BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, including late stage immuno-oncology agents. Our mission is to bring change to cancer care through our unique approach to both the science and business of oncology therapeutics. The Company was established in 2013 and is headquartered in the United States. Our lead asset, Plinabulin, is derived from a natural compound and has a number of biochemical activities providing multiple potential therapeutic potentials in a variety of cancers. We use a novel, highly scalable business model that integrates clinical resources in the U.S. and China that we believe could lead to regulatory approval for NSCLC in a timely, cost-efficient manner.
Targeted areas of interest include:
Non-Small Cell Lung Cancer
Based on encouraging results from the Phase 2 portion of a Phase 1/2 clinical trial in advanced NSCLC, and in consultation with the U.S. FDA, we are conducting a single, large global Phase 3 pivotal trial of Plinabulin in combination with Docetaxel, a well-established anti-mitotic chemotherapy medication. We have commenced enrolling patients in the U.S. And in China.
Neutropenia is an abnormally low concentration in the blood of neutrophils, a type of white blood cell. Patients with low numbers of neutrophils are more susceptible to bacterial infections and this condition can become life-threatening. A global 2/3 phase pivotal trial initialed in 2016.
Plinabulin + Nivolumab
Supported by Plinabulin’s Immuno-oncology mechanism, extended duration of response in Phase 2 data and strong non-clinical efficacy synergy data with checkpoint inhibitors, we are initiating a Plinabulin and Nivolumab combo Phase 1b/2 study in NSCLC with safety and preliminary biomarker efficacy readout. Nivolumab is a monoclonal antibody used to treat cancer. Currently, UCSD had been cleared from U.S. FDA to start this investigator-initiated study: https://clinicaltrials.gov/ct2/show/NCT02812667?term=Plinabulin+%2B+Nivolumab&rank=1
In multiple non-clinical studies, Plinabulin has shown anti-tumor activity in a variety of cancer models, including brain tumor and KRAS mutant tumors, which presents severe unmet medical needs. We are also expanding our portfolio with additional high potential assets, remaining focused on our purpose to address areas of critical unmet need.