NEW YORK, Sept. 24, 2020 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on developing innovative immuno-oncology therapies to transform the lives of patients with unmet medical needs, today announced new clinical data on the Company’s first-in-class late-stage asset, Plinabulin, showing that the drug candidate is a favorable option for preventing chemotherapy-induced neutropenia (CIN) during the COVID-19 pandemic, compared to Pegfilgrastim (Peg), a long-lasting G-CSF, which is currently the predominant therapy for CIN prevention. Dr. Douglas Blayney, global principal investigator of BeyondSpring’s Plinabulin CIN studies and Professor of Medicine at Stanford Medical School, presented the data as a poster at this year’s ESMO Virtual Congress.
In August 2020, the National Comprehensive Cancer Network (NCCN) updated its treatment guidelines for CIN prophylaxis due to the COVID-19 pandemic, which aim to preserve hospital and healthcare resources for COVID-19 patients without compromising the best care possible for cancer patients. Patients receiving chemotherapy typically develop neutropenia, a severe side effect that increases the risk of infection with fever (also called Febrile Neutropenia, or “FN”), which necessitates ER / hospital visits. The updated NCCN guidelines expand the use of prophylactic G-CSFs, such as Peg, to lower the FN risk in patients to avoid hospital / ER visits during the pandemic.
BeyondSpring’s e-poster presentation compares CIN study data with Plinabulin alone (20 mg/m2; n=29) to Peg alone (6 mg; n=35) from two different Phase 2 CIN studies (BeyondSpring’s PROTECTIVE-1 / Study 105 and PROTECTIVE-2 / Study 106) over four cycles. Plinabulin is given on the same day as chemotherapy, whereas Peg is given on the day after chemotherapy. In the Phase 2 PROTECTIVE-1 study, non-small cell lung cancer patients were given docetaxel chemotherapy; in the Phase 2 PROTECTIVE-2 study, breast cancer patients were given TAC (taxotere, doxorubicin, cyclophosphamide) chemotherapy.
In terms of Grade 4 neutropenia and clinical outcomes with severe neutropenia (hospitalizations, infections and sepsis), Plinabulin as a single agent was equally effective as Peg. Most importantly, when it came to all-grade thrombocytopenia and bone pain, Plinabulin demonstrated advantages over Peg.
“With its unique mechanism of action, Plinabulin has various differentiated benefits versus the standard of care with Peg and G-CSFs,” said Dr. Ramon Mohanlal, BeyondSpring’s Chief Medical Officer and Executive Vice President, Research and Development. “First, Plinabulin is given on Day 1 of chemotherapy, while Peg is given 24 hours after chemotherapy. Patients administered with Plinabulin have also experienced reduced bone pain and improved platelet counts, compared to Peg. At the same time, Plinabulin equally protected against the occurrence of CIN and its clinical consequences, which is especially important in the COVID-19 era. BeyondSpring has initiated an Expanded Access Program (EAP) to enable doctors across the U.S. to use Plinabulin to prevent cancer patients’ CIN, both alone and in combination with G-CSFs, during the pandemic.”
If you are a physician in the U.S. who would like to request Plinabulin’s EAP access for your patient, please email firstname.lastname@example.org. For more information on BeyondSpring’s Plinabulin EAP, please visit www.beyondspringpharma.com/EAP/. Supplies may be limited.
Headquartered in New York, BeyondSpring is a global, clinical-stage biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to improve clinical outcomes for patients with high unmet medical needs. BeyondSpring’s first-in-class lead immune asset, Plinabulin, is a potent antigen-presenting cell (APC) inducer. It is currently in two Phase 3 clinical trials for two severely unmet medical needs indications: one is for the prevention of chemotherapy-induced neutropenia (CIN), the most frequent cause for a chemotherapy regimen dose’s decrease, delay, downgrade or discontinuation, which can lead to suboptimal clinical outcomes. The other is for non-small cell lung cancer (NSCLC) treatment in EGFR wild-type patients. As a “pipeline drug,” Plinabulin is in various I/O combination studies to boost PD-1 / PD-L1 antibody anti-cancer effects. In addition to Plinabulin, BeyondSpring’s extensive pipeline includes three pre-clinical immuno-oncology assets and a drug discovery platform dubbed “molecular glue” that uses the protein degradation pathway.
Plinabulin, BeyondSpring’s lead asset, is a differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). Plinabulin’s CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.
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.