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FLORHAM PARK, N.J. - BeyondSpring Inc. (NASDAQ:BYSI), a clinical-stage biopharmaceutical company with a market capitalization of $89.91 million, announced on Monday that a clinical study published in Med (Cell Press) shows its lead drug Plinabulin, when combined with radiation and checkpoint inhibitors, demonstrated efficacy in patients who had failed prior immune checkpoint inhibitor (ICI) therapy. According to InvestingPro analysis, while the company maintains a healthy current ratio of 2.49, it’s currently burning through cash rapidly as it advances its clinical programs.
The Phase 1 translational trial evaluated the triple combination therapy in patients with eight different cancer types. Among evaluable ICI-relapsed patients, the treatment achieved a 23% objective response rate and 54% disease control rate in non-irradiated lesions. The stock has shown strong momentum, with InvestingPro data revealing a 36.81% year-to-date return, though analysts anticipate continued near-term profitability challenges.
The study highlighted particularly promising results in non-small cell lung cancer, head and neck squamous cell carcinoma, and Hodgkin lymphoma. Two Hodgkin lymphoma patients experienced durable responses exceeding 19 months despite having undergone 12-16 prior lines of therapy.
"These results offer early but important signals that Plinabulin’s dendritic cell maturation mechanism could play a pivotal role in reversing ICI-acquired resistance," said Dr. Steven Lin, Professor of Radiation Oncology at The University of Texas MD Anderson Cancer Center and corresponding author of the study.
The research also identified a potential biomarker – baseline GEF-H1 immune signature – that may help identify patients most likely to respond to treatment.
Plinabulin functions as a dendritic cell maturation agent that works through a GEF-H1-dependent mechanism. According to the company, this approach differs from traditional tubulin agents and may offer a unique strategy for addressing immunotherapy resistance.
The trial enrolled 19 patients who received the combination regimen with either pembrolizumab or nivolumab as the checkpoint inhibitor component. Radiation was administered only during the first cycle of treatment.
BeyondSpring is developing Plinabulin across multiple cancer indications, including non-small cell lung cancer. The company reported that the drug has demonstrated a favorable safety profile across approximately 800 patients in various clinical studies.
The information in this article is based on a press release statement from BeyondSpring. For deeper insights into BYSI’s financial health, valuation metrics, and additional analysis, including 10+ exclusive ProTips, visit InvestingPro.
In other recent news, BeyondSpring Inc. has reported promising interim results from a phase 2 study involving patients with metastatic non-small cell lung cancer (NSCLC) who had previously progressed on PD-1/L1 inhibitors. The study, which was presented at the American Society of Clinical Oncology Annual Meeting, showed that the combination therapy of Plinabulin with pembrolizumab and docetaxel nearly doubled the median progression-free survival to 6.8 months compared to the current standard of care. Furthermore, the disease control rate was 77.3%, and the 15-month overall survival rate was 78%, with the median overall survival not yet reached. The treatment was well tolerated, with no treatment-related deaths reported, although 51.1% of patients experienced grade 3 or higher adverse effects. BeyondSpring aims to advance Plinabulin in combination strategies to address the significant challenge of acquired resistance to checkpoint inhibitors in oncology. Additionally, BeyondSpring has scheduled its 2025 annual meeting of shareholders for September 15, with the record date set for July 25. Shareholder proposals for inclusion in the proxy statement must be received by July 14. Further details regarding the meeting will be provided in the company’s proxy statement filed with the SEC.
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