BeyondSpring’s Plinabulin Stimulates Both the Adaptive and Innate Immune System in Cancer Patients

February 10, 2020

Presentation at the 2020 ASCO-SITC Provides Strong Validation for Plinabulin as a Potent activator of the Innate Immune System

NEW YORK, Feb. 10, 2020 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that new clinical data on the Company’s first-in-class, late-stage asset, Plinabulin, shows its ability to potently stimulate the innate immune system. Previously, the Company reported that Plinabulin stimulates the adaptive immune system, through enhancing Dendritic Cell-dependent T-Cell proliferation (Mita, ASCO-SITC 2017). Dr. Ramon Mohanlal, BeyondSpring’s Chief Medical Officer and Executive Vice President, Research and Development, presented the new clinical evidence as a poster at this year’s ASCO-SITC Clinical Immuno-Oncology Symposium in Orlando, Fla.

Plinabulin can activate the body’s innate immune response by increasing plasma levels of both neutrophil count and the immune-modulatory protein haptoglobin.  In the Company’s Phase 2 106 Study in Breast Cancer patients receiving TAC (taxotere, doxorubicin, cyclophosphamide) chemotherapy, Plinabulin was administered as monotherapy at 10 (n=15), 20 (n=15) and 30 (n=12) mg/m² on Day One after TAC use. Haptoglobin and Absolute Neutrophil Number (ANC) profiles were obtained from blood draws taken before the first dose and almost daily, post-dose through Day 15 in the first cycle.  The data concluded:

• A single Plinabulin dose increased plasma haptoglobin levels within three days (p<0.03), and ANC levels within just one day (p<0.001).
• The mean haptoglobin (p<0.0005) and ANC (p<0.001) levels over 15 days in the first cycle increased approximately two-fold versus baseline levels.
• Haptoglobin levels remained increased for more than three weeks, and ANC levels for approximately one week following just a single dose of Plinabulin.

“This new clinical finding that Plinabulin induces a long-lasting increase in plasma haptoglobin levels is fascinating, considering haptoglobin’s potent ability to activate the innate immune system,” said Dr. Mohanlal. “This data, coupled with our previous observation that Plinabulin increases Neutrophil counts, another member of the innate immune system, we now have multiple lines of clinical evidence to prove that Plinabulin is a potent stimulator of the innate immune systems. The dual ability to stimulate both the adaptive and innate immune system by Plinabulin is very valuable in its use in the prevention of Chemotherapy Induced Neutropenia (CIN) and treatment of cancer.  This not only supports Plinabulin’s current Phase 3 studies in NSCLC and in CIN, but also positions Plinabulin as a preferred agent to be combined with IO therapies such as PD1/PD-L1 inhibitors. Therefore, we have initiated a broad program combining Plinabulin with checkpoint inhibitors with or without radiotherapy or chemotherapy, in collaboration with prominent academic centers and large pharma.”

About BeyondSpring
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, first-in-class agent Plinabulin as an immune and stem cell modulator, 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 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 differentiated immune and stem cell modulator. 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 durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). 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.

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.