Posted by Michael Wonder on 27 Apr 2022
OncoC4 announces fast track designation granted by the U.S. FDA for ONC-392 monotherapy in PD(L)1 resistant NSCLC
26 April 2022 - OncoC4 announced today that the U.S. FDA has granted fast track designation to ONC-392, the Company’s next-gen anti-CTLA-4 monoclonal antibody that preserves the CTLA-4 immune checkpoint function, as a single agent for the treatment of patients with metastatic non-small-cell lung carcinoma who have had disease progression on prior anti-PD-(L)1 therapy.
ONC-392 is currently in Phase 1 clinical testing to evaluate safety, pharmacokinetics, and efficacy as monotherapy and in combination with anti-PD-1 standard of care in advanced solid tumours and non-small-cell lung cancer.
