Sapience Therapeutics Announces FDA Acceptance of Investigational New Drug
核心洞察
The FDA has accepted Sapience Therapeutics (搜索)' IND application 184073 for ST316 in familial adenomatous polyposis (搜索), a rare inherited disorder causing hundreds to thousands of precancerous colorectal polyps.
ST316 is a first-in-class beta-catenin (搜索) antagonist that blocks the beta-catenin/BCL9 (搜索) interaction, designed to spare normal Wnt-dependent processes such as intestinal stem cell renewal and bone homeostasis.
In an ongoing Phase 2 expansion study in second-line metastatic colorectal cancer (搜索), ST316 plus FOLFIRI and bevacizumab produced a 47% confirmed objective response rate and 93% disease control rate.
Sapience Therapeutics (搜索) said the FDA has accepted an Investigational New Drug application (IND 184073) for ST316 in familial adenomatous polyposis (搜索) (FAP). ST316 already holds Orphan Drug designation from the FDA for FAP. FAP is a rare inherited condition driven by APC gene (搜索) mutations that produces numerous adenomatous polyps in the colon and rectum and carries a near-certain lifetime risk of colorectal cancer (搜索) without intervention. It affects an estimated 1 in 5,000 to 10,000 people in the United States, and there are no FDA-approved medical therapies for the condition, with management relying on intensive surveillance and prophylactic surgery.
ST316 is a first-in-class beta-catenin (搜索) antagonist that selectively inhibits oncogenic beta-catenin activity by blocking its interaction with BCL9 (搜索), a transcriptional co-activator in the Wnt/beta-catenin pathway. The design is intended to spare normal Wnt-dependent processes such as intestinal stem cell renewal and bone homeostasis, the mechanistic basis for dose-limiting gastrointestinal and bone toxicities seen with broad Wnt pathway inhibitors. Across 38 patients treated to date in the Phase 1 monotherapy cohort (n=23) and the Phase 2 FOLFIRI plus bevacizumab combination cohort (n=15), ST316 has not been associated with gastrointestinal or bone-related adverse events leading to dose reduction, interruption or discontinuation.
In the ongoing Phase 2 expansion study in second-line metastatic colorectal cancer (搜索), 15 patients received ST316 with standard of care FOLFIRI and bevacizumab. Based on an April 13, 2026 data cutoff presented at AACR 2026, the confirmed objective response rate was 47%, including seven confirmed partial responses, with a disease control rate of 93%, compared with a historical 11% objective response rate for FOLFIRI and bevacizumab in this setting. Responses occurred across subgroups including RAS-mutated and RAS wild-type tumors, liver metastases and prior bevacizumab exposure. Sapience's pipeline also includes lucicebtide (formerly ST101), a C/EBPbeta (搜索) antagonist, in a fully enrolled Phase 2 trial.
Source: PR Newswire