BeyondSpring Announces Planned Start of Phase I Investigator-Initiated Trial of Plinabulin Plus Nivolumab, Enters Immuno-Oncology Space

Poster on Trial Design and Timing Presented at WCLC 2015

NEW YORK, Sept. 15, 2015 (GLOBE NEWSWIRE) -- BeyondSpring Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, today announced that a Phase I investigator-initiated trial is planned to start, with first patient enrolled, in the fourth quarter of 2015 to evaluate its lead compound, Plinabulin, in combination with nivolumab, an immune-checkpoint inhibitor, in patients with metastatic non-small cell lung cancer (NSCLC). A poster discussing the design and timing of the trial was presented last week at the 16th World Conference on Lung Cancer (WCLC), which is hosted by the International Association for the Study of Lung Cancer (IASLC) and took place September 6-9, 2015 in Denver, CO.

Dr. Lyudmila Bazhenova, M.D., professor of Clinical Medicine at Moores Cancer Center, University of California San Diego (UCSD) and principal investigator of the Phase I trial, commented, "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. Based on data to date and confirmed studies showing benefit when adding immune-checkpoint inhibitors to microtubule-depolymerizing agents (MDAs), we believe the addition of Plinabulin to nivolumab will not only enhance the immune response, but add a broader profile of anti-tumor activities leading to enhanced patient response rates and longer overall survival. We were pleased to share details of the study design at WCLC 2015 and look forward to enrolling our first patient later this year and exploring the safety and anti-tumor activity of Plinabulin plus nivolumab in this NSCLC patient population, which continues to represent a major unmet medical need."

Abstract #602 / P2.01-087: A Phase 1 Trial Combining Plinabulin and Nivolumab for Metastatic Squamous NSCLC

First Author: Dr. Shihfan Yeh
Poster Session: Treatment of Advanced Diseases - NSCLC
Date, Time: Tue, September 8; 9:30 a.m. - 5:00 p.m. MT
Location: Exhibit Hall (Hall B+C)

The open-label, dose-escalation, two-part, single-site Phase 1 trial plans to enroll a total of 20 patients. Part I is a 3+3 designed dose-escalation study that will evaluate intravenously-infused Plinabulin across four dose levels (13.5 mg/m2, 20 mg/m2, 30 mg/m2, and 40 mg/m2) plus nivolumab (3 mg/kg). The primary endpoint for Part I is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of Plinabulin in combination with nivolumab. Part II is an expansion cohort of 20 patients to be treated at the RP2D, including those patients who will have received this dose in Part I. The primary objective of Part II is frequency and severity of toxicities of the combination treatment. Secondary objectives for all patients treated with the RP2D include objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS).

Dr. Lan Huang, Co-founder and CEO of BeyondSpring Pharmaceuticals, commented, "Dendritic cells (DCs) are essential for the initiation and regulation of anti-cancer immunity. When mature, DCs lead to differentiation of antigen-specific T-cells into effector T-cells. Plinabulin has been shown to induce DC maturation and anti-cancer cytokine release in a dose dependent manner, which leads us to belive that the combination of Plinabulin with nivolumab, a human PD-1 immune checkpoint inhibitor antibody approved for metastatic squamous NSCLC, will be able to demonstrate improved synergistic anti-tumor response, resulting in improved patient outcomes."

Patient inclusion criteria comprise patients with histologically or cytologically-confirmed metastatic NSCLC whose disease progressed during/after treatment with at least one platinum-containing chemotherapy. Patients whose tumors are known to harbor targetable mutations (EGFR del 19, L858R mutation, or ALK translocation) must have progressed on or had intolerance to corresponding targeted therapy. Based on National Comprehensive Cancer Network's (NCCN) recommendations, patients suffering from non-squamous NSCLC were included in the study. The criterion for such patients includes at least 1, and up to 3, prior systemic therapies for metastatic disease, adults at least 18 years of age, ECOG performance status of 0 or 1, measurable disease per RECIST 1.1, and treated and stable brain metastases.

About BeyondSpring Pharmaceuticals

BeyondSpring Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of innovative cancer therapies. BeyondSpring is focused on the advancement and commercialization of Plinabulin, a novel, Phase 3-ready cancer therapeutic initially targeting non-small-cell lung cancer (NSCLC). Led by an expert management team consisting of pharmaceutical industry veterans from the U.S. and China, the Company is well positioned to further advance lead product candidate, Plinabulin. For more information, visit

The Ruth Group Lee Roth (investors) (646) 536-7012 Kirsten Thomas (media) (508) 280-6592

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