Tolero Announces First Patient Dosed in Study of Investigational Agent TP-3654

Tolero Pharmaceuticals 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.

TP-3654 is an investigational second-generation selective PIM kinase inhibitor under evaluation in a Phase 1 study in patients with advanced solid tumors.

PIM kinases are major effectors of JAK/STAT proliferative signaling downstream of multiple growth factors and cytokines. PIM-1 is overexpressed in cancers and it may enhance the ability of fibroblasts to differentiate into myofibroblasts.

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