FDA Grants Fast Track Designation for Reqorsa in Combination with Keytruda for NSCLC

The FDA has granted fast track designation (FTD) for Reqorsa Immunogene Therapy (Genprex) in combination with Keytruda (Merck) for individuals with histologically confirmed unresectable stage III or IV non–small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda.

In the first quarter of 2022, Genprex expects to initiate its Acclaim-2 clinical trial, a multi-label, open-label phase 1/2 trial evaluating Reqorsa in combination with Keytruda for this population.

Genprex received its first FTD for Reqorsa in combination with AstraZeneca PLC’s Tagrisso for individuals with histologically confirmed unresectable stage 3 or 4 NSCLC with epidermal growth factor receptor mutations that progressed after treatment with Tagrisso.

“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,” Rodney Varner, president and CEO of Genprex, said in a statement.

Preclinical data have previously shown 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.

The 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, which is believed likely to contribute to the synergy between and Keytruda and Reqorsa.

“[The] 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,” Berger said.

“Advanced NSCLC represents a large patient population that is in desperate need of new therapies,” he said.

FTD recipients may also be eligible for accelerated approval or rolling review of the recipient’s biologics license application (BLA) if other criteria are met.

Additionally, FTD product candidates could be eligible for priority review if supported by clinical data at the time of the BLA submission.

The initial intended disease indication for the development of Reqorsa is NSCLC.

Genprex is a clinical-stage gene therapy company that focuses on developing therapies for individuals with cancer and diabetes and hope to provide new therapies for large patient populations that have limited treatment options.

Reference

Genprex receives US FDA fast track designation for Reqorsa Immunogene Therapy in combination with Keytruda for the treatment of non–small cell lung cancer. Business Wire. News release. January 3, 2022. Accessed January 4, 2022. https://www.businesswire.com/news/home/20220103005090/en