Sapience Therapeutics Announces FDA Acceptance of Investigational New Drug Application for ST316 in Familial Adenomatous Polyposis (FAP)

TARRYTOWN, N.Y., Sept. 14, 2026 /PRNewswire/ -- Sapience Therapeutics, Inc., a clinical-stage biotechnology company dedicated to developing first-in-class peptide therapeutics targeting the underlying oncogenic and immune mechanisms driving cancer and pre-cancerous disease, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company an Investigational New Drug (IND) application for ST316 (IND 184073) for the treatment of familial adenomatous polyposis (FAP), a rare inherited disorder associated with the development of hundreds to thousands of precancerous colorectal polyps and a significantly increased risk of colorectal cancer.

ST316 has previously received Orphan Drug designation from the FDA for the treatment of familial adenomatous polyposis.

"We are pleased to reach this important regulatory milestone for ST316," said Barry Kappel, Chief Executive Officer of Sapience Therapeutics. "ST316's unique mechanism of action is designed to selectively inhibit oncogenic β-catenin activity while avoiding the toxicities associated with broader Wnt pathway inhibition. The favorable safety and tolerability profile observed with ST316 monotherapy in the Phase 1 clinical study strengthens the potential of this differentiated approach, particularly in FAP, where long-term treatment requires a high bar for safety and tolerability. Together with supportive preclinical activity in FAP models of disease, we believe ST316 has the potential to become an important new therapeutic option for patients with this serious inherited condition."

ST316 has already demonstrated encouraging clinical activity in an ongoing Phase 2 expansion study in second-line metastatic colorectal cancer (2L mCRC). As presented at AACR 2026, and based on an April 13, 2026 data cutoff, 15 patients had been enrolled and treated with ST316 in combination with standard of care (FOLFIRI and bevacizumab), with a confirmed objective response rate (ORR) of 47%, including seven confirmed partial responses, and a disease control rate (DCR) of 93%. These results compare favorably to historical outcomes for FOLFIRI and bevacizumab in 2L mCRC patients, which have demonstrated an 11% ORR. Responses were observed across multiple patient subgroups, including those with RAS-mutated and RAS wild-type tumors, liver metastases, and prior bevacizumab exposure. In the 23-patient Phase 1 monotherapy portion of the study, ST316 demonstrated a favorable safety and tolerability profile, as previously disclosed at AACR 2026. These results provide clinical validation of β-catenin/BCL9 pathway antagonism in humans and support the rationale for evaluating ST316 in other β-catenin-driven diseases, including FAP, where the pathway is uniformly activated.

Familial adenomatous polyposis (FAP) is a rare inherited condition, characterized by the development of numerous adenomatous polyps in the colon and rectum, typically resulting from mutations in the APC gene. Without intervention, individuals with FAP face a near-certain lifetime risk of developing colorectal cancer. Current management strategies rely heavily on intensive surveillance and prophylactic surgery, underscoring the need for effective medical therapies that can reduce disease burden and delay or prevent surgical intervention. FAP affects an estimated 1 in 5,000 to 10,000 individuals in the United States, according to the National Organization for Rare Disorders, and there are currently no FDA-approved medical therapies for the condition.

About ST316
ST316 is Sapience Therapeutics' first-in-class β-catenin antagonist designed to selectively inhibit the oncogenic activity of β-catenin through blockade of its interaction with BCL9, a critical transcriptional co-activator in the Wnt/β-catenin signaling pathway. This selective mechanism is designed to spare normal Wnt-dependent processes such as intestinal stem cell renewal and bone homeostasis, the mechanistic basis for the dose-limiting gastrointestinal and bone toxicities seen with broad Wnt pathway inhibitors. Consistent with this rationale, ST316 has not been associated with any gastrointestinal or bone-related adverse events leading to dose reduction, interruption, or discontinuation among the 38 patients treated to date in the Phase 1 monotherapy (n=23) and Phase 2 FOLFIRI and bevacizumab combination cohort of the study (n=15). Aberrant β-catenin signaling is a key driver of numerous cancers and pre-cancerous diseases, including familial adenomatous polyposis (FAP). ST316 is currently being evaluated in an ongoing Phase 2 dose expansion study in second-line metastatic colorectal cancer (2L mCRC) in combination with standard-of-care therapy. ST316 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of FAP.

About 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. With in-house discovery capabilities, Sapience has built a pipeline of therapeutic candidates called SPEARs™ (Stabilized Peptides Engineered Against Regulation) that disrupt intracellular protein-protein interactions, enabling targeting of transcription factors which have traditionally been considered undruggable. Sapience can also direct cargo to cell surface targets with their new class of molecule called SPARCs™ (Stabilized Peptides Against Receptors on Cancer), enabling delivery of radioisotope payloads such as α-particles to cancer cells. The company's lead programs, ST316, a first-in-class antagonist of β-catenin, and lucicebtide (formerly known as ST101), a first-in-class antagonist of C/EBPβ, are currently being evaluated in fully enrolled Phase 2 clinical trials.

For more information on Sapience Therapeutics, please visit https://sapiencetherapeutics.com/ and engage with us on LinkedIn.

SOURCE Sapience Therapeutics, Inc.