Hanmi Pharm Presents Phase 2 Clinical Study on CCR4-Targeting Anticancer Agent


Hanmi Pharmaceutical presented the Phase 2 clinical trial on FLX475, an anticancer agent targeting CCR introduced from RART Therapeutics in the United States.

A representative of Hanmi Pharm’s clinical trial team (right) explains the clinical study results on FLX475 at an annual meeting of SITC in Washington D.C.

Hanmi Pharmaceutical announced that it had presented a poster on the Phase 2 clinical trial on FLX475 that is currently underway at the annual meeting of the Society for Immunotherapy of Cancer (SITC) in Washington DC from November 12 to 14.

The company is currently assessing the safety and effectiveness of concomitantly administering FLX475 and KEYTRUDA® (pembrolizumab) to progressive or metastatic stomach cancer patients in collaboration with MSD headquartered in the United States.

Hanmi Pharm administered 100mg of LFX475 every day (QD) and 200mg of KEYTRUDA every three weeks (Q3W) to assess the antitumor efficacy based on the objective response rate (ORR) and disease control rate (DCR) among other indicators. It is currently recruiting subjects to be assigned Cohort 1 and Cohort 2 (10 subjects each) based on whether they test negative for Epstein-Barr virus (EBV), with plans to increase the number of subjects up to 90.

The poster showed meaningful therapeutic effects in the clinical trial subjects, which garnered attention.

An 80-year-old male stomach cancer patient who was EBV-positive and HER2-negative joined the study this past May following an anticancer treatment, and he was administered FLX475 and KEYTRUDA. At Week 6, he exhibited a partial response (PR) with a 58% decrease in the size of the metastasized tumor.

According to Hanmi Pharm, safety risks have been controllable for all subjects to date, and there have not been any dropouts as a result of an adverse event.

Kwon Se-chang, President of Hanmi Pharm, said, “The clinical trial on the world’s first CCR-targeting anticancer agent introduced according to our open innovation strategy was presented at an international conference and helped open up more possibilities to offer patients with an innovative treatment option. [...] We will work closely with our partners, including RAPT Therapeutics and MSD, based on the results of the Phase 2 study and do our best to commercialize the drug as soon as possible.”

FLX475 is a CCR antagonist that is administered orally for cancer treatment. CCR4, which stands for CC chemokine receptor 4, is a protein receptor that is involved in the movement of regulatory T cells, which inhibits the effects of immunotherapy, inside a tumor.

MSD, which has entered into an agreement with Hanmi Pharm to conduct a clinical trial on FLX475, is a supplier of KEYTRUDA, while RAPT Therapeutics is carrying out clinical trials on concomitant and non-concomitant administration of FLX475 based on dose escalation and dose expansion at thirty-three institutions in the United States, Australia, and Taiwan among others.

Source: Cheongnyeon Uisa (Young Doctor)