Genprex, Inc. (NASDAQ:GNPX) shares moved higher in pre-market trading after the clinical-stage gene therapy company announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its therapeutic REQORSA in combination with Genentech's Tecentriq in patients with extensive-stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as an initial standard treatment.
The company has previously received two other FTDs for its therapeutic: one for REQORSA in combination with AstraZeneca’s Tagrisso in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso, and one for REQORSA in combination with Merck & Co's Keytruda in patients with late-stage NSCLC whose disease progressed after treatment with Keytruda.
The company said this third FDA FTD further validated the potential of REQORSA.
"We are very pleased to receive a third Fast Track Designation from the FDA for REQORSA, this time for patients with ES-SCLC in combination with the checkpoint inhibitor Tecentriq," said Genprex CEO said Rodney Varner in a statement.
"This is another exciting achievement in our REQORSA development program, which further validates REQORSA's potential not only in NSCLC but also in SCLC. We look forward to accelerating the clinical development of REQORSA, and potentially providing a new treatment option for patients with SCLC."
The company said it expects to enroll the first patient in its Acclaim-3 clinical trial, a Phase 1/2 dose escalation and clinical response study of maintenance therapy evaluating REQORSA in combination with Tecentriq for this patient population, during the third quarter of 2023.
Genprex chief medical officer Dr. Mark Berger commented: “We are very excited to soon begin treating patients in the Acclaim-3 clinical trial, which positions REQORSA as a component of initial standard therapy for SCLC rather than as a treatment for relapse. That will allow us to highlight the contribution of REQORSA to an earlier stage of treatment.”
Genprex shares were up 11.5% at US$0.83 about half an hour before the opening bell in New York on Wednesday.
Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes.
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