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.”

About BeyondSpring
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.

About BeyondSpring
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.

About Plinabulin
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.