Drugs / ST316
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05848739 | Jun 2023 → May 2026 overdue | colorectal cancer | Sapience Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | Sapience Therapeutics | Regulatory Sapience Therapeutics Announces FDA Acceptance of Investigational New Drug Application for ST316 in Familial Adenomatous Polyposis (FAP) sapiencetherapeutics.com ↗ |
| 2026-04-20 | Sapience Therapeutics | Results Sapience Therapeutics Presents First Clinical Results from Phase 2 Study of ST316, First-in-Class β-catenin Antagonist, in Second-Line Colorectal Cancer at the American Association for Cancer Research (AACR) Annual Meeting 2026 sapiencetherapeutics.com ↗
The confirmed objective response rate (ORR) per RECIST 1.1 was 47%, with 7 of 15 patients having a confirmed Partial Response (PR). |
| 2025-01-27 | Sapience Therapeutics | Results Sapience Therapeutics Presents ST316 Phase 1 Dose Escalation Data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium sapiencetherapeutics.com ↗
ST316 was shown to be safe and well tolerated at all doses tested. |
| 2024-12-19 | Sapience Therapeutics | Regulatory Sapience Therapeutics Receives FDA Orphan Drug Designation for ST316, a First-in-Class β-catenin Antagonist, for the Treatment of Familial Adenomatous Polyposis (FAP) sapiencetherapeutics.com ↗
announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ST316 for the treatment of familial adenomatous polyposis (FAP). |
| 2024-11-09 | Sapience Therapeutics | Results Sapience Therapeutics Presents Clinical Data on Two Lead Programs, Including ST101 Oral Presentation, at the Society for Immunotherapy of Cancer’s (SITC) 39th Annual Meeting sapiencetherapeutics.com ↗
today announced the presentation of clinical and non-clinical results on its lead programs, ST101 and ST316, at theSociety for Immunotherapy of Cancer’s (SITC) 39 th Annual Meeting, being held November 6-10, 2024, in Houston, TX. |
| 2024-04-08 | Sapience Therapeutics | Results Sapience Therapeutics Presents Three Posters at the American Association for Cancer Research (AACR) Annual Meeting 2024 sapiencetherapeutics.com ↗
These data demonstrate the ability of our lead SPEARs™, ST316 and ST101, to positively impact the tumor immune microenvironment, providing further evidence of their therapeutic promise. |
| 2024-03-05 | Sapience Therapeutics | Results Sapience Therapeutics to Present Multiple Posters at the American Association for Cancer Research (AACR) Annual Meeting 2024 sapiencetherapeutics.com ↗
ST316, a clinical peptide antagonist of beta-catenin, induces anti-tumor immune responses by multiple mechanisms of action |
| 2023-04-14 | Sapience Therapeutics | Results Sapience Therapeutics to Present Late-Breaking Data on ST101 and ST316 at the American Association for Cancer Research (AACR) Annual Meeting 2023 sapiencetherapeutics.com ↗
These datasets demonstrate the roles of ST101 and ST316 in shifting an immune-suppressive tumor microenvironment to an immune-active state, and support evaluating both agents in coordination with immune-oncology (I/O) therapeutic strategies. |
| 2023-03-14 | Sapience Therapeutics | Regulatory Sapience Therapeutics Receives IND Clearance from FDA to Proceed with Phase 1-2 Study of ST316 in Patients with Solid Tumors sapiencetherapeutics.com ↗
Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, announced today that the U.S. Food and Drug Administration (FDA) cleared the Company to proceed with its Phase 1-2 clinical trial of ST316 for the treatment of solid tumors. |
| 2022-04-11 | Sapience Therapeutics | Results Sapience Therapeutics Presents Late-Breaking Data at AACR 2022 Demonstrating the Potential of Targeting Intracellular Interactions to Drug Well-Validated Cancer Pathways sapiencetherapeutics.com ↗
These data illustrate the potential of targeting intracellular interactions to address cancer pathways that are well-validated but have previously been considered undruggable. |
All press releases naming this drug 16 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ST316 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05848739 ↗ |
| Route | Intravenous | “ST316 administered IV” NCT05848739 ↗ |