BeyondSpring Advancing Patient Targeting Strategies for Lead Asset Plinabulin


Newly Discovered Predictive Algorithms to be Presented at 2019 American Association for Cancer Research Annual Meeting

NEW YORK, March 25, 2019 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, announced today that the Company will present novel data relevant to predictive biomarkers for patient selection for its lead asset, Plinabulin, at the 2019 American Association for Cancer Research (AACR) Annual Meeting in Atlanta, Georgia. The results from this non-clinical study will be highlighted in a poster presentation titled, "Predictive Models for Tumor Cell Targeting with Plinabulin, Derived from In Vitro Screening and Affymetrix mRNA Expression Data," on April 1 from 8 a.m. to 12 p.m. local time.

In this study, BeyondSpring generated neural and logistic regression algorithms that utilized Affymetrix array-based mRNA measurements to predict the ability of Plinabulin to dramatically reduce the number of live breast, lung, prostate, ovarian and CNS cancer cells in vitro (43 cell line experiments). Predictive genes include CTNNB1 (beta-catenin; oncogene), CALD1 (caldesmon; inhibits myosin ATPase activity), ERI1 (RNA processing), LGR5 (adult stem cell biomarker), SECISBP2L (SLAN; prolongs mitosis) and TRAK1 (mitochondrial/endosome trafficking). The methods and predictive gene mRNAs discovered will be utilized to introduce a similar exploratory approach into Plinabulin clinical trials.

"There is an enormous need to predict, with confidence, an individual cancer patient's likelihood of response to therapies being considered," said Dr. James Tonra, Senior Vice President, Preclinical Development, BeyondSpring. "Yet patient selection strategies, beyond cancer type and line of therapy, are the exception rather than the rule. This nonclinical effort was undertaken to significantly advance the concept of patient selection, and we are very pleased with the ability of our algorithms to accurately and confidently predict potent Plinabulin anti-cancer effects."

"Plinabulin is already in global Phase 3 trials for NSCLC, and this new discovery opens up the potential of developing multiple indications for Plinabulin using this biomarker-based approach to patient selection for increased efficacy. Gene expression profiles at baseline that are predictive of outcomes are achievable and will allow BeyondSpring to identify the right chemotherapies and cancer types for this approach through relatively small, early proof-of-concept trials," added Dr. Ramon Mohanlal, Executive Vice President of R&D and Chief Medical Officer, BeyondSpring.

The AACR Annual Meeting will take place from March 29 through April 3, 2019, at the Georgia World Congress Center in Atlanta. BeyondSpring's abstract can be found on the AACR conference website here.

About Plinabulin

Plinabulin, a marine-derived small-molecule that sequesters tubulin heterodimers in a manner differentiated from other agents in this class, is BeyondSpring's lead asset. Following positive Phase 2 results, Plinabulin is currently in phase 3 clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia. Plinabulin reduced chemotherapy-induced neutropenia in association with reduced thrombocytopenia and increased circulating CD34+ progenitor cell mobilization in patients. Studies of Plinabulin's mechanism of action in animals indicate that these broad effects on the hematopoietic system may relate to positive effects on hematopoietic stem / progenitor cells in the bone marrow, with increased tissue cytokine / IL-6 secretion. The anticancer benefits of targeting tubulin / microtubules with 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.

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 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.


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Source: BeyondSpring, Inc.

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