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BeyondSpring Inc. (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company dedicated to developing innovative cancer therapies. The company focuses primarily on its lead asset, Plinabulin, a novel cancer therapeutic. Plinabulin is currently in a global Phase 3 trial for non-small-cell lung cancer (NSCLC) and is also being tested in a pivotal global Phase 3 trial for the prevention of docetaxel-induced neutropenia. This compound operates as a tubulin depolymerizing agent and functions through multiple mechanisms of action, including immune system enhancement, tumor cell apoptosis, and vascular disruption.
BeyondSpring is also expanding clinical trials to address additional cancer indications. These include immuno-oncology applications with immune checkpoint inhibitors in NSCLC, central nervous system malignancies such as glioblastoma (GBM), and KRAS-positive mutant cancers.
Recent developments highlight the promising potential of Plinabulin:
- Brain Cancer Research: New preclinical data from the University of Toledo College of Medicine demonstrate Plinabulin's anti-proliferative properties in glioblastoma multiforme (GBM) at therapeutic concentrations. The data confirm Plinabulin's ability to block GBM patient-derived sphere invasion and significantly decrease GBM cell survival and microtubule extension.
- Immunotherapy Advancements: BeyondSpring and MD Anderson presented at the Society for Immunotherapy of Cancer's (SITC) Annual Meeting, showcasing Plinabulin's immunomodulating activity. The Phase 1 clinical study revealed a high disease control rate in patients with various cancers who had progressed on PD-1, PD-L1, and/or CTLA-4 antibodies.
In addition to its focus on cancer therapies, BeyondSpring has a majority-owned subsidiary, SEED Therapeutics, which is advancing Targeted Protein Degradation (TPD) molecular glue technology for innovative drug discovery. SEED has made significant progress, including a collaboration with Eli Lilly for developing oncology assets.
The company continues to advance its programs strategically, with a notable reduction in R&D and G&A expenses in 2023. As of December 31, 2023, BeyondSpring reported $17.9 million in cash and short-term investments, positioning itself well for upcoming milestones in 2024.
BeyondSpring remains committed to improving clinical outcomes for patients with high unmet medical needs through groundbreaking technology and strategic partnerships.
BeyondSpring (NASDAQ: BYSI) presented updated Phase 2 trial results for a triple combination therapy in non-small cell lung cancer (NSCLC) patients who progressed after PD-1/PD-L1 inhibitor treatment. The study of 30 patients, with a median follow-up of 11.5 months, showed promising results with a disease control rate of 89.3% and median progression-free survival of 8.6 months. The treatment combination of pembrolizumab plus plinabulin/docetaxel achieved a confirmed overall response rate of 21.1% and median duration of response of 11.4 months. The therapy was generally well-tolerated, with 46.7% of patients experiencing grade 3 or higher treatment-related adverse effects.
BeyondSpring (NASDAQ: BYSI) presented final data on the DUBLIN-3 Phase 3 study at ESMO Congress 2024, showing significant improvements in overall survival, progression-free survival, and objective response rate for the plinabulin/docetaxel combination in 2L/3L EGFR wild-type NSCLC patients. The combination demonstrated a favorable benefit/risk ratio over docetaxel alone, including:
1. >80% relative reduction in Grade 4 neutropenia
2. Reduced use of G-CSF
3. Improved quality of life
4. Significant reduction in cycle-adjusted serious adverse events
The study suggests this combination could be a new option for second or third-line NSCLC patients without driver mutation, addressing an unmet medical need.
BeyondSpring (NASDAQ: BYSI) presented interim phase 2 data on the 303 Study at ESMO Congress 2024, evaluating a triple combination regimen of pembrolizumab plus plinabulin/docetaxel in 2L/3L NSCLC patients after progression on 1L PD-1/L1 inhibitors. The study showed promising results:
- Median PFS of 8.63 months (compared to historical 3-4 months)
- Disease Control Rate of 89.5%
- Confirmed ORR of 21.1%
- 6-month PFS rate: 67.1%; 12-month PFS rate: 49.2%
- Median Duration of Response: 11.40 months
The combination was well-tolerated, with 52.6% of patients experiencing grade 3 or higher treatment-related adverse effects. No treatment-related deaths were reported. The study is ongoing at Peking Union Medical College Hospital, aiming to enroll 47 patients total.
