Press Release

Study Opens of BeyondSpring’s Lead Asset, Plinabulin, and Nivolumab + Ipilimumab in Small-Cell Lung Cancer

Rutgers Trial Aims to Demonstrate Reduction in Immune-Related Adverse Events, While Adding to Anti-Cancer Immune Effects for Patients

NEW YORK, Oct. 04, 2018 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (BeyondSpring or the Company) today announced the opening of an investigator-initiated Phase 1 clinical trial with a triple combination therapy, consisting of BeyondSpring’s lead asset, Plinabulin, and Bristol-Myers Squibb's Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of small-cell lung cancer (SCLC). The trial, conducted through the Big Ten Cancer Research Consortium (Big Ten CRC), is currently enrolling subjects at Rutgers Cancer Institute of New Jersey. Jyoti Malhotra, MD, MPH, medical oncologist at Rutgers Cancer Institute, is the trial’s sponsor-investigator. The trial is expected to enroll approximately 15 patients in the Phase 1 portion of this Phase 1/2 combined study, and an additional 40 patients in the Phase 2 portion. The first patient received treatment on Sept. 11, 2018.

“Our collective mission is to bring the best possible therapy to SCLC patients around the world as quickly and efficiently as we can,” said Dr. Malhotra. “There is a need to explore novel immunotherapy combinations with the goal of improving clinical outcomes as well as reducing side effects.”

Approximately 10 to 15 percent of lung cancers are SCLC. Although it is less common than non- small cell lung cancer (NSCLC), SCLC is more aggressive, as these cancer cells tend to grow rapidly and metastasize more easily. Related to this, SCLC symptoms usually do not surface in patients until the cancer has progressed to a more advanced stage, setting a higher bar for therapeutic benefit.

Plinabulin is a novel small molecule with immune-enhancing effects and anti-cancer activity that induces dendritic cell maturation and T-cell activation. Plinabulin is in advanced Phase 3 testing to both increase the potency of standard-of-care chemotherapy (i.e., docetaxel), while at the same time alleviating chemotherapy-induced side effects. The aim of the present triple combination study is to accomplish similar goals with the standard-of-care immuno-oncology (I/O) therapies by reducing treatment-related side effects and increasing the therapeutic benefit to patients.

“Given that Plinabulin is also in Phase 3 clinical trials for both NSCLC treatment and the prevention of chemotherapy-induced neutropenia, this drug candidate is an I/O molecule with multiple possible indications,” concluded Dr. Ramon Mohanlal, Executive Vice President and Chief Medical Officer at BeyondSpring. “Plinabulin is not just a compound—it is a pipeline drug. Up to this point, the research around Plinabulin has advanced positively and significantly.”

About Plinabulin
Plinabulin, a marine-derived small-molecule, is BeyondSpring’s lead asset and is currently in late-stage clinical development for the prevention of CIN and as an anticancer therapy in NSCLC. Studies of Plinabulin's mechanism of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to up-regulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia by reducing the neutrophil breakdown.

About BeyondSpring
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 University of Washington in de novo drug discovery using ubiquitination platform. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 2/3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has a seasoned management team with many years of experience bringing drugs to the global market.

Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the anticipated amount needed to finance the company's future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, our expectations regarding the potential safety, efficacy or clinical utility of our product candidates, additional competition in the market, and other risk factors referred to in BeyondSpring’s current Form 20-F on file with the U.S. Securities and Exchange Commission. The forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Media Relations:
Caitlin Kasunich / Amrita Singh
KCSA Strategic Communications
212.896.1241 / 212.896.1207
ckasunich@kcsa.com / asingh@kcsa.com

Investor Contacts:
Laura Perry / Joe Rayne
Argot Partners
212.600.1902
BeyondSpring@argotpartners.com

 

BeyondSpring, Inc.