Investigator-Sponsored Plinabulin Combination Study for Metastatic Non-Small Cell Lung Cancer Granted FDA Clearance to Enroll Patients

NEW YORK, July 14, 2016 /PRNewswire/ -- BeyondSpring Pharmaceuticals, a clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, including a Phase III immuno-oncology compound, Plinabulin, and strong pipeline in collaboration with the Fred Hutchinson Cancer Research Center, announced today that on June 20, 2016, the U.S. FDA notified Dr. Lyudmila Bazhenova at the UC San Diego Moores Cancer Center that the Phase I/II study of Nivolumab in combination with Plinabulin for patients with metastatic non-small cell lung cancer (NSCLC) may proceed with enrolling patients. This follows Dr. Bazhenova's submission of an investigator-sponsored Investigational New Drug Application (IND) on May 23, 2016. 

"This clinical trial provides further opportunity to assess the mechanism of Plinabulin in a combination treatment while collecting much-needed information about the safety and preliminary efficacy profile of the combination," said Dr. Lan Huang, BeyondSpring Co-founder, Chairman and CEO. 

The study objectives are to define the maximum tolerated dose and/or recommended Phase II dose of Plinabulin in combination with Nivolumab for patients with metastatic NSCLC.

The small molecule immuno-oncology agent, Plinabulin, activates dendritic cell maturation, induces tumor antigen specific T cell activation and down-regulates Treg. Nivolumab is a programmed cell-death-1 (PD-1) inhibitor that has activity in NSCLC, compared to standard of care.

"The granting of this clearance to begin enrolling patients is an exciting next step for the development of Plinabulin," added Dr. Bazhenova. "We anticipate that the combination study may lead to additional synergistic efficacy with Nivolumab and a well-tolerated safety profile."

About BeyondSpring Pharmaceuticals

BeyondSpring is a global clinical stage biopharmaceutical company developing innovative cancer therapies targeting immuno-oncology and tumor vascularization.  BeyondSpring has advanced its lead asset, Plinabulin, into a Phase III clinical trial as a direct anticancer agent in non-small cell lung cancer.  The Company is also planning a Phase III clinical trial for Plinabulin in the prevention of Docetaxel-induced Neutropenia.  BeyondSpring's management team brought a combined 30+ drugs to market.  The Company's immuno-oncology pipeline is robust, including a collaboration agreement with the Fred Hutchinson Cancer Research Center.

About Plinabulin

Plinabulin is a small molecule agent that is administered by IV infusion (30-minute infusion) and is administered 60 minutes after completion of Docetaxel infusion, on the same day of Docetaxel infusion.

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SOURCE BeyondSpring Pharmaceuticals