NEW YORK, Sept. 19, 2018 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI), a global, clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, announced today that the U.S. Patent and Trademark Office (USPTO) has granted the Company a new patent—U.S. 10076518—for certain methods of treating brain cancer with administration of BeyondSpring’s lead asset, Plinabulin, a marine-derived small-molecule.
The patent covers administering Plinabulin for treatment methods by which the brain tumor is metastatic, anaplastic astrocytoma, glioblastoma multiforme, oligodendroglioma, ependymomas or a combination thereof, with patent protection until 2036. Dr. Lan Huang, BeyondSpring CEO, is the first author for this new patent. This same patent has been applied in 17 jurisdictions globally, including the E.U., Japan and China.
Plinabulin already has 69 patents granted in 34 countries, covering composition of matter and usage, among which 13 patents granted in the U.S. The composition of matter patent for Plinabulin is valid through 2025, with potential to extend five years to 2030.
“BeyondSpring has a robust patent portfolio surrounding Plinabulin, and the issuance of this latest patent extends our proprietary rights and further reinforces our global intellectual property position for our lead product,” said Dr. Huang. “Brain tumors represent a severe unmet medical need, especially metastatic brain cancer, for which the median overall survival for patients is 4.2 months. If Plinabulin can slow down metastasis to the brain, then this is an enormous contribution to the medical community.”
Plinabulin is currently in Phase 3 clinical development for the prevention of chemotherapy-induced neutropenia and as an anticancer therapy in non-small cell lung cancer.
Plinabulin, a small molecule derived from a marine fermentation product (phenylahistin), is BeyondSpring’s lead asset and is currently in late-stage clinical development for the prevention of chemotherapy-induced neutropenia (CIN) and as an anticancer therapy in non-small cell lung cancer (NSCLC). In addition to direct cytotoxic effects leading to tumor cell death, studies of Plinabulin's mechanism of action indicate that following tubulin binding, Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 affects downstream molecular pathways leading to increased dendritic cell maturation and antigen induced T-cell activation. With regard to CIN, nonclinical testing indicates that Plinabulin releases a chemotherapy induced block in the differentiation of bone marrow cells into neutrophils, allowing for a reduction in the incidence and duration of neutropenia.
BeyondSpring is a global, clinical-stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with University of Washington in de novo drug discovery using a ubiquitination platform. 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 2/3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has a seasoned management team with many years of experience bringing drugs to the global market.
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.