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leaptherapeutics Leap Therapeutics Reports First Quarter 2021 Financial Results May 14 , 2021 CAMBRIDGE , Mass . , May 14 , 2021 / PRNewswire / -- Leap Therapeutics , Inc. ( Nasdaq : LPTX ) , a biotechnology company focused on developing targeted and immuno - oncology therapeutics , today reported financial results for the first quarter ended March 31 , 2021 . Leap First Quarter Highlights : • Completed enrollment for first - line patient cohort in the DisTinGuish study , a clinical trial evaluating Leap's anti - Dickkopf - 1 ( DKK1 ) antibody , DKN - 01 , in combination with tislelizumab , BeiGene Ltd.'s anti - PD - 1 antibody , with or without chemotherapy , in patients with gastric or gastroesophageal junction cancer ( G / GEJ ) • Presented updated clinical data from the Phase 2 study of DKN - 01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological malignancies at the Society of Gynecologic Oncology ( SGO ) 2021 Virtual Annual Meeting on Women's Cancer • Announced partnership to use a clinically validated tumor expression assay utilizing RNAscope® and image analysis with Flagship Biosciences for patient enrollment " We're off to a strong start this year as we've continued to advance our understanding of DKN - 01 and the potential role it can play as both a monotherapy or in combination with existing treatments in multiple DKK1 biomarker defined cancer indications , " said Douglas E. Onsi , President and Chief Executive Officer of Leap . " The completion of enrollment of the first - line patient cohort in the DisTinGuish study brings us one step closer to an important milestone for us with our partner BeiGene , anticipated later this year . " DKN - 01 Development Update DKN - 01 is a humanized monoclonal antibody that binds to and blocks the activity of the DKK1 protein . DKK1 modulates the Wnt / Beta - catenin and Pl3kinase / AKT signaling pathways , which have an important role in tumor cell signaling and in mediating an immuno - suppressive tumor microenvironment through enhancing the activity of myeloid - derived suppressor cells and downregulating NK cell ligands on tumor cells . • Leap Announced Completion of Enrollment in First - Line Cohort in the DisTinGuish Study of DKN - 01 plus Tislelizumab and Chemotherapy in Gastric Cancer - In April 2021 , Leap announced the completion of enrollment for the first - line patient cohort in the DisTinGuish study ( NCT04363801 ) , a clinical trial evaluating DKN - 01 in combination with tislelizumab , BeiGene Ltd.'s anti - PD - 1 antibody , with or without chemotherapy , in patients with G / GEJ . The study , which is being conducted in two parts in the United States and the Republic of Korea , enrolled 25 patients with first - line G / GEJ cancer and will enroll up to 48 patients with second - line G / GEJ cancer whose tumors express high levels of DKK1 . Initial data is expected in the second half of 2021. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene for the development of DKN - 01 in Asia ( excluding Japan ) , Australia , and New Zealand . • Leap Presented Final Data for DKN - 01 in Gynecologic Cancers - At the SGO 2021 Virtual Annual Meeting on Women's Cancer , Leap presented the final data from the study of DKN - 01 as a monotherapy or in combination with paclitaxel in groups composed of epithelial endometrial cancer ( EEC ) , epithelial ovarian cancer ( EOC ) , or carcinosarcoma ( MMMT ) patients . The key findings from the study were : • EEC patients and patients with Wnt activating mutations express higher levels of DKK1 : EEC patients expressed higher levels of DKK1 and had a higher frequency of Wnt activating mutations than patients with EOC . Within EEC , patients with endometrioid histology had higher DKK1 expression than those with non - endometrioid histology . Patients whose tumors had Wnt activating mutations expressed 14.4 times higher levels of DKK1 . • DKN - 01 has enhanced activity in patients whose tumors express high levels of DKK1 : In the group of 22 EEC patients treated with DKN - 01 monotherapy for whom DKK1 expression data was available , patients with DKK1 - high tumors ( n = 7 ) had greater ORR ( 14 % vs. 0 % ) , DCR ( 57 % vs. 7 % ) , and median PFS ( 3.0 months vs. 1.8 months [ HR 0.39 ; 95 % CI : 0.14 , 1.1 ] ) compared to patients with DKK1 - low tumors ( n = 15 ) . Additionally , seven patients did not have DKK1 expression results available , of whom one had a complete response ( 14 % ) and five ( 72 % ) had a best response of stable disease , including three patients with Wnt activating mutations . In the group of 24 EEC patients treated with DKN - 01 plus paclitaxel , 72 % of whom had received three or more prior systemic therapies , DKK1 - high patients ( n = 11 ) had improved median PFS ( 5.4 months vs. 1.8 months [ HR 0.34 ; 95 % CI : 0.12 , 0.97 ] ) compared to DKK1 - low patients ( n = 9 ) . Four patients did not have DKK1 expression data available .