Great Novel Therapeutics Biotech & Medicals Corporation (GNTbm) Presented Preclinical Data on GNTnm-38, an Novel Epigenetic Immune Activator, at the 2025 ASCO Annual Meeting

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, /PRNewswire/ -- GNTbm (stock code: 7427, Taiwan) announced the preclinical data on GNTbm-38, an novel epigenetic immune activator for cancer immunotherapy. GNTbm-38 was presented as posters at the 2025 American Association of Clinical Oncology (ASCO) Annual Meeting, which is held in Chicago, USA, from May 30 to Jun 04, 2025.

Abstract: 2574

Title: Preclinical development of GNTbm-38, a novel class I histone deacetylase inhibitor, while combined with anti-VEGFR TKI or anti-PD-1 Ab: Assessment of immune activation and immune memory in cancer immunotherapy.

Session Date/Time: 6/2/2025, 1:30 PM-4:30 PM CT

Poster Board Number: 221

At present, there is no ICI-based drug combination for the treatment of advanced MSS colorectal cancer, which is a cold tumor. Studies have shown that epigenetic regulators such as class I HDAC inhibitors are an emerging and important drug component for combination therapy that can greatly increase the anti-cancer benefits of cancer immunotherapy. Therefore, rational drug combinations, containing class I HDACi, may provide opportunities in cancer immunotherapy.

GNTbm-38 is a new drug candidate independently developed by GNTbm. GNTbm-38 acts as a TME reprogramming regulator in immunotherapy. When combined with TKI, GNTbm-38 significantly improved tumor response rate and survival rate through synergistic effect by normalizing tumor vessels, increasing tumor antigen presentation, increasing activated CD8⁺ T cell infiltration into tumors, inducing memory T cell persistence, and inhibiting mobilization of immunosuppressive cells into tumors. On the other hand, treatment with GNTbm-38 plus anti-PD-1 antibody in the CT-26 model showed greatly improved tumor response rate and survival rate with a strong synergistic effect. Furthermore, in B-hPD-1/hPD-L1 mice (humanized model) subcutaneously injected with B-hPD-L1 CT-26 cells, treatment of pembrolizumab and GNTbm-38 resulted in a 46.5% inhibition on tumor growth. Therefore, our data provided a strong rationale to explore the combination of GNTbm-38 with anti-VEGF TKI with or without ICI. From these data GNTm-38 has been shown to display powerful induction of immune activation and immune memory in combination therapy with TKI/ICI against colon CT-26 cold tumor. Based on the in vitro, in vivo and preclinical studies, these data show that GNTbm-38 exhibits markedly superior pharmacokinetics, tolerability, and efficacy in animal models. It is expected to complete the US IND application by the end of 2025 and enter the clinical study.

About GNTbm-38

GNTbm-38 is a new chemical entity with potential as a pivotal drug component of a new generation of cancer immunotherapy independently developed by GNTbm. It is a drug candidate selected by an immuno-competent tumor-bearing animal testing platform, and has undergone many preclinical research studies to confirm that it has very outstanding anti-cancer activity in tumor microenvironment. GNTbm-38 is an oral drug with dual effects of epigenetic regulation of gene expression and immune activation, which is unique when compared to the mechanism of other epigenetic drugs. GNTbm-38 can remodel the tumor microenvironment (TME) through a unique epigenetic regulatory mechanism, including the cell composition and gene expression that affect the TME, so that "cold tumors" can be transformed into "hot tumors", which can attract CTL to infiltrate into the TME, and at the same time, it can also reduce the attraction of immunosuppressive cells (such as : TAM, Treg, and MDSCs) into the TME, so as to achieve the remodeling of the TME, which is more conducive to obtaining the therapeutic benefits of cancer immunotherapy. GNTbm-38 monotherapy can be used in the treatment of hematological tumors, and GNTbm-38 can also be combined with a unique multi-kinase inhibitor or immune checkpoint inhibitor for treatment of a variety of solid tumors, mainly through a unique anti-cancer immune-regulating mechanism to achieve anti-cancer treatment goals.

About GNTbm

GNTbm (stock code: 7427, Taiwan) is a company that has conducted clinical trials and developed a new drug against advanced breast cancer on the market in Taiwan. The GNTbm R&D team has the ability to independently develop new drugs, and has multiple anti-cancer drug candidates with global development rights, with the goal of meeting the unmet clinical needs of patients with advanced cancers. GNTbm mainly focuses on the development of drugs with innovative mechanisms for the new generation of cancer immunotherapy, conducts clinical validation, and hopes to successfully provide novel immunotherapy with excellent efficacy and safety for varieties of cancer indications, to fulfil the unmet medical needs of patients around the world and improve the quality of life of patients.