Leap Therapeutics, a biotechnology company developing targeted immuno-oncology therapeutics, and BeiGene, biopharma company focused on molecularly-targeted and immuno-oncology drugs, entered an exclusive option and license agreement for the clinical development and commercialization of DKN-01, Leap’s anti-Dickkopf-1 antibody, in Asia (excluding Japan), Australia, and New Zealand. Leap will retain exclusive rights for the development, manufacturing, and commercialization of DKN-01 for the rest of the world. Leap is also entering an agreement for a $27 million equity financing with BeiGene and two institutional investors.

Leap will receive $3 million upfront in exchange for granting BeiGene an option to an exclusive license to develop and commercialize DKN-01 in Asia (excluding Japan), Australia, and New Zealand, and will be eligible to receive an additional payment from BeiGene following initial proof-of-concept studies. Leap is also eligible to receive certain development, regulatory, and sales milestones totaling as much as $132 million, with royalties on sales of DKN-01 in the licensed territory. BeiGene will also make a $5 million equity investment in Leap as part of the $27 million equity financing.

 
“We are excited about the potential to combine our anti-PD-1 inhibitor tislelizumab with DKN-01 as there have been promising signals in a biomarker-defined population of gastric cancer patients in combination with checkpoint blockade,” said Yong Ben, M.D., chief medical officer, Immuno-Oncology at BeiGene. “This collaboration with Leap is another example of our commitment to developing novel treatments to address unmet medical needs in Asia and around the world.”
 

“Securing a collaboration to further develop DKN-01 has been our top strategic priority, and we are excited to begin working with BeiGene, a global leader in oncology,” said Christopher K. Mirabelli, Ph.D., president and chief executive officer of Leap Therapeutics. “BeiGene is the ideal partner for Leap given its extensive experience in the development of oncology drugs throughout Asia Pacific, where its expertise and product breadth can help us in our efforts to address serious unmet medical needs in esophagogastric, gynecologic, and other cancers.”

During the option period, Leap will study the combination of DKN-01 and tislelizumab in approximately 40 patients with second-line gastric cancer (GC) / gastroesophageal junction cancer (GEJ) whose tumors express high levels of DKK1. In addition, Leap plans to evaluate the combination of DKN-01 with tislelizumab and chemotherapy in approximately 20 patients with first-line GC/GEJ. Leap expects to initiate these trials in 1H20.