Genprex, Inc. (NASDAQ:GNPX) revealed that the US Food and Drug Administration (FDA) granted Fast Track designation to the company’s lead drug candidate, REQORSA Immunogene Therapy, in combination with Merck & Co Inc (NYSE:MRK)’s Keytruda in patients with stage III or IV non-small cell lung cancer (NSCLC), where disease progressed after treatment with Keytruda.
The Austin, Texas-based clinical-stage gene therapy company said that in the first quarter of 2022, it plans to initiate its Acclaim-2 clinical trial, which is an open-label, multicenter Phase 1/2 clinical trial evaluating REQORSA in combination with Keytruda, for this patient population.
Genprex previously received its first Fast Track designation for REQORSA in combination with AstraZeneca PLC (LSE:AZN)’s Tagrisso in patients with histologically confirmed unresectable stage III or IV NSCLC, with epidermal growth factor receptor (EGFR) mutations that progressed after treatment with Tagrisso.
READ: Genprex gears up for patient enrollment in its Acclaim-1 REQORSA trial after FDA feedback
"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," Genprex CEO Rodney Varner said in a statement.
"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, 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," he added.
The company’s chief medical officer Dr Berger noted that the Fast Track designation provides a company opportunity 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,” said Dr Berger. “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."
Genprex said preclinical data has 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,” said the company.
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 are eligible for accelerated approval, or rolling review of the recipient’s Biologics License Application (BLA) if other criteria are met.
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.
The American Cancer Society estimated that in 2021, there would be more than 235,000 new cases of lung cancer in the US and more than 131,000 deaths from lung cancer. The American Society of Clinical Oncology reports that NSCLC represents 84% of lung cancers and the five-year survival rate for patients with NSCLC with distant spread is 7%.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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