FDA Approves Hanmi's Innovative, Next-Generation Immunomodulatory Anticancer Drug for Phase 1 Clinical Trial

• Differentiation in IL-2 receptor binding characteristics, maximizing anticancer efficacy and significantly improving safety
• Identification of innovative potential achieving ‘complete remission’ in animal models
• Single subcutaneous administration per cancer treatment cycle
• Therapeutic efficacy expected in various cancer types

Professor Jongchul Park (center), principal investigator for the phase 1 clinical trial of Hanmi's next-generation immunomodulatory anticancer innovative new drug 'HM16390', Dr. Youngsu Noh, head of ONCO Clinical Research and Development (first from the left), Jaehyuk Choi, group leader of the R&D Center (fourth from the left), and Jinyoung Kim, part leader of the R&D Center (far right), all taking a commemorative photo at the Society of Immunotherapy and Oncology (SITC) held in San Diego, USA, last November.

Hanmi Pharm. Co., Ltd. announced the initiation of a phase 1 clinical trial for its next-generation immunomodulatory anticancer drug, which has demonstrated 'complete remission' in non-clinical studies by eliminating all malignant tumors.

The announcement was made on July 1 following the U.S. Food and Drug Administration’s (FDA) approval of the phase 1 Investigational New Drug (IND) application for HM16390 on June 29 (ET). The phase 1 clinical trials will focus on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamic properties of HM16390 in patients with advanced or metastatic solid tumors.

HM16390 is an innovative IL-2 variant that offers a novel approach to Interleukin-2 (IL-2), a key regulator for immune function involved in the differentiation and proliferation of immune cells. Utilizing the proprietary 'LAPSCOVERY' platform technology, Hanmi has maximized the drug's efficacy, safety, and durability. HM16390 is developed as a long-acting formulation for subcutaneous administration, designed to be administered once per cancer treatment cycle.

The currently approved IL-2 treatment, aldesleukin, is limited by severe side effects such as vascular leak syndrome and cytokine release syndrome. Previous IL-2 candidates aimed at minimizing these systemic side effects have faced significant development challenges. HM16390, with its novel development strategy distinct from existing approaches, achieves dual objectives: superior anti-tumor efficacy through IL-2 beta receptor binding ability and improved safety through optimized IL-2 alpha receptor binding.

Hanmi has validated HM16390’s efficacy in suppressing tumor growth and prolonging survival in a malignant melanoma animal model characterized by low immunogenicity. In a colon cancer animal model, researchers observed 'complete remission', indicating total tumor disappearance. Additionally, in the cured animal model, the drug activated tumor-specific memory T cells, preventing cancer recurrence for several months even after re-injection of tumor cells.

Hanmi anticipates that HM16390 will demonstrate efficacy in clinical trials treating various advanced or metastatic solid tumors. This expectation is based on the drug's excellent efficacy, confirmed in animal models of not only melanoma and colon cancer but also kidney cancer and pancreatic adenocarcinoma.

HM16390 also significantly increases tumor-infiltrating immune cells, even in cancers with low immunogenicity. This capability transforms the tumor microenvironment into a favorable setting for immune responses, making it a crucial treatment option for 'cold tumors' that do not respond to immune checkpoint inhibitors.

Dr. Jongchul Park, professor at the Head and Neck Cancer Center at Harvard Medical School, Massachusetts General Hospital (MGH), and principal investigator for the phase 1 clinical trial of HM16390, remarked, "Through presentations at several international conferences, we have demonstrated preclinical results showing HM16390’s differentiation from existing IL-2 agents. Based on this, we hope to achieve meaningful outcomes in upcoming clinical trials."

A Hanmi official stated, "We successfully obtained IND approval by incorporating the latest innovative clinical design mandated by the FDA. We will do our utmost to complete the development of this next-generation immunotherapy drug that overcomes the limitations of existing treatments and improves treatment efficacy."  

HM16390 was also selected as a national new drug development project in September 2022. This initiative, a government-backed R&D support program, aims to foster the development of new drugs by pharmaceutical and biotechnology companies, educational institutions, research centers, and hospitals to promote the development of treatments in areas with significant unmet medical needs.

■ Contact info:

Official Websites: www.hanmipharm.com

innovation@hanmi.co.kr, +08-2-410-0467