Sapience Therapeutics Begins Patient Enrolment in Phase 2 Study of ST316

Sapience Therapeutics Begins Patient Enrolment in Phase 2 Study of ST316

By, Admin 4 October 2024

Sapience Therapeutics begins patient enrolment in phase 2 study of first-in-class ß-catenin antagonist, ST316 in colorectal cancer

Overview

Sapience Therapeutics, Inc., a clinical-stage biotechnology company, announced that the first patient has been enrolled in its phase 2 dose expansion study evaluating ST316, the company’s first-in-class antagonist of ß-catenin.  Enrollment of the study’s phase 1 monotherapy dose escalation portion was completed in July 2024.

About the Molecule: ST316

  • ST316 is designed to selectively shut down the Wnt/ß-catenin signalling pathway in tumour cells but not in normal cells, allowing for anti-cancer activity without the toxicity related to broad inhibition of this pathway. 
  • The Wnt/ß-catenin signalling pathway is one of the most active pathways in several cancers and drives more than 80% of colorectal cancers (CRCs), the first indication to be evaluated in the ST316 phase 2 expansion. 
  • There are more than 1 million people living with CRC in the United States, with another 150,000 expected to be diagnosed this year alone.

Words from the CMO: Sapience

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.”

Words from the CEO: Sapience

  • 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.

The ST316-101 Study

  • ST316-101 (NCT05848739) is a first-in-human, open-label, phase 1-2 dose-escalation and expansion study designed to determine the safety, tolerability, PK, PD and early efficacy of ST316. 
  • The phase 1 dose escalation portion of the study tested various dose levels of ST316 in patients with select advanced solid tumours that are known to harbour abnormalities of the Wnt/ß-catenin signalling pathway, including CRC.  
  • The phase 1 portion completed enrollment in July 2024.  
  • In the phase 2 dose expansion portion of the study, ST316 is being tested in CRC patients in combination with relevant standards of care and in multiple lines of treatment.  
  • Sapience is conducting the phase 2 study across several sites in the United States.

The Peptide Antagonist: ST316

  • ST316 is a first-in-class peptide antagonist of the interaction between ß-catenin and its co-activator, BCL9, a complex responsible for driving oncogene expression in multiple cancers where aberrant Wnt/ß-catenin pathway signalling is observed. 
  • ST316 exposure in cancer cells prevents BCL9-driven nuclear localization of ß-catenin and inhibits formation of the Wnt enhanceosome protein complex. 
  • Disruption of this interaction selectively suppresses the transcription of oncogenic Wnt target genes that regulate proliferation, migration, invasion and the metastatic potential of tumour cells, as well as genes that regulate the immunosuppression of the tumour microenvironment. 
  • ST316 creates a pro-immune tumour microenvironment and in preclinical models has shown to be synergistic with checkpoint inhibition. 
  • Due to its selectivity and downstream modulation of the Wnt/ß-catenin pathway, ST316 presents an opportunity to safely and effectively target Wnt/ß-catenin driven cancers without the toxicities previously seen with other Wnt pathway agents.

About the Company: Sapience Therapeutics

Sapience Therapeutics, Inc. is a privately held, clinical-stage biotechnology company focused on discovering and developing peptide therapeutics to address oncogenic and immune dysregulation that drive cancer.

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