Sumitomo Pharma Oncology Receives Orphan Drug Designation for TP-3654, an Investigational Oral Inhibitor of PIM Kinases for the Treatment of Myelofibrosis

July 7, 2022

Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, recently announced that the FDA granted Orphan Drug Designation for TP-3654, the company’s proprietary investigational oral inhibitor of PIM kinases, for the treatment of myelofibrosis. 

“This designation is an important milestone in the development of TP-3654 and highlights the need for potential new treatment options for patients with myelofibrosis,” said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Pharma Oncology, Inc. “This rare hematologic cancer can also progress and worsen. We are excited about collaborating with investigators to advance this clinical-stage asset with the goal of improving patient outcomes.”

TP-3654 is currently being evaluated in a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with intermediate or high-risk primary or secondary myelofibrosis. It is being conducted in the United States and Japan. To learn more about the study and eligibility for enrollment visit clinicaltrials.gov (NCT04176198).