BeyondSpring Inc. is a clinical-stage biopharmaceutical company focused on developing novel cancer treatments. Its flagship product is Plinabulin, a selective immune-modulating and microtubule-binding agent. Plinabulin has successfully advanced through Phase III clinical trials for two distinct applications: the prevention of chemotherapy-induced neutropenia, and the treatment of advanced non-small cell lung cancer. The company is also exploring Plinabulin's efficacy in combination with various immuno-oncology drugs; specifically, alongside nivolumab (a PD-1 antibody) for NSCLC, and with nivolumab and ipilimumab (a CTLA-4 antibody) for small cell lung cancer (SCLC). Furthermore, it is being investigated in conjunction with PD-1 or PD-L1 antibodies and radiation to address a range of cancers. Beyond its lead asset, BeyondSpring's pipeline includes three preclinical-stage small molecule immune agents and a proprietary drug development platform. The company, founded in 2010, maintains its headquarters in New York, New York.
BeyondSpring Announces FDA Fast Track Designation for Plinabulin in Post-ICI Non-Squamous NSCLC and Strategic Transaction to Advance Global Phase 3 DUBLIN-4 Trial Toward Planned Interim Analysis
BeyondSpring received FDA Fast Track designation for Plinabulin plus docetaxel in second- or third-line post-ICI non-squamous NSCLC without actionable genomic alterations, the population in its global Phase 3 DUBLIN-4 trial.
The company also agreed to sell the majority equity interest in its Chinese subsidiary to Biolin Investment Limited, which will fund the China portion of DUBLIN-4 — roughly 221 of 442 planned patients — as non-cash consideration.
The transaction is non-dilutive and substantially reduces BeyondSpring's cash requirements while it retains global Plinabulin rights outside Greater China.
The next key milestone is the prespecified interim analysis at 221 PFS events, which management called a potential value inflection point if positive.