Genprex Receives U.S. FDA Fast Track Designation for REQORSA™ Immunogene Therapy in Combination with Keytruda® for the Treatment of Non-Small Cell Lung Cancer

Second FDA Fast Track Designation Further Validates the Potential of REQORSA

Genprex Announces Initiation of its Phase 1/2 Acclaim-1 Clinical Trial for REQORSA™ Immunogene Therapy in Combination with Tagrisso® to Treat Non-Small Cell Lung Cancer Following FDA Review

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

Genprex In-Licenses Additional Gene Therapy Technologies for Treatment of Lung Cancer

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

Genprex Announces Centralized Institutional Review Board Approval for Acclaim-1 Clinical Trial in Non-Small Cell Lung Cancer

Acclaim-1 clinical trial to treat late-stage NSCLC patients whose disease progressed on Tagrisso®

Genprex Initiates Site Recruitment for Acclaim-2 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer

Acclaim-2 Clinical Trial Combines REQORSA™ immunogene therapy with Merck & Co’s Keytruda®

Genprex Collaborators Report Positive Preclinical Data for REQORSA™ Immunogene Therapy in Non-Small Cell Lung Cancer at the 2021 AACR Annual Meeting

REQORSA Enhances Efficacy of Chemo-Immune Combination Therapy in KRAS-LKB1 Mutant NSCLC in Humanized Mice

Genprex Achieves Major Manufacturing Milestone for REQORSA™ Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer

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

Genprex Initiates Site Recruitment for Acclaim-1 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer

Acclaim-1 trial combines REQORSA™ immunogene therapy drug with AstraZeneca’s Tagrisso®

Genprex Receives Conditional FDA Acceptance of Proprietary Name REQORSA™ for Lead Drug Candidate for Treatment of Non-Small Cell Lung Cancer

Approval of new name marks important branding milestone and aligns with the program’s overall progress

NIH Awards Research Grant of $2.59 Million to University of Pittsburgh for Diabetes Gene Therapy Technology Licensed by Genprex

The grant will fund ongoing preclinical research for important proof-of-principle non-human studies in preparation for human gene therapy clinical trials.

Enters Into Exclusive Worldwide Patent and Technology License Agreement for Combination of its TUSC2 Gene Therapy with Immunotherapies

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.

Signs Exclusive License Agreement for Potentially Curative Gene Therapy Candidate for Diabetes

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.

Receives U.S. FDA Fast Track Designation for Gene Therapy that Targets Lung Cancer

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.

Reports Positive Preclinical Data for the Treatment of Some of the Most Resistant Metastatic Lung Cancers

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.

Independent researchers find TUSC2 prevents tumor growth in triple-negative breast cancer

Study finds that TUSC2 prevented tumor growth in triple-negative breast cancer, which is currently considered an incurable cancer with limited therapeutic options.

Demonstrates growth and expansion through recent achievements

Recent performance and achievements sets path for future milestones, commercialization.

Manufacturing partner completes significant step in manufacturing for Oncoprex™ clinical development program

Aldevron successfully completes the manufacturing of the TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA that will be used in clinical trials evaluating Oncoprex™.

Begins next phase of drug branding program

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.

Addison Whitney is retained for drug nomenclature branding

Collaboration with Addison Whitney begins the drug naming development process and Genprex begins submission of non-proprietary name selections.

Positive preclinical data is published from the Oncoprex + pembrolizumab study

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.

Enters into exclusive agreement with UT MDACC for Oncoprex + immunotherapies study

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.

Key partners are selected to support acceleration of clinical development programs and manufacturing technology transfer

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.

Genprex completes $10 Million Private Placement

Completes private placement raising $10 million of private stock.

Genprex begins trading under “GNPX” and expands operations

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.

Registration statement filed for proposed Initial Public Offering

The company prepares for its IPO with the Nasdaq Stock Market.

Positive preclinical data is published from the Oncoprex + immunotherapy study

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.

Positive interim data is published from the Phase II clinical trial evaluating Oncoprex + erlotinib

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.

Genprex expands its company management team and operations

The company appoints Julien Pham, MD, MPH as the company’s Chief Operating Officer and Ryan Confer, MS as Chief Financial Officer.

Preclinical studies evaluating Oncoprex + immunotherapies begin

Preclinical studies begin, evaluating Oncoprex in combination with immunotherapies, in mice with metastatic lung cancer.

Phase I/II clinical trial begins, evaluating Oncoprex + erlotinib

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.

Phase I monotherapy clinical trial is published

The Phase I monotherapy trial found that for the first time, a tumor suppressor gene can be safely administered intravenously in lung cancer patients.

Genprex is founded

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.