Genprex Announces FDA Fast Track Designation for Reqorsa™ Immunogene Therapy in Combination with Keytruda® for Advanced NSCLC

Recently, Genprex announced that the U.S. FDA has granted Fast Track Designation (FTD) to the gene therapy Reqorsa, for use in combination with MSD's重磅PD-1 inhibitor Keytruda (pembrolizumab), to treat patients with histologically confirmed unresectable stage III or IV non-small cell lung cancer (NSCLC). These patients have experienced disease progression after receiving Keytruda monotherapy. In the first quarter of 2022, Genprex expects to initiate an open-label, multi-center phase 1/2 clinical trial to evaluate the efficacy and safety of this combination therapy in this patient population.

Reqorsa consists of the tumor-suppressing gene TUSC2 encapsulated in positively charged lipid molecule nanoparticles, while tumor cells generally carry a negative charge. Administered intravenously, Reqorsa can specifically target tumor cells. It has a multimodal mechanism of action that interrupts cellular signaling pathways responsible for tumor cell replication and proliferation, re-establishes programmed tumor cell death pathways, and modulates the immune response against tumor cells. Reqorsa has also been shown to block mechanisms that cause drug resistance. Genprex believes that Reqorsa will be the first systemic gene therapy used to treat human cancer.

Previously published preclinical data showed that Reqorsa and Keytruda have a synergistic effect. Specifically, in mice with metastatic lung cancer and humanized immune systems, the combination of Reqorsa and Keytruda was more effective at improving their survival compared to Keytruda alone. Additionally, mouse models demonstrated Reqorsa's multiple effects on the immune system, such as increasing the production of natural killer cells and reducing PD-L1 expression on tumor cells, which is considered highly likely to contribute to the synergy with Keytruda.

Moreover, the combination therapy of Reqorsa with AstraZeneca's third-generation irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor Tagrisso has previously been granted Fast Track Designation (FTD) by the FDA for patients with histologically confirmed unresectable stage III or IV NSCLC. These patients carry EGFR mutations and have experienced disease progression after treatment with Tagrisso monotherapy.

References:

[1] Genprex Receives U.S. 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://www.businesswire.com/news/home/20220103005090/en/Genprex-Receives-U.S.-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

(Original text has been abridged)

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