Genprex Inc (NASDAQ: GNPX) is a clinical-stage gene therapy organization that concentrates on the development of life-changing gene therapies to treat people with diabetes and cancer. The company announced that it had received FTD (Fast Track Designation) from the Food and Drug Administration for its REQORSA Immunogene therapy and went up by 130%.
This lead drug candidate will be used to treat people with unresectable, histologically-confirmed stage 4 or 3 non-small cell lung cancer. In Q1 of 2022, the company expects to start its Acclaim II clinical trial. This will be a multi-center, open-label trial designed to evaluate REQORSA.
How does top management feel?
Genprex’s Chief Executive Officer and President, Rodney Varner, said:
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.
The CEO claimed they were delighted to get their second FTD for REQORSA to treat people with late-stage NSCLC. This second FTD is vital when it comes to accelerating the clinical development of this lead drug candidate. It also validates the potential this drug has as far as treating the unmet medical requirements of people with late-stage NSCLC,
With $42 million in cash on the books as of Q3 2021 and clinical trial management handled by Mark Berger, MD, the company’s Chief Medical Officer who joined in September last year, Genprex is well-positioned to start its Acclaim II and Acclaim I clinical trials. Dr. Berger said:
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.
The Chief Medical Officer continued and said, “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.”
Preclinical data
Previously presented preclinical information shows the synergy between Keytruda and REQORSA. In addition, this information showed that the combination of these two drugs was more effective than when Keytruda was used in isolation. The studies were conducted on mice with humanized immune systems that were battling metastatic lung cancer.
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