On October 20, 2021 BeyondSpring Pharmaceuticals (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported the presentation of preclinical data in patient-derived cancer models supporting the use of plinabulin in small cell lung cancer (SCLC) at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), held October 7-10, 2021 (Press release, BeyondSpring Pharmaceuticals, OCT 20, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-pharmaceuticals-announces-new-patient-derived-cancer-model-data-for-plinabulin-monotherpy-at-the-aacr-nci-eortc-virtual-international-conference-to-further-support-the-positive-clinical-d [SID1234591579]). Plinabulin is a selective immunomodulating microtubule-binding agent (SIMBA), which induces dendritic cell maturation for durable anti-cancer benefit, and selectively induces certain types of cancer cell apoptosis, both through immune defense protein GEF-H1 release and activation. This study demonstrates plinabulin’s direct single agent anti-cancer tumor effects in patient-derived models of SCLC and additional cancer types, including glioblastoma multiforme, bladder cancer, gastric cancer, sarcoma and triple-negative breast cancer.

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"The positive patient-derived (PDX) preclinical data increases our confidence in pursuing SCLC as an indication for plinabulin, which has shown high response rate data in human studies. This is supplemental to the maturation of dendritic cells in the cancer immune system and the induction of downstream mechanisms in specific cancer cell types," said Dr. Kenneth Lloyd, chief scientific officer of BeyondSpring. "The fact that plinabulin has already been associated with tumor responses in SCLC patients in a Phase 1 study presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting is a good indication that these patient-derived models are predictive. The preclinical data presented here supports our intended strategy for developing an option for cancer patients by combining plinabulin and checkpoint inhibitors in SCLC."

The study was intended to screen cancer cells for susceptibility to plinabulin. For this purpose, PDX models of cancer established from patient tumor biopsies were used in a manner that results in minimal chance for changes in cancer cell genetics, and hence, these models are considered more predictive of clinical response than common cancer models. Eighty PDX three-dimensional culture models were tested. Data showed that the cancer types most sensitive to plinabulin were:

SCLC (mean absolute IC70 = 35 nM; n = 7)
Bladder cancer (mean absolute IC70 = 38 nM; n = 9)
Soft tissue sarcoma (mean absolute IC70 = 57 nM; n = 10)
Dr. Lan Huang, BeyondSpring’s co-founder, CEO and chairwoman concluded, "We have been developing plinabulin in multiple cancer indications, based on the effects of plinabulin on dendritic cells and macrophages. Plinabulin’s anti-cancer effect is supported by the positive Phase 3 DUBLIN-3 non-small cell lung cancer study with evidence of the extension of overall survival. Plinabulin has also shown efficacy in preventing chemotherapy-induced neutropenia, which has received Breakthrough Designation and Priority Review from the U.S. FDA. Plinabulin’s single agent anti-cancer activity in PDX SCLC models and the relevant positive immuno-oncology combo preliminary clinical data in SCLC could potentially expand plinabulin’s cancer indications. We look forward to continuing to expand these anti-cancer indications in the clinic and to validate plinabulin as a ‘pipeline in a drug.’"

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, NDA stage asset for CIN prevention 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 of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). It is being developed as a "pipeline in a drug" in multiple cancer indications.