Hanmi Pharmaceutical's Next-Generation Anticancer Drug HM16390 Receives Approval for US Phase 1 Clinical Trial Plan

Hanmi Pharmaceutical announced on the 1st that it received approval from the U.S. Food and Drug Administration (FDA) on the 29th of last month (local time) for the clinical phase 1 trial plan of Raps Interleukin (IL)-2 analog (development name HM16390), an immune-modulating innovative anticancer drug. This clinical trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM16390 in patients with advanced or metastatic solid tumors.

HM16390 is a next-generation IL-2 mutant newly designed from IL-2, which is known to regulate immune function through the differentiation and proliferation of immune cells. Hanmi applied its proprietary platform technology, Rapscovery, to maximize efficacy, safety, and durability. It is being developed as a long-acting formulation that can be administered subcutaneously once per anticancer drug treatment cycle.

Hanmi Pharmaceutical confirmed tumor growth inhibition and prolonged survival effects when HM16390 was administered in an animal model of malignant melanoma with low immunogenicity. In particular, complete remission with tumor disappearance was observed in a colorectal cancer animal model. In the cured animal model, tumor-specific memory T cells were activated, and even after reinjection of tumor cells, cancer did not recur for several months or more. Based on the efficacy confirmed in animal models of melanoma, colorectal cancer, as well as kidney cancer and pancreatic adenocarcinoma, HM16390 is expected to demonstrate therapeutic efficacy in various advanced or metastatic solid tumors in clinical trials.

Professor Jongchul Park of the Head and Neck Cancer Center at Massachusetts General Hospital (MGH), Harvard Medical School, USA, who is the principal investigator of the HM16390 phase 1 clinical trial, said, “Through presentations at several international conferences, preclinical results have demonstrated that HM16390 can be differentiated from existing IL-2 formulations. Based on this, we expect meaningful outcomes in future clinical trials.”