On January 27, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its collaborators published positive preclinical data for the use of Genprex’s ONCOPREX Nanoparticle Delivery System for delivery of a FAS DNA plasmid to treat metastatic colorectal cancer. Published in the journal Cancers1, the preclinical study found that tumor selective ONCOPREX nanoparticles carrying FAS DNA plasmids suppress human colon tumor growth in vivo in mouse models, indicating that this may be an effective therapy for human colorectal cancer (Press release, Genprex, JAN 27, 2022, View Source [SID1234607437]).
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The manuscript, "Restoring FAS Expression via Lipid-Encapsulated FAS DNA Nanoparticle Delivery Is Sufficient to Suppress Colon Tumor Growth In Vivo," provides data indicating that complete loss of FAS expression is often observed in metastatic human colorectal tumors. Using Genprex’s ONCOPREX system to deliver the FAS gene, the researchers found that overexpression of codon usage-optimized FAS in metastatic mouse colon-tumor cells enabled FASL-induced elimination of FAS positive tumor cells in vitro, suppressed colon tumor growth, and increased the survival of tumor-bearing mice in vivo.
"These positive preclinical data validate that the ONCOPREX Nanoparticle Delivery System can be used to deliver tumor suppressor genes other than TUSC2, which we are using in lung cancer studies with REQORSA, to address multiple types of cancer," said Mark S. Berger, MD, Chief Medical Officer at Genprex. "The data also provide early support for FAS as a tumor suppressor gene in colorectal cancer. With this compelling data, Genprex is positioned to expand its oncology programs in the future and to further explore use of its delivery system for other therapeutic genes, alone or in combination with other approved cancer therapies, to provide new therapeutic approaches for patients with serious medical conditions and unmet medical needs. We will continue to evaluate FAS using our ONCOPREX delivery platform as a potential pipeline addition within our oncology program."
Genprex’s oncology program utilizes its unique, proprietary, non-viral ONCOPREX Nanoparticle Delivery System, which is the first systemic gene therapy delivery platform used for cancer in humans.
The ONCOPREX delivery system is used to deliver TUSC2 plasmid DNA in Genprex’s REQORSA immunogene therapy. REQORSA is being combined with Tagrisso (by AstraZeneca) in the Company’s Acclaim-1 clinical trial and is being combined with Keytruda (by Merck & Co.) in the Company’s Acclaim-2 clinical trial, both targeting progressing lung cancers.
In 2020, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for REQORSA for non-small cell lung cancer (NSCLC) in combination therapy with Tagrisso (osimertinib) for late-stage patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. In 2021, the FDA granted Fast Track Designation for REQORSA for NSCLC in combination therapy with Keytruda (pembrolizumab) for late-stage patients whose disease progressed after treatment with Keytruda.
The ONCOPREX Nanoparticle Delivery System is designed to deliver tumor suppressor genes, which are encapsulated in lipid nanoparticles. The nanoparticles are then administered intravenously and taken up by tumor cells where the encapsulated gene is translated to express proteins that are missing or depleted in cancer cells. Genprex has treated more than 50 NSCLC patients in clinical trials with REQORSA, the Company’s lead drug candidate that uses the ONCOPREX Nanoparticle Delivery System to deliver the TUSC2 gene.
A Phase 1 clinical trial showed that systemic, intravenous therapy using the ONCOPREX Nanoparticle Delivery System was shown to selectively and preferentially target tumor cells, resulting in clinically significant anticancer activity. The nanoparticles are non-immunogenic, allowing repetitive therapeutic dosing and providing extended half-life in the circulation.
1Cancers 2022, 14(2), 361; View Source