Leadership

Neil Desai, PhD
Founder, CEO and President

Neil is the Founder of Aadi Bioscience, Inc. He was former SVP, Global R&D, Abraxis Bioscience; VP, Strategic Platforms, Celgene Corp; Inventor of the nab® technology, Abraxane® and ABI-009. He successfully led the Abraxane team through all development stages. He has over 25 years of experience in novel therapeutic delivery systems with over 100 issued patents, over 40 peer-reviewed publications and book chapters, and over 200 presentations at scientific meetings. He is an active participant in FDA and EU Nanotechnology initiatives and a member of the Steering Committee for the National Cancer Institute (NCI) Alliance for Nanotechnology in Cancer. He holds board and advisory positions in various start-ups. He holds a M.S and Ph.D. in Chemical Engineering from the University of Texas at Austin, USA, and a B.S. in Chemical Engineering from the University Institute of Chemical Technology in Mumbai, India.

Mitchall Clark, Bpharm, MRPharmS
Regulatory Affairs and Quality Advisor
SVP, Regulatory Affairs and Quality Assurance

Mitch is was formerly Chief Regulatory /Quality, Atara Biotherapeutics, ; he was formerly SVP Regulatory Affairs, Nantworks, and SVP Regulatory affairs at Abraxis Bioscience where he was responsible for global approvals for Abraxane® and regulatory for early stage to post-marketing of nab products. He has 30+ yrs in international regulatory affairs with Schering AG, FH Faulding/Purepac & APP/Abraxis, Clinical and Manufacturing QA, drug safety and clinical operations.

Berta Grigorian, BS
VP, Clinical Operations

Berta was former Clinical Operations Manager, Amgen Inc. with 20 years industry experience in all phases of drug development, Oncology and Cardiovascular products. She led cross functional teams management to plan and execute a successful US BLA filing for an Amgen cardiovascular product, she has led global activities for various oncology studies to ensure quality, consistency, and integration of all study data, and she was responsible for global study management goals (enrollment, data flow, drug supply) for several clinical products.

Leadership

January, 3 2019, Aadi Bioscience, Inc. (Aadi), a clinical stage biopharmaceutical company focused on treating diseases driven by mTOR activation, today announced that its drug TARZIFYX™ (sirolimus albumin-bound nanoparticles for injectable suspension, ABI-009) has received Breakthrough Therapy Designation status from the FDA for the indication of Advanced (metastatic or locally advanced) Malignant PEComa (perivascular epithelioid cell tumor). The designation was granted based on data provided to the FDA from Aadi’s ongoing phase 2 registration trial (NCT02494570) in Advanced Malignant PEComa. In October 2018, Aadi also received Fast Track Designation from the FDA for TARZIFYX™ for the same indication. Aadi received orphan drug designation for TARZIFYX™ for the treatment of PEComa in December 2017. Aadi’s Phase 2 registration trial for Advanced Malignant Perivascular Epithelioid Cell Tumors (AMPECT), a rare form of sarcoma, has completed enrollment. Aadi previously received agreement from the FDA that this open label study in 30 efficacy evaluable patients with a primary endpoint of overall response rate could support the submission of an NDA for approval to treat this rare disease. mTOR inhibition is relevant in a number of disease states and has not been fully exploited in oncology, cardiovascular disease, CNS diseases, mitochondrial disease, diseases of ageing, etc. Due to the unique properties of Aadi’s drug including effective CNS penetration, it is being tested in nine ongoing clinical studies across these indications with encouraging results even outside of oncology in early studies in pulmonary hypertension and surgically refractory epilepsy. Aadi’s ongoing and planned clinical trials include Oncology (pediatric tumors, advanced sarcoma, first-line treatment of advanced colorectal cancer, newly diagnosed and recurrent glioblastoma, advanced neuroendocrine tumors), Cardiovascular indications (pulmonary arterial hypertension), CNS indications (surgically refractory epilepsy) and Mitochondrial disease (Leigh Syndrome). About Aadi and TARZIFYX™ (ABI-009) Aadi is a clinical stage biopharmaceutical company led by Dr. Neil Desai, an inventor of ABRAXANE®, TARZIFYX™ and the nab® technology platform. Aadi’s lead product TARZIFYX™ (sirolimus albumin-bound nanoparticles for injectable suspension, ABI-009) is an mTOR inhibitor complexed with human albumin that has significantly higher tumor accumulation and improved efficacy over other mTOR inhibitors in preclinical models. mTOR as a therapeutic target is well recognized in oncology, however Aadi aims to develop the full potential of albumin-bound sirolimus in therapeutic areas and diseases that are driven by mTOR activation and where the 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. These indications include oncology, cardiovascular, CNS, mitochondrial disease and diseases of ageing. About PEComa Perivascular epithelioid-cell tumors, defined by the World Health Organization as ‘mesenchymal tumors composed of distinctive cells that show a focal association with blood-vessel walls and usually express both melanocytic and smooth muscle markers,’ are a rare subset of soft-tissue tumors, with an undefined cell of origin. The PEComa family of tumors include lymphangioleiomyomatosis (LAM), angiomyolipoma (AML), clear-cell ‘sugar’ tumor of the lung (CCST), and a variety of morphologically and immunophenotypically similar tumors, which may arise in almost any body site (typically the uterus, retroperitoneum, genitourinary, and gastrointestinal tract), collectively termed PEComa-NOS. Malignant PEComas can have an aggressive clinical course including distant metastases and ultimate death. They have been shown to frequently harbor mutations in the TSC1 and/or TSC2 genes that result in the activation of mTORC1 pathway. Therefore, mTORC1 signaling is a promising therapeutic target for malignant PEComa, and anecdotal case reports have suggested clinical benefits of mTOR inhibitors in patients with malignant PEComas.   See original News Broadcast here: Businesswire.com/Aadi