GNPX - Genprex (GNPX) - Reqorsa Receives Second Fast Track Designation

Fast Track Designation With Immunotherapy. Genprex announced that the FDA has granted Fast Track Designation (FTD) for Reqorsa in combination with Keytruda (pembrolizumab) to treat non-small cell lung cancer (NSCLC). The company reiterated plans start testing the combination in the Phase 2 ACCLAIM-2 trial during 1Q22. We are raising our price target to $5 per share.Reqorsa Is A Gene Therapy With Multiple Actions Reqorsa uses the proprietary Oncoprex technology to deliver TUSC2, a gene with suppressive actions on pathways for cancer growth and tumor survival that also magnifies the immune response against cancer. These actions as a suppressor gene and an immune stimulator have given it the name “immuogene therapy”.Reqorsa’s Second Indication Now Has a Second Fast Track Designation Preclinical studies have shown increased numbers of immune cells in a tumor, improving the killing effect after inhibition of the PD-1/PD-L1 checkpoint interaction. Reqorsa may also reduce the expression of PD-L1 by the tumor. This data has led to the Fast Track Designation from the FDA.ACCLAIM-2 Is Expected to Begin In 1Q22 The ACCLAIM-2 Phase 2 study is designed to enroll patients with stage III or IV NSCLC who have had disease progression after treatment with Keytruda, and administer Reqorsa in combination with Keytruda and standard chemotherapy. The trial is expected to begin in 1Q22.Conclusion. We believe the Fast Track Designation shows that the FDA considers Reqorsa to be a clinically meaningful new therapy that warrants priority to reach the market faster. We are raising our price target to $5 per share, correlating with a market capitalization of $250 million. Read More >>