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Plinabulin Protects Cartilage Bottom from Chemotherapy-Induced Deficiencies with a Differentiated Yet Complimentary Apparatus to G-CSF for CIN Prevention

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NEW YORK, Dec. 19, 2019 (GLOBE NEWSWIRE) — BeyondSpring Inc. (BYSI), a all-around biopharmaceutical aggregation focused on the development of avant-garde immuno-oncology blight therapies, today appear that the associate advised account Blight Chemotherapy and Pharmacology appear a address on the altered apparatus of action (MoA) of the Company’s advance asset, Plinabulin. The address demonstrates that Plinabulin can auspiciously amusement chemotherapy-induced neutropenia (CIN) acquired by assorted chemotherapies. In addition, Plinabulin has absolute furnishings on cartilage bottom cells, with a apparatus audible from G-CSF-based therapies, the accepted accepted of affliction for CIN.

The paper, titled, “Plinabulin ameliorates neutropenia induced by assorted chemotherapies through a apparatus audible from G‑CSF therapies,” letters on Plinabulin’s adeptness to abate neutropenia induced by docetaxel, cyclophosphamide or doxorubicin chemotherapy, after affecting cartilage bottom or claret G-CSF levels. The after-effects abutment Plinabulin’s analytic testing as a non-G-CSF-based analysis for CIN associated with chemotherapies of altered mechanisms.

“Importantly, our nonclinical abstracts additionally approved the absolute furnishings of Plinabulin on cartilage bottom cells—consistent with analytic after-effects afresh appear in animal capacity at ASH 2019—which authenticate that Plinabulin increases the cardinal of circulating white claret beef absolute for CD34 (a brand for hematopoietic axis and antecedent cells, or HSPC, in humans), as able-bodied as the award that Plinabulin protects cartilage bottom lymphoid and myeloid antecedent beef from the abrogating furnishings of chemotherapy,” said James R. Tonra, Senior Vice President, Preclinical Development at BeyondSpring and the advance columnist of the article. “A analysis that increases cartilage bottom HSPC calculation additionally has the abeyant to allay chemotherapy-induced deficiencies (chemo-assault) in assorted complete corpuscle populations aural the hematopoietic system. In band with this potential, Plinabulin alleviates docetaxel-induced thrombocytopenia, as able-bodied as neutropenia, in NSCLC patients.”

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“By accumulation these two molecules – Plinabulin and G-CSF – patients get the account of these altered and accretion mechanisms of action that can assignment calm to actualize a new accepted of affliction in preventing CIN,” added Dr. Ramon Mohanlal, BeyondSpring’s Chief Medical Officer and Executive Vice President, Analysis and Development. “CIN not abandoned puts chemotherapy patients at added accident of infections and mortality, but additionally can abjure them from accepting the best anti-cancer care, as CIN about leads to a abatement / adjournment or cessation of contrarily able chemotherapy. A chemotherapy dosage abridgement of aloof 15 percent can abate abiding adaptation by as abundant as 50 percent. Plinabulin has additionally approved anti-cancer action in studies to date, and the accession of Plinabulin to G-CSF potentially offers the audible advantage of bigger aegis adjoin CIN adjoin G-CSF alone, abstention of G-CSF-related cartilage affliction and convalescent outcomes.”

The commodity is authored by BeyondSpring’s James Tonra, Ph.D.; Ramon Mohanlal, MD, Ph.D.; G. Kenneth Lloyd, Ph.D., Chief Scientific Officer; and Lan Huang, Ph.D., Co-Founder, Chairman and CEO.

About BeyondSpring BeyondSpring is a global, clinical-stage biopharmaceutical aggregation focused on the development of avant-garde immuno-oncology blight therapies. BeyondSpring’s advance asset, Plinabulin, is in two Phase 3 all-around analytic programs, one as a absolute anticancer abettor in the analysis of non-small corpuscle lung blight (NSCLC) and the added in the blockage of chemotherapy-induced neutropenia (CIN). BeyondSpring has able R&D capabilities with a able-bodied activity in accession to Plinabulin, including three immuno-oncology assets and a biologic analysis belvedere appliance the ubiquitination abasement pathway. The Aggregation additionally has a acclimatized administering aggregation with abounding years of acquaintance bringing drugs to the all-around market.

