PACIFIC PALISADES, CALIFORNIA and SHANGHAI, CHINA – 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, today jointly announced an exclusive license agreement for the development and commercialization of ABI-009 (FYARRO) in Greater China including mainland China, Hong Kong, Macau and Taiwan.
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 (FYARROTM)
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 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 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.
About Aadi Bioscience
Aadi is a clinical stage biopharmaceutical company developing precision therapies for genomically defined cancers. Aadi’s primary goal is to bring transformational outcomes to cancer patients with mTOR pathway driver alterations where other mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety or effective targeting to the disease site. Aadi’s initial focus is on treating patients with aberrant TSC1 or TSC2 genes, tumor suppressors that when mutated are the source of many different cancer types. Aadi’s AMPECT pivotal trial of ABI-009 demonstrated meaningful clinical efficacy in Malignant PEComa, a type of cancer with the highest known mutation rate of TSC1 or TSC2 genes. Based on the AMPECT trial, 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 cancers harboring TSC1 or TSC2 pathogenic, inactivating mutations with a planned initiation in 2021.
Aadi also has ongoing studies across multiple high unmet need, advanced cancers including colorectal cancer, sarcoma, and glioblastoma to identify activity of ABI-009 in additional mTOR pathway driver alterations and combination regimens. For more information on Aadi Bioscience, Inc., please visit www.aadibio.com.
About EOC Pharma
EOC Pharma, a spin-off of the oncology division of Eddingpharm, is an integrated biopharmaceutical company focusing on the discovery, research, development, and commercialization of innovative oncology products. Leveraging a highly integrated product development platform, EOC Pharma’s goal is to build a portfolio of first- and best-in-class oncology drugs through independent R&D and strategic partnerships to benefit the millions of patients who currently have limited access to high quality oncology treatments in China. EOC’s most advanced program is EOC103, a novel oral HDAC inhibitor for the treatment of breast cancer in pre-NDA stage in China. In addition, EOC has initiated a Phase II study of EOC 202, a novel Lag-3 lgG Fc protein targeting breast cancer following the positive Phase 2b clinical study results in Europe. Additional targeted therapies in clinical development include EOC315 (VFGFR), EOC317 (FGFR), EOC406 (RANKL), and EOC611 (HER2/EGFR). For more information on EOC Pharma, please visit www.eocpharma.com.