- Plinabulin in combination with G-CSF is undergoing regulatory review for potential approval in the U.S. and China for the prevention of CIN, with a U.S. PDUFA date of November 30, 2021.
NEW YORK, Sept. 09, 2021 (GLOBE NEWSWIRE) — BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, today announced three poster presentations of new data supporting the combination of plinabulin and G-CSF for the prevention of chemotherapy-induced neutropenia (CIN) at the European Society for Medical Oncology 2021 Congress taking place virtually September 16-21, 2021. Plinabulin in combination with G-CSF is currently under U.S. and China regulatory review with an FDA PDUFA date of November 30, 2021. The posters will become available on September 16, 2021 at 8:30 AM CEST and will remain available throughout the entire duration of the Congress.
Title: Severe Neutropenia (Grade 4, Gr4N) as a Population-Based Predictor for Adverse Clinical Outcome of Chemotherapy Induced Neutropenia (CIN)
Presentation Number: 1708P
Speaker: Ramon Mohanlal, M.D., Ph.D., executive vice president, research and development, chief medical officer, BeyondSpring Pharmaceuticals
Title: Prediction of Febrile Neutropenia (FN), Hospitalization (Hosp) Rates, and Infection (Inf) Rates in Chemotherapy-Induced Neutropenia (CIN) Patients (pts) Treated with the Plinabulin and Pegfilgrastim Combination (Plin+Peg) using a Meta-Analysis (MA)-based Tool
Presentation Number: 1709P
Speaker: Stephan Ogenstad, Ph.D., founder and president of Statogen Consulting LLC, North Carolina
Title: Impact of Adding Plinabulin to Pegfilgrastim for the Prevention of Chemotherapy Induced Neutropenia (CIN), on Patient Quality of Life (QoL)
Presentation Number: 1710P
Speaker: Douglas W. Blayney, M.D., professor of medicine (oncology), Stanford Medicine
“We’re pleased to have three poster presentations supporting our CIN program included at this year’s ESMO Congress, highlighting the clinically meaningful benefit of the plinabulin and G-CSF combination in preventing CIN,” said Dr. Ramon Mohanlal, executive vice president, R&D, and chief medical officer, BeyondSpring Pharmaceuticals. “It’s critical that we continue to raise awareness about the unmet need in CIN since it can be a life-threatening side effect of chemotherapy, and preventing it can make a significant impact on the lives of patients. Plinabulin has received Breakthrough Designation, and in combination with G-CSF, is currently undergoing the U.S. and China’s regulatory review for CIN prevention. We look forward to bringing this new treatment option to patients in need.”
Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected, NDA stage asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC). Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received Breakthrough Therapy designation from both U.S. and China FDA for the CIN prevention indication. As a “pipeline in a drug,” plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody-resistant patients.
Headquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs. BeyondSpring’s first-in-class lead asset plinabulin, is being developed as a “pipeline in a drug.” It is filed for approval and has received Priority Review in the U.S. and China for the prevention of chemotherapy-induced neutropenia (CIN) with a PDUFA date of November 30, 2021 in the U.S. Plinabulin and docetaxel combination has met the primary endpoint of extending overall survival in a global, randomized, active controlled Phase 3 study (DUBLIN-3) in 2nd/3rd line NSCLC (EGFR wild type). Additionally, it is being broadly studied in combination with various immuno-oncology regimens that could boost the effects of PD-1 / PD-L1 antibodies. In addition to plinabulin, BeyondSpring’s extensive pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform.
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, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All 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.
Ashley R. Robinson
LifeSci Advisors, LLC
Darren Opland, Ph.D.