On November 3, 2022 Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, reported preliminary clinical data for investigational agent TP-3654 will be presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, which is being held December 10-13 in New Orleans, Louisiana (Press release, Sumitomo Pharmaceuticals, NOV 3, 2022, View Source;exposition-301667810.html [SID1234623050]). The data will be shared in an oral podium presentation during the Myeloproliferative Syndromes: Clinical and Epidemiological: Latest Data for Combination and Emerging Targeted Therapies in Myelofibrosis session on December 10 at 3:15 p.m. CST.

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The presentation will include preliminary clinical data from patients enrolled in a Phase 1/2 study evaluating TP-3654, an investigational selective oral PIM-1 kinase inhibitor, in patients with myelofibrosis previously treated with or ineligible for JAK inhibitor therapy. Data in the dose escalation portion of the study show encouraging signs of clinical activity in spleen volume reduction, symptom improvement and cytokine reduction with TP-3654 monotherapy in patients previously treated with JAK inhibitors. In this study, TP-3654 was well-tolerated with limited myelosuppressive adverse events.

"We are excited to present data evaluating the potential of TP-3654 in advancing the treatment of patients with myelofibrosis," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Pharma Oncology, Inc. "These data reflect our relentless commitment to propelling drug discovery in oncology and our progress in advancing research in hematologic and solid malignancies."

Below are the details for the oral presentation for TP-3654:

Abstract Title

Detail

Authors

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

Session Name:

Myeloproliferative Syndromes: Clinical and Epidemiological: Latest Data for Combination and Emerging Targeted Therapies in Myelofibrosis

Session Date: Saturday, December 10, 2022

Presentation Time: 3:15 p.m. CST

Room: Ernest N. Morial Convention Center, 217-219

Oral Podium Presentation

Firas El Chaer, MD, James McCloskey, MD, Lindsay A.M. Rein, MD, Randy A. Brown, MD, Steven D. Green, MD, Jeffrey J. Pu, MD, PhD, Shuichi Shirane, MD, PhD, Kazuya Shimoda, MD, PhD, Michiko Ichii, MD, PhD, Junichiro Yuda, MD, PhD, Joseph Scandura, MD, PhD, Sujan Kabir, MD, Jason M. Foulks, PhD, Jian Mei, PharmD, Huyuan Yang, PhD, Mark Wade, PhD, Carl Stapinski, PharmD, Claudia Lebedinsky, MD,

Anudishi Tyagi, PhD, Stanley Ly, Bin Yuan, PhD, Fouad El-Dana, MD, Vivek Ananad, PhD, Appalaraju Jaggupilli, PhD, Gautam Borthakur, MD, Jason M. Foulks, PhD, Steven L. Warner, PhD, and V. Lokesh Battula, PhD

ASXL1 Mutations Are Associated with a Response to the Combination of Alvocidib and 5-Azacytidine in Higher-Risk Myelodysplastic Syndromes

Vladimir Riabov, PhD, Qingyu Xu, Nanni Schmitt, MSc, Alexander Streuer, MD, Guo Ge, Johann-Christoph Jann, MD, Alina Wein, Eva Altrock, PhD, Felicitas Rapp, PhD, Verena Nowak, Nadine Weimer, Julia Obländer, Iris Palme, Melda Göl, Mark Wunderlich, MS, Ahmed Jawhar, MD, Ali Darwich, MD, Patrick Wuchter, MD, Christel Weiss, PhD, Jason M. Foulks, Daniel T Starczynowski, PhD, Feng-Chun Yang, MD, PhD, Georgia Metzgeroth, MD, Laurenz Steiner, MD, Wolf-Karsten Hofmann, MD, Daniel Nowak, MD, and Mohamad Jawhar, MD

Additional information can be found on the 64th ASH (Free ASH Whitepaper) Annual Meeting & Exposition Schedule and Program page 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.1,2 TP-3654 was observed to inhibit proliferation and increased apoptosis in murine and human hematopoietic cells expressing clinically relevant JAK2V617F mutation.2 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.2 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).