GNTbm-38 / GNT Biotech - LARVOL DELTA

GNTbm's self-developed anti-cancer new drug GNTbm-38 has obtained IND approval from the U.S. FDA for Phase I clinical trials (The Manila Times) - "On January 30, 2026 (U.S. time), it completed the IND application for Phase I clinical trials with the U.S. FDA. After review and response to the review comments, it was approved on February 28, 2026 (U.S. time) to conduct Phase I clinical trials."

IND • New P1 trial • Peripheral T-cell Lymphoma • Solid Tumor

Preclinical development of GNTbm-TKI, a novel multi-receptor tyrosine kinase inhibitor, while combined with GNTbm-38 showing potent induced tumor microenvironment remodeling activity in cancer immunotherapy (ESMO 2025) - "Conclusions Collectively, GNTbm-TKI is an anti-cancer drug with potential for cancer immunotherapy, while combined with GNTbm-38, will obtain superior anti-cancer immune benefits, and can also greatly improve the therapeutic benefits through combination with immune checkpoint inhibitors. Legal entity responsible for the study The authors."

IO biomarker • Preclinical • Tumor microenvironment • Colon Cancer • Colorectal Cancer • Head and Neck Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • AXL • CD8 • KDR • NTRK2 • ROS1

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. (ASCO 2025) - "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. Collectively, our data show that GNTbm-38 exhibits markedly superior pharmacokinetics, tolerability, and efficacy in animal models. 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."

Epigenetic controller • IO biomarker • Preclinical • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • CD8 • IFNG

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

Preclinical • Solid Tumor

[Announcement] Huashang Biomedical signed a contract with a well-known pharmaceutical company in Taiwan for the development and manufacture of entrusted tablets for the independent development of oral new ingredient anticancer drug candidate GNTbm-38 [Google translation] (stock.yahoo) - "Huashang Biomedical signed an entrusted tablet development and manufacturing contract with a well-known pharmaceutical company in Taiwan for the independent development of oral new ingredient anticancer drug candidate GNTbm-38..."

Licensing / partnership • Breast Cancer • Oncology • Solid Tumor