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Tolero Pharmaceuticals Announces First Patient Dosed in Phase 1 Study of Investigational Agent TP-3654 in Patients with Advanced Solid Tumors

SALT LAKE CITY, Utah, May 14, 2019– Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, today announced the first patient has been dosed in a Phase 1 study evaluating the investigational agent TP-3654, a PIM kinase inhibitor, in patients with advanced solid tumors. The open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic study will evaluate the dose-limiting toxicities and clinical activity of oral TP-3654 administered in patients with advanced solid tumors. 
“TP-3654 is a second generation PIM inhibitor and is an important compound within our pipeline of multiple oncology assets being developed in various solid and liquid tumors.” said David J. Bearss, CEO of Tolero. “By targeting PIM kinases, which are key signaling mediators downstream of several cytokines, we are hopeful that TP-3654 may provide an opportunity to not only target cancer cells but also alter the tumor microenvironment, potentially leading to meaningful outcomes for patients.”
The primary objective of the Phase 1 study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of orally administered TP-3654 in patients with advanced solid tumors. Secondary objectives in the study are to evaluate the pharmacokinetics and pharmacodynamics of TP-3654, observe patients for any evidence of antitumor activity of TP-3654 by objective radiographic assessment, and establish the recommended Phase 2 dose for future studies with TP-3654. 
The trial 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 (NCT03715504). 
In addition, at the most recent American Society of Hematology Annual Meeting, Tolero scientists and their collaborators presented data in an oral presentation, reporting that TP-3654 in combination with Ruxolitinib exhibited improvement of myelofibrosis in murine models.  It is planned that after the initiation of the solid tumor phase 1 clinical trial, a trial in myelofibrosis patients will be commenced.
About TP-3654
TP-3654 is an investigational second-generation selective PIM kinase inhibitor under evaluation in a Phase 1 study in patients with advanced solid tumors (NCT03715504). 
About PIM Kinase
PIM kinases are major effectors of JAK/STAT proliferative signaling downstream of multiple growth factors and cytokines.1  PIM-1 is overexpressed in cancers and it may enhance the ability of fibroblasts to differentiate into myofibroblasts.1
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.

Reference

1 Zemskova MY, Song JH, Cen B, et al. Regulation of prostate stromal fibroblasts by the PIM1 protein Kinase. Cell Signaling. 2017;27(1):135-146

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