Hanmi Pharm, Approved for Phase II Clinical Trials for an Oral Immunotherapy Drug by the Ministry of Food and Drug Safety


On February 8th, Hanmi Pharm (128940) received approval from the Ministry of Food and Drug Safety for Phase II Clinical Trials of FLX475, which is being developed jointly with a U.S. pharmaceutical company called RAPT Therapeutics. FLX475 is an anticancer immunotherapy drug candidate targeting CCR4 (Chemokine (C-C motif) receptor 4). In the clinical trials, FLX475 is administered in combination with pembrolizumab to patients with advanced or metastatic gastric cancer.

On this day, the Ministry of Food and Drug Safety (MFDS) announced that it would approve Hanmi Pharma’s FLX475 Phase II Clinical Trial to evaluate the safety and efficacy of FLX475 when administered in combination with pembrolizumab in patients with advanced or metastatic gastric cancer. It was confirmed that the clinical trial would be conducted at Seoul National University Hospital.

FLX475 is an oral immunotherapy drug designed to re-activate the immune system to attack cancer cells. The tablet’s substance is an immuno-oncology (IO) drug that was being developed by RAPT Therapeutics in the United States and introduced (In-license) by Hanmi Pharm at the end of 2019. At that time, Hanmi Pharm agreed to share profits from its commercialization by paying Raptor an initial down payment of $4 million (about ₩4.5 billion) and the milestone payment of $54 million (about ₩60.5 billion) upon completion of certain phases of clinical development in the future.

FLX475 targets regulatory T-cells that suppress immunity and CCR4 proteins that are involved in the movements of these cells, unlike existing immunotherapy drugs that enhance the T-cell activation function. Pembrolizumab (chemical name) administered in combination with the tablet is the component name of the immune checkpoint inhibitor of Keytruda (the brand name). It is a drug that helps kill cancer cells by binding to the PD-1 membrane protein of T-cells faster than cancer cells. It was said that the binding of PD-1 to the cancer cells bore programmed cell death protein ligand-1 (PD-L1); T-cells cannot attack cancer cells.

Since September 2018, Raptor has been conducting global Phase I/II clinical trials during which FLX475 and pembrolizumab have been co-administered. Meanwhile, Hanmi Pharm said that when it introduced FLX475, it would conduct Phase II Clinical Trials of FLX475 for gastric cancer patients in Korea and China. It is believed that the Phase II Clinical Trials correspond to that announcement.

A Professor at the Department of Hematology-Oncology-Internal Medicine, Seoul National University Hospital, Young-Ju Bang, who was selected as the investigator to conduct clinical development at the time, said, “FLX475 targets gastric cancer, non-small cell lung cancer, triple-negative breast cancer, and head and neck cancer, which are "charged” tumor types. I expect it to be a new treatment option for patients in desperate need of treatment, especially in Korea, as the country has the highest gastric cancer rates in the world.”

Source: The Value News