On April 6, 2020 Boston Biomedical, Inc. reported the first patient has been dosed in a phase 1 study evaluating the investigational agent TP-3654, a PIM kinase inhibitor, in patients with intermediate-2 and high-risk primary or secondary myelofibrosis (Press release, Boston Biomedical, APR 6, 2020, View Source [SID1234556156]). The multicenter, open-label, dose-escalation study will identify the maximum tolerated dose (MTD) and recommended phase 2 dose as well as assess the overall safety of oral TP-3654 as a monotherapy administered in patients with myelofibrosis who have been previously treated and failed or are ineligible to receive treatment with a Janus kinase (JAK) inhibitor.
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"The initiation of this study marks an important milestone for our company as we continue to advance our oncology portfolio of investigational compounds into the clinical setting. Also, it is the first compound originating from our affiliate, Tolero Pharmaceuticals, that Boston Biomedical will develop," said Patricia S. Andrews, Chief Executive Officer and Global Head of Oncology. "We look forward to learning more about the safety profile and potential activity of TP-3654 in myelofibrosis."
Secondary objectives of the study are to establish the pharmacokinetic profile, assess preliminary clinical activity and determine the safety profile of TP-3654 as a single agent. The study also includes an exploratory objective to evaluate potential pharmacodynamic markers in patients receiving TP-3654 as monotherapy.
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 (NCT04176198).
About TP-3654
TP-3654 is an investigational second-generation selective PIM kinase inhibitor under evaluation in a phase 1 study in patients with myelofibrosis (NCT04176198), led by Boston Biomedical, as well as a phase 1 study in patients with advanced solid tumors (NCT03715504), led by Tolero Pharmaceuticals, Inc.
About PIM Kinase
PIM kinases are major effectors of JAK/STAT proliferative signaling downstream of multiple growth factors and cytokines.1 PIM is overexpressed in cancers and it may enhance the ability of fibroblasts to differentiate into myofibroblasts.1