Benzinga | Jun 8, 2021 07:17AM EDT

BeyondSpring To Present PROTECTIVE-2 Phase 3 Data On Plinabulin In Combination With Pegfilgrastim At Federation of Clinical Immunology Societies Annual Meeting Jun. 8-11

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.