BeyondSpring Announces Positive Pre-NDA Meeting with the U.S. FDA for its Lead Asset, Plinabulin
NEW YORK, Dec. 27, 2018 (GLOBE NEWSWIRE) — BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that it had a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead asset, Plinabulin. The focus of this meeting was the content of the chemistry, manufacturing and control (CMC) sections of the Company’s planned NDAs for Plinabulin for the treatment of non-small cell lung cancer (NSCLC) and chemotherapy-induced neutropenia (CIN) prevention.
“We are very pleased with the outcome of this meeting, as we have confirmed our alignment with the FDA regarding expectations for the CMC sections of our planned NDAs for Plinabulin,” said Dr. Lan Huang, CEO and co-founder at BeyondSpring. “We have been working diligently on these submission packages, assembling their regulatory, preclinical, and most recently the clinical components of these indications. Now with agreement on the CMC sections, we are well on track to submit these NDA packages for Plinabulin to the FDA.”
“We truly appreciate the guidance provided by the FDA during our recent pre-NDA meeting for Plinabulin, and look forward to working with the Agency to achieve our goal of addressing the unmet clinical needs of cancer patients,” added Dr. Gordon Schooley, BeyondSpring’s Chief Regulatory Officer.
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 which contributes to durable anti-cancer benefit and the up-regulate of IL6 in the tissue micro-environment, contributing to the prevention of neutropenia.
About Non-Small Cell Lung Cancer
Lung cancer is the leading cause of cancer deaths worldwide. According to the World Health Organization, there will be approximately 2.1 million diagnosed cases and 1.8 million estimated deaths caused by the disease in 2018. Lung cancer is manifested in two main forms: NSCLC and small cell lung cancer. NSCLC is the more common form, accounting for approximately 85 percent of all lung cancer cases. Over 85 percent of second- and third-line NSCLC is of EGFR wild type in the Western population, of which only four therapies have been approved. These four therapies include docetaxel, pemetrexed, ramucirumab and docetaxel, and PD-1/PD-L1 treatments, all of which have their own limitations. This presents a severe unmet medical need, which is targeted by the Phase 3 trial of Plinabulin and docetaxel combination.
About Chemotherapy-Induced Neutropenia
CIN 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 and can be fatal.
The current standard of care for CIN 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 or 4 neutropenia. Additionally, as many as 70 percent of patients using G-CSF monotherapy experience bone pain while on therapy. 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.
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 and two Phase 2/3 clinical programs in the prevention of chemotherapy-induced neutropenia. BeyondSpring has internal R&D capabilities with a robust pipeline including, in addition to Plinabulin, three immuno-oncology assets and a drug discovery platform using ubiquitination degradation pathway. The Company 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.
Source: BeyondSpring, Inc.
Posted: December 2018
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