Appclon announced on the 30th that a Phase 2 clinical study on AC101 and its combination therapy was published in the October issue of Med, a sister journal of the prestigious CELL Press. AC101, a first-line treatment for HER2-positive advanced gastric and esophageal cancer, is being developed under the code name HLX22 by Henlius in China through a technology transfer.
The journal also featured a paper by clinicians from Harvard Medical School-affiliated hospitals in the United States, analyzing the Phase 2 clinical trial of AC101 and expressing optimism. The authors reviewed the limited efficacy of existing gastric cancer treatments, the limitations of drugs currently in clinical trials, and the distinctiveness of AC101.
The clinicians explained that the combination therapy study of AC101 showed significant progress in the treatment of HER2-positive gastric cancer. Although the scale was small, it significantly extended patients' progression-free survival (PFS) and duration of response (DOR) compared to previous clinical studies. Tumor response was also improved, and the safety profile was manageable, demonstrating the clinical benefits and potential of dual HER2 inhibition therapy.
AC101 targets the cancer-causing protein HER2 but binds to a different site than the existing treatment Herceptin. It is known to bind to HER2 simultaneously with Herceptin, producing a synergistic anticancer effect, and further research presentations on this unique mechanism of action are expected.
Earlier, in July, Henlius announced results from a Phase 2 clinical trial in China showing an objective response rate (ORR) more than seven times higher than existing treatments. The clinical trial application (IND) for a global Phase 3 study combining AC101 with existing drugs as a first-line treatment for HER2-positive gastric cancer has been approved in China, the United States, and Japan.
An Appclon representative stated, “The reality is that not only existing approved treatments but also new drugs under clinical trials have fallen far short of expectations,” adding, “Especially, the prognosis for HER2-related advanced gastric cancer is poor, highlighting the urgent need for more effective treatment strategies.”
They continued, “With the ongoing AC101 clinical trials opening new possibilities for treating HER2-positive gastric cancer, it is highly likely to become the global first-line standard treatment,” emphasizing, “Good results are expected from large-scale Phase 3 trials in the United States, Japan, and China.”
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