Genprex begins dosing of phase 1/2 trial of REQORSA, Tagrisso combo

Genprex has dosed the first patient in the Acclaim-1 phase 1/2 clinical trial of REQORSA immunogene therapy candidate in combination with Tagrisso (osimertinib) in a certain patient population having late-stage non-small cell lung cancer (NSCLC).

The combination of REQORSA and Tagrisso is being evaluated in the trial in late-stage NSCLC patients with activating epidermal growth factor receptor (EGFR) mutations, whose disease progressed after treatment with AstraZeneca’s FDA approved lung cancer drug  Tagrisso.

In 2020, the clinical-stage gene therapy company secured fast track designation from the US Food and Drug Administration (FDA) for the same indication.

Mark S. Berger — Chief Medical Officer of Genprex said: “This is an exciting milestone for Genprex that we believe brings us one step closer to achieving our goal to validate the potential benefits of REQORSA in NSCLC patients who have life-limiting disease and few treatment options.

“Based on both the preclinical data and previous clinical data, REQORSA has the potential to improve the response to current targeted therapies, such as Tagrisso, for this study patient population. We look forward to continuing to advance this important trial.”

Genprex is expected to enroll up to 18 patients in the phase 1 part of the Acclaim-1 clinical trial in a dose escalation study aimed at determining the maximum tolerated dose of the REQORSA, Tagrisso combination.

On the other hand, the phase 2 part of the NSCLC clinical trial is likely to enroll nearly 74 patients to be grouped randomly at a ratio of 1:1 to be subjected to either REQORSA and Tagrisso combo therapy or Tagrisso monotherapy.

The primary endpoint of the phase 2 part of the Acclaim-1 trial is progression-free survival, which is the time from randomization to progression or death. An interim analysis will be carried out at 25 events, said Genprex.

Mark S. Berger said: “Despite recent advances in immuno-oncology and other targeted treatments, NSCLC remains a significant unmet medical need as resistance to Tagrisso and other targeted therapies is a common clinical problem.

“REQORSA is a pan-kinase inhibitor shown to inhibit both the EGFR and AKT oncogenic kinase pathways. We believe that REQORSA’s multimodal activity will block emerging bypass pathways, reducing the probability that drug resistance develops.”