BeyondSpring Announces First Patient Enrolled in Phase 1b/2 Investigator-Initiated Trial of Plinabulin plus Nivolumab for Non-Small Cell Lung Cancer

NEW YORK, Sept. 27, 2016 /PRNewswire/ -- BeyondSpring Pharmaceuticals, a clinical stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, announced today that the first patient in the Phase 1b/2 trial of its lead immuno-oncology asset Plinabulin in combination with Nivolumab, an immune-checkpoint inhibitor, in patients with metastatic non-small cell lung cancer (NSCLC) was enrolled on September 7, 2016 at the University of California San Diego Moores Cancer Center. This patient has completed the first cycle of the combo treatment by Dr. Lyudmila Bazhenova, who is the principal investigator for this trial. The University of California San Diego Moores Cancer Center is at the forefront in the fight against cancer, developing promising new therapies with extensive experience with conducting clinical trials in NSCLC.

The open-label, dose-escalation, two-part, single-site Phase 1b/2 trial is expected to enroll approximately 12 patients in the Phase 1b portion and a total of 20 patients in the Phase 2 portion. 

"This study will be instrumental in further understanding Plinabulin's multiple mechanisms of action and its ability to target the tumor micro-environment, and will help determine its capacity as an immune-oncology agent," said Dr. Lyudmila Bazhenova, M.D. "We anticipate the addition of Plinabulin to Nivolumab will confirm the preclinical efficacy synergy data. This combination will potentially not only improve the immune response, but also add a broader profile of anti-tumor activities leading to enhanced patient response rates and longer overall survival."

Dr. Lan Huang, Co-founder, Chairman and CEO of BeyondSpring stated, "The mechanism behind the efficacy synergy of Plinabulin and PD-1 antibody, Nivolumab, is due to Plinabulin's immune enhancing activities by activating dendritic cell maturation and subsequent tumor antigen specific T cell activation and Treg down-regulation".

"This clinical trial provides additional research to assess the mechanism of Plinabulin in a combination treatment while collecting crucial information about the immune-related adverse events and preliminary efficacy profile of the combination," said Dr. Ramon Mohanlal, M.D., Ph.D., Chief Medical Officer of BeyondSpring. "Our principal mission is focused on patient safety and to develop an innovative and cost-effective oncology therapeutic to aid patients suffering from NSCLC, which accounts for approximately 85 percent of all lung cancer cases."

About BeyondSpring Pharmaceuticals
BeyondSpring is a global clinical stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with Fred Hutchinson Cancer Research Center and University of Washington. BeyondSpring has advanced its lead asset, Plinabulin, into a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer. The Company is also planning a Phase 2/3 clinical trial for Plinabulin in the prevention of chemotherapy-induced Neutropenia. BeyondSpring's experienced management team brought a combined 30+ drugs to market.

About Plinabulin
Plinabulin is an innovative small molecule agent that has multiple mechanism of action, with immune enhancing mechanism, tumor vasculature targeting, and activating JNK pathway to induce cancer cell apoptosis. 

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SOURCE BeyondSpring Pharmaceuticals