Hanmi Pharmaceutical's Immune-Modulating Anticancer Innovative Drug Makes Steady Progress in Global Clinical Trials

Four Research Findings on HM16390 Presented at the American Immuno-Oncology Society

Hanmi Pharmaceutical announced on the 28th that it presented four posters at the Immuno-Oncology Society (SITC) held from November 5 to 9 (local time) in National Harbor, Maryland, USA, showcasing research achievements and clinical progress on the "LAPS IL-2 Analog (HM16390)."

JaeHyuk Choi, Group Leader of Hanmi Pharmaceutical R&D Center, is explaining the poster content that includes the differentiated development strategy of the innovative anticancer drug HM16390 and research results confirming its excellent efficacy at the Immuno-Oncology Society. Hanmi Pharmaceutical

HM16390 is a next-generation IL-2 fusion-based immuno-oncology drug, newly designed with a differentiated strategy for IL-2 (interleukin-2), which regulates the differentiation and proliferation of immune cells. By applying its proprietary platform technology, "LAPScovery," Hanmi Pharmaceutical aims to maximize both therapeutic efficacy and safety. The drug is being developed as a long-acting formulation that allows for once-per-cycle subcutaneous administration during anticancer drug therapy.

Currently approved recombinant IL-2 therapies are recommended for limited use due to serious side effects such as vascular leak syndrome and cytokine release syndrome. Previous IL-2 candidates focused on minimizing these systemic side effects, but they failed to sufficiently demonstrate efficacy during development, clearly revealing their limitations.

Hanmi Pharmaceutical's HM16390 pursues a new development strategy, aiming to "capture both rabbits" by achieving excellent antitumor efficacy through enhanced IL-2 beta receptor binding affinity and ensuring safety through optimized IL-2 alpha receptor binding affinity.

At this conference, Hanmi Pharmaceutical directly demonstrated in knockout models that HM16390, based on its optimized IL-2 alpha receptor binding affinity, temporarily and selectively increases regulatory T cells only in the bloodstream-not in tumors-thereby alleviating excessive immune responses and reducing systemic toxic reactions.

In another presentation, a direct comparison with a variant lacking IL-2 alpha receptor binding affinity showed that only HM16390 significantly increased "tumor-specific CD8+ T cells (TST)," most of which expressed PD-1 on their surface in an activated state. This provides evidence that the IL-2 alpha receptor binding property of HM16390 contributes not only to safety but also to antitumor efficacy, further strengthening its mechanistic differentiation.

At this conference, Hanmi Pharmaceutical, in collaboration with the laboratory of Professor Choi Jungkyun from the Department of Bio and Brain Engineering at KAIST (Korea Advanced Institute of Science and Technology), also presented results from a study to identify immune response predictive biomarkers for HM16390 prior to the full-scale combination clinical trial with MSD's anti-PD-1 immuno-oncology drug Keytruda (ingredient: pembrolizumab).

In this study, the team integrated and analyzed large-scale transcriptome data from the blood and tumor tissues of approximately 5,000 patients (across nine cancer types) who received immuno-oncology therapy, as well as single-cell transcriptome data from about 600 patients (across five cancer types). The results indicated that IL-2-related immune signaling pathways and T cell characteristics are associated with response to immune checkpoint inhibitor therapy.

The research findings suggest that, by utilizing statistical multivariate predictive model analysis based on large-scale patient transcriptome data, it is possible to predict responses to immuno-oncology therapy and establish patient selection criteria. This is expected to enable Hanmi Pharmaceutical to apply personalized treatment strategies based on these biomarkers in future global Phase 1 clinical trials of HM16390.

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