Third FDA Fast Track Designation Further Validates the Potential of REQORSA
Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the Company's lead drug candidate, REQORSA® Immunogene Therapy, in combination with Genentech, Inc.'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 initial standard treatment.
In the third quarter of 2023, Genprex expects to enroll the first patient in its Acclaim-3 clinical trial, which is a Phase 1/2 dose escalation and clinical response study of maintenance therapy evaluating REQORSA in combination with Tecentriq for this patient population. The Company has previously received two other FTDs for REQORSA, for REQORSA in combination with AstraZeneca PLC's Tagrisso® in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso, and for REQORSA in combination with Merck & Co's Keytruda® in patients with late-stage NSCLC whose disease progressed after treatment with Keytruda.
https://finance.yahoo.com/news/genprex-receives-u-fda-fast-123500766.html
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.