Alligator Bioscience Announces IND Approval for Second Phase 2 Clinical Trial of AC101 (HLX22) in Gastric Cancer developed by Shanghai Henlius Biotech in China

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  • Study to evaluate AC101 (HLX22) in combination with anti-PD-1 antibody serplulimab, trastuzumab and chemotherapy in gastric cancer
  • Phase 2 comes in addition to ongoing study evaluating AC101 (HLX22) in 1st line gastric cancer in combo with chemo and Trastuzumab, with data expected in Q2 2023
  • AC101 (HLX22) was out-licensed to Shanghai Henlius Biotech for clinical and commercial development in China on which Alligator is eligible to part of the economics

Lund, Sweden, November 8, 2022 – Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces that Shanghai Henlius Biotech, Inc. has received investigational new drug (IND) approval from China's National Medical Products Administration (NMPA) for a Phase 2 clinical trial of AC101 (HLX22), a monoclonal HER2 antibody, in combination with anti-PD-1 monoclonal antibody HANSIZHUANG (serplulimab), HANQUYOU (trastuzumab) and chemotherapy as a 1st line treatment for HER2-positive locally advanced/metastatic gastric cancer patients.

Alligator out-licensed AC101 (HLX22) 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.
In September 2022, Henlius announced the completion of the Phase 1 trial of AC101 (HLX22) in patients with HER2 overexpressing advanced solid tumors, in which it demonstrated a good safety and tolerability profile.

“Henlius is making very encouraging progress in its clinical development of AC101 (HLX22) in gastric cancer," said Søren Bregenholt, CEO of Alligator Bioscience. “Following the good safety and tolerability results from the Phase 1 study in September, this is now the second Phase 2 study the company has initiated with this candidate in this indication. It is a further boost to the potential of our AC101 (HLX22) asset, and we are particularly looking forward to seeing what results this new combination setting yields, especially as it includes the addition of the anti-PD-1 monoclonal antibody serplulimab.”

Henlius initiated a prior Phase 2 clinical trial to evaluate AC101 (HLX22) in combination with HANQUYOU (trastuzumab) and chemotherapy as a first-line treatment for HER2-positive locally advanced/metastatic gastric cancer patients in September 2021. The estimated primary completion date is April 2023, and the study completion date is expected in September 2024.

The information was submitted for publication, through the agency of the contact persons set out below, at 9.30 a.m. CET on November 8, 2022.

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Updated 2022-11-08