On June 8, 2021 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, reported a late-breaking poster presentation of the company’s lead asset plinabulin, a selective immunomodulating microtubule-binding agent (SIMBA), in combination with pegfilgrastim in breast cancer as part of the Phase 3 PROTECTIVE-2 chemotherapy-induced neutropenia (CIN) study, at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting being held from June 8-11, 2021 (Press release, BeyondSpring Pharmaceuticals, JUN 8, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-a-late-breaking-poster-presentation-of-protective-2-phase-3-data-showing-plinabulin-in-combination-with-pegfilgrastim-reverses-the-immune-suppressive-effects-of-pegfilgrastim [SID1234585695]).
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BeyondSpring’s poster titled "Adding Plinabulin (Plin) to Pegfilgrastim (Peg) Reverses the Immune Suppressive Potential of Peg while Offering Superior Prevention of Chemotherapy Induced Neutropenia (CIN) versus Peg Alone)," will be presented on June 9, 2021 at 3:15 p.m. PDT and authors will be available at the poster reception on June 10, 2021 from 4:45 p.m. – 5:30 p.m. PDT (Poster number TH58). Plinabulin in combination with pegfilgrastim demonstrated a superior immune profile and CIN prevention outcomes for patients treated with plinabulin in combination with pegfilgrastim compared to pegfilgrastim alone in breast cancer patients dosed with TAC (Taxotere, doxorubicin, and cyclophosphamide) in PROTECTIVE-2 Phase 3 study. Compared to pegfilgrastim alone (n=110), the plinabulin and pegfilgrastim combination (n=111) showed decreased production of immature neutrophil band (p=0.0012), and decreased promyelocytes and myelocyte production (p=0.0488). Immature neutrophil band and promyelocytes and myelocytes are less functional defending against infection and have potentially deleterious immune suppression effects.
"Plinabulin has broad effects on the immune system and tumor microenvironment. We are excited to see that in addition to the well-demonstrated CIN prevention benefits, we also see that plinabulin can protect against some of the immune-suppressive side effects of pegfilgrastim," said Ramon Mohanlal M.D., Ph.D., Chief Medical Officer and Executive Vice President of Research and Development at BeyondSpring "Plinabulin is a pipeline-in-a-drug and we are seeing more evidence of this with every study, demonstrating that it can help patients with cancer, from side-effects to cancer treatment."
The Company has submitted New Drug Applications (NDA) for plinabulin in combination with pegfilgrastim as a treatment for the prevention of CIN for review in both the U.S. and China. The U.S. FDA accepted the NDA with Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) action date of November 30, 2021.
About The Federation of Clinical Immunology Societies (FOCIS) Annual Meeting
The Federation of Clinical Immunology Societies (FOCIS) exists to improve human health through immunology by fostering interdisciplinary approaches to both understand and treat immune-based diseases. The Federation of Clinical Immunology Societies is a key forum where opinion leaders come together to chart the path to the next major breakthrough in disease therapy. Through FOCIS, researchers and clinicians share knowledge across traditional disease borders, and identify commonalities between treatments and therapies that are life-changing for those impacted by immune-mediated diseases. Initially established as a cross-disciplinary meeting, FOCIS held its first Annual Meeting in 2001. After two successful consecutive meetings, FOCIS incorporated as a 501(c)3 organization in 2003. Today, FOCIS has 58 Member Societies, representing roughly 65,000 clinician scientists.
About CIN
CIN remains a severely unmet medical need and is the primary cause for the 4D’s (Decrease, Delay, Discontinue dose and Downgrade regimen) that compromise carefully selected cancer treatment regimens. Treatment or prevention of CIN with G-CSF has been the standard of care since Neupogen was approved in 1991. The main benefit of G-CSF treatment, however, is in Week 2 after chemotherapy. Week 1 after chemotherapy is considered the "neutropenia vulnerability gap" where over 75% of CIN-related clinical complications occur, including febrile neutropenia, infection, hospitalization and death. Plinabulin is the first drug seeking FDA approval that has the potential to fill this gap. Combining plinabulin and G-CSF may maximize the protection of patients for the full cycle of chemotherapy, as demonstrated in the PROTECTIVE-2 Phase 3 registration study.
Each year in the U.S., 110,000 patients receiving chemotherapy are hospitalized after developing CIN, a severe side effect that increases the risk of infection with fever (also called FN). Due to the COVID-19 pandemic, the updated National Comprehensive Cancer Network (NCCN) guidelines expanded the use of prophylactic G-CSFs, including pegfilgrastim, from high-risk patients only (chemo FN rate >20%), to include intermediate-risk patients (FN rate between 10-20%), to reduce the number of hospital/ER visits related to CIN. The revision of the NCCN guidelines effectively increases the addressable market of patients to approximately 467,500 cancer patients in the U.S. annually.
About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA). It is a novel, intravenous infused, patent-protected, NDA ready asset for CIN prevention indication 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 action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received breakthrough designation from both US and China FDA for 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.