BeyondSpring’s lead oncology asset, Plinabulin, is an anti-cancer agent that targets and alters the tumor microenvironment. As a synthetic analogue of a marine microbial product, Plinabulin has the potential to fill an unmet medical need by improving outcomes as a second line and third line treatment for patients with advanced non-small cell lung cancer (NSCLC) and preventing neutropenia induced by docetaxel.
In preclinical studies, Plinabulin has shown favorable safety and anti-tumor activity in a variety of cancer models, including brain tumors and KRAS mutant tumors, demonstrating its potential efficacy across a broad spectrum of cancers, including gastrointestinal, breast, ovarian, prostate and hematological cancers.
Plinabulin has been administered in more than 140 patients to date through now completed Phase 1 and 2 trials. It has proven to be well-tolerated and shown encouraging anti-tumor activity. Based on consultation with the U.S. FDA, BeyondSpring is conducting an ongoing single, large global Phase 3 pivotal trial for second line and third line NSCLC, which was initiated in the third quarter of 2015. The global study is taking place in the U.S., other western countries and China. Learn more about Plinabulin clinical trials here and here.
Plinabulin will also be evaluated in a Phase 3 pivotal trial for neutropenia prevention in patients who have docetaxel approved indications.