On September 16, 2021 BeyondSpring Pharmaceuticals (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of innovative cancer therapeutics, reported 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) (Free ESMO Whitepaper) 2021 Congress taking place from September 16-21, 2021 (Press release, BeyondSpring Pharmaceuticals, SEP 16, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-pharmaceuticals-announces-new-positive-data-on-plinabulin-from-its-chemotherapy-induced-neutropenia-prevention-program-at-the-european-society-for-medical-oncology-2021-congress [SID1234587817]). 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 (Free ESMO Whitepaper) website starting on September 16 at 8:30 a.m. CEST and will remain available on the ESMO (Free ESMO Whitepaper) website throughout the entire duration of the Congress.

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"We’re pleased to present additional positive data at this year’s ESMO (Free ESMO Whitepaper) 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.
About Plinabulin

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.