Leap Therapeutics’ DKN-01 demonstrates preclinical tumor regression in study

Leap Therapeutics will be presenting updated data from Part B of the DisTinGuish study evaluating DKN-01 in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, in second-line gastroesophageal adenocarcinoma – GEA – cancer patients whose tumors express high levels of DKK1 at the Society of Immunotherapy for Cancer Annual Meeting in Boston on November 8-12. Leap is also presenting preclinical DKN-01 data supporting the DeFianCe study, a Phase 2 study of DKN-01 in combination with bevacizumab and standard of care chemotherapy in patients with advanced colorectal cancer – CRC – who have received one prior systemic therapy. "The combination of DKN-01 plus tislelizumab continues to demonstrate a well-tolerated and active combination in previously treated, DKK1-high, anti-PD-1/PD-L1 naive GEA cancer patients," said Samuel Klempner, who leads the gastric and esophageal cancer program at Massachusetts General Hospital Cancer Center and principal investigator on the DisTinGuish study. "In Keynote-061, anti-PD-1 monotherapy generated a 2% ORR in second-line GEA patients with PD-L1 expression combined positive score less than 1 and a 24.5% ORR in patients with CPS greater than 10. As DKK1-high patients appear to have more aggressive disease, the updated second-line DKN-01 plus tislelizumab Part B data provides further evidence of activity in this difficult-to-treat patient population, particularly among the DKK1-high/PD-L1-high patients. These results continue to support the decision to start Part C, the randomized controlled clinical trial in first-line patients." "The preclinical results in CRC models showed impressive monotherapy and chemotherapy combination activity in multiple xenograft models, including those that are resistant to 5-FU treatment, which is commonly used to treat metastatic disease," said Cynthia Sirard, MD, Chief Medical Officer of Leap Therapeutics. "Colorectal cancer is the third most frequent cancer globally and the second leading cause of death. We enrolled our first patient in the Phase 2 DeFianCe study in October evaluating DKN-01 in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with CRC and look forward reporting initial data in mid-2023."