Xynomic Pharma and UCSF Entered Strategic Partnership in Conducting a Phase 2/3 Trial of Abexinostat against Renal Cell Carcinoma
05/26/2017 Uncategorized admin

CHEYENNE, Wyo., May 22, 2017 /PRNewswire/ — Xynomic Pharma, a clinical stage US oncology drug R&D company, today announced that it has entered into a strategic partnership with the University of California San Francisco (“UCSF”) to conduct PAX Study, a multi-national, multi-center, randomized Phase 2/3 study of Pazopanib plus Abexinostat versus Pazopanib monotherapy in patients with locally advanced or metastatic renal cell carcinoma (“RCC”).

The study, to be led by UCSF’s Pamela Munster, MD, and Rahul Aggarwal, MD, will leverage encouraging clinical data from a recently completed Phase 1b study, sponsored by the National Cancer Institute and conducted by UCSF, entitled “Pazopanib Hydrochloride and Abexinostat in Treating Patients with Metastatic Solid Tumors,” in which 51 heavily pre-treated patients with metastatic solid tumors, including 22 RCC patients, were treated with Abexinostat and Pazopanib.  Durable tumor regressions were observed in 70% of patients with Pazopanib-refractory disease, including one RCC patient with ongoing response of more than 3.5 years. This is the first-ever clinical trial demonstrating epigenetic modification with HDAC inhibition may provide the means to recapture response and reverse resistance to Pazopanib in RCC and other solid tumors.

“Drs. Munster and Aggarwal’s groundbreaking Phase 1b study in combining Abexinostat with VEGF inhibitors such as Pazopanib to treat metastatic solid tumors shows Abexinostat can epigenetically prime tumors and re-sensitize tumors to prior therapies. The PAX Study, with expanded sites and larger patient population, is a key study that will bring us closer to regulatory approval in the US and other key markets,” said Mark Xu, Chairman and CEO of Xynomic.

“Through the new Xynomic partnership, we will work closely with regulatory agencies to plan out this important Phase 2/3 trial, which could accelerate the development and potential approval of Abexinostat as the first epigenetic drug treating solid tumors,” commented Dr. Munster, a UCSF Professor of Medicine and Director of the Early Phase Clinical Trials Unit at UCSF.

A potentially best-in-class HDAC inhibitor, Abexinostat has already been tested in 17 Phase 1 and 2 clinical trials worldwide.  In NHL Abexinostat shows impressive efficacy against FL, DLBCL and PTCL.  Xynomic aims to initiate registrational trials worldwide in both hematological and solid tumors in 2H’2017.

Xynomic’s pipeline also includes Avasimibe, a first-in-class ACAT-1 inhibitor treating prostate and pancreatic cancers.