BeiGene offers expertise in clinical
development and commercialization in Asia
Leap and BeiGene have entered into an exclusive option and license agreement for the clinical development and commercialization of DKN-01 in Asia (excluding Japan), Australia, and New Zealand. Leap retain exclusive rights for the development, manufacturing, and commercialization of DKN-01 for the rest of the world.
Under the terms of the agreement, Leap received an upfront cash payment of $3 million from BeiGene 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. Leap will be eligible to receive an additional payment of greater than $10 million from BeiGene upon BeiGene’s exercise of the option following initial proof-of-concept studies. Additionally, Leap is eligible to receive payments from BeiGene based upon the achievement of certain development, regulatory, and sales milestones for a total deal value of up to $132 million, together with tiered royalties on any product sales of DKN-01 in the licensed territory. BeiGene also made $12.25 million in equity investments in Leap.
During the option period, Leap is conducting the DisTinGuish study, a clinical trial of DKN-01 in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, in patients with gastric and gastroesophageal junction cancer. In the DisTinGuish study, Leap is evaluating DKN-01 with tislelizumab in up to 48 second-line patients whose tumors express high levels of DKK1 to build upon the positive clinical experience of DKN-01 in combination with other PD-1 inhibitors in these patients. In addition, Leap is evaluating the combination of DKN-01 with tislelizumab and chemotherapy in 25 first-line patients.