-Treatment with ST101 resulted in 1 confirmed partial response (PR) in a patient with cutaneous melanoma lasting more than 51 weeks and 2 patients with ongoing stable disease –
– Favorable safety and tolerability profile at all doses with no DLTs or SAEs related to ST101 –
HARRISON, N.Y., June 3, 2022 /PRNewswire/ — Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, announced today data from a Phase 1 study demonstrating efficacy proof-of-concept of the Company’s lead program, ST101, in patients with refractory solid tumors. The data will be presented in a poster discussion session at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on June 5, 2022.
ST101, a first-in-class peptide antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). The primary objectives of the Phase 1 clinical study were to evaluate the safety and tolerability of ST101 and to determine the recommended Phase 2 dose. Secondary and exploratory objectives included pharmacokinetics (PK), preliminary efficacy (RECIST 1.1), and pharmacodynamic (PD) evaluation. The study used a 3+3 dose-escalation design, with once-weekly IV infusion dosing of ST101 at 0.5, 1, 2, 4, 6, 9 mg/kg or a flat dose of 500 mg.
Phase 1 Study Results:
- As of May 5, 2022, 25 patients with multi-metastatic disease that were refractory to standard therapy received a median of 8 weeks of treatment
- Three patients show ongoing clinical benefit:
- One confirmed PR lasting more than 51 weeks in a patient with cutaneous melanoma
- Eight patients with varying histologies had stable disease lasting 9-81+ weeks (2 ongoing)
- No DLTs, dose modifications, or serious adverse events (SAEs) related to ST101
- Pharmacokinetics and pharmacodynamics support the selection of a 500 mg flat dose as the recommended Phase 2 dose
Dr. Alice Bexon, Sapience’s Chief Medical Officer, commented, “We remain extremely pleased with the safety and efficacy ST101 has demonstrated in Phase 1, with evidence of clinical benefit across the whole dose range explored, particularly at higher doses and in patients with melanoma. The Phase 2 expansion portion of the study is going very well, with all cohorts enrolling, and a confirmed partial response in a patient with recurrent glioblastoma, which is very exciting. We believe that ST101’s unique mechanism of action targeting C/EBPß represents a potentially transformative approach to treating cancer.”
Phase 1 Patients with Clinical Benefit (SD, PR):
|Tumor type||Dose||Response||Duration (wks)|
|Signet ring adenoCa||0.5 mg/kg||SD||81+|
|Small bowel adenoCa||2 mg/kg||SD||18|
|Abdominal sarcoma||2 mg/kg||SD||9|
|Cutaneous melanoma||4 mg/kg||PR||51+|
|Hepatocellular carcinoma||6 mg/kg||SD||18|
|Esophageal adenoCa||6 mg/kg||SD||9|
|Cutaneous melanoma||9 mg/kg||SD||35+|
|Uveal melanoma||500 mg (flat dose)||SD||18|
|Mucosal melanoma||500 mg (flat dose)||SD||18|
|+indicates ongoing treatment|
Details of the poster presentation at ASCO 2022 are as follows:
Abstract Number: 3014
Title: Efficacy proof-of-concept from a phase 1 study of a novel therapeutic peptide, ST101, targeting the oncogenic transcription factor C/EBPβ in patients with refractory solid tumors
Session Title/Track: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Type: Poster Discussion Session
Date/Time: June 5, 2022, 2:30 PM CDT
Abstracts and full session details can be accessed through the ASCO meeting planner: Abstracts | ASCO Annual Meeting
About ST101 and the Phase 1-2 Study
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 expansion. In the ongoing dose escalation study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a confirmed partial response in a patient with recurrent GBM. Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, locally advanced or metastatic hormone-receptor positive breast cancer and castration-resistant prostate cancer. ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.
About Sapience Therapeutics
Sapience Therapeutics, Inc. is a privately held, clinical-stage biotechnology company focused on discovering and developing peptide therapeutics for major unmet medical needs, particularly high mortality cancers. Sapience’s approach holds potential to target intracellular interactions that are traditionally considered “undruggable targets”. Its lead program, ST101, is a peptide antagonist of C/EBPβ that has demonstrated clinical proof-of-concept in multiple indications, including confirmed partial responses in cutaneous melanoma in Phase 1 and GBM in Phase 2. ST101 is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study with potential applications in various solid tumors and hematologic malignancies. For more information on Sapience Therapeutics, please visit www.sapiencetherapeutics.com and engage with us on LinkedIn.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements. Any statements herein other than statements of historical fact could be deemed to be forward-looking statements. These forward-looking statements may include, among other things, statements regarding future events that involve significant risks and uncertainties (including with respect to Sapience’s preclinical and clinical development programs). These forward-looking statements are based on management’s current expectations, and actual results and future events may differ materially as a result of certain factors, including, without limitation, our ability to obtain additional funds, and meet applicable regulatory standards and receive required regulatory approvals. Forward-looking statements speak only as of the date of this press release. Sapience does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise, except as required by law.
Sapience Therapeutics, Inc.
Barry Kappel, Ph.D., M.B.A.
President and Chief Executive Officer
Media and Investor Contact:
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SOURCE Sapience Therapeutics
Released June 3, 2022