NEW YORK – California-based drug company Aadi Bioscience and EOC Pharma, a firm based in China specializing in cancer therapies, have signed an exclusive licensing deal to develop and commercialize Aadi's mTOR inhibitor ABI-009 in Greater China.
Under the teams of their agreement, EOC will garner exclusive rights to develop and commercialize ABI-009, also called nab-sirolimus, in China, Hong Kong, Macau, and Taiwan, and pay Aadi up to $271 million in upfront, regulatory, and sales-based milestone payments. Aadi is also eligible for tiered royalties based on the annual net sales of the drug.
EOC will handle development, regulatory submissions, and commercialization of the drug in the Greater China market, while Aadi will retain rights to the product outside of this territory. "The mTOR pathway plays a major role in multiple critical cellular processes, and mTOR activation is associated with specific mutations across a broad range of cancers and other diseases," EOC Pharma CEO Xiaoming Zou said in a statement. "We are happy to work with Aadi to advance ABI-009 to address unmet medical needs for Chinese patients with malignant PEComa, specific mutation-driven solid tumors and other mTOR-driven conditions."
Aadi last June initiated a rolling new drug application submission for ABI-009 with the US Food and Drug Administration as a treatment for advanced, malignant PEComa, a rare sarcoma frequently characterized by TSC1 or TSC2 gene mutations. In the AMPECT registrational trial, 39 percent of patients with advanced, malignant PEComa saw their tumors shrink with ABI-009, and an exploratory analysis showed that 89 percent of patients with TSC2 mutations responded to the drug.
Based on conversations with the FDA and data showing that the drug also has activity in other cancers with TSC1 or TSC2 mutations, Aadi is initiating a tumor-agnostic registrational trial in patients with solid tumors with these biomarkers this year. TSC1/2 mutations show up in 1 percent to 2 percent of solid tumors and are more frequent in melanoma, and bladder, kidney, breast and hepatocellular cancers.