- 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, September 16, 2021 (GLOBE NEWSWIRE) — BeyondSpring Pharmaceuticals (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of innovative cancer therapeutics, today announced new positive data on plinabulin from its chemotherapy-induced neutropenia (CIN) prevention program with three poster presentations at the European Society for Medical Oncology (ESMO) 2021 Congress taking place from September 16-21, 2021. Plinabulin, the Company’s first-in-class lead asset, in combination with G-CSF for the prevention of chemotherapy-induced neutropenia (CIN) is currently under U.S. and China regulatory review with an FDA PDUFA date of November 30, 2021. The posters will be made available for viewing on the ESMO website starting on September 16 at 8:30 a.m. CEST and will remain available on the ESMO website throughout the entire duration of the Congress.
“We’re pleased to present additional positive data at this year’s ESMO Congress to show that the Grade 4 neutropenia endpoint is correlated with clinically meaningful endpoints in a meta-analysis with >7000 patients in various cancer and various chemotherapy. This adds to our existing body of data in CIN prevention, a critically important indication for cancer patients,” said Dr. Ramon Mohanlal, executive vice president, R&D, and chief medical officer at BeyondSpring Pharmaceuticals. “Over the last few years, plinabulin has continued to show its potential in preventing this life-threatening side effect of chemotherapy, and we remain committed to bringing this therapy to patients in need globally as we eagerly await November’s PDUFA date.”
A summary of the data can be found below:
Severe Neutropenia (Grade 4, Gr4N) as a Population-Based Predictor for Adverse Clinical Outcome of Chemotherapy Induced Neutropenia (CIN). Poster #3574.
Ramon Mohanlal, M.D., Ph.D., executive vice president, R&D, chief medical officer, BeyondSpring Pharmaceuticals
- The meta-analysis dataset included data from 36 published world literature (n > 7000) in various cancers and chemotherapy as well as the plinabulin CIN program including all 105 and 106 CIN studies (n=496).
- Correlations of exponential equations between rate of febrile neutropenia (FN), duration of severe neutropenia (DSN) and absolute neutrophil count (ANC) nadir were statistically significant (p<0.0001) and in agreement with each other.
- Grade 4 neutropenia (Gr4N) is a valid binary predictor of CIN outcomes, and a 65% Gr4N threshold depicts low vs. high CIN outcome risk.
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. Poster # 3627.
Stephan Ogenstad, Ph.D., founder and president of Statogen Consulting LLC, North Carolina
- In the PROTECTIVE-2 Phase 3 trial, the combination of plinabulin and pegfilgrastim had superior efficacy in preventing Gr4N versus pegfilgrastim alone; Gr4N of 68% in the combination vs. Gr4N of 86% for pegfilgrastim alone, p = 0.0015.
- Based on the meta-analysis detailed above in n>7000 patients, the reduction in Gr4N frequency from 86% in pegfilgrastim alone to 68% in the combination is predicted to result in a statistically significant and clinically meaningful reduction (approximately 50% reduction) in key clinically relevant CIN outcomes including mean DSN, FN rate, mean ANC nadir, hospitalization rate and infection rate (all p<0.0001), if used in an “all chemotherapy and all cancers” setting.
Impact of Adding Plinabulin to Pegfilgrastim for the Prevention of Chemotherapy Induced Neutropenia (CIN), on Patient Quality of Life (QoL). Poster# 3857.
Douglas W. Blayney, M.D., professor of medicine (oncology), Stanford Medicine
- The physical wellbeing (in particular, pain and energy levels) of patients receiving plinabulin and pegfilgrastim was significantly less impacted by TAC compared to those receiving pegfilgrastim alone.
- In addition, patients receiving plinabulin and pegfilgrastim recovered to their pre-chemotherapy physical wellbeing levels more rapidly and experienced less deterioration in their QoL over the duration of the 4-cycle trial.
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). It is being developed as a “pipeline in a drug” in multiple cancer indications.
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” in various cancer indications as direct anti-cancer agent and to prevent chemotherapy induced neutropenia (CIN). Plinabulin and G-CSF combination has filed for approval and has received breakthrough designation and Priority Review in the U.S. and China for the prevention of CIN with a PDUFA date of November 30, 2021, in the U.S. In the DUBLIN-3 study, a global, randomized, active controlled Phase 3 study, the plinabulin and docetaxel combination has met the primary endpoint of extending overall survival compared to docetaxel alone, 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 efficacy of PD-1/PD-L1 antibodies in seven different cancers. 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.