- Adding plinabulin to a myelosuppressive chemotherapy regimen rapidly reversed (within 24 hours) chemotherapy-induced neutropenia and leukopenia in the PROTECTIVE-1 and -2 clinical studies, suggesting protection of the granulocyte-monocyte-progenitor stem cells as plinabulin’s mechanism of action for the prevention of chemotherapy-induced neutropenia (CIN), at a level of p<0.0001 with the CIN dose of plinabulin
- The data were presented in a poster at ASH on
Sunday, December 12, 2021
“This clinical data provides evidence confirming the hypothesized progenitor stem cell protective mechanism of action for plinabulin, which further validates the positive Phase 3 data from the PROTECTIVE-2 clinical program. These data also build upon the rapid effect seen in clinical trials to date and support the opportunity for enhanced CIN prevention care with plinabulin,” said Dr.
Dr.
This poster was presented on
Poster Title: Plinabulin Rapidly (within 24 Hours) Reverses Myelosuppression Induced by Chemotherapy
Abstract Number: 2056
Key Findings:
- This new data analysis from the PROTECTIVE-1 and 2 studies aimed to further evaluate plinabulin’s fast onset mechanism of action (MoA) and potential progenitor stem cell involvement in plinabulin’s fast onset MoA.
- The comparison was made between cancer patients receiving plinabulin 40 mg (n=228) or not receiving plinabulin (n=172), and with all patients receiving myelosuppressive chemotherapy (docetaxel with or without doxorubicin and cyclophosphamide). Plinabulin 40 mg was given 30 minutes after chemotherapy.
- Plinabulin rapidly (within 24 hours) reversed chemo-induced myelosuppression in both the PROTECTIVE-1 and 2 human studies. Plinabulin-mediated increases in cell numbers are dose-dependent and correlated among cells of the myeloid, lymphoid and erythroid lineages.
- Neutrophils (p<0.0001; increase by >3x10E9/L with plinabulin and decrease by >0.5x10E9/L without plinabulin)
- Monocytes (p=0.0023)
- Eosinophils (p=0.0775)
- Basophils (p<0.0001)
- The data suggest that plinabulin targets granulocyte-monocyte-progenitor (GMP) stem cells (N, M, B and E progenitor) as well as progenitor cells further upstream in the hematopoietic lineage.
About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC) with recently released positive topline data. 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 of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received Breakthrough Therapy designation from both
About BeyondSpring Pharmaceuticals
Headquartered in
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