NEW YORK – On Tuesday, Turning Point Therapeutics and Zai Lab said that they entered into an exclusive license agreement for the development and commercialization of repotrectinib in China, Hong Kong, Macau and Taiwan.
The agreement will give Zai Lab exclusive rights to develop and commercialize repotrectinib in those territories. Turning Point Therapeutics will receive a $25 million upfront payment, up to $151 million in developmental and regulatory, and sales-based milestone payments, as well as royalties based on sales of repotrectinib.
Repotrectinib is Turning Point Therapeutics' lead drug candidate for patients with advanced solid tumors harboring ROS1, NTRK1-3, or ALK molecular rearrangements.
Zai Lab said in a statement that it anticipates opening additional sites for the Phase II TRIDENT-1 registrational study of repotrectinib.
The ongoing TRIDENT-1 study is currently active in 11 countries and enrolling patients with ROS1-positive advanced non-small cell lung cancer and NTRK-positive solid tumors.
Last year, the US Food and Drug Administration approved Almac Diagnostic Services' assay for determining whether cancer patients have ROS1, NTRK1-3, and ALK gene fusions and are eligible to enroll in the Phase II study.