CAMBRIDGE, MA, USA I April 03, 2017 I Leap Therapeutics, Inc. (LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported non-clinical and clinical data for its GITR agonist antibody, TRX518, and its Dickkopf-1 inhibitor antibody, DKN-01, at the 2017 American Association for Cancer Research (AACR) Annual Meeting.

TRX518 Data Presentation, Abstract Number: CT018

Roberta Zappasodi, Ph.D., Research Scholar at Memorial Sloan Kettering Cancer Center led an oral presentation during the clinical trials plenary session titled “Intratumor and peripheral Treg modulation as a pharmacodynamic biomarker of the GITR agonist antibody TRX-518 in the first in-human trial.” Dr. Zappasodi presented updated data on clinical biomarkers and the mechanism of action of TRX518. The data were generated in the Merghoub and Wolchok group in the Ludwig Collaborative, Parker Institute and Swim Across America Lab at Memorial Sloan Kettering Cancer Center. Taha Merghoub, Ph.D., is Associate Attending laboratory member in the Melanoma and Immunotherapeutics Service and Jedd Wolchok, M.D. Ph.D., is Chief of Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center.

Data from the TRX518 Phase 1 trial showed that a single-dose of TRX518 was associated with a reduction in immunosuppressive regulatory T cells in patients’ tumors and in circulating blood. Further analysis in donor blood samples in vitro showed that TRX518 induces T-Bet upregulation and increases cell death in regulatory T cells.

“These clinical data further demonstrate a direct effect of GITR stimulation with TRX518 on human regulatory T cells. As such, GITR stimulation may be an important therapeutic tool to generate anti-tumor immunity, to be considered for future immune therapy based combination trials,” said Dr. Merghoub.

About TRX518

TRX518 is a humanized monoclonal antibody with agonist activity targeting glucocorticord-inducible TNF-superfamily receptor (GITR). TRX518 is engineered to enhance immune responses to cancer. TRX518 is being studied in two ongoing repeat-dose clinical trials in patients with advanced solid tumor malignancies.

DKN-01 Data Presentation, Abstract Number: 369

Data from the DKN-01 Phase 1 trial and non-clinical data characterizing DKN-01 were also presented at the conference in a poster session titled “Therapeutic targeting of the Wnt antagonist DKK1 with a humanized monoclonal antibody in oncology indications.” The poster included the characterization of DKN-01’s binding epitope, data in animal models, and data summarizing the clinical activity and biomarkers of DKN-01 in cancer to-date.

About DKN-01

DKN-01 is a humanized monoclonal antibody that binds to and blocks the action of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling. DKK1 expression has been associated with poor prognosis in multiple cancers, and has been implicated with increased tumor cell proliferation, metastasis, and angiogenesis. Recent literature suggests DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment. DKN-01 is being studied in clinical trials in patients with esophageal, gastric, and biliary tract cancers. DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients. 

About Leap Therapeutics

For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via http://www.investors.leaptx.com/.

SOURCE: Leap Theraeutics