The World's First CCR4 Target Immuno-cancer Drug
Hanmi Pharmaceutical announced on Nov. 17 that its CCR4 target immuno-cancer drug "FLX475," which is under joint development with Rapt and MSD of the United States, has reduced the size of a tumor metastasized to a gastric cancer patient by 58 percent.
Hanmi Pharmaceutical presented a poster introducing the phase 2 clinical trial for FLX475 at the 2021 Conference of the Society for Immunotherapy of Cancer (SITC), which ran in Washington from Nov. 12 to 14. FLX475 is an oral, small molecule antagonist of CCR4 protein, which is known to be involved in the intra-tumor migration of regulated T cells that suppress immune anticancer effects. Hanmi Pharmaceutical licensed it from Rapt in 2019.
This phase 2 clinical trial is aimed at evaluating the safety of FLX475 by administering the drug, together with Keytruda (pembrolizumab), the world's most commonly used immuno-cancer drug, to patients with progressive or metastatic gastric cancer. FLX475 100mg will be administered once a day and Keytruda 200mg every three weeks to evaluate overall anti-tumor efficacy, including objective response rates (ORRs) and disease control rates (DCRs). Ten patients each in cohorts 1 and 2 are being recruited, depending on whether the Epstein-Barr Virus (EBV) is negative or positive.
The announcement included the case of a patient who showed meaningful treatment effects. When FLX475 and Keytruda were administered in combination to an EBV-positive and HER2-negative 80-year-old gastric cancer patient, who received chemotherapy in advance and participated in clinical trials beginning from May 2021, the size of a tumor metastasized to the liver was found to have been reduced by 58 percent in the sixth week. In addition, all patients who participated in the clinical trial have shown manageable safety so far and showed no cases of drug administration discontinuation due to negative side effects.