Genprex Amends Options to License Additional Cancer Fighting Technologies from the University of Texas MD Anderson Cancer Center

Source:  Genprex, Inc.-August 28, 2018

Genprex, Inc. (NASDAQ: GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, announced today that it has entered into amendments with The University of Texas MD Anderson Cancer Center (MD Anderson) to extend the terms of two option agreements between Genprex and MD Anderson pertaining the use of TUSC2, the active agent in Genprex’s lead product candidate Oncoprex, in combination with immunotherapies and the development and the use of biomarkers to predict patient response to TUSC2 therapy.

“These agreements will provide the opportunity to obtain additional patent protection for our TUSC2 gene therapy platform,” said Rodney Varner, CEO of Genprex. “With these amended agreements in place, we will continue to advance and expand our clinical development program with Oncoprex for the treatment of non-small cell lung cancer and other potential therapeutic targets.”

The first amended agreement provides Genprex with an option to exclusively license patent applications and related intellectual property relating to methods of treating cancer by combining TUSC2 with any of the immune checkpoint inhibitors known to stimulate immune responses, including but not limited to nivolumab (Opdivo®), pembrolizumab (Keytruda®), ipilimumab (Yervoy®), and anti-KIR antibodies such as lirilumab.

Researchers at MD Anderson reported data from preclinical research at the 2017 meeting of the American Association for Cancer Research demonstrating that TUSC2 alone or in combination with checkpoint blockade (anti-PD-1 and/or anti-CTLA4) significantly prolonged mouse survival in a non-small cell lung cancer (NSCLC) metastasis model compared to checkpoint blockade alone. The greatest increase in survival was seen with TUSC2 combined with checkpoint blockade. The treatment response was associated with high infiltration of NK cells and CD8 T cells, and low infiltration of myeloid-derived suppressor cells (MDSC) in the tumor microenvironment.

The second amended agreement provides Genprex with an option to exclusively license an issued U.S. patent, foreign patent applications, and related intellectual property pertaining to methods for predicting a patient’s response to a TUSC2 therapy and methods for treating a patient previously predicted to have a favorable response to a TUSC2 therapeutic in conjunction with an epidermal growth factor receptor (EGFR) inhibitor and/or a protein kinase inhibitor.

Each amendment extends the term of the related option agreement to March 13, 2019, in consideration of the payment of $25,000.

About Genprex, Inc.
Genprex, Inc. is a clinical stage gene therapy company developing a new approach to treating cancer, based upon a novel proprietary technology platform, including Genprex’s initial product candidate, Oncoprex™ immunogene therapy for non-small cell lung cancer (NSCLC). Genprex’s platform technologies are designed to administer cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. Oncoprex has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance.

Genprex Provides Clinical and Corporate Update for Second Quarter 2018

Source:  Genprex, Inc.-August 15, 2018

Genprex, Inc. (NASDAQ:GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, today announced a clinical and corporate update, and the filing of quarterly results for the second quarter ended June 30, 2018 on Form 10-Q with the Securities and Exchange Commission.

Rodney Varner, Chairman and CEO, remarked, “We have made significant progress in recent months to advance the development of Oncoprex™ for treatment of non-small cell lung cancer (NSCLC), including engaging collaborators with expertise and other resources necessary for important pre-clinical and clinical services. We also obtained an additional $10 million in capital, which provides additional financial resources to position the Company to achieve its critical milestones in its path toward developing and commercializing Oncoprex. ”

Julien L. Pham, MD, MPH, President and Chief Operating Officer, stated, “We are moving toward resuming enrollment in the Phase I/II clinical evaluating the combination of Oncoprex™ and erlotinib (Tarceva®) for the treatment of Stage IV non-small cell lung cancer (NSCLC), adding an additional preclinical trial to study Oncoprex in combination with immunotherapies, and progressing with manufacturing scale-up.”

Clinical Development Highlights (May 2018 to present)

• Selected Accenture to provide clinical data management services to help accelerate the clinical development of Genprex’s lead drug candidate, Oncoprex™.
• Entered an agreement to use WIRB-Copernicus Group (WCG) to provide site selection and feasibility services, including Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) oversight for new clinical trial sites that Genprex anticipates adding to participate in its Phase I/II clinical trial evaluating the combination of Oncoprex^TM and erlotinib (Tarceva®) in NSCLC.
• Selected 4Clinics as a CRO to provide clinical and regulatory support for the clinical development program in the form of biostatistics, statistical programming and analysis, as well as medical and scientific writing for the Phase I/II clinical trial.
• Entered an agreement with The University of Texas MD Anderson Center under which Genprex is sponsoring a pre-clinical study intended to develop a novel therapeutic approach for the treatment of cancer using a combination of the multifactorial tumor suppressor gene TUSC2 and immunotherapy, including the immune checkpoint inhibitors anti-PD1 and/or anti CTLA-4. This study will include the identification of biomarkers to predict the response to TUSC2-immunotherapy combinations.
• Amended its agreement with The University of Texas MD Anderson Cancer Center to resume patient enrollment in its Phase I/II trial evaluating the combination of Oncoprex™ and erlotinib (Tarceva®) for the treatment of Stage IV non-small cell lung cancer (NSCLC).

