CAMBRIDGE, Mass., Apr. 8, 2022 /PRNewswire/ Sumitomo Pharma Oncology, Inc., (SMP Oncology) a clinical-stage company focused on research and development for novel cancer therapeutics, today announced 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) Annual Meeting, held April 8-13, 2022, in New Orleans, LA.
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 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).
About Sumitomo Pharma Oncology
Sumitomo Pharma Oncology, Inc., 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 relentlessly committed to advancing purposeful science by transforming new discoveries into meaningful treatments for patients with cancer. SMP Oncology’s robust and diverse pipeline of preclinical and advanced-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 https://oncology.sumitomo-pharma.com/
About Sumitomo Pharma
Sumitomo Pharma 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 more than 7,000 employees worldwide. Sumitomo Pharma 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 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. Kim W, Haws H, Peterson P, et al. TP-1287, an oral prodrug of the cyclin-dependent kinase-9 inhibitor alvocidib [Abstract 5133]. Cancer Res. 2017;77(12 suppl). doi:10.1158/1538-7445.AM2017-5133.
2. Yin T, Lallena MJ, Gandhi V, Plunkett W. Transcription inhibition by flavopiridol: mechanism of chronic lymphocytic leukemia cell death. Blood. 2005;106(7):2513-2519.
3. Boffo S, Damato A, Alfano L, Giordano A. CDK9 inhibitors in acute myeloid leukemia. J Exp Clin Cancer Res. 2018;37(1):36.
4. Huang H, Weng H, Zhou H, Qu L. Attacking c-Myc: targeted and combined therapies for cancer. Curr Pharm Des. 2014;20(42):6543-6554.
5. Goto M, Nakamura M, Suginobe N, et al. DSP-7888, a novel cocktail design of WT1 peptide vaccine, and its combinational immunotherapy with immune checkpoint-blocking antibody against PD-1. Blood. 2016;128(22):4715.
6. Miyakoshi S, Usuki K, Masumura I, et al. Preliminary results from a phase 1/2 study of DSP-7888, a novel WT1 peptide-based vaccine, in patients with myelodysplastic syndrome (MDS). Blood. 2016. 2016:128(22):4715.
7. Peterson P, Kim W, Haws H, et al. The ALK-2 inhibitor, TP-0184, demonstrates high distribution to the liver contributing to significant preclinical efficacy in mouse models of anemia of chronic disease [Abstract]. Blood. 2016;128:263.
8. Peterson P, Whatcott C, Siddiqui-Jain A, et al. TP-0184 inhibits ALK2/ACVR1, decreases hepcidin levels, and demonstrates activity in preclinical mouse models of functional iron deficiency. Blood. 2017;13(suppl 1):937.
9. Zhou L, Nguyen AN, Sohal D, et al. Inhibition of the TGF-beta receptor I kinase promotes hematopoiesis in MDS. Blood. 2008;112(8):3434-3443.
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