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BeyondSpring presents data on stem cell-based application for plinabulin » 07:2706/3006/30/20
BeyondSpring announced that the Company presented clinical data on BeyondSpring's late-stage asset, Plinabulin, showing potent CD34+ progenitor cell mobilization from bone marrow, which has broad applications for stem cell-based therapies, gene therapy and regenerative medicine. These findings potentially add another indication to Plinabulin, which is known as a "pipeline in a drug." Dr. Ramon Mohanlal, BeyondSpring's CMO and EVP, Research and Development, presented this new data as a poster at this year's ISSCR Annual Meeting. Current approved agents for CD34+ progenitor cell mobilization, such as G-CSFs or Plerixafor, have many limitations. While G-CSFs are highly effective in preventing chemotherapy-induced neutropenia, they come with severe side effects, such as bone pain and thrombocytopenia. To add, multiple doses of short-acting G-CSFs are often needed for the therapy to be effective. Plerixafor is also given by daily injections for four to five days and is a very expensive process and not as effective for CD34+ cells. Additionally, G-CSFs are contra-indicated in Sickle Cell Disorder patients undergoing gene therapy. This results in high rates of adverse events requiring hospitalization, including vaso-occlusive crises, multi-organ failure and even death. Lastly, when side effects such as bone pain, leukocytosis and / or myalgia occur, a G-CSF dose is often reduced to 50 percent, which is less effective for CD34+ cell mobilization. Plinabulin is a novel and potent agent for the prevention of CIN and does not cause bone pain or thrombocytopenia. Plinabulin is given as a single fixed dose - as a 30-minute intravenous infusion - and has a mechanism of action independent from G-CSF of CXCR4. In BeyondSpring's PROTECTIVE-2 Phase 2 study, the team evaluated the effects of CD34+ cell mobilization through combining Plinabulin with the full dose of Pegfilgrastim at 6mg and at lower doses of 3mg and 1.5mg in breast cancer patients receiving taxotere, doxorubicin and cyclophosphamide. The data shows that combining Plinabulin with a low dose of Pegfilgrastim produces statistically significant CD34+ cell counts and increases to values that are comparable to, or numerically higher than, the full dose of Pegfilgrastim alone under severe myelosuppressive conditions. In BeyondSpring's PROTECTIVE-1 Phase 2 study, the Company previously reported that lung cancer patients receiving docetaxel who received a single dose of Plinabulin saw an increase of CD34+ counts to clinically and statistically significant levels under myelosuppressive conditions.
BeyondSpring reports preclinical data on plinabulin » 08:1306/2306/23/20
BeyondSpring announced new preclinical research findings that indicate BeyondSpring's lead asset, Plinabulin, enhances immuno-radiotherapy for cancer patients. The results of this preclinical study was highlighted in a poster presentation titled, "Plinabulin, a microtubule destabilizing agent, improves tumor control by enhancing dendritic cell maturation and CD8 T cell infiltration in combination with immunoradiotherapy," at this year's American Association for Cancer Research Virtual Annual Meeting on June 22, 2020. Based on these preclinical findings, including a 100% complete response of the triple I/O combination of Plinabulin, anti-PD-1, and radiation in a PD-1 antibody non-responsive model, the compound is being advanced toward a Phase 1 clinical trial in patients who failed or progressed on PD-1 / PD-L1 antibody treatments. Principal investigator Steven H. Lin, M.D., Ph.D., associate professor of radiation oncology at The University of Texas MD Anderson Cancer Center, presented the research data. Additional data highlights include: Preclinical effectiveness: The triple I/O combination of Plinabulin, anti-PD-1 and radiation achieved a 100 percent complete response in a breast cancer model that is not responsive to PD-1 antibody alone. Sequential benefit: Plinabulin's effects on dendritic cell maturation are greater when administered after each dose of fractionated radiotherapy, compared to administration before radiation, or administration only once after the first dose of radiotherapy. Abscopal effect: The Plinabulin triple combination anticancer effects in both irradiated and non-irradiated tumors in the same mice indicate the activation of a systemic anticancer immune response. Notably, CD8 cell levels in the non-irradiated tumors were almost double in the triple combination group compared to anti-PD-1 and radiation alone. Dendritic cell MHCII up-regulation and T-cell tumor infiltration: Plinabulin triple combination significantly increased dendritic cell MHCII expression and T-cell infiltration in the tumor. I/O mechanism: AP-1 and NF-kB molecular pathways are crucial in the Plinabulin-induced maturation of dendritic cells. Peer-reviewed 2019 publications in Chem and Cell Reports demonstrated that Plinabulin is differentiated from all other tubulin-targeted agents through its binding site and kinetics and is among the most potent agents that induce dendritic cell maturation. Dendritic cells are key immune cell types in the activation of the immune system against cancer cells, but currently approved immuno-oncology agents, such as antibodies to PD-1, only take the brakes off of T-cells without activating antigen-presenting cells that stimulate T-cells to attack foreign proteins expressed by cancer cells.
Fly Intel: Wall Street's top stories at midday » 12:1606/1906/19/20
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Fly Intel: Pre-market Movers » 08:5606/1906/19/20
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BeyondSpring 1.93M share Spot Secondary priced at $13.00 » 06:1306/1906/19/20
The deal range was…
The deal range was $13.00-$13.50. Jefferies and William Blair acted as joint book running managers for the offering.
BeyondSpring $30M Spot Secondary; price range $13.00-$13.50 » 16:1806/1806/18/20
Jefferies and William…
Jefferies and William Blair are acting as joint book running managers for the offering.
BeyondSpring files to sell common stock, no amount given » 16:0806/1806/18/20
Jefferies and William…
Jefferies and William Blair will be acting as joint book-running managers for the offering.
BeyondSpring can 'disrupt' $6.5B neutropenia market, says William Blair » 10:4806/1506/15/20
BeyondSpring announced that the Phase III PROTECTIVE-2 trial, which examines the safety and efficacy of plinabulin plus Neulasta versus Neulasta monotherapy, met the primary endpoint of preventing severe neutropenia, which represents the first major advancement in the space after Neupogen's approval in 1991, William Blair analyst Andy Hsieh tells investors in a research note. The announcement "meaningfully reduced the clinical risks of plinabulin and paves the way for a timely submission in both the United States and China," says Hsieh. The analyst believes the statistically significant results reaffirm his view of plinabulin's "potential to disrupt" the large $6.5B chemotherapy-induced neutropenia market in both the United States and China. Hsieh reiterates an Outperform rating on BeyondSpring shares.
BeyondSpring price target raised to $46 from $30 at H.C. Wainwright » 10:1506/1506/15/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Joseph Pantginis raised the firm's price target on BeyondSpring to $46 from $30 and reiterates a Buy rating on the shares after the company announced interim results from the ongoing PROTECTIVE-2 Phase 3 study testing Plinabulin plus Neulasta versus Neulasta alone. It appears that Plinabulin provides patients with "strong protection" against the risks of severe neutropenia during cycle 1 of chemotherapy, Pantginis tells investors in a research note.
Fly Intel: Pre-market Movers » 08:5806/1506/15/20
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