henlius Biotech are making with the development of HLX22 in gastric cancer,” says Søren Bregenholt, CEO of Alligator Bioscience. “The Phase 2 results presented at ASCO earlier this year followed by this Phase 3 IND clearance demonstrate our ability to deliver an asset like HLX22 with a highly differentiated profile and a great deal of potential to improve treatment outcomes for patients suffering from a devastating disease like gastric cancer.”
Photo of Søren Bregenholt: Alligator Bioscience
Updated: September 16, 2024, 08:34 am
Published: May 21, 2024
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