Genprex Inc said it has opened patient enrollment for its Acclaim-2 clinical trial evaluating the company's lead drug candidate, REQORSA Immunogene Therapy.
Acclaim-2 is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA Immunogene Therapy in combination with Keytruda (pembrolizumab) in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda.
In 2021, Genprex received US Food and Drug Administration's Fast Track Designation for the treatment of the Acclaim-1 patient population.
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"We are pleased to have opened Acclaim-2 for patient enrollment and expect to promptly begin screening patients for their eligibility to participate in the trial," said Dr. Mark Berger, chief medical officer of Genprex.
"This marks an important milestone in our clinical development program for REQORSA as we continue to engage with prestigious clinical trial sites to build patient enrollment and provide hope to lung cancer patients who suffer from this devastating disease and who are in desperate need of new treatment options. We look forward to completing the Phase 1 portion of Acclaim-2 by the end of the first quarter of 2023 and to generating data to show the synergistic effects REQORSA combined with immunotherapies can have in patients."
Previously presented preclinical data have shown synergy between REQORSA and Keytruda, the company said.
Those data showed that REQORSA combined with the checkpoint inhibitor Keytruda was more effective than Keytruda alone in increasing the survival of mice with a humanized immune system that had metastatic lung cancer. Those studies in mice with a humanized immune system also documented multiple effects of REQORSA on the immune system, such as an increase in natural killer cells and a decrease in myeloid-derived suppressor cells in the tumor that are likely to contribute to the synergy seen with Keytruda.
The company said it expects the Phase 1 portion of the Acclaim-2 trial to enroll up to 30 patients in a dose-escalation study to determine the maximum tolerated dose of the combination of REQORSA and Keytruda.
The Phase 2 portion of the study is expected to enroll approximately 126 patients to be randomized 2:1 to receive either REQORSA and Keytruda combination therapy or docetaxel and/or ramucirumab.
The primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as the time from randomization to progression or death. An interim analysis will be performed after 50 events.
Genprex said it expects to complete the Phase 1 portion of Acclaim-2 by the end of the first quarter of 2023.
In 2020, Genprex entered into a worldwide, exclusive license agreement with a major cancer research center in Houston, Texas for the use of REQORSA in combination with immunotherapies, including Keytruda, and also for the use of REQORSA in a three-drug combination of TUSC2, immunotherapy, and chemotherapy.
Keytruda is a registered trademark of Merck & Co. and is its largest selling drug with 2021 sales of more than $17 billion.
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