GNTbm's self-developed anti-cancer new drug GNTbm-38 has obtained IND approval from the U.S. FDA for Phase I clinical trials

TAIPEI, March 5, 2026 /PRNewswire/ -- Great Novel Therapeutics Biotech & Medicals Corporation (GNTbm) (stock code: 7427) announced that its independently developed novel epigenetic immunoactivator GNTbm-38, with global rights for cancer immunotherapy, has received approval from the U.S. FDA for its IND application and will proceed with patient enrollment for a Phase I clinical trial in the United States.

Clinical Trial Title: A Phase 1a/1b, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GNTbm‑38 in Adult Patients with Advanced Solid Tumors and Relapsed/Refractory Peripheral T-Cell Lymphoma.

GNTbm independently developed the epigenetic immune-activating new drug GNTbm-38, which has global development rights. After five years of development, it completed preclinical studies that meet U.S. regulatory requirements. 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. GNTbm-38 is the achievement of years of research by the GNTbm R&D team in the fields of epigenetics and cancer immunotherapy. Over 10,000 pages of research reports have been accumulated, and it has successfully obtained IND approval from the U.S. FDA. This marks another highly valuable and significant milestone for GNTbm, following the successful development and domestic launch in Taiwan of the anticancer new drug "Kepida^®".

The R&D team of GNTbm, guided by the belief of 'Taiwanese innovative R&D to benefit late-stage cancer patients worldwide', continually strives for excellence in innovating new drug and has developed the 'next-generation epigenetic immune-activating dual-function drug'—GNTbm-38. GNTbm-38 has been filed for global patent applications in multiple countries around the world and has already been granted in 40 countries. GNTbm-38 possesses exceptionally superior anti-tumor activity, mainly due to its unique epigenetic regulatory mechanism, which can significantly activate the immune system and achieve highly effective anti-tumor immune activity. In 2025, GNTbm-38's research findings were presented at ASCO; in the same year, it was recognized with the 22nd Taiwan National Innovation Award, and currently also received IND approval from the U.S. FDA, providing tremendous encouragement to GNTbm's R&D team. GNTbm will collaborate with internationally experienced CRO companies to advance GNTbm-38 into multi-national, multi-center clinical trials primarily in the United States, China, and Taiwan, aiming to offer new treatment options for late-stage cancer patients.

Dr. Chia-Nan Chen, Chairman of GNTbm, stated: "GNTbm-38 is a new generation anti-cancer immunotherapy drug independently developed by the GNTbm R&D team after years of experiences on developing new drug Kepida^®." GNTbm-38 is a brand new orally administered new chemical entity drug independently developed in Taiwan. GNTbm-38 has excellent epigenetic regulation and immune activation mechanisms, which can control the on-off switches of genes and further impact the expression of genes and proteins at a deeper level. The R&D team of GNTbm has already planned a clinical development strategy for multiple indications for GNTbm-38, prioritizing the development of relapsed or refractory peripheral T-cell lymphoma to obtain orphan drug designation; subsequently, new indications will be expanded. GNTbm-38 is a broad-spectrum, oral, anti-cancer new drug with immense development potential. It can be used in combination with drugs of different mechanisms, including unique multi-kinase inhibitors, immune checkpoint inhibitors, or anti-PD-1/VEGF bispecific antibodies, generating stronger synergistic anti-cancer effects and providing patients with better treatment benefits.

About GNTbm-38

GNTbm-38 is the key drug of a new generation of cancer immunotherapy independently developed by GNTbm and has obtained IND approval from the U.S. FDA to enter Phase I clinical trials. It is an anticancer candidate drug selected through a tumor-loaded animal testing platform with an intact immune system and has been confirmed through multiple preclinical studies to possess excellent anticancer activity in tumor immunity. GNTbm-38 is an oral drug with dual unique activities of epigenetic regulation to control gene expression and immune activation, which is significantly different from the mechanism of previously developed epigenetic drugs and focuses mainly on a distinctive immunoactivating pharmacological mechanism. GNTbm-38 can substantially remodel the tumor microenvironment (TME) through a unique epigenetic regulatory mechanism, primarily affecting the cellular composition and gene expression of the TME, turning originally "cold tumors" into "hot tumors," thereby attracting more CTL infiltration into the TME. At the same time, it can also reduce the recruitment of immunosuppressive cells (such as TAMs, Tregs, and MDSCs) to the TME to achieve TME remodeling, which is more favorable for the anticancer therapeutic effect of cancer immunotherapy. GNTbm-38 monotherapy can be used to treat hematological tumors, while GNTbm-38 combination therapy can be used in combination with unique multi-kinase inhibitors, immune checkpoint inhibitors and anti-PD-1/VEGF bispecific antibodies to treat various solid tumors, primarily achieving superior anticancer therapeutic goals through a unique cancer immunotherapy mechanism.

About GNTbm

GNTbm's stock code in Taiwan is 7427. It is a company that independently develops new chemical entity drugs and has already launched a new drug, Kepida^®, which has been launched in Taiwan market for the treatment of HR⁺/Her-2^- advanced breast cancer, and whose National Health Insurance reimbursement became effective on December 1, 2025. Recently, GNTbm's independently developed epigenetic immune-activating new drug GNTbm-38 has obtained IND approval from the U.S. FDA and will enter phase I clinical trials. GNTbm's R&D team has the capability to independently develop new drugs and lay out the global patent applications, aiming to address unmet clinical needs of patients. GNTbm focuses mainly on developing new drugs with innovative mechanisms, conducting clinical validation for next-generation cancer immunotherapy, with the hope of successfully developing innovative cancer immunotherapies that can be used for multiple indications. These new drugs are expected to provide more effective and safer innovative treatments to meet the treatment needs of advanced cancer patients globally, improve patients' quality of life, and help patients and their families regain precious moments together.

Press Spokesperson of GNTbmSenior Vice President: Dr. Ye-Su ChaoE mail: [email protected]

SOURCE Great Novel Therapeutics Biotech & Medicals Corporation