- FDA Submission to Change the Primary Endpoint for Study 106 Phase 3 into an Industry First and Robust Clinical Measure to Evaluate Superiority in CIN - -.
NEW YORK, April 30, 2020 -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (Nasdaq: BYSI), a global biopharmaceutical company focused on the development of innovative.
BeyondSpring Inc. (the “Company” or “BeyondSpring”) (BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced the appointments of Drs. Daniel Zabrowski and Ramon Mohanlal to the Company’s Board of Directors. Dr. Zabrowski previously worked for more than 20 years at Roche in a number of key global leadership positions, including Global Head of Regulatory Affairs, Global Head of Development Operations and Global Head of Pharma Partnering.
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BeyondSpring (the “Company” or “BeyondSpring”) (BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the United States Patent and Trademark Office (USPTO) has granted the Company a new patent, U.S. 10,596,169, for methods of treating severe chemotherapy-induced neutropenia (CIN) from Taxane in cancer patients by administering its lead asset Plinabulin, with protection through 2033. “This is the first U.S. patent establishing Plinabulin’s beneficial effects in reducing CIN associated with taxane, one of the most commonly used chemotherapies,” said Dr. Lan Huang, BeyondSpring’s Co-founder, Chairman and CEO, and the inventor of this patent.
BeyondSpring Inc. (the “Company” or “BeyondSpring”) (BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, announced today the appointment of Dr. James Tonra, Ph.D. as Chief Science Officer, effective immediately. Dr. Tonra had previously served as Senior Vice President, Preclinical Development at BeyondSpring since April 2018.
BeyondSpring Inc. (the “Company” or “BeyondSpring”) (BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that the Company will host its third-quarter 2019 financial results and operational update conference call on Wednesday, December 18, 2019, at 8 a.m. Eastern Time. BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. The Company also has a seasoned management team with many years of experience bringing drugs to the global market.
BeyondSpring Inc. (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.
Preparing to Submit NDA in China for Chemotherapy-Induced Neutropenia (“CIN”) in Q1 2020 Plinabulin’s Anti-Cancer and CIN Prevention Mechanism Published in Peer.
BeyondSpring Inc. (BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company’s novel trial design for Study 103 with lead asset, Plinabulin, was selected for poster presentation at this year’s Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, MD. The poster, titled, “Validation of a Single-Blinded (Patients Only) Study Design for the Prevention of Premature Patient Consent Withdrawal in the Immuno-Oncology Trial DUBLIN-3,” was presented on November 9. As cancer patients generally prefer immunotherapy over chemotherapy, they may prematurely withdraw their consent to participate in a clinical trial if they are allocated to the chemotherapy comparator arm, which may negatively impact the study’s outcome.
BeyondSpring Inc. (the “Company” or “BeyondSpring”) (BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that new clinical data on the Company’s first-in-class, late-stage asset, Plinabulin, shows its ability to potently stimulate the innate immune system. Previously, the Company reported that Plinabulin stimulates the adaptive immune system, through enhancing Dendritic Cell-dependent T-Cell proliferation (Mita, ASCO-SITC 2017).
BeyondSpring Inc. (the “Company” or “BeyondSpring”) (BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced the submission of a provisional U.S. patent application for its pipeline asset BPI-002, for methods of treating viral infections, including COVID-19, when administered alone or in combination with a vaccine. BPI-002 can potentially activate the adaptive immune system (including CD4+ helper T cells and CD8+ cytotoxic T cells), the body’s strongest line of defense, to directly attack and kill virally infected cells, including RNA virus, such as those causing COVID-19.
BeyondSpring Inc. (the “Company” or “BeyondSpring”) (BYSI), a New York-based global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that, following discussions with the U.S. Food and Drug Administration (FDA), the Company has formally changed the primary endpoint for its Study 106 Phase 3 superiority clinical trial with first-in-class lead asset, Plinabulin, for chemotherapy-induced neutropenia (CIN) prevention. For more than 20 years, the standard primary endpoint for CIN trials has been the duration of severe (Grade 4) neutropenia (DSN).
BeyondSpring Inc. (BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the peer reviewed journal Cancer Chemotherapy and Pharmacology published a report on the unique mechanism of action (MoA) of the Company’s lead asset, Plinabulin. The report demonstrates that Plinabulin can successfully treat chemotherapy-induced neutropenia (CIN) caused by multiple chemotherapies.
Image source: The Motley Fool. BeyondSpring Inc. (NASDAQ: BYSI)Q4 2019 Earnings CallApr 30, 2020, 9:00 a.m. ETContents: Prepared Remarks Questions and Answers Call Participants Prepared Remarks: OperatorGood morning, and welcome to BeyondSpring's Fourth Quarter and Full Year 2019 Financial Results Conference Call.
BeyondSpring Inc. (BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company has appointed Gregg Russo as Senior Vice President, Human Resources, effectively immediately. “We are excited to Bring Mr. Russo on board as we move closer toward regulatory approval and potential commercialization of our lead compound, Plinabulin, for the treatment of non-small cell lung cancer and chemotherapy-induced neutropenia,” said Dr. Lan Huang, BeyondSpring’s CEO.
BeyondSpring Inc. (the “Company” or “BeyondSpring”) (BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company will present new clinical data on BeyondSpring’s first-in-class, late-stage asset, Plinabulin, showing its potential ability to prevent tissue iron overload, a common cause of vital organ damages, in cancer patients who are receiving chronic blood transfusions as a result of their chemotherapy. Dr. Ramon Mohanlal, BeyondSpring’s Chief Medical Officer and Executive Vice President, Research and Development, will present the data as a poster at this year’s National Comprehensive Cancer Network (NCCN) Annual Conference.
BeyondSpring Inc. (the “Company” or “BeyondSpring”) (BYSI), a global biopharmaceutical company headquartered in New York focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company has initiated the rolling submission of its New Drug Application (NDA) with the Company’s lead asset, Plinabulin, for the chemotherapy-induced neutropenia indication to China’s National Medical Products Administration (NMPA). “Commencing the NDA rolling submission in China marks a significant milestone for BeyondSpring, bringing Plinabulin one step closer to commercialization to enhance the lives of cancer patients,” said Dr. Lan Huang, BeyondSpring’s co-founder and CEO.
BeyondSpring Inc. (the “Company” or “BeyondSpring”) (BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that the Company will report its fourth-quarter and full-year 2019 financial results and host an operational update conference call on Thursday, April 30, 2020, at 8 a.m. Eastern Time. BeyondSpring is a global clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. 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.
BeyondSpring Inc. (BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company’s abstract for its Phase 3 Study 106 clinical trial design with lead asset, Plinabulin, for chemotherapy-induced neutropenia (CIN) prevention was accepted for poster presentation at this year’s American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. The abstract titled, “A Randomized Phase 3 Clinical Trial of the Combination of Plinabulin (Plin) + Pegfilgrastim (Peg) versus (vs) Peg Alone for TAC (docetaxel, doxorubicin, cyclophosphamide) Induced Neutropenia (CIN),” provides rationale for combining Plinabulin with Pegfilgrastim (Neulasta) due to their differing mechanisms of action for preventing CIN.