Genprex has received approval from the Safety Review Committee (SRC) to advance to the Phase II expansion portion of the Acclaim-1 Phase I/II clinical trial of REQORSA combined with Tagrisso (osimertinib) to treat late-stage non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

The Phase I dose escalation portion has been completed and showed that REQORSA immunogene therapy was well tolerated with no dose-limiting toxicities.

Based on full safety data, the SRC determined that the recommended Phase II REQORSA dose will be 0.12mg/kg.

Three physicians of SRC will act as principal investigators of the trial.

They will recommend if the study continues at the same dose or at a lower dose, or escalates to an increased dose, or that the trial be terminated due to safety concerns.

The Phase II expansion portion intends to enrol nearly 66 patients. Out of the total, 33 patients will be those who previously received treatment with Tagrisso while the remaining with Tagrisso and chemotherapy.

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It will determine efficacy and other endpoints, as well as the toxicity profiles of patients with different eligibility criteria.

An interim analysis will also be performed at 28 events following the treatment of 19 patients in each cohort.

The company anticipates starting the Phase II expansion portion in the third quarter of this year.

Genprex chairman, president and CEO Rodney Varner said: “We are proud of the notable progress we made during the Phase 1 portion of the Acclaim-1 clinical trial, and the SRC recommendation to move into the Phase 2 expansion portion of the trial is another validation for our REQORSA development programme.

“As we move into the Phase II expansion portion of the trial, we remain steadfast in our efforts to bring new therapies to lung cancer patients with unmet medical needs.”

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