October 17, 2019

BeyondSpring's Lead Asset, Plinabulin, Granted U.S. Patent Covering Methods of Treating Brain Tumors


The patent, which expires in 2036, covers methods for Plinabulin’s use in the treatment of brain tumors, including metastatic brain tumor, with no approved chemotherapy on the market, and glioblastoma multiforme (GBM), the most common adult brain tumor. Both are known for their lethality and lack of response to treatment using the current standard of care. Dr. Lan Huang, BeyondSpring co-founder and CEO, is the inventor of the new patent.

Only surgery and radiation, but no chemotherapy had ever been granted in metastatic brain tumor, with survival at around 4 to 6 months. Without the current advancement in primary tumor treatment, more patients would develop metastatic brain tumor with grim outcome. In recent years, there have been no substantial improvements in treatment options, and minimal improvements in the survival prospects for patients with GBM. The average life expectancy for GBM after symptoms onset is approximately 6 to 12 months.

“The cancer-fighting properties of Plinabulin, either alone or combined with other compounds, continues to show promise as our clinical trials show beneficial outcomes in a myriad of cancers,” said Dr. Huang. “When it comes to brain cancer, there remains an urgent need for improved treatments, as most of the current treatment methods – like chemotherapy – have limitations as they cannot penetrate the blood-brain barrier on their own. We are pleased with the long runway of Plinabulin patents, including a composition of matter patent directed to Plinabulin monohydrate crystalline form, which currently expires in 2036. Currently we have 74 granted patents in 36 jurisdictions globally and 17 patents granted in the U.S. directed to Plinabulin and Plinabulin analogs, their synthesis, and their use in the treatment of various disorders.”

Plinabulin is currently in Phase 3 global clinical development for the treatment of non-small cell lung cancer (NSCLC) and for the prevention of chemotherapy-induced neutropenia (CIN).

About BeyondSpring
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.

About Plinabulin
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 positively affect 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.

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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.

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