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About PlinabulinPlinabulin, BeyondSpring’s advance asset, is a marine-derived baby atom that sequesters tubulin heterodimers in a differentiated address from added agents in this class. Plinabulin is currently in late-stage analytic development to access all-embracing adaptation in blight patients, as able-bodied as to allay chemotherapy-induced neutropenia (CIN). The anticancer allowances of Plinabulin accept been associated with absolute furnishings on antigen presenting beef and T-cell activation, as able-bodied as to the absolute killing of blight cells. Plinabulin’s CIN abstracts highlights the adeptness to addition the cardinal of hematopoietic axis / antecedent beef (HSPCs), or lineage-/cKit /Sca1 (LSK) beef in mice. Furnishings on HSPCs could explain the adeptness of Plinabulin to not abandoned amusement CIN but additionally to abate chemotherapy-induced thrombocytopenia and access circulating CD34 beef in patients.

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About Chemotherapy-Induced Neutropenia (CIN)CIN is a common, generally astringent ancillary aftereffect that blight patients who are ability analysis acquaintance involving the abolition of neutrophils, which are a blazon of white claret corpuscle and a patient’s aboriginal band of aegis adjoin infections. The accepted accepted of affliction for CIN blockage is G-CSF monotherapy, which has austere limitations as declared in its artefact advice summary.

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As abounding as 90 percent of patients who accept high-risk chemotherapy and G-CSF monotherapy may still acquaintance brand 3 or 4 neutropenia [Lee et al., Annals of Surgical analysis and analysis 94(5): 223-228 (2018)]. Patients with brand 4 (severe) neutropenia accept an abnormally low absorption of neutrophils, authoritative these patients added affected to bacterial / fungal infections and sepsis, which can crave analysis and be fatal. Brand 4 CIN can accept an adverse aftereffect on chemotherapy administering and is usually advised a cogent augur of low about dosage acuteness (RDI), dosage delays and dosage reductions [Lalami Y, Critical Reviews in Oncology / Hematology, 120: 163 – 179 (2017)]. Even a 15 percent chemotherapy dosage abridgement can abate abiding adaptation by as abundant as 50 percent [Bonadonna, Med Oncol 29:1495–1501 (2012)].

Additionally, as abounding as 70 percent of patients appliance G-CSF monotherapy acquaintance cartilage affliction [Moore et al., Annals of Pharmacotherapy 51(9): 797-803 (2017)]. Twenty-five percent of patients additionally address that the affliction is severe. The National Comprehensive Blight Network (NCCN) guidelines crave that patients with brand 3 or 4 neutropenia abatement chemotherapy dosage intensity, adjournment chemotherapy aeon timing or abandon chemotherapy, anniversary of which can accept a abrogating aftereffect on the abiding outcomes of blight affliction [Lalami et al., Critical Reviews in Oncology / Hematology 120: 163-179 (2017)].

Cautionary Note Apropos Forward-Looking StatementsThis columnist absolution includes advanced statements that are not actual facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “potential,” “suggest,” “objective,” “goal,” or variations thereof and variations of such words and agnate expressions are advised to analyze such advanced statements. Advanced statements are based on BeyondSpring’s accepted ability and its present behavior and expectations apropos accessible approaching contest and are accountable to risks, uncertainties and assumptions. Certain of the statements fabricated in this columnist absolution are forward-looking, such as those, amid others, apropos to BeyondSpring’s expectations apropos the achievement of the proposed offering. No affirmation can be accustomed that the alms discussed aloft will be consummated, or that the net gain of the alms will be acclimated as indicated. Consummation of the alms and the appliance of the net gain of the alms are accountable to abundant accessible events, factors and conditions, abounding of which are aloft the ascendancy of the Aggregation and not all of which are accepted to it, including, after limitation, bazaar altitude and those declared beneath the branch “Risk Factors” in the Company’s Annual Address on Form 20-F for the year concluded December 31, 2018, as adapted by those accident factors included in the Company’s consecutive filings beneath the Securities Exchange Act of 1934, as amended, which can be accessed at the SEC’s website at www.sec.gov. Actual after-effects and the timing of contest could alter materially from those advancing in these advanced statements as a aftereffect of several factors including, but not bound to, the advancing bulk bare to accounts the Company’s approaching operations, abrupt after-effects of analytic trials, delays or abnegation in authoritative approval process, its expectations apropos the abeyant safety, ability or analytic account of its artefact candidates, or added antagonism in the market, and added accident factors referred to in BeyondSpring’s accepted Form 20-F on book with the SEC. The advanced statements fabricated herein allege abandoned as of the date of this absolution and BeyondSpring undertakes no obligation to amend about such advanced statements to reflect consecutive contest or circumstances, except as contrarily appropriate by law.

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