Sumitomo Pharma Oncology Presents New Data from Investigational Pipeline of Novel Cancer Therapeutics at AACR Annual Meeting 2022

CAMBRIDGE, Mass., April 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:

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

Below are the details for the poster:

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).

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).

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).

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/ 

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.

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.

SOURCE Sumitomo Pharma Oncology, Inc.