On December 10, 2022 Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, reported new data from the ongoing Phase 1/2 study evaluating TP-3654, an investigational selective oral PIM1 kinase inhibitor, in patients with myelofibrosis (MF) previously treated with or ineligible for JAK inhibitor therapy (Press release, Sumitomo Pharmaceuticals, DEC 10, 2022, View Source;exposition-301699788.html [SID1234625038]). These results were presented during an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, being held Dec 10-13, 2022, in New Orleans, LA.

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Preliminary findings from the Phase 1 dose escalation study indicated TP-3654 is well tolerated with limited myelosuppressive adverse events. TP-3654, as a single agent, showed preliminary signs of clinical activity in the study, including spleen volume reduction, symptom improvement, and broad cytokine reduction, in patients previously treated with JAK inhibitors.1

"We are pleased by these preliminary clinical data and are encouraged by the safety and tolerability data seen in the ongoing TP-3654 dose escalation study. We remain committed to progressing this program, including expanding our clinical sites, and contributing to the advancement of possible treatment options which may improve outcomes for patients with myelofibrosis," said Patricia S. Andrews, Chief Executive Officer and Global Head of Oncology, Sumitomo Pharma Oncology, Inc.

The dose escalation portion of the study has enrolled 9 patients at the time of the analysis. To date, five dose levels of TP-3654 were evaluated, including once-daily and twice-daily regiments. No dose-limitation or related serious adverse event was observed up to the time of the analysis.

The data showed an early signal of clinical activity with spleen volume reduction (SVR). Six of 8 evaluable patients on treatment for at least 12 weeks experienced SVR, including 2 of 8 patients having at least 35% SVR. Additionally, a reduction in the symptom burden, measured by change in treatment score symptom (TSS), was experienced by 7 of the 8 evaluable patients, with 5 out of 8 patients having greater than 50% reduction. TP-3654 treatment was associated with reduced levels of cytokines associated with MF as early as 4 weeks, with cytokine reductions correlating with improved TSS.

Overall, TP-3654 appears to be well tolerated with no dose limiting toxicity (DLT) to date. The most common adverse events are Grade 1 gastrointestinal toxicities, which resolved in 1-2 weeks. Additionally, patients showed stable blood counts and no cytopenia with extended time on treatment. Currently, there are no discontinuations due to adverse events.

"These preliminary data presented at ASH (Free ASH Whitepaper) 2022 Annual Meeting & Exhibition are encouraging as we learn more about how TP-3654’s inhibition of PIM1 kinase may lead to reductions in bone marrow fibrosis and splenomegaly, and improved overall survival in patients with myelofibrosis," said Jatin J. Shah, M.D., Chief Medical Officer and Global Head of Development, Sumitomo Pharma Oncology (SMP Oncology). "We look forward to continuing to advance this study to evaluate the potential role of TP-3654 as a monotherapy, in addition to exploring combination opportunities with JAK inhibitors, for patients with myelofibrosis." Below are the details for the SMP Oncology presentation:

Abstract Title

Details

Presenter

Preliminary Data From the Phase I/II Study of TP-3654, a Selective Oral PIM1 Kinase Inhibitor, in Patients With Myelofibrosis Previously Treated with or Ineligible for JAK Inhibitor Therapy

Presentation #240 Saturday, December 10 at 3:15 p.m. CST
Oral Podium Presentation

Firas El Chaer, MD, Division of Hematology/Oncology, University of Virginia Health System, Charlottesville, VA

To view the full presentation, please visit to our website here.

About TP-3654
TP-3654 is an oral investigational inhibitor of PIM kinases, which has shown potential antitumor and anti-fibrotic activity through multiple pathways, including induction of apoptosis in preclinical models.2,3 TP-3654 was observed to inhibit proliferation and increased apoptosis in murine and human hematopoietic cells expressing clinically relevant JAK2V617F mutation.3 TP-3654 alone and in combination with ruxolitinib also showed normalized WBC and neutrophil counts, and reduced spleen size and bone marrow fibrosis in JAK2V617F and MPLW515L murine models of myelofibrosis.3 TP-3654 is currently being evaluated in a Phase 1/2 study of oral TP-3654 in patients with intermediate and high-risk myelofibrosis (NCT04176198).