On the 8th, AbClon announced that China’s Henlius Biotech (Henlius) has received approval from the U.S. Food and Drug Administration (FDA) for the submission of an Investigational New Drug (IND) application for its Phase 3 clinical trial of HLX22.

HLX22 is based on AC101, which AbClon licensed to Henlius in 2016. It is being developed as a first-line treatment for HER2-positive locally advanced and metastatic gastric cancer and is currently undergoing a Phase 2 clinical trial in combination with Herceptin and chemotherapy. The Phase 2 trial is expected to be completed this year.

According to Henlius, this therapy can target areas that immune checkpoint inhibitors fail to reach. HLX22 has demonstrated more than three times the efficacy of standard therapy in terms of objective response rate (ORR), a key indicator of treatment effectiveness.

The median progression-free survival (mPFS) for HLX22 was confirmed to be at least 15.1 months, significantly outperforming competing treatments. In comparison, the current standard therapy has an mPFS of 6.7 months, while the combination therapy with Keytruda achieves 10.8 months.

Additionally, the median duration of response (mDOR) for the HLX22 regimen was recorded at a minimum of 12.4 months, compared to 6.9 months for standard therapy and 11.2 months for the Keytruda combination. With its differentiation from global treatments, HLX22 has demonstrated the potential to become a First & Best-in-Class therapy.

An AbClon representative stated, “If the results of AC101’s Phase 2 clinical trial are validated, this will bring great hope to gastric cancer patients as a global first-line treatment for HER2-positive gastric cancer.”

Meanwhile, on January 22, SangSangIn Investment & Securities Co.,Ltd. reported that AbClon’s AT101 pipeline is expected to bring global licensing opportunities upon successful clinical results. AbClon plans to present follow-up data from its AT101 Phase 1 clinical trial at the upcoming American Society of Clinical Oncology (ASCO) meeting in June.