Sumitomo Pharma Oncology to Present Preliminary Clinical Data Evaluating Investigational Agent TP-3654 at the 64th ASH Annual Meeting & Exposition

CAMBRIDGE, Mass., Nov. 3, 2022 /PRNewswire/ -- Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, today announced preliminary clinical data for investigational agent TP-3654 will be presented at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition, which is being held December 10-13 in New Orleans, Louisiana. 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.

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 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 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, and Raajit K Rampal, MD, PhD

Also, at ASH 2022 Sumitomo Pharma Oncology, Inc. will present preclinical data for two additional assets in posters.

Below are the details for the posters:

Abstract Title Details Presenter
Activin-like Kinase 2 (ALK2/ACVR1) is a Resistance Factor and Therapeutic Vulnerability to FLT3 Inhibition in Acute Myeloid Leukemia Session Name:
Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster I
Session Date: Saturday, December 10, 2022
Presentation Time: 5:30 – 7:30 p.m. CST
Location: Ernest N. Morial Convention Center, Hall D
Poster Presentation
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 Session Name: Myelodysplastic Syndromes—Basic and Translational: Poster III
Session Date: Monday, December 12, 2022
Presentation Time: 6:00 – 8:00 PM CST
Location: Ernest N. Morial Convention Center, Hall D

Poster Presentation
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 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).

About Sumitomo Pharma Oncology, Inc.

Sumitomo Pharma Oncology, Inc., (SMP Oncology) is a wholly owned subsidiary of Sumitomo Pharma Co., Ltd. As a global oncology organization with teams in the U.S. and Japan, SMP Oncology is committed to the goal of advancing purposeful science by transforming new discoveries into meaningful treatments for patients with cancer. SMP Oncology's robust and diverse pipeline of preclinical and clinical-stage assets spans multiple areas, including oncogenic pathways, survival mechanisms and novel protein interactions, which aim to address unmet clinical needs in oncology. For more information, visit www.oncology.sumitomo-pharma.com.

About Sumitomo Pharma Co., Ltd.

Sumitomo Pharma Co., Ltd. is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries with about 7,000 employees worldwide. Sumitomo Pharma Co., Ltd. defines its corporate mission as "To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide." Additional information about Sumitomo Pharma Co., Ltd. is available through its corporate website at https://www.sumitomo-pharma.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.

References

1. Foulks JM, Carpenter KJ, Luo B, et al. A small-molecule inhibitor of PIM kinases as a potential treatment for urothelial carcinomas. Neoplasia. 2014;16(5):403-412.

2. Nath D, Yang Y, Dutta A, Whatcott C. The PIM kinase inhibitor TP-3654 in combination with ruxolitinib exhibits marked improvement of myelofibrosis in murine models. Blood. 2018. 132(suppl 1):54. doi:10.1182/blood-2018-99-119421

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