Leap Therapeutics Announces Encouraging Data from TRX518 Phase 1 in Immunosuppressive Cell Reduction (MCUR)

November 14, 2016 6:53 AM EST

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Leap Therapeutics, Inc. announced the presentation of data from its Phase 1 clinical trial of TRX518 in patients with advanced relapsed or refractory solid tumors. Roberta Zappasodi, Ph.D., Parker Institute Scholar and Research Scholar in the Ludwig Collaborative Laboratory at Memorial Sloan Kettering Cancer Center, a site participating in the Phase 1 study, led an oral presentation during the Presidential Session entitled “Analysis of pharmacodynamic biomarkers in the first-in-human trial of GITR co-stimulation with the agonist antibody TRX-518 in advanced solid cancer patients.”

Data from the trial showed that a single-dose of TRX518 is associated with a reduction in immunosuppressive cells, known as regulatory T cells, inside patients’ tumors and in circulating blood.

The research collaboration with Leap is led by Dr. Taha Merghoub, Ph.D., Associate Attending Lab Member of the Ludwig Collaborative Laboratory at the Memorial Sloan Kettering Cancer Center. Dr. Merghoub said, “These are the first cases of a GITR agonist modulating T-cell activity in advanced cancer patients. These early data suggest that GITR stimulation may become an important immunotherapeutic tool alongside other cancer therapies.”

The data presented were among the results of a Phase 1 single dose study conducted by lead investigators Jedd Wolchok, M.D. Ph.D., Chief of Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center and Henry Koon, M.D., Disease Team Leader, Melanoma, UH Cleveland Medical Center, and Vamsidhar Velcheti, M.D., Assistant Professor, Taussig Cancer Institute, Cleveland Clinic.

Leap is continuing to enroll patients with advanced solid tumors in two clinical studies to assess the safety, pharmacokinetics, pharmacodynamics, and efficacy of TRX518 when dosed at various dose levels and frequencies.

About Leap Therapeutics

Leap Therapeutics’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with esophageal cancer in combination with paclitaxel and in patients with cholangiocarcinoma in combination with gemcitabine and cisplatin. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response. Leap has signed a Merger Agreement with Macrocure Ltd (Nasdaq: MCUR) which is expected to result in Leap becoming a public company. For more information about Leap Therapeutics or the merger with Macrocure, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov.



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