On September 09, 2021 BeyondSpring, a global pharmaceutical company focused on the development of cancer therapeutics, reported 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 (Press release, BeyondSpring Pharmaceuticals, SEP 9, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-three-poster-presentations-about-its-chemotherapy-induced-neutropenia-prevention-program-at-the-european-society-for-medical-oncology-2021-congress [SID1234587468]). 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.
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Additional Details:
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 (Free ESMO Whitepaper) 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."
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). 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.