In June this year, the therapy, in combination with Genentech’s Tecentriq received FDA fast track designation (FTD) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) patients.
Genprex also received FTD for REQORSA’s two other indications, including REQORSA along with Tagrisso for non-small cell lung cancer (NSCLC) patients who have progressed after receiving Tagrisso, and together with Keytruda for NSCLC.
Genprex president, chairman and CEO Rodney Varner said: “This FDA orphan drug designation in combination with our recently received FDA Fast Track designation underscores the great need for better treatment options for patients with SCLC, ES-SCLC and NSCLC.
“We look forward to initiating the Acclaim-3 clinical trial expected in the fourth quarter of 2023 in order to bring hope of an effective new therapy to patients suffering with this life-limiting cancer.”
The Phase I/II open-label, dose escalation and clinical response Acclaim-3 trial of maintenance therapy will assess REQORSA and Tecentriq in ES-SCLC patients who did not develop tumour progression after treatment with Tecentriq and chemotherapy as initial standard treatment.
REQORSA comprises a plasmid that expresses TUSC2, a tumour suppressor gene protein. It is being assessed in three studies for NSCLC and small cell lung cancer SCLC.