Alligator Announces First Dosing in Henlius Phase 3 Trial

Alligator Bioscience, headquartered in Lund, Sweden, has announced a significant milestone in its partnership with Shanghai Henlius Biotech, Inc. The first patient has been dosed in a Phase 3 international multi-centre clinical trial for HLX22/AC101, a treatment aimed at HER2-positive advanced gastric and gastroesophageal junction cancers. This development follows the out-licensing of HLX22/AC101 to AbClon, Inc. by Alligator Bioscience in October 2016, which was further sub-licensed to Shanghai Henlius Biotech for clinical development.

Søren Bregenholt, CEO of Alligator Bioscience, expressed satisfaction with Henlius Biotech's progress, highlighting the achievement as a testament to Henlius' dedication to the HLX22/AC101 program. The initiation of this Phase 3 trial also signals the potential completion of the ongoing Phase 2 trial, which would result in a milestone payment to Alligator Bioscience.

Alligator Bioscience is a clinical-stage biotechnology company that specializes in developing immuno-oncology antibody drugs that target tumors. Their approach centers on the CD40 receptor, which plays a crucial role in priming tumor-specific T cells and counteracting the immunosuppressive environment of tumors. This strategy promises substantial benefits for cancer patients across various types of cancer.

The company's portfolio features mitazalimab, a leading drug candidate that has shown remarkable survival data at an 18-month follow-up for first-line metastatic pancreatic cancer patients in Phase 2 trials. Mitazalimab is currently being prepared for Phase 3 development. Another promising candidate, the bispecific antibody ATOR-4066, is undergoing preclinical testing.

Alligator Bioscience leverages a proprietary technology platform that includes two antibody libraries, ALLIGATOR-GOLD® and ALLIGATOR-FAB™, along with the robust protein optimization strategy FIND®, and the bispecific antibody format RUBY™. These technologies facilitate the rapid design and development of innovative therapeutic drugs.

Listed on Nasdaq Stockholm under the ticker ATORX, Alligator Bioscience continues to advance its mission of developing effective cancer treatments. The company's recent achievement with Henlius Biotech in advancing the HLX22/AC101 clinical trial underscores its commitment to improving cancer therapies and outcomes for patients globally.