Sapience Therapeutics Announces First Patient Dosed in Phase 2 Clinical Trial of ST101

HARRISON, N.Y., Jan. 6, 2022 /PRNewswire/ -- Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, announced today the initiation of Phase 2 and dosing of the first patient in the glioblastoma (GBM) expansion cohort in the ongoing Phase 1-2 Study of ST101.  

The expansion cohorts in the study include patients with refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and GBM, and are designed to determine proof-of-concept efficacy of ST101 and provide further insights into safety, pharmacokinetics (PK) and pharmacodynamics (PD).  

"Following successful conclusion of dose escalation, we are pleased to expand our ST101 program with the initiation of Phase 2 and dosing of the first patient in the GBM cohort at Columbia University Irving Medical Center," commented Dr. Alice Bexon, Sapience's Chief Medical Officer.  "ST101 has shown very encouraging efficacy and safety in Phase 1, with demonstrated clinical proof-of-concept with a durable clinical response and evidence of long-lasting stable disease in several patients with refractory solid tumors.  We are excited about the potential of ST101 to treat these four aggressive cancers."

Dr. Barry Kappel, Sapience's founder, CEO and President, added, "Moving to Phase 2 and testing ST101 in our tumor specific expansion cohorts is a great moment for us at Sapience.  Having the first patient be treated at Columba University, where Sapience licensed its initial intellectual property from, makes this significant milestone even more meaningful for us."

About ST101 and the Phase 1-2 Study
ST101, a 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).   This 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: a Phase 1 dose escalation/regimen exploration phase and a Phase 2 expansion phase.  In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients.  Sapience has initiated Phase 2 and has dosed the first patient in the GBM expansion cohort.  Sapience also plans to initiate dosing in the additional expansion cohorts in refractory, locally advanced or metastatic hormone-receptor-positive breast cancer, metastatic cutaneous melanoma and castrate-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 designation from the U.S. Food and Drug Administration and 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-based therapeutics for major unmet medical needs, particularly high mortality cancers. With platform-based discovery of peptide therapeutics that disrupt protein-protein interactions, Sapience's molecules hold potential to target intracellular interactions that are traditionally considered "undruggable targets".  Its lead compound, ST101, is a first-in-class molecule 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, risks related to the application of the net proceeds from the offering to Sapience's product development objectives, 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.

Contacts
Sapience Therapeutics, Inc.
Barry Kappel, Ph.D., M.B.A.
President and Chief Executive Officer
[email protected]

Media and Investor Contact:
Amy Conrad
Juniper Point
(858) 366-3243
[email protected]

SOURCE Sapience Therapeutics, Inc.