Pharma Focus Europe

Tyligand Bioscience Initiates Phase 1/2 Clinical Trial for TSN1611, a Selective Oral KRAS G12D Inhibitor, with First Patient Dosed

Monday, May 27, 2024

Tyligand Bioscience, a prominent biotechnology company focused on developing cutting-edge cancer therapies, has reached a significant milestone with the initiation of the Phase 1/2 trial of TSN1611 in the United States. This trial targets KRAS G12D mutant solid tumors, and the program received IND clearance from both the U.S. FDA in February and the China NMPA in April 2024.

TSN1611 is a novel small molecule designed to selectively target the G12D mutant of the KRAS oncogene. It demonstrates promising enzymatic and cellular activities, engaging both the ON-state (GTP-bound) and OFF-state (GDP-bound) of KRAS G12D. Preclinical studies have shown its effectiveness in vivo across various animal models, along with favorable physicochemical properties and notable brain penetration potential.

The ongoing first-in-human clinical trial (NCT06385925) aims to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of TSN1611 in patients with advanced solid tumors harboring the KRAS G12D mutation. Patient recruitment is underway in the United States, with plans to expand to China soon.

Tyligand Bioscience, expressed confidence in TSN1611's potential as a leading candidate for treating KRAS G12D-driven cancers. He praised the efforts of the company's teams in the discovery and early development stages, thanking partners and investors for their support.



Thermo Fisher Scientific - mRNA ServicesWorld Orphan Drug Congress 2024World Vaccine Congress Europe 2024Advanced Therapies USA 2024