Tolero Pharmaceuticals Announces First Patient Dosed with Investigational Agent TP-1287 in Phase 1 Study in Patients with Advanced Solid Tumors

SALT LAKE CITY, Utah, /PRNewswire/ -- Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, today announced that the first patient has been dosed in a Phase 1 study evaluating the investigational agent TP-1287, an oral cyclin-dependent kinase 9 (CDK9) inhibitor, in patients with advanced solid tumors. The open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic study will evaluate the maximum tolerated dose and dose-limiting toxicities of  TP-1287 administered in patients with advanced solid tumors.  

"The initiation of this study is an important step forward in understanding the potential of TP-1287 in patients with solid tumors," said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals. "We believe that the oral administration of TP-1287 may be beneficial in disease settings where this form of administration is preferred or when used in combination with other targeted agents."

The primary objective of the Phase 1 study is to determine the maximum tolerated dose and dose-limiting toxicities of oral TP-1287 administration in patients with advanced solid tumors. The study is being conducted at sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03604783).

About TP-1287
TP-1287 is an investigational oral cyclin-dependent kinase 9 (CDK9) inhibitor entering into a Phase 1 study in patients with advanced solid tumors (NCT03604783). TP-1287 has shown favorable oral bioavailability in preclinical models.

About Tolero Pharmaceuticals, Inc.
Tolero Pharmaceuticals is a clinical-stage biopharmaceutical company researching and developing treatments to improve and extend the lives of patients with hematological and oncological diseases. Our diverse pipeline targets important biological drivers of blood disorders to treat leukemias, anemia, and solid tumors, as well as targets of drug resistance and transcriptional control. Tolero Pharmaceuticals is based in the United States and is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., a pharmaceutical company based in Japan.

Additional information about the company and its product pipeline can be found at www.toleropharma.com.

Tolero Pharmaceuticals Forward-Looking Statements
This press release contains "forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. The forward-looking statements in this press release are based on management's assumptions and beliefs in light of information presently available, and involve both known and unknown risks and uncertainties, which could cause actual outcomes to differ materially from current expectations. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

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SOURCE Tolero Pharmaceuticals, Inc.