On January 11, 2021 Aadi Bioscience (Aadi), a biopharmaceutical company focusing on precision therapies for genomically defined cancers and EOC Pharma (EOC), a leading oncology specialty biopharmaceutical company in China, repoted an exclusive license agreement for the development and commercialization of ABI-009 (FYARRO) in Greater China including mainland China, Hong Kong, Macau and Taiwan (Press release, Aadi, JAN 11, 2021, View Source [SID1234573813]).
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Under the terms of the agreement, EOC Pharma will obtain exclusive rights to develop and commercialize ABI-009 in Greater China. Aadi will receive an upfront payment, regulatory and sales-based milestone payments totaling up to $271M as well as tiered royalties based on annual net sales of ABI-009. EOC will be responsible for development, regulatory submissions, and commercialization in the territory. Aadi Bioscience retains full worldwide rights outside of the partnered territory.
"We are very excited to partner with the experienced team at EOC Pharma. Through this collaboration, we will work together to bring ABI-009, a potential best-in-class mTOR inhibitor targeted to inactivating mutations in tumor-suppressor genes in the mTOR pathway such as TSC1, TSC2 or PTEN, to patients globally including in Greater China", said Neil Desai, Ph.D., CEO and Founder of Aadi Bioscience.
"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. 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", said Xiaoming Zou, Ph.D., CEO of EOC Pharma
About ABI-009 (FYARRO)
FYARRO (ABI-009, sirolimus albumin-bound nanoparticles) is an mTOR inhibitor complexed with human albumin that has demonstrated significantly higher tumor accumulation, mTOR target suppression and superior efficacy over other mTOR inhibitors in preclinical models (Hou 2019, AACR (Free AACR Whitepaper) Abstract 348).
Aadi recently initiated a rolling NDA submission for ABI-009 to the FDA for treatment of advanced malignant PEComa, a rare type of sarcoma with high frequency of mutations in the TSC1 or TSC2 genes and no previously approved treatments. Long-term data on the AMPECT registrational trial in PEComa was presented at ASCO (Free ASCO Whitepaper) and CTOS (Wagner 2020, Abstract 11516 and Wagner 2020, Abstract 3463014 respectively). The study met its primary endpoint response rate with a manageable safety profile and durable responses on long-term follow-up. ABI-009 has received Breakthrough Therapy, Fast Track, and Orphan Designations from the FDA.
Based on emerging data for ABI-009 in other solid tumors with TSC1 or TSC2 mutations and following discussions with the FDA, Aadi is proceeding with a tumor-agnostic registrational trial in solid tumors harboring TSC1 or TSC2 pathogenic, inactivating mutations with planned initiation in 2021. TSC1 and TSC2 mutations occur across a broad range of cancers at an average frequency of 1-2% and are further enriched in specific types of cancer including bladder cancer, kidney cancer, melanoma, breast cancer and hepatocellular carcinoma.