On October 9, 2020 Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, reported 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 (Press release, Sumitomo Dainippon Pharma, OCT 9, 2020, View Source [SID1234568273]).

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"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-1454 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