BeyondSpring, Inc. engages in the development and commercialization of immuno-oncology cancer therapies. It operates through the Plinabulin Pipeline and TPD Platform segments. The Plinabulin Pipeline segment focuses on the development of cancer therapies. The TPD Platform segment engages in the development of therapeutic agents and discover chemical entities. The company was founded by Lan Huang and Lin Qing Jia in 2010 and is headquartered in Florham Park, NJ.
Clinical Trials
6
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
16.7%
Completed
4
66.7%
Not yet recruiting
1
16.7%
No approval data available
- BeyondSpring's Phase 3 DUBLIN-3 study demonstrated that plinabulin combined with docetaxel achieved a statistically significant overall survival benefit with a hazard ratio of 0.72 (p=0.0078) in EGFR wild-type non-small cell lung cancer patients. - Early clinical data suggests plinabulin may restore sensitivity to checkpoint inhibitors in patients who have developed resistance, addressing a major unmet need affecting approximately 60% of patients on PD-1/PD-L1 therapies. - The company plans to initiate the global Phase 3 DUBLIN-4 confirmatory study focusing on EGFR wild-type non-squamous NSCLC patients who progressed on prior PD-1/L1 inhibitors. - BeyondSpring will present combination data on plinabulin with antibody-drug conjugates at the 2026 AACR Annual Meeting, expanding its therapeutic applications beyond checkpoint inhibitor combinations.
- BeyondSpring's plinabulin plus docetaxel demonstrated clinically meaningful survival improvements in EGFR wild-type non-squamous NSCLC patients who progressed after anti-PD-(L)1 therapy, with median overall survival reaching 15.8 months versus 11.7 months for docetaxel alone. - The combination significantly reduced docetaxel-induced grade 4 neutropenia from 33.58% to 5.13% and decreased new brain metastasis incidence from 7.83% to 4.32%, supporting improved tolerability and clinical outcomes. - Asian subset analysis from the Phase 3 DUBLIN-3 trial showed statistically significant overall survival benefit with hazard ratio of 0.81, particularly strong in non-squamous patients with HR of 0.69. - BeyondSpring plans to initiate global Phase 3 DUBLIN-4 trial as a confirmatory study to support future NDA submission for this patient population with significant unmet medical need.
- BeyondSpring published a clinical study in Med (Cell Press) demonstrating that Plinabulin, combined with radiation and checkpoint inhibitors, induces dendritic cell maturation and elicits tumor responses in patients who had failed prior immune checkpoint inhibitor therapy. - The study achieved a 23% overall response rate and 54% disease control rate in non-irradiated lesions, suggesting promising clinical activity for treatment-resistant cancers. - Researchers identified that Plinabulin works through the GEF-H1–dependent pathway to mature dendritic cells, potentially allowing prediction of patient response through baseline GEF-H1 immune signature analysis. - Phase 2 data from the 303 Study showed the triple combination of Plinabulin, pembrolizumab, and docetaxel achieved median progression-free survival of 6.8 months and 15-month overall survival rate of 78% in NSCLC patients.
- BeyondSpring's Plinabulin combined with radiation and PD-1 inhibitors achieved a 23% overall response rate and 54% disease control rate in patients who failed prior checkpoint inhibitor therapy. - The study published in Med (Cell Press) identified GEF-H1-dependent dendritic cell maturation as Plinabulin's mechanism of action, offering potential for patient pre-selection. - Particularly strong responses were observed in non-small cell lung cancer, head and neck squamous cell carcinoma, and Hodgkin lymphoma patients. - Two Hodgkin lymphoma patients achieved durable responses exceeding 19 months despite having received 12-16 prior lines of therapy.
- BeyondSpring's Plinabulin demonstrated statistically significant survival benefits in second and third-line non-small cell lung cancer (EGFR wild-type) patients, with results published in The Lancet Respiratory Medicine. - Phase 2 studies show Plinabulin's potential to resensitize tumors that have progressed on PD-1/PD-L1 inhibitors in metastatic NSCLC, addressing a significant unmet need as 60% of patients develop resistance to checkpoint inhibitors. - SEED Therapeutics, co-founded by BeyondSpring, secured a research collaboration with Eisai worth up to $1.5 billion and received FDA Rare Pediatric Disease and Orphan Drug Designations for its RBM39 degrader.
- SEED Therapeutics' ST-01156, a novel molecular glue targeting RBM39, has been granted Rare Pediatric Disease and Orphan Drug designations by the FDA. - ST-01156 degrades RBM39, an RNA splicing factor relevant in multiple solid tumor indications, and is being advanced towards an IND filing expected in H1 2025. - The Rare Pediatric Disease designation provides SEED Therapeutics the potential to receive an FDA priority review voucher upon ST-01156 approval. - BeyondSpring, SEED's largest shareholder, will retain approximately 14.4% of SEED’s outstanding shares after selling a portion of its Series A-1 Preferred Shares.
