Sapience Therapeutics Receives United Kingdom Authorization to Initiate a Phase 1/2 Trial of Lead Candidate ST101 in Advanced Cancer Indications
HARRISON, NY / ACCESSWIRE / May 7, 2020 / Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult to treat oncology indications, announced today that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has accepted the Clinical Trial Authorization (CTA) application for ST101, a peptide therapy being evaluated for the treatment of adults with unresectable and metastatic solid tumors.
"The MHRA's acceptance of the CTA to evaluate ST101 in patients with advanced cancer indications enables the initiation of our first clinical development program," said Barry Kappel, Ph.D., M.B.A., founder and Chief Executive Officer of Sapience Therapeutics. "We are eager to commence trials of ST101 to evaluate the first of our targeted peptide therapeutics that are capable of disrupting specific intracellular protein-protein interactions occurring within the cancer cell. The ability to reach these previously ‘undruggable targets' has the potential to change outcomes for patients who critically need new treatment options."
ST101 is a peptide antagonist of the transcription factor C/EBPβ, which is typically expressed and active in stem cells or early progenitor cells but not in most mature or differentiated cells. Certain cancers activate C/EBPβ, which results in the expression of genes with roles in cell proliferation, differentiation, and the cell cycle. Disruption of this transcription factor with ST101 results in targeted killing of cancer cells, as normal cells do not rely on C/EBPβ driven transcription for survival.
The Phase 1/2 study will be carried out in patients who are not eligible for other therapies or have progressed on prior therapies. In addition to evaluating safety and tolerability, the study will assess preliminary efficacy of ST101 in patients with four specific solid tumor types, including glioblastoma, locally advanced/metastatic breast cancer, castration-resistant prostate cancer and melanoma. Sapience expects to open the study at several clinical sites later this year.
About Sapience Therapeutics
Sapience Therapeutics, Inc., is a privately held, preclinical 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. In 2016, Sapience Therapeutics closed its Series A financing, which was led by Eshelman Ventures and included investments from Celgene Corporation, TaiAn Technologies Corporation and Healthlink Capital. For more information on Sapience Therapeutics, please visit www.sapiencetherapeutics.com.
This press release contains forward-looking statements, and any statements 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. These 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. These are forward-looking statements, which 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.
Sapience Therapeutics, Inc.:
Barry Kappel, Ph.D., M.B.A.
President and Chief Executive Officer
SOURCE: Sapience Therapeutics, Inc.:
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Released May 7, 2020