Leap Therapeutics, Inc. (LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, recently reported financial results for the year ended December 31, 2016 and top-line progression-free survival (PFS) data. Earlier this year, Leap merged with Macrocure Ltd. and became listed on NASDAQ.
The company’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 gastroesophageal cancer in combination with paclitaxel and in patients with biliary tract cancers in combination with gemcitabine and cisplatin. DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response.
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.
The open-label, dose-escalation study enrolled 27 patients with treatment-naïve advanced biliary tract cancer. Patients received two dose levels of DKN-01 in combination with gemcitabine and cisplatin. The primary objective of this study is to evaluate the safety, pharmacokinetics, and efficacy of DKN-01 in combination with gemcitabine and cisplatin. The study has recently been expanded to enroll an additional 20 patients to enhance biomarker collection and analysis.
For more information about Leap Therapeutics, visit www.leaptx.com