US FDA approves patient enrolment in Phase I/II study of Nivolumab with Plinabulin

14th July 2016 (Last Updated July 14th, 2016 18:30)

The UC San Diego Moores Cancer Centre has secured a US FDA clearance to enrol patients with metastatic, non-small-cell lung cancer (NSCLC) for the Phase I/II study of Nivolumab in combination with Plinabulin.

The UC San Diego Moores Cancer Centre has secured a US FDA clearance to enrol patients with metastatic, non-small-cell lung cancer (NSCLC) for the Phase I/II study of Nivolumab in combination with Plinabulin.

Dr. Bazhenova of the UC San Diego Moores Cancer Centre sought approval for an investigator-sponsored, investigational new drug application (IND) on 23 May.

Plinabulin is a Phase III, immuno-oncology compound of clinical stage biopharmaceutical company BeyondSpring Pharmaceuticals, which is focused on the development of innovative cancer therapies.

BeyondSpring co-founder, chairman and CEO Dr. Lan Huang said: "This clinical trial provides further opportunity to assess the mechanism of Plinabulin in a combination treatment, while collecting much-needed information about the safety and preliminary efficacy profile of the combination."

"The granting of this clearance to begin enrolling patients is an exciting next step for the development of Plinabulin."

The study aims to ascertain the maximum tolerated dose and / or recommended Phase II dose of Plinabulin in combination with Nivolumab for patients suffering with with metastatic NSCLC.

Plinabulin is a small molecule, immuno-oncology agent that activates dendritic cell maturation, induces tumour antigen specific T-cell activation and down-regulates Treg.

Nivolumab is a programmed cell-death-1 (PD-1) inhibitor that has activity in NSCLC, compared to standard of care.

Dr. Bazhenova said: "The granting of this clearance to begin enrolling patients is an exciting next step for the development of Plinabulin.

"We anticipate that the combination study may lead to additional synergistic efficacy with Nivolumab and a well-tolerated safety profile."