Sumitomo Dainippon Pharma Oncology Announces First Patient Dosed with TP-1454 in Patients with Advanced Solid Tumors

CAMBRIDGE, Mass., Oct. 9, 2020 /PRNewswire/ -- Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, today announced that the first patient has been dosed with TP-1454, an investigational small-molecule pyruvate kinase M2 isoform (PKM2) activator, administered alone and in combination with ipilimumab and nivolumab, in a Phase 1/1b study in patients with advanced metastatic or progressive solid tumors.

"Dosing the first patient in this study marks an important milestone, as TP-1454 is the first PKM2 activator to be evaluated in patients with cancer," said Patricia S. Andrews, Chief Executive Officer and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "The novel mechanism of action for TP-1454 aims to target the underlying drivers of tumor growth and tumor-driven immune suppression. We look forward to further understanding the safety and efficacy of TP-1454 alone and in combination in patients with solid tumors and applying these learnings to advance the compound."

The primary objectives of the first-in-human, open-label study are to assess the safety of oral TP-1454 administered once daily as monotherapy in patients with advanced metastatic or progressive solid tumors and as combination therapy with ipilimumab and nivolumab. The study will also establish the dose of TP-1454 alone and in combination with ipilimumab and nivolumab for future studies in select advanced solid tumors. Secondary objectives include assessing the pharmacokinetic (PK) profile and preliminary antitumor activity of TP-1454 alone and in combination with ipilimumab and nivolumab and evaluating pharmacodynamics of TP-1454.

The trial is being conducted in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT04328740).

About TP-1454

TP-1454 is an investigational oral pyruvate kinase M2 isoform (PKM2) activator, that is currently being evaluated in a Phase 1/1b study in patients with advanced metastatic or progressive solid tumors (NCT04328740). TP-145 is the first PKM2 activator to be evaluated in cancer patients. Pyruvate kinase is the enzyme responsible for catalyzing the last step of glycolysis. PKM2 plays a critical role in the metabolic changes observed in cancer and immune cells and establishes a metabolic advantage for tumor cells over the tumor immune microenvironment.1

About Sumitomo Dainippon Pharma Oncology

Sumitomo Dainippon Pharma Oncology, Inc., is a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. As a global oncology organization with teams in the U.S. and Japan, SDP Oncology is relentlessly committed to advancing purposeful science by transforming new discoveries into meaningful treatments for patients with cancer. SDP 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 www.sdponcology.com.

About Sumitomo Dainippon Pharma

Sumitomo Dainippon Pharma is among the top-10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the Oncology area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-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

1Alves-Filho JC, Pålsson-McDermott EM. Pyruvate Kinase M2: A Potential Target for Regulating Inflammation. Front Immunol. 2016;7:145.

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