Genprex Unveils New Branding for Upcoming Combination Clinical Trials in Non-Small Cell Lung Cancer

New branding will support upcoming combination clinical trials, including the Company’s trial combining REQORSA™ immunogene therapy drug with AstraZeneca’s Tagrisso®, which received FDA Fast Track Designation earlier in 2020

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, today announced the launch of new branding for its upcoming oncology clinical trials combining its lead drug candidate, REQORSA(quaratusugene ozeplasmid), with AstraZeneca’s Tagrisso® (osimertinib), which received U.S. Food and Drug Administration (FDA) Fast Track Designation earlier this year, and for the combination of REQORSA with Merck’s Keytruda® (pembrolizumab), for the treatment of non-small cell lung cancer (NSCLC).

These trials will use the trial brand “Acclaim,” which the Company believes evokes its enthusiasm and the hope these trials represent for NSCLC patients and the oncology community. Acclaim-1 will be used to identify the REQORSA and Tagrisso combination clinical trial, and Acclaim-2 will be used to identify the REQORSA and Keytruda combination clinical trial.

“We are enthusiastically preparing for our upcoming clinical trials and are excited to launch the adoption of this branding,” said Rodney Varner, President and Chief Executive Officer of Genprex. “We believe the Acclaim brand communicates our passion for providing hope to NSCLC patients for important new treatment options in the fight against this devastating disease and aligns us with the clinical, medical and patient communities.”

The trial brand was developed in order to encourage early exposure of the Company’s clinical programs to the broad audience that Genprex’s business addresses, including patients, healthcare practitioners, clinical investigators, investors, employees and others. Genprex plans to initiate the Acclaim-1 clinical trial and the Acclaim 2 clinical trial in the first-half of 2021. Acclaim-1 is a Phase 1/2 clinical trial using a combination of REQORSA with Tagrisso in patients with late stage NSCLC with mutated epidermal growth factor receptors (“EGFRs”) whose disease progressed after treatment with Tagrisso. Acclaim-2 is a Phase 1/2 clinical trial using a combination of REQORSA with Keytruda in NSCLC patients who are low expressors (1 to 49%) of the protein, programmed death-ligand 1 (PD-L1).

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing potentially life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also

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Upcoming Supreme Court Ruling Could Jeopardize Health Insurance for People with COVID

The death of Supreme Court Justice Ruth Bader Ginsburg—and President Donald Trump’s controversial nomination of Amy Coney Barrett to fill her seat—have ignited concerns over how a court with a six-to-three conservative majority might rule on an upcoming case on the Affordable Care Act (ACA).

The Senate Judiciary Committee is scheduled to vote on Barrett’s confirmation this Thursday. On November 10 the court will hear Texas v. California. That case will decide whether to uphold a lower court’s ruling that the ACA’s individual mandate to purchase health insurance makes the entire act unconstitutional—or to declare that the mandate is “severable” from the rest of it. If the ACA as a whole is struck down, 20 million people in the U.S. would lose their insurance. Even if it is partially struck down, up to 129 million could lose protections for preexisting conditions—including the more than eight million who have had COVID-19. If she is confirmed before the case is heard, Barrett has given no assurances that she will vote to uphold the landmark health care law.

Many legal scholars say the case for nixing the entire ACA is very weak. But even if the court severs the mandate from most of the law—as Justice Brett Kavanaugh and others have hinted—and strikes down only parts of it, that decision could still do significant damage because the ACA is so intricately tied to the health care system, a number of experts say. Invalidating the law would “throw the nation into economic chaos, in addition to people not having health insurance,” says Georges Benjamin, executive director of the American Public Health Association, a professional organization that promotes public health. “The unintended consequences of even a small tinkering of the ACA could have enormous implications.”

In 2012 the Supreme Court ruled in National Federation of Independent Business v. Sebelius that the ACA’s individual mandate was constitutional because the penalty for not being insured could be considered a tax. But in 2017 Congress passed a tax bill that lowered the penalty to $0, beginning in January 2019. As a result, Texas and other states filed a civil suit claiming the mandate was unconstitutional in 2018. A federal judge in Texas ruled that the individual mandate was unconstitutional and nonseverable, making the entire law unconstitutional—but he did not overturn it. The decision was appealed and eventually made it to the Supreme Court, which is now preparing to hear the case.

A range of different outcomes is possible, according to Katie Keith, a part-time research faculty member at the Center on Health Insurance Reforms at Georgetown University and a principal at the consulting firm Keith Policy Solutions. First, the court will have to determine whether the plaintiffs have standing to challenge the mandate. “If the answer is no, the case kind of goes away,” she says. Second, it must decide whether the mandate is constitutional or not. “Reasonable minds could disagree,” she says, but the case also goes away if the mandate is found to be constitutional.

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