On April 19, 2023 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 research collaborators presented positive preclinical data for the NPRL2 gene (also known as the TUSC4 gene) (Press release, Genprex, APR 19, 2023, View Source [SID1234630326]). The studies used the Company’s non-viral ONCOPREX Nanoparticle Delivery System in KRAS/STK11 mutant anti-PD1 resistant metastatic human non-small cell lung cancer (NSCLC) humanized mouse models and were presented at the 2023 American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, which took place from April 14-18, 2023 in Orlando, Florida.
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"We are pleased to have these positive data that support the therapeutic potential of our non-viral delivery system, which is being used in our current REQORSA clinical oncology programs, presented before some of the world’s leading cancer researchers," said Rodney Varner, President and Chief Executive Officer at Genprex. "The use of the ONCOPREX Nanoparticle Delivery System to deliver the NPRL2 tumor suppressor gene positions Genprex to expand our clinical pipeline with a new drug candidate."
"The preclinical data also provide further evidence that the ONCOPREX Nanoparticle Delivery System has the ability to be successful using genes other than the TUSC2 gene that we are already using in clinical trials with REQORSA," stated Varner. "These compelling outcomes give us further confidence in the potentially broad-based application of our non-viral delivery system, which may provide a multitude of potential pipeline opportunities in the future."
Genprex’s ONCOPREX Nanoparticle Delivery System, is a novel non-viral approach utilizing lipid nanoparticles to deliver tumor suppressor genes that have been deleted during the course of cancer development. The platform allows for the intravenous delivery of various tumor suppressor genes, and potentially other genes, to achieve a therapeutic affect without the risk of toxicity often associated with viral delivery systems.
Featured Genprex-supported posters presented at AACR (Free AACR Whitepaper) 2023 include:
Event: Americal Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
Session Category: Immunology
Session Title: Combination Immunotherapies 2
Location: Section 22
Session Date and Time: Tuesday, April 18 from 1:30-5:00 p.m. ET
Title: "NPRL2 gene therapy induces effective antitumor immunity in KRAS/STK11 mutant anti-PD1 resistant metastatic human NSCLC in a humanizedmouse model"
Presenters: Jack A. Roth, MD, The University of Texas MD Anderson Cancer Center
Poster Board Number: 23
Abstract Presentation Number: 5120
The abstract entitled, "NPRL2 gene therapy induces effective antitumor immunity in KRAS/STK11 mutant anti-PD1 resistant metastatic human non-small cell lung cancer (NSCLC) in a humanized mouse model," is available on the AACR (Free AACR Whitepaper) website. The presentation reported results from this study, which investigated the antitumor immune responses to NPRL2 gene therapy on anti-PD1 resistant KRAS/STK11 mutant NSCLC in a humanized mouse model. In the study, humanized mice were treated with NPRL2 gene therapy, immunotherapy pembrolizumab (Keytruda), or the combination. A dramatic antitumor effect was mediated by NPRL2 treatment, whereas pembrolizumab was ineffective. A significant antitumor effect was also found in non-humanized NSG mice, although the antitumor effect was greater in humanized mice, suggesting that the immune response played a role in inducing antitumor activity.
The study data suggest that NPRL2 gene therapy induces antitumor activity on KRAS/STK11 mutant anti-PD1 resistant tumors through DC mediated antigen presentation and cytotoxic immune cell activation.
A KRAS mutation occurs in approximately 25% of patients with NSCLC, and one study found that KRAS/STK11 combination mutations were found in approximately 6.5% of NSCLC patients.
"These data are encouraging because they not only validate Genprex’s non-viral oncology platform to deliver a variety of tumor suppressor genes, but they also provide further evidence of the important role that tumor suppressor genes play in cancer, particularly NSCLC," said Mark Berger, MD, Chief Medical Officer at Genprex. "KRAS is the most frequent oncogene mutated in NSCLC, and KRAS mutations are often associated with resistance to drug therapyi. Targeting KRAS/STK11 mutant NSCLC with the NPRL2 gene, and potentially with anti-PD1 as well, may provide therapeutic potential for this group of lung cancer patients."
Genprex currently has three clinical trials evaluating the Company’s lead drug candidate, REQORSA Immunogene Therapy (quaratusugene ozeplasmid) in lung cancer. The Acclaim-1 clinical trial, which received FDA Fast Track Designation, is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Tagrisso (osimertinib) in patients with late-stage NSCLC with activating epidermal growth factor receptor ("EGFR") mutations whose disease progressed after treatment with Tagrisso. The Acclaim-2 clinical trial, which received FDA Fast Track Designation, is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Keytruda (pembrolizumab) in patients with late-stage NSCLC whose disease progressed after treatment with Keytruda. The Acclaim-3 clinical trial, expected to open for enrollment by the end of the third quarter of 2023, is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Tecentriq (atezolizumab) in patients with extensive-stage small-cell lung cancer (SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as an initial treatment.