NEW YORK – Shanghai-based Zai Lab on Monday said it has exclusively licensed the rights to develop, manufacture, and commercialize Cullinan Oncology's EGFR inhibitor CLN-081 in Greater China.
Under the terms of their agreement, Cambridge, Massachusetts-based Cullinan will receive $20 million upfront from Zai Lab and is eligible to receive up to $211 million in development, regulatory, and sales-based milestone payments. Cullinan will also receive high-single-digit to low-teen tiered royalties based on annual net sales of CLN-081 in mainland China, Hong Kong, Macau, and Taiwan.
Researchers are currently studying CLN-081 in a Phase I/IIa trial in non-small cell lung cancer patients harboring EGFR exon 20 insertion mutations, who have been previously treated with platinum-based chemotherapy or another standard therapy. According to preliminary data presented at the European Society for Medical Oncology's Virtual Congress this year, 35 percent of 17 evaluable patients in this trial saw their tumors shrink on CLN-081.
Zai Lab will work with Cullinan on developing the drug in this setting. "Partnering with Cullinan for their potential best-in-class EGFR inhibitor targeting exon 20 insertion mutations provides potential synergies with Zai's existing lung cancer franchise and further strengthens our disease area stronghold in lung cancer," Zai Lab Founder, Chairwoman and CEO Samantha Du said in a statement. "The unmet need in non-small cell lung cancer with [exon 20 insertion] mutations is significant in China, where EGFR mutation rates are some of the highest in the world."
Zai has a collaboration, development, and license agreement with GlaxoSmithKline for the development and commercialization of the PARP inhibitor niraparib (Zejula) in Mainland China, Hong Kong and Macau. The company is also developing drugs that target HER2, PD-1, and FGFR2b.