On March 14, 2018 Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported its presented promising clinical data from the study evaluating DKN-01, Leap’s anti-DKK1 monoclonal antibody, as a monotherapy in patients with advanced esophagogastric cancer (Press release, Leap Therapeutics, MAR 19, 2018, View Source [SID1234524889]). In addition, Leap announced that the first patient has been enrolled in the study evaluating DKN-01 in patients with gynecological cancers. Leap also announced two upcoming scientific presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting.
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DKN-01 Monotherapy in Patients with Esophagogastric Cancer
Data presented today at the Barclays Global Healthcare Conference included 16 patients with advanced esophagogastric cancer who were treated with DKN-01 monotherapy. Central imaging review identified two patients (12.5%) with a best response of a partial response and five patients (31.3%) with stable disease, representing a total disease control rate of 43.8%. This cohort of patients had received many different lines of prior therapy. One patient who had failed prior investigational immunotherapies, including a PD-L1 antagonist and IDO inhibitor, had a partial response on DKN-01 monotherapy and remained on study for over a year.
"The results of the DKN-01 monotherapy cohort demonstrate promising single agent activity in a very difficult to treat population of heterogeneous esophagogastric cancer. This data, in addition to the encouraging activity we have seen with DKN-01 in preclinical models and in patients in combination with chemotherapy, provides a strong foundation for our ongoing study in combination with the anti-PD-1 therapy Keytruda," commented Cynthia Sirard, MD, Vice President of Clinical Development for Leap.
DKN-01 Gynecologic Malignancies Study
Leap also announced that the first patient has been dosed in a Phase 2 clinical trial evaluating DKN-01 as a monotherapy and in combination with paclitaxel chemotherapy in patients with advanced endometrioid gynecologic malignancies. The study is part of Leap’s strategy to treat cancer patients with documented mutations of the Wnt signaling pathway, a biomarker identified in patients who have responded to DKN-01 therapy. Data presented today by Leap demonstrates that uterine cancer patients with these mutations often have elevated intratumoral levels of DKK1.
"Mutations of the Wnt pathway, particularly beta-catenin, are highly prevalent in endometrioid gynecologic cancers, and often thought to be a driver of an aggressive subgroup of the disease," commented Michael Birrer, M.D., Ph.D., Director of the Comprehensive Cancer Center at the University of Alabama at Birmingham and an investigator on the study. "We are excited to begin this trial of DKN-01, which has shown promising activity in patients with Wnt signaling mutations in other solid tumor malignancies."
The study is a Phase 2 basket study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with relapsed/refractory endometrioid endometrial cancer (EEC) or endometrioid ovarian cancer (EOC). The study contains four groups and is designed to evaluate the efficacy, safety, and pharmacodynamics of DKN-01 monotherapy and combination therapy in both EEC and EOC, with each group following a 2-stage Simon Minimax design. The study will enroll approximately 94 patients, of which ~ 50% will be required to have documented activating mutations of beta-catenin or other Wnt signaling alterations.
Upcoming Presentation at AACR (Free AACR Whitepaper) Annual Meeting
Additionally, Leap announced two poster session presentations at the AACR (Free AACR Whitepaper) Annual Meeting, being held April 14 – 18, 2018, in Chicago, IL.
Abstract Number and Title: 1710 / 5 – DKN-01, a therapeutic DKK1 neutralizing antibody, has immune modulatory activity in nonclinical tumor models
Session Title: Immune Response to Therapies 2
Session Date and Time: April 16, 2018, 8:00 AM – 12:00 PM
Session Location: McCormick Place, Poster Section 32
Abstract Number and Title: 1699 / 24 – Treatment with agonist anti-GITR antibody after chemotherapy enhances tumor immunity
Session Title: Immune Checkpoints 1
Session Date and Time: April 16, 2018, 8:00 AM – 12:00 PM
Session Location: McCormick Place, Poster Section 31