US-based biopharmaceutical company BeyondSpring has enrolled the first patient in its Phase Ib/II trial of plinabulin combined with nivolumab to treat metastatic non-small-cell lung cancer (NSCLC).
Plinabulin is a small molecule agent developed with multiple mechanisms of action that are the immune enhancing mechanism, tumour vasculature targeting, and activating c-Jun N-terminal protein kinase (JNK) pathway resulting in cancer cell apoptosis.
Nivolumab is a fully human immunoglobulin (Ig) G4 monoclonal antibody that acts against the negative immunoregulatory human cell surface receptor programmed death-1 (PD-1,PCD-1,) with immune checkpoint inhibitory and antineoplastic activities.
The open-label, dose-escalation, two-part, single-site Phase Ib/II trial is planning to involve about 12 patients in the Phase Ib portion and a total of 20 patients in the Phase II portion.
According to principal investigator Dr Lyudmila Bazhenova, the trial intends to probe into Plinabulin's multiple mechanisms of action and its ability to target the tumour micro-environment, which will evaluate its efficacy as an immune-oncology agent.
BeyondSpring chief medical officer Dr Ramon Mohanlal said: "This clinical trial provides additional research to assess the mechanism of Plinabulin in a combination treatment while collecting crucial information about the immune-related adverse events and preliminary efficacy profile of the combination.
"Our principal mission is focused on patient safety and developing an innovative and cost-effective oncology therapeutic to aid patients suffering from NSCLC, which accounts for approximately 85% of all lung cancer cases."
The company is currently conducting a global Phase III trial of plinabulin to treat NSCLC in combination with docetaxel.
Image: Micrograph displaying a form of NSCLC. Photo: courtesy of Nephron.