Sapience Therapeutics Initiates patient enrolment in phase 2 study

Sapience Therapeutics, Inc., a biotechnology company in the clinical stage, has reported the enrollment of the initial patient in its phase 2 dose expansion study for ST316, the company's innovative antagonist of ß-catenin. The study's phase 1 monotherapy dose escalation portion finished enrolling participants in July 2024.

ST316 is created to specifically block the Wnt/ß-catenin signaling pathway in cancer cells without affecting normal cells, leading to effective anti-cancer effects while avoiding toxicity from widespread pathway inhibition. The Wnt/ß-catenin signaling pathway is highly active in many cancers and is responsible for over 80% of colorectal cancers (CRCs), making it the primary focus of assessment in the ST316 phase 2 expansion. Over 1 million individuals reside in the US with CRC, and an additional 150,000 are projected to receive a diagnosis this year.

Dr. Abi Vainstein-Haras, Sapience’s chief medical officer, stated, “The promising results seen in our phase 1 study demonstrate ST316’s potential to be an effective therapy for Wnt pathway-driven cancers, including CRC among others.  Given ST316’s favourable safety and tolerability profile, together with robust pre-clinical data, Sapience is committed to maximizing the potential of ST316 in various therapeutic combinations across lines of treatment.”

“CRC patients who are refractory to current therapies desperately need new options like ST316,” said Dr. Barry Kappel, Sapience’s founder and chief executive officer. “With CRC being the second-leading cause of cancer death in the United States, and with alarming increases in incidence among younger Americans, we are dedicated to widening the treatment options for this devastating disease."