On April 8, 2022 Sumitomo Pharma Oncology, Inc., (SMP Oncology) a clinical-stage company focused on research and development for novel cancer therapeutics, reported it will present new clinical and preclinical data on a range of investigational agents from the company’s pipeline at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held April 8-13, 2022, in New Orleans, LA (Press release, Sumitomo Pharmaceuticals, APR 8, 2022, View Source [SID1234611774]).

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The data that will be presented at the meeting includes Phase 1 clinical data evaluating the potential anti-cancer activity of the cyclin dependent kinase 9 (CDK9) inhibitor oral TP-1287, the WT1 immunotherapeutic cancer vaccine DSP-7888 plus nivolumab (NIV) or pembrolizumab (PEM), and the activin receptor-like kinase-2 (ALK2) inhibitor oral TP-0184.

"The data emphasize our commitment to, and the progress being made in advancing our pipeline to discover novel approaches to address unmet needs in the oncology space," said Patricia S. Andrews, CEO and Global Head of Oncology, SMP Oncology. "These trials represent a significant step forward for patients as we continue toward advancing purposeful research and drug development in oncology."

Below are the details for the presentations:

Abstract Title

Details

Presenter/Authors

CT191 / 16 – Phase 1, first-in-human, dose-escalation study of oral TP-1287, a cyclin dependent kinase 9 (CDK9) inhibitor, in patients (pts) with advanced solid tumors (ASTs)

Abstract

Wednesday April 12, 2022, 9:00AM – 12:30PM

Session PO.CT01.02 – Phase I Clinical Trials 2

Nicholas J. Vogelzang, Ben George, Nissa Ashenbramer, William J. Edenfield, Donald Richards, Mitchell E. Gross, Gil D. Fine, Pablo Martinez. Comprehensive Cancer Centers of Nevada, Las Vegas, NV, LaBahn Pancreatic Cancer Program, Departments of Medicine-Hematology/ Oncology, Medical College of Wisconsin, Milwaukee, WI, Sumitomo Pharma Oncology, Inc., Cambridge, MA, Greenville Health System Cancer Institute, Greenville, SC, Department of Oncology, US Oncology Research, Texas Oncology-Tyler, Tyler, TX, University of Southern California, Keck School of Medicine, Lawrence J. Ellison Institute for Transformative Medicine, Los Angeles, CA

Preliminary safety and efficacy of DSP-7888 plus nivolumab (NIV) or pembrolizumab (PEM) in patients (pts) with advanced solid tumors (ASTs): a phase (Ph) 1b/2 open-label study

Abstract

Monday, April 11, 2022, 1:30PM – 5:00PM

Session PO.CT01.01 – Phase I Clinical Trials 1

Wael A. Harb, Makoto Origuchi, Patrick W. Cobb, Trisha Wise-Draper, Natsuko Suginobe, Megumi Nakamura, Masashi Goto, Aaron Chen, Jian Li, James L. Wade III. Syneos Health, Morrisville, NC, Horizon Oncology Center, Lafayette, IN, Sumitomo Pharma Oncology, Inc., Cambridge, MA, St. Vincent Frontier Cancer Center, Billings, MT, Department of Internal Medicine, Division of Hematology/Oncology, University of Cincinnati, Cincinnati, OH, Sumitomo Pharma Co., Ltd., Osaka, Japan, Cancer Care Specialists of Illinois, Decatur, IL

CT134 / 1 – Phase 1, first-in-human, dose-escalation, safety, pharmacokinetic (PK), and pharmacodynamic study of oral TP-0184, an activin receptor-like kinase-2 (ALK2) inhibitor, in patients (pts) with advanced solid tumors (ASTs)

Abstract

Tuesday April 11, 2022, 1:30PM – 5:00PM

Session PO.CT01.01 – Phase I Clinical Trials 1

Joaquina Baranda, Michael S. Gordon, Aparna R. Parikh, Huyuan Yang, Gregory K. Pennock, Philip Komarnitsky, Muhammad S. Beg. Division of Medical Oncology, Department of Medicine, University of Kansas Cancer Center, Westwood, KS, HonorHealth Research Institute, Scottsdale, AZ, Massachusetts General Hospital Cancer Center and Department of Medicine, Harvard Medical School, Boston, MA, Sumitomo Pharma Oncology, Inc., Cambridge, MA, The University of Texas Southwestern Medical Center, Dallas, TX

Additionally, at AACR (Free AACR Whitepaper) SMP Oncology will present preclinical data on TP-1287 in sarcomas in a poster.

Below are the details for the poster:

Poster Title

Details

Presenter/Authors

CDK9 as a potential therapeutic target in sarcomas

Poster:

Wednesday April 12, 2022, 9:00AM – 12:30PM

Session PO.MCB06.01 – Cell Cycle Control and Cell Cycle Regulators as Therapeutic Targets

Yuta Matsumura, Hiroki Umehara, Jun Oishi, Adam Siddiqui, Jason M. Foulks, Setsuko Yamamoto, Steven L. Warner. Sumitomo Pharma Oncology, Inc., Lehi, UT, Sumitomo Pharma Co., Ltd., Osaka, Japan

About TP-1287
TP-1287 is an investigational oral CDK9 inhibitor that has shown favorable oral bioavailability in preclinical models. TP-1287 is enzymatically cleaved, yielding the active moiety, a potent inhibitor of CDK9.1 Inhibiting CDK9 is thought to downregulate the transcription of target genes, including MCL-1, reducing leukemic blast viability in MCL-1–dependent hematologic malignancies, and c-MYC, an important oncogene across multiple tumor types.2, 3, 4 TP-1287 is in a Phase 1 first-in-human study of oral TP-1287 in patients with advanced solid tumors (NCT03604783).

About DSP-7888
Ombipepimut-S Emulsion (DSP-7888) is an investigational immunotherapeutic cancer vaccine containing 2 peptides that induce WT1-specific cytotoxic T lymphocytes (WT1-CTLs) and helper T cells to attack WT1-expressing cancerous cells found in various types of hematologic malignancies and solid tumors.5, 6 Researchers have identified that adding helper T-cell–inducing peptides improved WT1-specific CTL induction, which may contribute to tumor cytotoxicity.5 Ombipepimut-S Emulsion is in a Phase 1/2 study with immune checkpoint inhibitors in adult patients with advanced solid tumors (NCT03311334).

About TP-0184
TP-0184 is an investigational inhibitor of activin receptor-like kinase 2 (ALK2) and ALK5 (also known as TGFβR1). This bimodal inhibitor is believed to downregulate multiple TGF-β superfamily signaling pathways, enabling hematopoietic regulation in myelodysplastic syndrome (MDS) through hepcidin decreases, bioavailable iron increases, and hemoglobin restoration, as well as antitumor activity in several cancers.7, 8, 9 TP-0184 is in two clinical trials; A Phase 1/2 study to treat anemia in adults with IPSS-R low or intermediate risk MDS (NCT04623996); A first-in-human study of oral TP-0184 in patients with advanced solid tumors (NCT03429218).