BeyondSpring’s Abstracts on Clinical Evidence for Bone Marrow Stem Cell Protection as Plinabulin’s Mechanism of Action for CIN Accepted at American Society of Hematology’s 2019 Annual Meeting
December 9, 2019
Data Suggest Protective Effects of Plinabulin on Bone Marrow Granulocyte-Monocyte Progenitor (GMP) and Common Lymphoid Progenitor (CLP) Cells
NEW YORK, Dec. 09, 2019 (GLOBE NEWSWIRE) — BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that two Company abstracts on the unique mechanism of action for its lead asset, Plinabulin, have been accepted as e-publications at this year’s American Society of Hematology’s (ASH) Annual Meeting, taking place on December 7 through 10 in Orlando, Fla.
The first abstract, titled, “Clinical Evidence of Granulocyte-Monocyte Progenitor (GMP) Stem Cell Involvement in Plinabulin’s Mechanism of Action (MoA) for the Prevention of Docetaxel (Doc) Chemotherapy (Chemo)-Induced Neutropenia (CIN),” involves BeyondSpring’s Study 105 and highlights Plinabulin’s ability to protect GMP, a hematopoietic stem cell which differentiates into neutrophils and other white blood cells. GMP protection not only preserves patients’ neutrophil counts, protecting them from bacterial infection, but also significantly and positively increases peripheral monocytes, basophils and eosinophils, which are other types of white blood cells that protect patients as a part of the innate immune system.
The second abstract, titled, “Clinical Evidence Against the Continuum of Low-Primed Uncommitted Hematopoietic and Progenitor Cells (CLOUD-HSPC) Concept for Hematopoiesis,” also analyzed data from BeyondSpring’s Study 105, suggesting Plinabulin protects CLP, another hematopoietic stem cell that is responsible for producing lymphocytes, which protect patients as a part of the adaptive immune system.
“Following our previously presented data at ASH 2018, demonstrating evidence of bone marrow CD34+ mobilization with Plinabulin, we now have additional evidence of a bone marrow progenitor stem cell protective effect of Plinabulin as an important MoA for the prevention of CIN. This data is particularly intriguing, as Plinabulin appears to protect bone marrow stem cells without causing bone pain,” said Dr. Douglas Blayney, the Principal Investigator of the CIN program with Plinabulin.
“Our collective clinical trial dataset has provided strong evidence of Plinabulin’s potent ability to prevent CIN through protection from chemo-induced bone marrow suppression, and the data from our abstracts further our understanding of Plinabulin’s MoA for CIN. BeyondSpring is well-positioned to complete the Phase 3 CIN studies 105 and 106 in support of our intended NDA filing in China in the first quarter of 2020 and in the U.S. in 2020,” added Dr. Ramon Mohanlal, BeyondSpring’s Chief Medical Officer and Executive Vice President, R&D.
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to Plinabulin, including three immuno-oncology assets and a drug discovery platform using the ubiquitination degradation pathway. The Company also has a seasoned management team with many years of experience bringing drugs to the global market.
Plinabulin, BeyondSpring’s lead asset, is a marine-derived small molecule that sequesters tubulin heterodimers in a differentiated manner from other agents in this class. 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 anticancer benefits of Plinabulin have been associated with positive effects on antigen presenting cells and T-cell activation, as well as to the direct killing of cancer cells. 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.
RECENT NEWS ARTICLES
BeyondSpring Announces First Patient Treated in Phase 2 Study with Plinabulin Combined with Nivolumab + Ipilimumab in Patients in 3rd Line Recurrent Small-Cell Lung Cancer Patients Who Failed Checkpoint Inhibitors
—The study is conducted by the Big Ten Cancer Research Consortium in up to 26 patients across 7 states in the U.S. —In the Phase 1 study, plinabulin combination was able to induce tumor responses in patients who had progressed on platinum and checkpoint inhibitors,...
BeyondSpring Pharmaceuticals Announces New Patient-Derived Cancer Model Data for Plinabulin Monotherapy at the AACR-NCI-EORTC Virtual International Conference to Further Support the Positive Clinical Data Already Reported for the Treatment of Small Cell Lung Cancer
Plinabulin’s anti-cancer effects were tested against approximately 80 patient-derived tumor models with small cell lung cancer (SCLC) tumor types being the most sensitive to Plinabulin monotherapy at IC70 of 35 nM The preclinical data is consistent with clinical...
BeyondSpring Pharmaceuticals Announces Positive Final Phase 3 DUBLIN-3 Data with the Plinabulin/Docetaxel Combination versus Docetaxel Alone in 2nd/3rd Line Non-Small Cell Lung Cancer Patients with EGFR Wild Type at the European Society for Medical Oncology (ESMO) 2021 Congress
Study met the primary endpoint showing statistically significant improvement in overall survival (OS) for the combination (DP) vs. docetaxel (D). Study met key secondary endpoints showing statistically significant improvement for DP vs. D in ORR, PFS, and 24- and...
BeyondSpring Pharmaceuticals Announces New Positive Data on Plinabulin from Its Chemotherapy-Induced Neutropenia Prevention Program at the European Society for Medical Oncology 2021 Congress
Plinabulin in combination with G-CSF is undergoing regulatory review for potential approval in the U.S. and China for the prevention of CIN, with a U.S. PDUFA date of November 30, 2021. NEW YORK, September 16, 2021 (GLOBE NEWSWIRE) — BeyondSpring Pharmaceuticals...
- Management to host a call today at 8:00 am ET NEW YORK, Sept. 10, 2021 – BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced its financial...
BeyondSpring Announces Three Poster Presentations About its Chemotherapy-Induced Neutropenia Prevention Program at the European Society for Medical Oncology 2021 Congress
Plinabulin in combination with G-CSF is undergoing regulatory review for potential approval in the U.S. and China for the prevention of CIN, with a U.S. PDUFA date of November 30, 2021. NEW YORK, Sept. 09, 2021 (GLOBE NEWSWIRE) -- BeyondSpring (the “Company” or...
NEW YORK, Sept. 08, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (“BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that management will present at and participate in the Morgan...
BeyondSpring to Host Second Quarter Financial Results and Corporate Update Conference Call on September 10, 2021
NEW YORK, Sept. 07, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (“BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that management will host a conference call to report its...
BeyondSpring Announces Late-Breaking Oral Presentation of Final Phase 3 DUBLIN-3 Data with the Plinabulin/Docetaxel Combination Versus Docetaxel Alone in 2nd/3rd Line Non-Small Cell Lung Cancer Patients with EGFR Wild Type at the European Society for Medical Oncology 2021 Congress
Topline results, released in early August, demonstrated improvement in overall survival (OS) for the combination vs. docetaxel alone as well as improvement in ORR, PFS, 24- and 36-month OS rates and incidence of Grade 4 neutropenia. NEW YORK, Aug. 31, 2021 (GLOBE...
BeyondSpring Announces Exclusive Commercialization and Co-development Agreement with Jiangsu Hengrui Pharmaceuticals for Plinabulin in Greater China
Wanchunbulin, BeyondSpring’s 58%-owned subsidiary in China, to partner with Hengrui, the leader in oncology product R&D and commercialization in China, for the exclusive commercial and co-development rights for plinabulin in Greater China markets (“the Territory”)...
RECENT MEDIA COVERAGE
Seed Therapeutics Launches Protein Degradation Research Platform and Appoints Edward Dongheng Liu as Chief Financial Officer
JAMA Oncology Highlights Plinabulin’s Efficacy in Preventing Chemotherapy-Induced Neutropenia as a Monotherapy