BeyondSpring’s Plinabulin May Prevent Tissue Iron Overload in Anemic Cancer Patients Receiving Chronic Blood Transfusions During Chemotherapy
March 23, 2020
New Data to be Presented at NCCN 2020 Annual Conference
NEW YORK, March 23, 2020 (GLOBE NEWSWIRE) — BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: 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’sNational Comprehensive Cancer Network (NCCN) Annual Conference.
Chemotherapy typically causes myelosuppression (bone marrow suppression), which leads to reduced white and red blood cell counts (anemia) in cancer patients. During the resulting blood transfusions, a high level of free iron / hemoglobin complex is released in the blood (called hemolysis) and binds haptoglobin. As a result, the haptoglobin concentration is depleted quickly, leaving the patient unprotected from an increase in toxic iron levels. Increased free iron levels are deposited in the patient’s tissue, damaging vital organs such as the heart, liver, endocrine system and bone marrow, which leads to increased morbidity and mortality.
The body’s natural defense mechanism to neutralize the free iron / hemoglobin complex is haptoglobin which, upon binding, safely removes iron. The data that will be presented at NCCN shows that Plinabulin is a potent inducer of haptoglobin, which could restore the rapid depletion in haptoglobin levels during blood transfusions. A single dose of Plinabulin increased haptoglobin levels in a dose-dependent manner (p<0.01) to maximum levels doubling the normal haptoglobin levels (p<0.0001) for more than three weeks in patients receiving severe myelosuppressive chemotherapies.
“Recent advances in cancer care – immunotherapy combined with chemotherapy, for example – is transforming cancer from a deadly disease to a chronic disorder, with long life expectancy in a large number of patients,” said Dr. Mohanlal. “Cancer patients who receive frequent blood transfusions with chemotherapies are bound to have long-term consequences of the tissue iron overload, thus negatively impacting their overall survival. Plinabulin’s induction of haptoglobin, which may safely remove iron overload in tissue is a potentially viable strategy for improved outcomes in cancer patients.”
Headquartered in New York, BeyondSpring is a global, clinical-stage biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to improve clinical outcomes for patients with high unmet medical needs. BeyondSpring’s first-in-class lead immune asset, Plinabulin, is a potent antigen-presenting cell (APC) inducer. It is currently in two Phase 3 clinical trials for two severely unmet medical needs indications: one is for the prevention of chemotherapy-induced neutropenia (CIN), the most frequent cause for a chemotherapy regimen dose’s decrease, delay, downgrade or discontinuation, which can lead to suboptimal clinical outcomes. The other is for non-small cell lung cancer (NSCLC) treatment in EGFR wild-type patients. As a “pipeline drug,” Plinabulin is in various I/O combination studies to boost PD-1 / PD-L1 antibody anti-cancer effects. In addition to Plinabulin, BeyondSpring’s extensive pipeline includes three pre-clinical immuno-oncology assets and a drug discovery platform dubbed “molecular glue” that uses the protein degradation pathway.
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, first in class agent 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 differentiated immune and stem cell modulator. 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 durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). 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 Strengthens Board with the Addition of Ex-Immunomedics and Constellation Commercial Head Brendan Delaney
NEW YORK, July 14, 2021 -- BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, today announced the appointment of Brendan Delaney to its Board of Directors, effective...
NEW YORK, July 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 participate in the William Blair Biotech...
BeyondSpring to Host R&D Day to Discuss Novel Immune Agent Plinabulin’s Development Program in Anti-cancer Indications
NEW YORK, June 17, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced it will host a Research and Development...
- NDA Filed by U.S. Food and Drug Administration (FDA) and given Priority Review for plinabulin plus G-CSF for the prevention of CIN. A PDUFA date of November 30, 2021 has been assigned by the FDA - Highlighted PROTECTIVE-2 Phase 3 data at two scientific conferences –...
BeyondSpring to Host First Quarter Financial Results and Corporate Update Conference Call on June 16, 2021
NEW YORK, June 11, 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 Final Positive Data from the PROTECTIVE-1 Phase 3 CIN Program of Plinabulin as a Single Agent Compared to Pegfilgrastim at the American Society of Clinical Oncology (ASCO) Annual Meeting
- Data further supports plinabulin’s fast onset of action and CIN prevention benefit in week 1 following chemotherapy - Single agent plinabulin (day 1 dose as chemotherapy), had non-inferior protection against CIN compared to pegfilgrastim (day 2 dose), while...
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 and Offers Superior Prevention of Chemotherapy-Induced Neutropenia (CIN) at the FOCIS Annual Meeting
Presentation data demonstrates that plinabulin, in combination with pegfilgrastim, not only improves CIN prevention but also reverses some of the immune suppressive profile of monotherapy pegfilgrastim NEW YORK, June 08, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the...
BeyondSpring Announces Three Presentations Highlighting Positive Clinical Outcome Data from the Phase 3 Program of Plinabulin in Combination with Pegfilgrastim for the Prevention of Chemotherapy-Induced Neutropenia at the American Society of Clinical Oncology (ASCO) Annual Meeting
- Data demonstrate that combination of plinabulin and pegfilgrastim offers superior benefit for reducing the incidence and severity of febrile neutropenia (FN) and hospitalization, with better quality-of-life (QoL), compared to pegfilgrastim alone NEW YORK, June 07,...
BeyondSpring Announces First Patient Dosed in a Triple Combination Study with Plinabulin, PD-1/PD-L1 Inhibitor and Radiotherapy for the Reversal of Resistance to PD-1/PD-L1 Inhibitors in Patients with Advanced Solid Tumors
Resistance to immunotherapy is a severe unmet medical need that plinabulin aims to address in combination with checkpoint inhibitors and radiotherapy First patient who failed Keytruda and chemotherapy has been dosed with plinabulin, Keytruda and radiation combination...
BeyondSpring Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Plinabulin and G-CSF Combination for the Prevention of Chemotherapy-Induced Neutropenia (CIN)
- The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for November 30, 2021 - Plinabulin and G-CSF combination has the potential to raise the standard of care in CIN prevention for the first time in 30 years NEW YORK, June 01, 2021 (GLOBE...
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