BeyondSpring Announces a Late-Breaking Poster Presentation of PROTECTIVE-2 Phase 3 Data Showing Plinabulin, in Combination with Pegfilgrastim, Reverses the Immune-Suppressive Effects of Pegfilgrastim and Offers Superior Prevention of Chemotherapy-Induced Neutropenia (CIN) at the FOCIS Annual Meeting
BeyondSpring Inc. (NASDAQ: BYSI) announced a late-breaking poster presentation regarding plinabulin, demonstrating its efficacy in preventing chemotherapy-induced neutropenia (CIN) in combination with pegfilgrastim.
The Phase 3 PROTECTIVE-2 study showed significant improvements in immune profiles and CIN prevention compared to pegfilgrastim alone. The U.S. FDA accepted the New Drug Application with Priority Review, setting a PDUFA action date of November 30, 2021. With 110,000 annual hospitalizations due to CIN in the U.S., plinabulin is positioned to address this critical medical need, expanding its market potential significantly.
- Plinabulin demonstrated superior CIN prevention and improved immune profiles in the PROTECTIVE-2 Phase 3 study.
- The U.S. FDA granted Priority Review for the NDA submission with a PDUFA action date of November 30, 2021.
- The expanded NCCN guidelines increase the addressable market to approximately 467,500 cancer patients annually.
- The main benefit of pegfilgrastim treatment is seen in Week 2 post-chemotherapy, highlighting the vulnerability gap during Week 1.
- Despite advancements, the competitive landscape remains high with multiple treatments available for CIN.
Presentation data demonstrates that plinabulin, in combination with pegfilgrastim, not only improves CIN prevention but also reverses some of the immune suppressive profile of monotherapy pegfilgrastim
NEW YORK, June 08, 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 a late-breaking poster presentation of the company’s lead asset plinabulin, a selective immunomodulating microtubule-binding agent (SIMBA), in combination with pegfilgrastim in breast cancer as part of the Phase 3 PROTECTIVE-2 chemotherapy-induced neutropenia (CIN) study, at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting being held from June 8-11, 2021.
BeyondSpring’s poster titled “Adding Plinabulin (Plin) to Pegfilgrastim (Peg) Reverses the Immune Suppressive Potential of Peg while Offering Superior Prevention of Chemotherapy Induced Neutropenia (CIN) versus Peg Alone),” will be presented on June 9, 2021 at 3:15 p.m. PDT and authors will be available at the poster reception on June 10, 2021 from 4:45 p.m. – 5:30 p.m. PDT (Poster number TH58). Plinabulin in combination with pegfilgrastim demonstrated a superior immune profile and CIN prevention outcomes for patients treated with plinabulin in combination with pegfilgrastim compared to pegfilgrastim alone in breast cancer patients dosed with TAC (Taxotere, doxorubicin, and cyclophosphamide) in PROTECTIVE-2 Phase 3 study. Compared to pegfilgrastim alone (n=110), the plinabulin and pegfilgrastim combination (n=111) showed decreased production of immature neutrophil band (p=0.0012), and decreased promyelocytes and myelocyte production (p=0.0488). Immature neutrophil band and promyelocytes and myelocytes are less functional defending against infection and have potentially deleterious immune suppression effects.
“Plinabulin has broad effects on the immune system and tumor microenvironment. We are excited to see that in addition to the well-demonstrated CIN prevention benefits, we also see that plinabulin can protect against some of the immune-suppressive side effects of pegfilgrastim,” said Ramon Mohanlal M.D., Ph.D., Chief Medical Officer and Executive Vice President of Research and Development at BeyondSpring “Plinabulin is a pipeline-in-a-drug and we are seeing more evidence of this with every study, demonstrating that it can help patients with cancer, from side-effects to cancer treatment.”
The Company has submitted New Drug Applications (NDA) for plinabulin in combination with pegfilgrastim as a treatment for the prevention of CIN for review in both the U.S. and China. The U.S. FDA accepted the NDA with Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) action date of November 30, 2021.
About The Federation of Clinical Immunology Societies (FOCIS) Annual Meeting
The Federation of Clinical Immunology Societies (FOCIS) exists to improve human health through immunology by fostering interdisciplinary approaches to both understand and treat immune-based diseases. The Federation of Clinical Immunology Societies is a key forum where opinion leaders come together to chart the path to the next major breakthrough in disease therapy. Through FOCIS, researchers and clinicians share knowledge across traditional disease borders, and identify commonalities between treatments and therapies that are life-changing for those impacted by immune-mediated diseases. Initially established as a cross-disciplinary meeting, FOCIS held its first Annual Meeting in 2001. After two successful consecutive meetings, FOCIS incorporated as a 501(c)3 organization in 2003. Today, FOCIS has 58 Member Societies, representing roughly 65,000 clinician scientists.
About CIN
CIN remains a severely unmet medical need and is the primary cause for the 4D’s (Decrease, Delay, Discontinue dose and Downgrade regimen) that compromise carefully selected cancer treatment regimens. Treatment or prevention of CIN with G-CSF has been the standard of care since Neupogen® was approved in 1991. The main benefit of G-CSF treatment, however, is in Week 2 after chemotherapy. Week 1 after chemotherapy is considered the “neutropenia vulnerability gap” where over
Each year in the U.S., 110,000 patients receiving chemotherapy are hospitalized after developing CIN, a severe side effect that increases the risk of infection with fever (also called FN). Due to the COVID-19 pandemic, the updated National Comprehensive Cancer Network (NCCN) guidelines expanded the use of prophylactic G-CSFs, including pegfilgrastim, from high-risk patients only (chemo FN rate >
About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA). It is a novel, intravenous infused, patent-protected, NDA ready asset for CIN prevention indication and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC). Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received breakthrough designation from both US and China FDA for CIN prevention indication. As a “pipeline in a drug,” plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody resistant patients.
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, is being developed as a “pipeline in a drug.” It is filed for approval in the US and China for the prevention of chemotherapy-induced neutropenia (CIN) and has a fully enrolled pivotal study to test an anti-cancer benefit with an overall survival primary endpoint in 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, and re-sensitize PD-1/PD-L1 antibody resistant patients. 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 the 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:
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LifeSci Advisors, LLC
+1 617-430-7577
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Media Contact:
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FAQ
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