Last mentioned: Mar 5, 2026
Data Readout
Expected preliminary safety results from the Phase I cohort.
Data Readout
Anticipated preliminary safety and pharmacokinetic results from Phase I.
Phase I Commencement
Anticipated start of patient recruitment for safety and dosage studies.
Trial Initiation
Expected commencement of patient recruitment and site activation.
FDA IND Approval
The U.S. FDA approves the application to begin human clinical trials.
FDA IND Approval
GNTbm receives official clearance to begin Phase I trials for GNTbm-38.
Preclinical Development
GNTbm completes laboratory and animal testing for GNTbm-38.
GNTbm has received Investigational New Drug (IND) approval from the U.S. FDA to initiate Phase I clinical trials for its self-developed anti-cancer therapy, GNTbm-38. This milestone marks the company's formal entry into the U.S. clinical landscape, targeting advanced malignancies with its proprietary therapeutic candidate.
The U.S. FDA has granted Investigational New Drug (IND) approval to GNTbm for its self-developed anti-cancer candidate, GNTbm-38. This milestone allows the company to initiate Phase I clinical trials in the United States, marking its transition into a clinical-stage biopharmaceutical entity.