Appclon "Henlius Biotech Receives US Approval for Phase 3 Clinical Trial of Gastric Cancer Antibody Therapy"

Appclon announced on the 8th that HLX22, developed by China’s Henlius Biotech (hereinafter Henlius), has received approval from the U.S. Food and Drug Administration (FDA) for the submission of an Investigational New Drug (IND) application for Phase 3 clinical trials.

HLX22 is based on AC101, which Appclon licensed to Henlius in 2016. Targeting first-line treatment for HER2-positive locally advanced and metastatic gastric cancer, it is currently undergoing Phase 2 clinical trials with a combination of Herceptin and chemotherapy. The Phase 2 trials are expected to be completed this year.

According to Henlius, this treatment can target areas that immune checkpoint inhibitors cannot. HLX22 has demonstrated more than three times superior objective response rate (ORR), a measure of treatment efficacy, compared to standard therapy.

The median progression-free survival (mPFS) was confirmed to be at least 15.1 months, significantly extending patient survival compared to competing treatments. Existing standard therapy shows 6.7 months, and Keytruda combination therapy shows 10.8 months.

Additionally, the median duration of response (mDOR) for HLX22 therapy was recorded at a minimum of 12.4 months. Standard therapy and Keytruda combination therapy recorded 6.9 months and 11.2 months, respectively. Based on its differentiation from global treatments, HLX22 is considered to have the potential to be the First & Best In Class within its category.

An Appclon representative stated, "If the Phase 2 results of AC101 are replicated, it will offer great hope to gastric cancer patients as a global first-line treatment for HER2-positive gastric cancer."

Meanwhile, on the 22nd of last month, SangSangIn Securities analyzed that a global market launch opportunity (LO) is expected upon the clinical results of Appclon’s AT101 pipeline. Appclon will update follow-up data on patients from the Phase 1 clinical trial of AT101 at the American Society of Clinical Oncology (ASCO) conference in June.

This content was produced with the assistance of AI translation services.