Corporate Update

• Entered an agreement with the University of Texas at Austin Dell Medical School to establish executive offices at the school’s Health Discovery Building, joining the WorkSpaces @ Texas Health CoLab. WorkSpaces @ Texas Health CoLab is designed to identify and support people and companies that share Dell Medical School’s commitment to improving health outcomes to patients and reducing healthcare costs.
• Established offices in Cambridge, MA, where Dr. Julien Pham, President and COO will oversee the clinical development of Genprex’s lead drug candidate, Oncoprex™.
• Completed a $10 million private placement.

Forward Looking Statements
Statements contained in this press release that are not statements of historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because these statements are subject to risks and uncertainties, the actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements about Genprex’s business plans, statements about the timing and success of the Company’s existing and planned clinical trials, statements about the development of the Company’s current and potential future product candidates, statements about the Company’s plans to seek regulatory approval of its product candidates, and statements about the services the Company expects to receive from its development partners and the effect of those services on the development of Oncoprex. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost and timing of the Company’s product candidate development activities and current and planned clinical trials; the Company’s ability to execute on its strategy; regulatory developments in the United States and foreign countries; the Company’s estimates regarding expenses, future revenue and capital requirements; and the ability of the Company’s development partners to provide services to the Company and the Company’s ability to utilize those services, and the ability of those services to influence the development of Oncoprex. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Genprex’s filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Genprex does not undertake any obligation to update these statements to reflect any events that occur or facts that exist after the date on which the statements were made.

About Genprex, Inc.
Genprex, Inc. is a clinical stage gene therapy company developing a new approach to treating cancer, based upon a novel proprietary technology platform, including Genprex’s initial product candidate, Oncoprex™ immunogene therapy for non-small cell lung cancer (NSCLC). Genprex’s platform technologies are designed to administer cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. Oncoprex has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance. Visit the company’s web site at www.genprex.com or follow Genprex on Twitter at https://twitter.com/genprex and Facebook at https://www.facebook.com/genprexinc/.

Genprex Updates Agreement with University of Texas MD Anderson Cancer Center to Resume Patient Enrollment in Phase I/II Study Evaluating Oncoprex/Erlotinib Combination Therapy in Non-Small Cell Lung Cancer

Source:  Genprex, Inc.-August 2, 2018

Genprex, Inc. (NASDAQ:GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, today announced that it has amended its agreement with The University of Texas MD Anderson Cancer Center to resume patient enrollment in its Phase I/II clinical trial evaluating the combination of the company’s investigational drug Oncoprex™ and erlotinib (Tarceva®) for the treatment of Stage IV non-small cell lung cancer (NSCLC).

Oncoprex is a TUSC2 gene encapsulated in a positively charged nanovesicle made from lipid molecules and injected intravenously, which can specifically target cancer cells and insert wild-type TUSC2 into cellular DNA, effectively increasing expression of the TUSC2 protein and promoting tumor cell death.

Previously announced interim data from nine patients from the Phase II portion of this Phase I/II clinical trial showed a disease control rate of 78%, with seven out of nine patients achieving stable disease or better, including one complete response. In a previous Phase I clinical trial at MD Anderson evaluating Oncoprex as a monotherapy, five of 23 patients with late-stage NSCLC achieved stable disease or better, with one durable metabolic response.

“We look forward to completing the Oncoprex/erlotinib trial and expanding the study of Oncoprex in combination with other targeted and immunotherapies in the future,” said Rodney Varner, Chairman and Chief Executive Officer of Genprex. “We believe the data from the more than 50 late-stage NSCLC patients treated to date provide persuasive evidence of Oncoprex’s anti-tumor effects and favorable safety profile.”

A subset of NSCLC patients (approximately 10% of NSCLC patients of North American and European descent and approximately 30% to 50% of NSCLC patients of Asian descent) carry an EGFR mutation that makes their tumors sensitive to tyrosine kinase inhibitors, or TKIs, such as erlotinib. However, even for these patients, tumor resistance to TKIs frequently develops within two years, resulting in eventual disease progression. While next generation TKIs show promise in targeting resistant EGFR positive tumors that carry a mutation known as T790M, only about one-half of EGFR positive patients (5% to 7.5% of all NSCLC patients of North American and European descent and 15% to 25% of NSCLC patients of Asian descent) carry the T790M mutation. This leaves a significant majority of NSCLC patients—those who are EGFR negative and those who are EGFR positive but have become resistant to erlotinib and do not have the T790M mutation—without a targeted therapy for their cancer.

