On January 3, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the Company’s lead drug candidate, REQORSA Immunogene Therapy, in combination with Merck & Co’s Keytruda in patients with histologically-confirmed unresectable stage III or IV non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda (Press release, Genprex, JAN 3, 2022, View Source [SID1234597954]). In the first quarter of 2022, Genprex expects to initiate its Acclaim-2 clinical trial, which is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Keytruda, for this patient population. The Company previously received its first FTD for REQORSA in combination with AstraZeneca PLC’s Tagrisso in patients with histologically confirmed unresectable stage III or IV NSCLC, with EGFR mutations that progressed after treatment with Tagrisso.

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"We are thrilled to receive a second Fast Track Designation from the FDA for REQORSA in patients with late-stage NSCLC, this time in combination with the checkpoint inhibitor Keytruda," said Rodney Varner, President and Chief Executive Officer at Genprex. "This Fast Track Designation is an important step in our efforts to accelerate clinical development of REQORSA and another validation of the potential of REQORSA to treat the unmet medical need of patients with late-stage NSCLC. With a strong balance sheet of $42 million in cash as of the end of the third quarter of 2021 and expert clinical trial management led by Chief Medical Officer and industry veteran Mark Berger, MD who joined Genprex in September 2021, we are well positioned to advance our Acclaim-1 and Acclaim-2 clinical trials in a meaningful way in 2022."

Dr. Berger added, "Fast Track Designation provides a company opportunities to have more frequent engagement with the FDA to discuss the drug candidate’s development plan and also provides potential eligibility for priority review, which has a six-month review timeline. FDA may award Fast Track Designation if it determines that non-clinical or clinical data demonstrate the potential for a drug to address unmet medical need for a serious or life-threatening disease or condition. This provision is intended to facilitate development and expedite review of such drugs so that a product, if approved, can reach the market expeditiously. Advanced NSCLC represents a large patient population that is in desperate need of new therapies."

Previously presented preclinical data have shown synergy between REQORSA and Keytruda. Those data showed that REQORSA combined with Keytruda was more effective than Keytruda alone in increasing the survival of mice with a humanized immune system that had metastatic lung cancers. 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 PD-L1 expression on tumor cells, that is believed likely to contribute to the synergy seen with Keytruda.

Fast Track Designation recipients may also be eligible for accelerated approval or rolling review of the recipient’s Biologics License Application (BLA) if other qualifying criteria are met. In addition, Fast Track product candidates could be eligible for priority review if supported by clinical data at the time of BLA submission.

The initial intended disease indication for development of REQORSA is NSCLC. According to the World Health Organization, in 2020 lung cancer was the leading cause of cancer deaths worldwide, causing more deaths than colorectal, breast, liver or stomach cancers. There were more than 2 million new lung cancer cases and 1.8 million deaths from lung cancer worldwide. In the United States, according to the American Cancer Society, it is estimated that in 2021, there will be more than 235,000 new cases of lung cancer and more than 131,000 deaths from lung cancer. The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) reports that NSCLC represents 84 percent of all lung cancers and the five-year survival rate for patients with NSCLC with distant spread is 7 percent.

For more information on the U.S. FDA’s Fast Track Designation, please visit the FDA’s Fast Track webpage.