Plinabulin Newly Granted Patent Covering Method of Use in Prevention of Neutropenia

BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that the Japan Patent Office (JPO) has granted the Company a new patent—JP Patent No. 6,411,523—for certain methods of preventing chemotherapy-induced neutropenia (CIN) with BeyondSpring’s lead asset, Plinabulin, a marine-derived small-molecule, in combination with taxane.

The patent covers methods for Plinabulin’s use in treating or reducing the incidence of grade 3 or 4 CIN in patients who are being treated with taxane, including instances where the taxane is docetaxel, with patent protection until 2033 in Japan. Dr. Lan Huang, BeyondSpring co-founder and CEO, is the author of this newly granted patent. This same patent has been applied in 17 jurisdictions globally, including the U.S., EU, and China.

“Plinabulin already has over 70 patents granted in 34 countries, covering its composition of matter and method of use in cancer treatment. The issuance of this patent provides us with expanded freedom to operate and greater flexibility to extend our development and commercialization plan to the Japanese market,” said Dr. Huang. “Not only does this patent add to our already robust global patent portfolio for Plinabulin, it also provides us with greater opportunity to reach a large patient population in Japan, the world’s third largest market for CIN after the U.S. and China, in need of new treatment options that can provide better outcomes in preventing CIN.”

Plinabulin is currently in Phase 3 global clinical development for the prevention of CIN.

About Plinabulin
Plinabulin, a marine-derived small-molecule, is BeyondSpring’s lead asset and is currently in late-stage clinical development for the prevention of chemo-induced neutropenia and as an anticancer therapy in non-small cell lung cancer. Studies of Plinabulin’s mechanism of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the maturation of dendritic cells, which in turn leads to T-cell activation and the up-regulate of IL6 in the tissue micro environment, contributing to the prevention of neutropenia.

About Chemotherapy-Induced Neutropenia
Chemotherapy-induced neutropenia is a common side effect in cancer patients undergoing treatment that involves the destruction of a type of white blood cell, the neutrophil, which is a patient’s first line of defense against infections. Patients with grade 4 (severe) neutropenia have an abnormally low concentration of neutrophils, making these patients more susceptible to bacterial and fungal infections and sepsis, which can require hospitalization.

The current standard of care for chemotherapy-induced neutropenia prevention is G-CSF monotherapy. However, G-CSF monotherapy has limitations as described in its product information summary. As many as 90 percent of patients on chemotherapy and G-CSF monotherapy may still experience grade 3/4 neutropenia. NCCN guidelines require that patients with grade 3/4 neutropenia decrease chemotherapy dose intensity, delay chemotherapy cycle timing or discontinue chemotherapy, each of which can have a negative effect on the long-term outcomes of cancer care.

About BeyondSpring
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 the 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 and two Phase 2/3 clinical programs in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to the global market.

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