NEW YORK, Jan. 17, 2018 (GLOBE NEWSWIRE) — BeyondSpring Inc. (NASDAQ:BYSI), a global clinical stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company will present initial data from the Phase 2 portion of its global Phase 2/3 clinical trial (Study 105) for the prevention of docetaxel chemotherapy-induced neutropenia (CIN), comparing BeyondSpring’s lead asset, Plinabulin, to pegfilgrastim (Neulasta), a long-lasting G-CSF, at the 2018 ASCO-SITC Clinical Immuno-Oncology Symposium in San Francisco on Jan. 25, 2018. In December 2017, BeyondSpring announced that the primary objective in the Phase 2 portion of the study had been met.
Dr. Ramon Mohanlal, BeyondSpring’s Chief Medical Officer, will present a poster titled, “Plinabulin, a novel small molecule clinical-stage IO agent with anti-cancer activity, to prevent chemo-induced neutropenia and immune-related AEs” (Abstract 126), during Poster Session A on Jan. 25, 2018, from 11:30 a.m.-1 pm PT and 5:30-6:30 p.m. PT. In addition, in the same poster, BeyondSpring will present Phase 1 data from a study of Plinabulin in combination with Nivolumab for the treatment of non-small cell lung cancer (NSCLC), which is being conducted by collaborators at the Fred Hutchinson Cancer Research Center and University of California at San Diego.
“Presenting our Phase 2 data from Study 105 at this year’s ASCO-SITC is a vital moment for BeyondSpring, because we achieved our primary endpoint of determining the recommended dose for the Phase 3 portion of the trial,” said Dr. Mohanlal. “This study was an important component of the Plinabulin CIN program, as it also represented the first head-to-head comparison of Plinabulin versus Neulasta. Additionally, strong interest in Plinabulin among the medical and patient communities has resulted in strong enrollment and rapid trial advancement. We remain steadfast in our goal to bring a novel treatment to patients with CIN and better serve a market that has seen little innovation in more than a generation.”
BeyondSpring management will host a conference call with the investment community to review these important data on Jan. 29, 2018, at 8:30 a.m. ET. The conference call will feature remarks by Dr. Lan Huang, BeyondSpring’s CEO, Dr. Mohanlal and Dr. Douglas Blayney, Board Member of the NCCN Guidelines for neutropenia management, who served as an investigator in clinical trials for Neupogen and Neulasta, and is the principal investigator for both of BeyondSpring’s ongoing registrational neutropenia trials. The dial-in numbers for the call are +1.877.451.6152 (U.S. toll free) or +1.201.389.0879 (international). Please ask the operator to join the BeyondSpring call.
A live webcast of the call will also be available online, which can be accessed through the Investor Relations section of BeyondSpring’s website: http://ir.beyondspringpharma.com. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.
For interested individuals who are unable to join the conference call, a replay of the call will be available through Feb. 12, 2018, at +1.844.512.2921 (U.S. toll free) or +1.412.317.6671 (international). Participants must use the following code to access the replay of the call: 13675621. Also, a replay of the webcast will remain available on http://ir.beyondspringpharma.com for 30 days following the call.
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 University of Washington in de novo drug discovery using ubiquitination platform. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer (Study 103) and two Phase 2/3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN) – Studies 105 and 106. BeyondSpring has a seasoned management team with many years of experience bringing drugs to market.
Studies on 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 activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to upregulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia. Plinabulin is given as a single IV infusion in each cycle, 30 minutes to 1 hour after completion of the chemotherapy, offering same day dosing, whereas G-CSF is given 24 hours after chemotherapy. In addition, the use of Plinabulin is not associated with bone pain, which is a frequent side effect with G-CSF.
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, the anticipated amount needed to finance the company’s future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, our expectations regarding the potential safety, efficacy or clinical utility of our product candidates, or additional competition in the market. The 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.