- Clinical Trials
Second FDA Fast Track Designation Further Validates the Potential of REQORSA
Genprex announced that the U.S. Food and Drug Administration (FDA) has reviewed and confirmed all comments have been addressed regarding the Company’s clinical trial protocol for the Acclaim-1 clinical trial
Newly licensed technologies include use of Genprex’s TUSC2 gene therapy combined with EGFR inhibitors or other anti-cancer therapies in patients predicted to be responsive to TUSC2 therapy
Acclaim-1 clinical trial to treat late-stage NSCLC patients whose disease progressed on Tagrisso®
Acclaim-2 Clinical Trial Combines REQORSA™ immunogene therapy with Merck & Co’s Keytruda®
REQORSA Enhances Efficacy of Chemo-Immune Combination Therapy in KRAS-LKB1 Mutant NSCLC in Humanized Mice
Company passes final release tests of scaled-up clinical grade production to supply drug product for upcoming Acclaim-1 and Acclaim-2 clinical trials in lung cancer
Acclaim-1 trial combines REQORSA™ immunogene therapy drug with AstraZeneca’s Tagrisso®
Approval of new name marks important branding milestone and aligns with the program’s overall progress
The grant will fund ongoing preclinical research for important proof-of-principle non-human studies in preparation for human gene therapy clinical trials.
Genprex entered into a Patent and Technology License Agreement with MD Anderson Cancer Center in which MD Anderson granted to Genprex an exclusive worldwide license to a portfolio of 16 patent applications and related technology for the treatment of cancer using Genprex’s TUSC2 gene therapy in combination with immunotherapies.
Genprex signed an exclusive license agreement with the University of Pittsburgh for a diabetes gene therapy that may have the potential to cure Type 1 and Type 2 diabetes, which together currently affect approximately 30.3 million people in the U.S.
Genprex was granted FDA Fast Track Designation for Oncoprex™ immunogene therapy in combination with EGFR inhibitor osimertinib for the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations that progressed after treatment with osimertinib alone.
Genprex’s TUSC2 gene therapy was found to increase the effectiveness of anti-PD1 immunotherapy and anti-PD1 immunotherapy combined with platinum chemotherapy in a humanized mouse model.
Study finds that TUSC2 prevented tumor growth in triple-negative breast cancer, which is currently considered an incurable cancer with limited therapeutic options.
Recent performance and achievements sets path for future milestones, commercialization.
Aldevron successfully completes the manufacturing of the TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA that will be used in clinical trials evaluating Oncoprex™.
Initiates the first phase of branding its lead drug candidate and completes the creation and submission of non-proprietary drug name selections to the USAN Council.
Collaboration with Addison Whitney begins the drug naming development process and Genprex begins submission of non-proprietary name selections.
The study found that the combination of Oncoprex and the checkpoint inhibitor was more effective than checkpoint blockade alone in increasing the survival of humanized mice that had metastatic lung cancer. The combination treatment also slowed tumor growth significantly.
The sponsored research agreement with the University of Texas MD Anderson Cancer Center is evaluating TUSC2 with immunotherapies, including immune checkpoint inhibitors, anti-PD1 and CTLA-4.
Genprex hires a consulting agency, an Institutional Review Board and Institutional Biosafety Committee, a Contract Research Organization and a commercial manufacturer to support the expansion of clinical development programs.
Completes private placement raising $10 million of private stock.
The company closes its IPO and begins trading under the ticker symbol “GNPX” on the Nasdaq Stock Market. Genprex also expands operations to Cambridge, Mass to accelerate the clinical development of Oncoprex.
The company prepares for its IPO with the Nasdaq Stock Market.
The study reveals that Oncoprex, in combination with the anti-PD1 antibody, has significantly greater anti-tumor effect in lung cancer patients than either agent alone.
The study found that 4 of 9 patients had tumor regression within two cycles, and the trial’s disease control rate was 78%. One patient had a Complete Response.
The company appoints Julien Pham, MD, MPH as the company’s Chief Operating Officer and Ryan Confer, MS as Chief Financial Officer.
Preclinical studies begin, evaluating Oncoprex in combination with immunotherapies, in mice with metastatic lung cancer.
The Phase I portion of a I/II clinical trial is evaluating Oncoprex in combination with erlotinib in patients with Stage IIIB/IV metastatic lung cancer.
The Phase I monotherapy trial found that for the first time, a tumor suppressor gene can be safely administered intravenously in lung cancer patients.
The company’s founders saw good potential in the science behind Genprex’s lead drug candidate, Oncoprex™ immunogene therapy, which has become the foundation of the company’s potentially life-changing technologies for cancer patients based on a unique proprietary technology platform.