Express treatment of advanced lung cancer, tumor suppressor gene therapy/Keytruda combination obtained FDA fast track qualification

▎WuXi AppTec content team editor recently, Genprex announced that the U.
S.
FDA has granted the gene therapy Reqorsa Fast Track Designation (FTD), and Merck (MSD)'s blockbuster PD-1 inhibitor Keytruda (pembrolizumab, pembrolizumab) Combined use to treat patients with stage III or IV non-small cell lung cancer (NSCLC) whose histologically confirmed unresectable
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These patients developed disease progression after receiving Keytruda monotherapy
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In the first quarter of 2022, Genprex is expected to initiate an open-label, multi-center Phase 1/2 clinical trial to evaluate the efficacy and safety of this treatment combination in this patient population
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Reqorsa is composed of tumor suppressor gene TUSC2 encapsulated in nanoparticles with positively charged lipid molecules, and tumor cells are generally negatively charged
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Reqorsa can be specifically targeted to tumor cells by intravenous injection
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Reqorsa has a multi-modal mechanism of action, which can interrupt the cell signaling pathway that causes tumor cell replication and proliferation, re-establish the tumor cell programmed death pathway, and regulate the immune response to tumor cells
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Reqorsa has also been shown to block the mechanism of resistance
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Genprex believes that Reqorsa will be the first systemic gene therapy for the treatment of human cancer
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 Image source: The preclinical data previously published on Genprex's official website shows that Reqorsa and Keytruda have a synergistic effect
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Specifically, in metastatic lung cancer mice with humanized immune systems, the combination of Reqorsa+Keytruda treatment more effectively improved their survival rate than Keytruda monotherapy
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In addition, the mouse model also proved that Reqorsa has multiple effects on the immune system, such as increasing the production of natural killer cells and reducing the expression of PD-L1 on tumor cells, which is believed to be likely to contribute to the synergy with Keytruda
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In addition, Reqorsa and AstraZeneca third-generation irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor Tagrisso (Tagrisso) for patients with stage III or IV NSCLC who have been confirmed by histology to be unresectable The combined treatment combination has previously been granted FTD by the FDA
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These patients carry EGFR mutations and develop disease progression after Teresa monotherapy
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Mr.
Rodney Varner, President and CEO of Genprex, said: "We are very pleased that the FDA has granted Reqorsa the second fast-track qualification for the treatment of patients with advanced NSCLC.
This time it will be used in combination with the checkpoint inhibitor Keytruda
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This fast-track qualification is We strive to accelerate the clinical development of Reqorsa and once again verify the potential of Reqorsa to solve the unmet medical needs of patients with advanced NSCLC
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"Reference: [1] Genprex Receives US FDA Fast Track Designation for REMORSE™ Immunogene Therapy in Combination With Keytruda® for the Treatment of Non-Small Cell Lung Cancer.
Retrieved January 3, 2022, from https:// com/news/home/20220103005090/en/Genprex-Receives-US-FDA-Fast-Track-Designation-for-REQORSA%E2%84%A2-Immunogene-Therapy-in-Combination-With-Keytruda%C2%AE- for-the-Treatment-of- Non-Small-Cell-Lung-Cancer Disclaimer: WuXi content teams to focus progress of biomedical research on global health introduction
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in the
article .
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