BeyondSpring Inc. reports developments tied to its clinical-stage oncology pipeline, led by Plinabulin, an immune-modulating cancer therapy studied in non-small cell lung cancer and other indications. Recurring updates cover DUBLIN-3 data analyses, Plinabulin combinations with docetaxel, checkpoint inhibitors and antibody-drug conjugates, and presentations at oncology and immuno-oncology medical meetings.
Company news also includes periodic financial results, annual-report announcements, capital and corporate updates, and disclosures related to BeyondSpring’s equity interest in SEED Therapeutics and molecular glue degrader programs. These updates connect the company’s research activity, clinical-development strategy and financing actions with its public-company reporting cycle.
BeyondSpring reported positive Phase 3 results for plinabulin in non-small cell lung cancer (NSCLC), showing improved overall survival and reduced severe neutropenia compared to docetaxel alone. The company established a partnership with Hengrui for plinabulin in Greater China, including an upfront payment of approximately $30 million and potential milestone payments of up to $170 million. BeyondSpring also plans to submit a new drug application (NDA) for plinabulin in NSCLC in the second half of 2022, while R&D expenses decreased slightly year-over-year.
BeyondSpring Pharmaceuticals has released new data at the ASH Annual Meeting demonstrating that plinabulin rapidly reverses chemotherapy-induced neutropenia (CIN) and leukopenia within 24 hours. This effect is attributed to its mechanism of protecting granulocyte-monocyte-progenitor stem cells, with statistical significance marked at p<0.0001. The findings affirm the positive results from the Phase 3 PROTECTIVE-2 study, supporting plinabulin's role in enhancing CIN prevention strategies and potentially improving patient outcomes during chemotherapy.
BeyondSpring Pharmaceuticals (NASDAQ: BYSI) presented analyses from its PROTECTIVE-2 trial at the San Antonio Breast Cancer Symposium on December 10, 2021. The data indicated that the combination of plinabulin and pegfilgrastim significantly alleviates pegfilgrastim-related bone pain and enhances health-related quality of life (HrQoL) for breast cancer patients. Key findings showed lower incidences of bone pain and improved absolute neutrophil counts in patients receiving the combination therapy. Plinabulin is a promising candidate for preventing chemotherapy-induced neutropenia (CIN) and is being explored for various cancer therapies.
BeyondSpring Pharmaceuticals (NASDAQ: BYSI) announced it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for plinabulin in combination with G-CSF for preventing chemotherapy-induced neutropenia (CIN). The FDA's review concluded that the results from the Phase 3 trial were insufficient, requiring an additional well-controlled trial for approval. BeyondSpring remains optimistic about the drug's potential and plans further discussions with the FDA to explore the clinical pathway.
BeyondSpring (NASDAQ: BYSI), a global pharmaceutical company, announced management participation in the 4th Annual Evercore ISI HealthCONx Conference from November 30 to December 2, 2021. The Fireside Chat is scheduled for November 30 at 4:20 PM ET, with a webcast accessible via their website. BeyondSpring focuses on innovative cancer therapies, particularly its lead asset, plinabulin, which aims to prevent chemotherapy-induced neutropenia (CIN) and has received breakthrough designation in the U.S. and China. A significant PDUFA date of November 30, 2021, is noted for the U.S. approval process.
BeyondSpring (NASDAQ: BYSI) announced management will present at the virtual Jefferies London Healthcare Conference on November 18-19, 2021. Investors can access the on-demand presentation starting November 18. A replay will be available on the company’s website for 30 days post-conference. BeyondSpring focuses on developing innovative cancer therapies, including its lead asset, plinabulin, which is under Priority Review in the U.S. and China for preventing chemotherapy-induced neutropenia with a PDUFA date of November 30, 2021. Recent data shows positive results from the Phase 3 pivotal study in non-small cell lung cancer (NSCLC).
BeyondSpring Pharmaceuticals (NASDAQ: BYSI) announced the appointment of Mark Santos to its Board of Directors. Santos, who has over 30 years of experience in the healthcare sector, will support BeyondSpring's transition into an R&D and commercial company. Previously President of ION Solutions, he brings significant expertise in oncology, which is critical as BeyondSpring advances its lead asset, plinabulin, for preventing chemotherapy-induced neutropenia and anti-cancer benefits. Plinabulin is under Priority Review in the U.S. and China, with a PDUFA date of November 30, 2021.
BeyondSpring (NASDAQ: BYSI) has announced the commencement of a Phase 2 study for its lead asset, plinabulin, which is combined with nivolumab and ipilimumab in treating recurrent small-cell lung cancer (SCLC) patients who failed prior therapies. The Phase 1 study showed a promising 43% overall response rate (ORR) with significant tumor reductions and a notable decrease in adverse effects compared to historical data. Conducted by the Big Ten Cancer Research Consortium, the study aims to evaluate the triple combination's efficacy and safety, addressing an urgent medical need in SCLC.
BeyondSpring Pharmaceuticals (BYSI) announced promising preclinical data showcasing the effectiveness of plinabulin against small cell lung cancer (SCLC) at the 2021 AACR-NCI-EORTC conference. Plinabulin demonstrated strong **anti-cancer effects** in 80 patient-derived tumor models, particularly in SCLC with an **IC70 of 35 nM**. The combination of plinabulin with nivolumab and ipilimumab reported a **46% objective response rate** in clinical trials. These findings bolster BeyondSpring’s strategy for developing plinabulin as a key cancer treatment option and highlight its potential in combination therapies.
BeyondSpring Pharmaceuticals reported positive results from its DUBLIN-3 Phase 3 trial for plinabulin combined with docetaxel in treating 2nd/3rd line NSCLC. The combination achieved a statistically significant improvement in overall survival (OS) and other key endpoints compared to docetaxel alone. Notably, the mean OS was 15.08 months for the combination versus 12.77 months for docetaxel (p=0.0332). BeyondSpring plans to seek FDA and China NMPA approval, with an NDA filing expected in the first half of 2022. Results will be presented at the ESMO Congress and discussed in a conference call today.