Genprex Inc CEO Rodney Varner tells Proactive the FDA has granted Fast Track designation to the company’s lead drug candidate, REQORSA Immunogene Therapy, in combination with Merck & Co Inc (NYSE:MRK) (Merck & Co Inc (NYSE:MRK))’s Keytruda in patients with stage III or IV non-small cell lung cancer (NSCLC), where disease progressed after treatment with Keytruda.
The Austin, Texas-based clinical-stage gene therapy company said that in the first quarter of 2022, it plans to initiate its Acclaim-2 clinical trial, which is an open-label, multicenter Phase 1/2 clinical trial evaluating REQORSA in combination with Keytruda, for this patient population.