Clinical Advisors

Daniel D. Von Hoff, M.D., F.A.C.P. : Clinical Advisor

  • Mayo Clinic, TGen, US Oncology.
  • Physician in Chief, Distinguished Professor, Director of Clinical Translational Research Division at TGen;
  • CSO, US Oncology Research;
  • Professor of Medicine, Mayo Clinic, Scottsdale, AZ.
  • Recognized expert in Oncology drug development;
  • PI on numerous phase I-III clinical trials including Abraxane; >620 papers, 137 book chapters
  • 2010 David A. Karnofsky Memorial Award from ASCO; Past President of the AACR; Appointed to President Bush’s National Cancer Advisory Board in 2004-2010.
  • Founder of ILEX™ Oncology.

Sant Chawla, MD, FRACP : Advisor, Oncology Programs

  • Director, Sarcoma Oncology Center, Santa Monica, CA.
  • Academic appointments and affiliations: Stanford Univ Medical Center, MD Anderson Cancer Center, David Geffen School of Medicine UCLA, Keck School of Medicine USC, Cedars Sinai Medical Center
  • Extensive Clinical trial experience (>30 yrs) : Phase 1-3. Pazopanib, Denosumab, Ridoforolimus (rapamycin analog), Palifosfomide, Aldoxorubicin, TH302, belinostat, ofatumumab, AMG655, MEK162 and others

James McKiernan, MD : Columbia University Medical Center

  • Chair, Department of Urology
  • John and Irene Given Professor of Urology, Herbert Irving Comprehensive Cancer Center
  • Recognized expert in treatment of early stage bladder cancer
  • PI, AADI Bladder cancer Phase I/II trial
  • > 130 publications
  • Investigator in numerous clinical trials

Mark Gladwin, MD : University of Pittsburgh School of Medicine [PAH]

  • Chief of the Pulmonary, Allergy and Critical Care Medicine Division
  • Recognized expert in pulmonary hypertension and sickle cell disease
  • PI, AADI Pulmonary Hypertension Phase I/II trial
  • > 200 publications
  • Investigator in > 25 clinical trials

Clinical Advisors

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: