Great Novel Therapeutics Biotech & Medicals Corporation (GNTbm) says its independently developed novel epigenetic immunoactivator GNTbm-38, for cancer immunotherapy, has received approval from the U.S. FDA for its IND application and will proceed with patient enrolment for a phase I clinical trial in the US.
The new milestone for GNTbm follows the successful development and domestic launch in Taiwan of the new anticancer drug Kepida.
GNTbm-38 possesses anti-tumour activity due to its unique epigenetic regulatory mechanism, which can significantly activate the immune system. In 2025, GNTbm-38’s research findings were presented at ASCO; in the same year, it was recognised with the 22nd Taiwan National Innovation Award, and currently also received IND approval from the U.S. FDA. GNTbm will collaborate with international CRO companies to advance GNTbm-38 into multi-national, multi-centre clinical trials primarily in the US, China, and Taiwan, aiming to offer new treatment options for late-stage cancer patients.
Chia-Nan Chen, chairman of GNTbm, said: “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 an orally administered new chemical entity drug 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 has planned a clinical development strategy for multiple indications for GNTbm-38, prioritising the development of relapsed or refractory peripheral T-cell lymphoma to obtain orphan drug designation; subsequently, new indications will be expanded. GNTbm-38 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.
The full trial title is: 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.