The news comes after the FDA granted fast track designation (FTD) for the therapy in combination with Genentech’s Tecentriq for patients with extensive-stage SCLC (ES-SCLC) in June.
With ES-SCLC, the cancer has spread from one lung to the other, or to other parts of the body. Extensive-stage is the most common type of SCLC.
The FDA has also granted FTD to Genprex for two other indications of Reqorsa Immunogene Therapy. These include Reqorsa in combination with Tagrisso for non-small cell lung cancer (NSCLC) in patients who have progressed after Tagrisso treatment, and Reqorsa in combination with Keytruda for NSCLC in patients who have progressed after Keytruda treatment.
The FDA grants ODD status to investigational therapies being developed to treat, diagnose, or prevent a rare disease or condition affecting fewer than 200,000 people in the United States.
ODD provides benefits to drug developers, including assistance in the drug development process, tax credits for qualified trials, waiver of certain FDA fees, and potential for seven years of post-approval marketing exclusivity.
Genprex said it expects to initiate the Acclaim-3 clinical trial (NCT05703971) investigating the Reqorsa and Tecentriq combination therapy in Q4 2023.
The phase 2 open-label, dose-escalation and clinical response study will evaluate the combination therapy’s effectiveness in patients with extensive-stage SCLC who did not initially respond to Tecentriq and chemotherapy.
Rodney Varner, Genprex president, chairman and CEO, said: “We are excited to receive Orphan Drug Designation from the FDA for REQORSA for patients with SCLC. 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."