Therapy Areas: Respiratory
WuXi Biologics announces FDA clearance of IND application for next generation antibody ONC-392
2 January 2020 -

Biologics technology company WuXi Biologics (HK:2269) reported on Wednesday the receipt of clearance from the US Food and Drug Administration (FDA) for its partner OncoImmune's Investigational New Drug (IND) application for ONC-392, a next generation anti-CTLA-4 antibody.

ONC-392 is OncoImmune's second biological product to reach clinical testing.

A Phase 1A/1B clinical trial designed to assess its safety, pharmacokinetics and efficacy as a single agent in advanced solid tumours and in combination with anti-PD(L) standard of care in Non-Small Cell Lung Cancer is expected to start in early 2020.

Under the terms of the collaboration, WuXi Biologics provided comprehensive and integrated services for the ONC-392 programme, including CMC development and GMP manufacturing of the drug substance and drug product, through its world-class development and manufacturing capacities and capabilities.

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