Hanmi Pharmaceutical said on the 30th that it presented a total of four posters on research outcomes and clinical progress of "Laps IL-2 analog (HM16390)" at the Society for Immunotherapy of Cancer (SITC), held Nov. 5–9 (local time) in National Harbor, Maryland.
HM16390 is an IL-2 conjugate–based immuno-oncology drug that redesigns interleukin-2 (IL-2), which regulates immune cell differentiation and proliferation. The company is developing it as a long-acting formulation that allows one subcutaneous injection per dosing cycle, and aims to enhance therapeutic efficacy and safety by applying its in-house platform technology "Lapscovery."
Hanmi Pharmaceutical said at the conference that it identified a mechanism by which HM16390, based on its optimized IL-2 alpha receptor binding affinity, temporarily and selectively increases regulatory T cells (Treg) in the blood rather than in tumor tissue. Through this, it said it confirmed in a Treg-deficient model the action of mitigating excessive immune responses to reduce systemic toxicity.
In another study, compared with a variant lacking IL-2 alpha receptor binding affinity, only HM16390 showed a significant increase in tumor-specific CD8+ T cells (TST), most of which were activated and characterized by PD-1 expression. The company assessed that, based on this, the receptor-binding properties of HM16390 contribute not only to safety but also to antitumor efficacy.
Hanmi Pharmaceutical, together with a research team led by Professor Choi Jeong-gyun at KAIST's Department of Bio and Brain Engineering, also disclosed results of a preclinical combination study with MSD's anti–PD-1 immunotherapy Keytruda (pembrolizumab) to discover immune-response biomarkers for predicting treatment response. The team integrated analysis of blood and tumor tissue transcriptome data from about 5,000 people (nine cancer types) and single-cell transcriptome data from about 600 people (five cancer types) and concluded that IL-2–related immune signaling pathways and T-cell characteristics are associated with responsiveness to immune checkpoint inhibitors.
At the conference, Hanmi Pharmaceutical also presented the clinical research background, design, and progress of HM16390. The global phase 1 trial is currently in the dose-escalation part of the monotherapy cohort, and the company plans to expand to a combination cohort with Keytruda in the first half of next year.
Choi In-young, head of Hanmi Pharmaceutical's R&D Center (executive director), said, "HM16390 is a next-generation immunomodulatory anticancer drug designed to secure both antitumor efficacy and safety," adding, "We are reviewing broad applicability across various cancer types, and it is a promising candidate that induces a strong immune response while minimizing side effects."