Genprex has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its lead drug candidate, REQORSA Immunogene Therapy (quratusugene ozeplasmid), to treat small cell lung cancer (SCLC).
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.