BeyondSpring Inc. (NASDAQ: BYSI) presented final Phase 3 data of its lead anti-cancer asset Plinabulin at ISLAC 2024 World Conference on Lung Cancer. The DUBLIN-3 study showed statistically significant and clinically meaningful efficacy data for Plinabulin plus Docetaxel vs. Docetaxel alone in EGFR wild-type NSCLC patients after progression on platinum-based therapy. Key findings include:
- Improved overall survival (OS) with HR=0.82
- Better progression-free survival (PFS) with HR=0.79
- Nearly doubled objective response rate (ORR)
- Doubled 24-month and 36-month OS rates
- 82% reduction in Grade 4 neutropenia
The combination showed a favorable benefit/risk ratio and could be considered as a new treatment option for this population with high unmet medical needs.
BeyondSpring Inc. (NASDAQ: BYSI) announces upcoming presentations showcasing its lead anti-cancer asset, Plinabulin, at two major oncology conferences. At the 2024 World Conference on Lung Cancer on September 9, an oral presentation will reveal final efficacy data of Plinabulin and docetaxel combination vs. docetaxel from the Dublin-3 phase 3 study in EGFR wild-type 2L/3L non-small cell lung cancer (NSCLC).
Additionally, at the ESMO Congress 2024 on September 14, two poster presentations will cover the Dublin-3 study safety outcome and the 303 Study, an investigator-initiated study supported by Merck in 2L/3L NSCLC patients who failed PD-1/PD-L1 inhibitors. These presentations highlight BeyondSpring's ongoing efforts in developing innovative cancer therapies, particularly for lung cancer patients.
SEED Therapeutics has announced a strategic research collaboration with Eisai Co., to discover and develop novel molecular glue degraders for neurodegeneration and oncology targets. SEED is entitled to receive up to $1.5 billion in upfront and milestone payments, plus tiered royalties. Concurrently, SEED has launched a Series A-3 financing with a first close of $24 million led by Eisai, with a second close targeted for Q4 2024.
The collaboration leverages Eisai's expertise in neurodegeneration and cancer. SEED will lead preclinical discovery activities, while Eisai will have exclusive rights to develop and commercialize resulting compounds. The financing will advance SEED's clinical development of internal programs, including an oral RBM39 Degrader for cancer and a Tau degrader for Alzheimer's disease, as well as expand its TPD platform and pipeline.
BeyondSpring hosted an R&D Day on May 15, 2024, spotlighting their lead asset Plinabulin, which shows promise in treating cancer patients who have failed prior PD-1/PD-L1 inhibitors. Plinabulin has demonstrated significant efficacy in extending overall survival (OS) in phase 3 NSCLC studies and shows potential in combination therapies with chemotherapy or radiation.
SEED Therapeutics, BeyondSpring's subsidiary, focuses on developing molecular glues for undruggable targets using their proprietary TPD platform. SEED plans to file an IND for an oral RBM39 degrader in early 2025 and has a robust pipeline with collaborations, including a partnership with Eli Lilly, which has led to multiple milestone payments.
BeyondSpring Inc. (NASDAQ: BYSI) announced a Research and Development (R&D) Day to discuss Plinabulin's potential as a cancer therapy and updates for SEED Therapeutics. Key Opinion Leaders will present on Plinabulin's immunomodulatory activity and unmet needs post immune-checkpoint-inhibitor failure. SEED Therapeutics updates will also be featured.
BeyondSpring, a biopharmaceutical company, reported positive results for 2023. The company dosed patients in Phase 2 trials for Plinabulin and Keytruda combinations, achieved milestones in molecular glue discovery, and made director appointments. SEED Therapeutics, a subsidiary, reached important pre-clinical milestones. The company's lead drug candidate, Plinabulin, showed promise in various studies, aiming to address unmet medical needs in cancer treatment. Financially, R&D and G&A expenses decreased, resulting in a net loss of $21.0 million for 2023.
BeyondSpring Inc. (NASDAQ: BYSI) has filed its annual report on Form 20-F for the fiscal year ended December 31, 2023 with the SEC, showcasing audited financial statements. The report can be accessed on the SEC's website and the company's site, offering hard copies to shareholders upon request.
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