BeyondSpring Inc.

06/17/2021 | Press release | Distributed by Public on 06/18/2021 06:27

BeyondSpring to Host R&D Day to Discuss Novel Immune Agent Plinabulin’s Development Program in Anti-cancer Indications

NEW YORK, June 17, 2021 (GLOBE NEWSWIRE) - BeyondSpring Inc. (the 'Company' or 'BeyondSpring') (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced it will host a Research and Development (R&D) Day to discuss the development program for its novel immune agent, Plinabulin, in anti-cancer indications on Friday, June 25th, at 8:00 a.m. ET.

The webinar will feature presentations by Key Opinion Leaders (KOLs) Steven Lin, M.D. (MD Anderson Cancer Center), and Trevor M. Feinstein, M.D. (Piedmont Cancer Institute), who will discuss the current treatment landscape and unmet medical need in treating patients with non-small cell lung cancer (NSCLC) and patients who failed checkpoint inhibitors. Drs. Lin and Feinstein will be available to answer questions following the formal presentations.

Also featured will be a management discussion of BeyondSpring's pipeline, including lead asset plinabulin, a selective immunomodulating microtubule-binding agent (SIMBA), being developed as a 'pipeline in a drug.' Topics management will cover include:

  • Plinabulin and G-CSF combination, which received priority review by the U.S. Food and Drug Administration (FDA) for its NDA for prevention of chemotherapy-induced neutropenia (CIN), which also received breakthrough designation. The Company has a PDUFA date of November 30, 2021.
  • Plinabulin and docetaxel combination, which is in a fully enrolled pivotal Phase 3 global study (DUBLIN-3) as a potential direct anticancer agent in patients with NSCLC. DUBLIN-3 is expected to report data in mid-2021.
  • Plinabulin in combination immune-oncology regimens, leveraging its MOA as a potent APC (antigen presenting cell) inducer. Plinabulin has demonstrated promising Phase 1 data in 2nd/3rd line SCLC (ASCO 2021); company has recently initiated a Phase 1 study in 7 cancers which failed checkpoint inhibitors to investigate plinabulin's potential to reverse resistance to immunotherapy.

To register for the webinar, please click here.

If you would like to ask a question during the live Q&A, please submit your request via email, click here.

Steven Lin, M.D., Ph.D.
Dr. Lin is an Associate Professor and Physician-Scientist at MD Anderson Cancer Center, with joint appointments in the Departments of Radiation Oncology and Experimental Radiation Oncology. Dr. Lin's practice focuses on thoracic malignancies, and he oversees several clinical trials including the use of proton beam therapy for esophageal cancer and in the combination of immunotherapy with radiotherapy in lung and esophageal cancers. Dr. Lin runs a translational research team that evaluates biomarkers for treatment response and disease outcomes after chemoradiation therapy and immunotherapy. On the basic science side, Dr. Lin's main interests lie in identifying novel approaches that could enhance radiotherapy and immunotherapy combinations in lung cancer that could be translated to innovative clinical trials for patients.

Trevor M. Feinstein, M.D.
Dr. Feinstein is board certified in medical oncology and hematology by the American Board of Internal Medicine and is director of research at Piedmont Fayette Hospital. He joined Piedmont Cancer Institute in 2011 from private practice in West Palm Beach, Florida where he cared for cancer patients. Dr. Feinstein is actively involved in clinical trials focused on improved therapies for various cancers and is a certified member of MD Anderson Cancer Network. He is a co-investigator on several peer-reviewed research projects and has authored numerous publications and abstracts in Hematology and Oncology. Dr. Feinstein graduated from University of Illinois medical school and completed his residence and fellowships at the University of Pittsburgh.

About BeyondSpring
Headquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs. BeyondSpring's first-in-class lead asset plinabulin, a Selective Immunomodulating Microtubule-Binding Agent (SIMBA), is being developed a 'pipeline in a drug.' It is filed for approval and has received Priority Review in the U.S. and China for the prevention of chemotherapy-induced neutropenia (CIN) with a PDUFA date of November 30, 2021 in the U.S., and has a fully enrolled pivotal study (Dublin-3) to test an anti-cancer benefit with an overall survival primary endpoint in non-small cell lung cancer (NSCLC). Additionally, it is being broadly studied in combination with various immuno-oncology regimens that could boost the effects of PD-1 / PD-L1 antibodies. In addition to plinabulin, BeyondSpring's extensive pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform.

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.

Investor Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
+1 617-430-7577
[email protected]

Media Contact:
Darren Opland, Ph.D.
LifeSci Communications
+1 646-627-8387
[email protected]