CAMBRIDGE, Mass., April 03, 2017 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc. (Nasdaq: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.
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.
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.
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FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include statements relating to Leap’s expectations with respect to the development and advancement of DKN-01, TRX518, and other programs, including the initiation, timing and design of future studies, enrollment in future studies, business development, and other future expectations, plans and prospects. Leap has attempted to identify forward looking statements by such terminology as ‘‘believes,’’ ‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics’ periodic filings with the Securities and Exchange Commission (the "SEC"), including Leap Therapeutics’ Form 10-K that Leap filed with the SEC on March 31, 2017. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
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