- FDA IND follows promising Phase 2 results presented at 2024 ASCO GI revealing that the addition of HLX22 (AC101) to biosimilar trastuzumab and chemotherapy led to dose-dependent increase in Progression Free Survival
Gastric/gastroesophageal junction (G/GEJ) cancer is one of the most common cancers and approximately 20% of these patients show HER2 amplification or overexpression. Despite the approval of Herceptin® (trastuzumab) in the US in 2010, the median overall survival of patients suffering from HER2+ gastric cancer remains limited.
HLX22 (AC101) is an innovative monoclonal anti-HER2-antibody, which was out-licensed by Alligator to the South Korean company
In
“We are very pleased to see the highly encouraging progress Henlius Biotech are making with the development of HLX22 in gastric cancer,” said 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.”
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