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

Mitch is Chief Regulatory /Quality, Atara Biotherapeutics; he was formerly SVP Regulatory Affairs, Nantworks, 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,cClinical and manufacturing QA, drug safety and clinical operations.

Berta Grigorian, BS
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

Aadi Bioscience, Inc. (Aadi), a clinical stage biopharmaceutical company focused on treating diseases driven by mTOR activation, today announced the completion of a $23 Million Series A round. The financing was led by Hermed Capital with participation from Celgene Corporation, Vivo Capital, Decheng Capital, the Helsinn Investment Fund and Star Summit Ventures. The company will use the capital to drive the clinical programs for ABI-009, its targeted albumin-bound mTOR inhibitor.

“We are extremely pleased with the participation and interest of our investors and now stand poised to develop the potential of what we believe is a best-in-class mTOR inhibitor,” said Neil Desai, Ph.D., Founder and CEO of Aadi.

Aadi is currently enrolling its registration trial for advanced Perivascular Epithelioid Cell tumors (PEComa), an extremely rare form of sarcoma. Aadi received agreement from the FDA on the design of its phase 2 registration study for the treatment of advanced PEComa with ABI-009. The study will enroll approximately 30-35 patients and the primary endpoint for the study is the overall response rate. Earlier this month, an independent data monitoring committee (DMC) reviewed the available data and concluded that the study should continue without modification.

Aadi’s other planned clinical programs include pulmonary hypertension (phase 1), early stage bladder cancer (phase 2) and pediatric cancers (phase 1). It continues to investigate applications of ABI-009 in cancer indications as well as cardiovascular and other diseases.

Dr. Desai is also pleased to welcome new directors to the board of Aadi including Carlo Montagner (Specialised Therapeutics), Richard Maroun (Frazier Healthcare Partners), Jerry Xiao (Hermed Capital) and Mahendra Shah (Vivo Capital).

About Aadi and ABI-009

Aadi is a clinical stage biopharmaceutical company led by Dr. Neil Desai, an inventor of ABRAXANE®, ABI-009 and the nab® technology platform. Aadi’s lead product is ABI-009, a nanoparticle albumin-bound mTOR inhibitor based on sirolimus or rapamycin, also known as nab-rapamycin. Aadi aims to develop the full potential of the albumin-bound mTOR inhibitor in diseases that are driven by mTOR activation and where the mTOR inhibitors have not or cannot be effectively exploited due to problems of effective drug delivery, safety or effective targeting to the disease site. In a phase 1 study ABI-009 was well tolerated at intravenous doses significantly higher than other mTOR inhibitors and its pharmacokinetic profile, with high Cmax and AUC, is very different from the approved mTOR inhibitors. In animal models, ABI-009 has greater antitumor efficacy than the oral mTOR inhibitors at the same dose. Similar to ABRAXANE®, albumin-bound rapamycin is expected to have high tumor penetration due to mechanisms of albumin uptake in tumors and other areas with tissue remodeling or inflammation. ABI-009 was licensed to Aadi in 2014 by Celgene Corporation (NASDAQ:CELG).

ABRAXANE® and nab® are registered trademarks of Celgene Corporation.