Boston Biomedical, Inc. Announces First Patient Dosed in Phase 1 Study of Investigational Agent TP-3654 in Patients with Myelofibrosis

CAMBRIDGE, Mass., April 6, 2020 /PRNewswire/ -- Boston Biomedical, Inc. 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 intermediate-2 and high-risk primary or secondary myelofibrosis. 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.

"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

About Boston Biomedical, Inc. 
Boston Biomedical, Inc. is a developer of novel cancer therapeutics with the goal of significantly improving patient outcomes. The company's most advanced research programs are focused on investigational agents that inhibit multiple oncogenic pathways, including cancer stemness pathways, and modifying immune responses.

Headquartered in Cambridge, Massachusetts, Boston Biomedical, Inc. is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., a pharmaceutical company based in Japan. Boston Biomedical works closely with its parent company, Sumitomo Dainippon Pharma, and Tolero Pharmaceuticals, also a wholly owned subsidiary, to advance a pipeline of innovative oncology treatments. The organizations apply their expertise and collaborate to achieve a common objective – expediting the discovery, development and commercialization of novel treatment options.

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

Disclaimer Regarding 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. 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.

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.

SOURCE Boston Biomedical, Inc.