Henlius expands AbClon’s AC101 into colorectal cancer, bringing programs to nine

  • AbClon said Henlius expanded AC101 clinical development to colorectal cancer.
  • 180 patients will join a new Phase 2 trial for advanced HER2-positive colorectal cancer.
  • Seven programs were added in about one year from the two existing indications.

AbClon said its licensing partner Henlius has expanded clinical development of AC101, also known as HLX22, into colorectal cancer, bringing the antibody drug candidate’s programs to nine. The candidate targets HER2 (a cancer growth receptor) and was licensed to China’s Henlius. Seven programs have been added in about a year from the two indications in place at the end of last year: gastric cancer and HER2-low breast cancer. Henlius registered a Phase 2 trial on Sept. 22 involving 180 patients with advanced, unresectable or metastatic HER2-positive colorectal cancer across 47 top-tier medical institutions in China, including Sun Yat-sen University Cancer Center. The study will test AC101 with chemotherapy in treatment-naive patients and with trastuzumab in patients who have failed at least two standard therapies. Henlius also added a Phase 2 trial in 90 breast cancer patients whose disease progressed after HER2-targeting antibody-drug conjugates (targeted cancer medicines) such as Enhertu. AbClon said the broader development could support royalty income beyond metastatic gastric cancer, which is slated for commercialization in 2028, depending on future trial results, approvals and commercial performance. Custom Market Insights projects the global colorectal cancer market will expand to $30.0959 billion by 2033 from $22.2753 billion in 2024.

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