Analysts at Noble Capital have reiterated an 'Outperform' rating and $5 price target on Genprex Inc which recently announced that the first cohort from its Phase 1/2 Acclaim-1 trial in non-small cell lung cancer (NSCLC) has shown sufficient safety to allow treatment of a second cohort at a higher dose.
The approval came from the Safety Review Committee (SRC) after it analyzed patient data in the first cohort. Genprex said it expects all three cohorts in the Phase 1 portion to be completed by year-end 2022.
In a note to clients, Noble's analysts said the recommendation from the Safety Review Committee is a positive milestone for the company, and noted that the preliminary data from earlier studies with Tarceva, an older EGF inhibitor, indicate Genprex's REQUORSA treatment could be additive or synergistic with Tagrisso (osimertinib).
READ: Genprex secures higher dose approval for REQORSA in combination with Tagrisso Phase 1 clinical trial
They pointed out that the Acclaim-1 study is a Phase 1/2 trial testing the combination of Tagrisso’s action as an EGF inhibitor with REQORSA’s delivery of the TUSC2 cancer suppressor gene. REQORSA adds the inhibition of several pathways leading to tumor growth and proliferation, and restores pathways that defend against cancer. The REQORSA combination has received Fast-Track designation for NSCLC from the US Food & Drug Administration (FDA).
Patients in the first cohort received a 21-day treatment cycle combining a Day-1 intravenous dose of 0.06 mg/kg REQORSA with 80 mg of Tagrisso taken daily. The planned REQORSA dose for the second cohort is 0.09 mg/kg, followed by 0.12 mg/kg in the third cohort. The complete Phase 1 will enroll up to 18 patients to identify the maximum tolerated dose and select the best dose for Phase 2, the analysts noted.
REQORSA has also been shown to affect the immune response to cancer, including the downregulation of the PDL-1 (Programmed death ligand-1) receptor. Preliminary data has shown that REQORSA in combination with checkpoint inhibitors showed improved response and efficacy. In March 2022, Genprex began enrollment of the Phase 1/2 ACCLAIM-2 study testing REQORSA in combination with Keytruda, the Noble analysts added.
Contact the author at jon.hopkins@proactiveinvestors.com