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

GNTbm's novel class I histone deacetylase inhibitor, GNTbm-38, demonstrated promising preclinical results in combination with anti-VEGFR TKI or anti-PD-1 antibodies, showing improved tumor response and survival rates in models of MSS colorectal cancer. The drug, which aims to reprogram the tumor microenvironment and convert 'cold tumors' into 'hot tumors,' is expected to complete its US IND application by the end of 2025 and enter clinical trials, potentially offering a new approach to cancer immunotherapy.

Analysis

GNTbm (stock code: 7427) has presented compelling preclinical data for its novel, independently developed class I histone deacetylase inhibitor, GNTbm-38, highlighting its potential in cancer immunotherapy, particularly for 'cold tumors' like advanced MSS colorectal cancer. The drug candidate acts as a tumor microenvironment (TME) reprogramming regulator, demonstrating synergistic effects when combined with anti-VEGFR TKI or anti-PD-1 antibodies. Specifically, these combinations led to significantly improved tumor response and survival rates in animal models by normalizing tumor vessels, increasing tumor antigen presentation, boosting activated CD8+ T cell infiltration, inducing memory T cell persistence, and inhibiting immunosuppressive cell mobilization. Notably, in a humanized mouse model, the combination of GNTbm-38 and pembrolizumab achieved a 46.5% inhibition of tumor growth. GNTbm-38, an oral drug, is distinguished by its dual mechanism of epigenetic regulation and immune activation, and has shown superior pharmacokinetics, tolerability, and efficacy in preclinical studies. The company anticipates completing the US Investigational New Drug (IND) application by the end of 2025, enabling the commencement of clinical trials. The reported sentiment score of 0.85 (extremely positive) underscores the promising nature of these findings.

Key Decisions for Investors

• Investors should monitor GNTbm's progress towards the US IND application for GNTbm-38 by the end of 2025, as this is a significant near-term catalyst for the company.
• The strong preclinical efficacy of GNTbm-38 in combination therapies, especially its potential to convert 'cold' tumors to 'hot' tumors, warrants attention for its long-term value, contingent on successful clinical translation.
• Given the early stage of development, despite the extremely positive preclinical data and sentiment, investors should carefully weigh the potential against the inherent risks of biotech drug development before initiating or increasing positions, and keenly observe upcoming clinical trial results.