Abclon is showing strong performance. The news that a Phase 2 clinical study on AC101 and its combination therapy was published in the October issue of Med, a medical sister journal of the prestigious CELL Press, appears to be influencing the stock price. AC101, a first-line treatment for HER2-positive advanced gastric and esophageal cancers, is being developed under the code name HLX22 by Henlius in China through technology transfer.
As of 11:18 AM on the 30th, Abclon's stock is trading at 17,200 KRW, up 7.9% from the previous day.
AC101, an antibody drug targeting HER2, is a bio-synergistic antibody drug that can expand indications and demonstrate superior efficacy that Herceptin, an existing HER2 antibody drug, does not have when used in combination with Herceptin. AC101 is expected to be an innovative antibody drug effective against HER2-overexpressing gastric cancer. It binds to a different epitope than Herceptin and shows differentiated efficacy compared to Herceptin alone or the combination of Perjeta and Herceptin in gastric cancer. In May, the U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for a global, multicenter Phase 3 clinical trial combining AC101 (HLX22) with the existing standard therapy of HER2 antibody Herceptin and chemotherapy (XELOX) as a first-line treatment for HER2-positive advanced gastric cancer.
The journal also published a paper by clinicians from Harvard Medical School-affiliated hospitals 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 treating 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 improved, and the safety profile was manageable, demonstrating the clinical benefits and potential of dual HER2 inhibition therapy.
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 IND for a global Phase 3 clinical trial combining AC101 with existing drugs as a first-line treatment for HER2-positive gastric cancer in China, the U.S., and Japan has been approved.
An Abclon representative stated, "The reality is that not only existing approved treatments but also new drugs under clinical trials have fallen far short of expectations. Especially, the prognosis for HER2-related advanced gastric cancer is poor, highlighting the urgent need for more effective treatment strategies."
They added, "With the ongoing AC101 clinical trials opening new possibilities for HER2-positive gastric cancer treatment, it is highly likely to establish itself as a global first-line standard therapy. We expect good results from the large-scale Phase 3 clinical trials in the U.S., Japan, and China," emphasizing the point.
Meanwhile, gastric cancer is a type of cancer that affects about one million people worldwide annually and approximately 26,000 people annually in Korea, ranking as the fourth leading cause of cancer-related deaths.
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