Combination therapies targeting multiple anti-cancer pathways represent a promising approach to achieving greater response rates, and may also allow the expanded use of targeted therapies and immunotherapies in a larger population of cancer patients who are not currently candidates for these treatments.

About Lung Cancer
According to the World Health Organization, lung cancer is the leading cause of cancer deaths worldwide, and is the second most common type of cancer. Each year, there are over 1.8 million new lung cancer cases and 1.6 million deaths from lung cancer worldwide, and in the United States there are over 225,000 new cases and more than 150,000 deaths from lung cancer per year. NSCLC represents 80% of all lung cancers. According to a 2016 American Cancer Society report, the five-year survival rate for Stage IV (metastatic) NSCLC is about 1%, and overall survival for lung cancer has not improved appreciably in the last 25 years.

About Genprex
Genprex, Inc. is a clinical stage gene therapy company developing a new approach to treating cancer, based upon a novel proprietary technology platform, including Genprex’s initial product candidate, Oncoprex™ immunogene therapy for non-small cell lung cancer (NSCLC). Genprex’s platform technologies are designed to administer cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. Oncoprex has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance.

Genprex Enters Agreement with the University of Texas MD Anderson Cancer Center to Study Oncoprex in Combination with Immunotherapies

Source:  Genprex, Inc.-July 26, 2018

New study will evaluate synergistic effect of Oncoprex gene therapy on checkpoint inhibition

Study may identify biomarkers that can predict the response to therapy across different cancers 

Genprex, Inc. (NASDAQ:GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, has entered a Sponsored Research Agreement (“Agreement”) with The University of Texas MD Anderson Cancer Center under which Genprex will sponsor a pre-clinical study, entitled “A Novel Therapeutic Approach for the Treatment of Cancer Using a Combination of the Multifactorial Tumor Suppressor Gene TUSC2 and Immunotherapy,” to be conducted under the direction of Jack A. Roth, MD, FACS. TUSC2 is the active agent in Genprex’s investigational drug candidate Oncoprex™.  

The study, which is built upon strong data from pre-clinical research conducted at MD Anderson, is intended to develop a novel therapeutic approach for the treatment of cancer using a combination of the multifactorial tumor suppressor gene TUSC2 and immunotherapy, including the immune checkpoint inhibitors anti-PD1 and/or anti CTLA-4. The study will include the identification of biomarkers to predict the response to TUSC2-immunotherapy combinations.

Under the Agreement, MD Anderson will provide all necessary personnel, equipment, supplies, facilities and resources to perform the study; and Genprex will pay MD Anderson an amount equal to its expenditures and reasonable overhead in conducting the study in an amount of $2.0 million.

"This research program will evaluate the ability of TUSC2 gene therapy to synergistically enhance the effect and clinical utility of anti-PD1 and/or anti-CTLA-4 therapies,” said Rodney Varner, Chairman and Chief Executive Officer of Genprex. “Identifying biomarkers that can predict response rates for Oncoprex-immunotherapy combinations may allow us to explore the utility of this treatment regimen in a broader array of cancers.”

Varner added, “While immunotherapies represent an important advance in treating cancer, even in highly immunogenic tumors, the majority of patients do not respond to checkpoint inhibition. Combination therapies targeting multiple anti-cancer pathways represent a promising approach to achieving greater response rates, and may also allow the expanded use of immunotherapies in a larger population of cancer patients who are not currently candidates for these treatments.”

Researchers at MD Anderson reported data from preclinical research at the 2017 meeting of the American Association for Cancer Research demonstrating that TUSC2 alone or in combination with checkpoint blockade (anti-PD-1 and/or anti-CTLA4) significantly prolonged mouse survival in a non-small cell lung cancer metastasis model compared to checkpoint blockade alone. The greatest increase in survival was seen with TUSC2 combined with checkpoint blockade. The treatment response was associated with high infiltration of natural killer (NK) cells and CD8 T cells, and low infiltration of myeloid-derived suppressor cells (MDSC) in the tumor microenvironment.

About Genprex, Inc.
Genprex, Inc. is a clinical stage gene therapy company developing a new approach to treating cancer, based upon a novel proprietary technology platform, including Genprex’s initial product candidate, Oncoprex™ immunogene therapy for non-small cell lung cancer (NSCLC). Genprex’s platform technologies are designed to administer cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. Oncoprex has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance.