BeyondSpring’s Rationale for the Plinabulin-Neulasta Combination for Neutropenia Prevention Accepted as Abstracts at 2019 ASCO Annual Meeting

NEW YORK, May 16, 2019 (GLOBE NEWSWIRE) -- (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that two of the Company’s abstracts on its lead asset, Plinabulin, have been accepted for publication in the Proceedings of this year’s ASCO Annual Meeting. The data, derived from BeyondSpring’s Phase 2 Study 106, provides a strong rationale for the Plinabulin Neulasta (pegfilgrastim) combination for the prevention of chemotherapy-induced neutropenia (CIN) for improved CIN control. Additionally, the Plinabulin Neulasta combination nearly eliminated patients’ treatment-related bone pain. Study 106 Phase 2 included breast cancer patients receiving TAC (docetaxel, doxorubicin, cyclophosphamide) which has risk for febrile neutropenia.

BeyondSpring’s first abstract (No. e12030), “Comparison of 6mg Pegfilgrastim, Plinabulin and the Combination for CIN Prevention: Rationale for the Combination,” evaluates whether combining Plinabulin with Neulasta, would protect patients against CIN throughout the entire chemotherapy cycle. The two agents have different mechanisms of action, with Plinabulin predominantly protective in the first week of the cycle, and Neulasta predominantly protective in the second week of the cycle. Protection was measured by evaluating the absolute neutrophil count (ANC). The data shows that Plinabulin, when added to the standard dose of Neulasta, offered CIN protection throughout the entire cycle, something that could not be achieved by each of these agents alone. The addition of Plinabulin to Neulasta, almost completely eliminated the Neulasta-induced bone pain, reducing its incidence of at least 1 day of bone-pain from 95 percent (with the standard dose of Neulasta) to 6 percent (with the Plinabulin-Neulasta combination) (p < 0.0001).

BeyondSpring’s second abstract (No. e12017), “Plinabulin Combined with Half Dose (3mg) Pegfilgrastim, Compared with Full Dose (6mg) Pegfilgrastim Alone for CIN: Neutrophil, Bone Pain and Immunosuppressive Effects,” compared patients who received a combination of Plinabulin with a half dose of Neulasta to patients who received a full dose of Neulasta alone to test the effects on CIN, bone pain and the immune-suppressive profile. The data highlights that a half dose of Neulasta, combined with Plinabulin, is equally effective against CIN as a full dose of Neulasta alone (demonstrating a strong neutropenia benefit). In addition, the combination therapy offered significantly lower levels of bone pain for patients, as well, along with a favorable immune profile compared to Neulasta alone.

“These results suggest that combining Plinabulin with Neulasta, the existing standard of care for CIN, makes the treatment better and more effective for patients,” said Dr. Douglas W. Blayney, global Principal Investigator for BeyondSpring’s CIN development program and Professor of Medicine at the Stanford University School of Medicine. “We can say that the Plinabulin-Neulasta combination creates added benefits that are not seen with Neulasta used alone. Together these data provide additional rationale for the Plinabulin-Neulasta combination to treat CIN.”

“The combination of Plinabulin and Neulasta or G-CSF has the opportunity to improve care for patients, providers and payers,” added Dr. Ramon Mohanlal, Executive Vice President of R&D and Chief Medical Officer, BeyondSpring. “Our ultimate goal is to provide better patient outcomes, and we believe that combination therapies like the Plinabulin-Neulasta treatment represent the future of medicine.”

The ASCO Annual Meeting will take place on May 31 through June 4, 2019, at McCormick Place in Chicago. BeyondSpring’s abstracts can be found on the ASCO conference website .

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 (NSCLC) and two Phase 2/3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to Plinabulin, including three immuno-oncology assets and a drug discovery platform using the ubiquitination degradation pathway. The Company also has a seasoned management team with many years of experience bringing drugs to the global market.

About Plinabulin

Plinabulin, BeyondSpring’s lead asset, is a marine-derived small molecule that sequesters tubulin heterodimers in a differentiated manner from other agents in this class. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The anticancer benefits of 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. Plinabulin’s CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

About Chemotherapy-Induced Neutropenia (CIN)

CIN is a common, often severe side effect that cancer patients who are undergoing treatment experience involving the destruction of neutrophils, which are a type of white blood cell and a patient’s first line of defense against infections. The current standard of care for CIN prevention is G-CSF monotherapy, which has serious limitations as described in its product information summary.

As many as 90 percent of patients who receive high-risk chemotherapy and G-CSF monotherapy may still experience grade 3 or 4 neutropenia [Lee et al., Annals of Surgical treatment and research 94(5): 223-228 (2018)]. Patients with grade 4 (severe) neutropenia have an abnormally low concentration of neutrophils, making these patients more susceptible to bacterial / fungal infections and sepsis, which can require hospitalization and be fatal. Grade 4 CIN can have an adverse effect on chemotherapy administration and is usually considered a significant predictor of low relative dose intensity (RDI), dose delays and dose reductions [Lalami Y, Critical Reviews in Oncology / Hematology, 120: 163 – 179 (2017)]. Even a 15 percent chemotherapy dose reduction can reduce long-term survival by as much as 50 percent [Bonadonna, Med Oncol 29:1495–1501 (2012)].

Additionally, as many as 70 percent of patients using G-CSF monotherapy experience bone pain [Moore et al., Annals of Pharmacotherapy 51(9): 797-803 (2017)]. Twenty-five percent of patients also report that the pain is severe. The National Comprehensive Cancer Network (NCCN) guidelines require that patients with grade 3 or 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 [Lalami et al., Critical Reviews in Oncology / Hematology 120: 163-179 (2017)].

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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