[{"orgOrder":0,"company":"Aadi Bioscience","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aadi Bioscience Initiates Rolling Submission of NDA to FDA for nab-sirolimus for Advanced Malignant PEComa","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Aadi Bioscience","sponsor":"Eoc Pharma","pharmaFlowCategory":"D","amount":"$271.0 million","upfrontCash":"Undisclosed","newsHeadline":"Aadi Bioscience and EOC Pharma Announce License and Collaboration Agreement for ABI-009 (FYARRO) in Greater China","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 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Find Clinical Drug Pipeline Developments & Deals by Aadi Bioscience
ABI-009 (Nab-sirolimus) is a novel albumin-bound nanoparticle form of the mTOR inhibitor sirolimus and is approved for the treatment of locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Under the terms of the collaboration agreement, Mirati will be responsible for sponsoring and operating the Phase 1/2 study of Adagrasib (MRTX849), and jointly with Aadi, will oversee and share the cost of the study.
The company intends to use net proceeds from the financing to fund research and development of Nab-sirolimus and additional clinical opportunities with FYARRO and for working capital and general corporate purposes.
Nab-sirolimus is an albumin-bound mTOR inhibitor approved by the U.S. Food and Drug Administration (FDA) as FYARRO™ for the treatment of adult patients with locally advanced unresectable or metastatic malignant PEComa.
Partners will collect and analyze clinical and molecular data to determine which patients may be eligible to participate in Aadi’s PRECISION 1 clinical trial for ABI-009. The goals are to increase patient match rate, reduce screen failure rate and increase speed of enrollment.
Based on data from the AMPECT trial with FYARRO and following discussions with the FDA about other emerging data with FYARRO, Aadi has initiated PRECISION 1, a tumor-agnostic registrational trial in mTOR inhibitor-naïve solid tumors.
FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
nab-Sirolimus (ABI-009), an mTOR inhibitor bound to human albumin that has demonstrated significantly higher tumor accumulation, greater mTOR target suppression, and increased tumor growth inhibition over other mTOR inhibitors.
The combined, publicly traded company will focus on the advancement, expansion and commercialization of Aadi’s clinical stage pipeline, including Aadi’s lead program for its nanoparticle albumin-bound mTOR inhibitor, FYARRO™, an mTOR inhibitor bound to human albumin.
Proceeds from the PIPE financing are expected to be used for the commercialization of FYARRO in advanced malignant PEComa, a planned tumor-agnostic registrational trial in solid tumors harboring inactivating alterations in the mTOR pathway genes TSC1 and TSC2.
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