Leap Therapeutics, Inc. Presents Biomarker Data from Clinical Study of DKN-01 in Combination with Paclitaxel in Esophageal Cancer
January 19, 2017 at 08:30 pm
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Leap Therapeutics, Inc. reported updated clinical and biomarker data from an ongoing study of DKN-01 in patients with cancer of the esophagus and gastroesophageal junction. Data from the trial identified genetic mutations that may be responsive to DKN-01 therapy, as well as decreased circulating immunosuppressive and angiogenic markers that are consistent with the anticipated mechanism of action of DKK1 inhibition. Four of 19 patients evaluated with genetic testing were found to have activating/stabilizing mutations of beta-catenin, which is a molecule in the Wnt signaling pathway implicated in oncogenesis, metastasis, and immune suppression. Of these 4 patients, 2 achieved partial responses (PR) per RECIST v.1.1 and 1 had prolonged stable disease. One patient has an ongoing response exceeding 20 months, of which the past 9 months have been on DKN-01 monotherapy with continued improvements in the disease. In the study to date, company has enrolled 44 patients with advanced esophageal and gastroesophageal junction cancers who had received between 1 and 7 prior lines of therapy. 10 of 41 evaluable patients achieved a PR and 15 patients achieved a best overall response of stable disease, representing a total disease control rate of 61%. Company is continuing to enroll patients in this study and has opened a new cohort specifically for patients with gastric cancer with known Wnt pathway mutations.
Leap Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on developing targeted and immuno-oncology therapeutics. Its advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-related protein 1 (DKK1) protein. DKK1 is also a modulator of CKAP4/PI3K/AKT signaling. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. Its second clinical-stage program is FL-301, a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. It also has two preclinical antibody programs, FL-302 and FL-501. FL-302 is a Claudin18.2/CD137 (also known as 4-1BB) bispecific antibody that is in preclinical development. FL-501 is a monoclonal antibody in preclinical development that targets growth and differentiation factor 15 (GDF15), which is a cytokine that is produced at elevated levels in response to various stresses.