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Genprex, Inc. has announced plans to accelerate the opening of clinical trial sites for the Acclaim-1 trial, which investigates the combination of REQORSA™ and AstraZeneca's Tagrisso® in treating non-small cell lung cancer (NSCLC). Four sites are opening to enroll patients in the Phase 1 portion of the trial, with additional sites anticipated for Phase 2. The trial will evaluate the therapy’s efficacy in patients previously treated with Tagrisso. An interim analysis will be conducted at 25 events, and the Phase 2 primary endpoint is progression-free survival.
Positive
Accelerated opening of four clinical trial sites for Acclaim-1 trial.
Collaboration with community-based oncology practices enhances patient access.
Phase 1 aims to enroll 18 patients to find maximum tolerated dose.
Phase 2 expected to randomize 74 patients for further efficacy study.
Negative
No interim data available yet from ongoing trials.
Potential delays in patient enrollment due to competitive landscape.
Multiple clinical trial sites to be opened under oncology research network collaboration
AUSTIN, Texas--(BUSINESS WIRE)--
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 a plan to accelerate the opening of clinical trial sites for the Acclaim-1 clinical trial which combines the Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid) Immunogene Therapy with AstraZeneca’s Tagrisso®, as a potential innovative treatment for non-small cell lung cancer (NSCLC). Under a collaboration agreement with a large network of integrated, community-based oncology practices, the opening of four clinical trial sites to enroll patients in the Phase 1 portion of Genprex’s Acclaim-1 clinical trial is underway, with an expectation of opening additional sites in the Phase 2 portion of the study.
“We are pleased to target community based oncology practices for the conduct of our Acclaim-1 clinical trial,” said Mark S. Berger, MD, Genprex’s Chief Medical Officer. “Not only does this approach provide cancer patients with access to innovative oncology treatments at the office of their primary oncologist, it also allows Genprex to more readily access patients for the clinical trial and move it forward in a more efficient and expeditious manner. Our Acclaim-1 trial offers a unique opportunity to transform cancer care for patients with advanced lung cancer who have EGFR mutations that are no longer responsive to standard targeted therapies.”
The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA™ Immunogene Therapy, in combination with Tagrisso in patients with late-stage NSCLC whose disease progressed after treatment with Tagrisso. Genprex expects the Phase 1 portion of the Acclaim-1 trial to enroll up to 18 patients in a dose escalation study to determine the maximum tolerated dose of the combination. The Phase 2 portion of the study is expected to enroll approximately 74 patients to be randomized 1:1 to receive either REQORSA and Tagrisso combination therapy or Tagrisso monotherapy. The primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as time from randomization to progression or death. An interim analysis will be performed at 25 events.
In January 2020, Genprex received FDA Fast Track Designation for the Acclaim-1 patient population. Additional information about the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing 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. Genprex’s oncology program utilizes its unique, proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is then administered intravenously, where it is then taken up by tumor cells that express proteins that are deficient. 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 been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso® (osimertinib) for patients with EGFR mutations whose tumors progressed after treatment with Tagrisso. In 2021, the FDA granted Fast Track Designation for REQORSA for NSCLC in combination therapy with Merck & Co’s Keytruda® (pembrolizumab) for late-stage patients whose disease progressed after treatment with Keytruda.
Cautionary Language Concerning Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K and “Part II, Item 1A” of Genprex’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021.
Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex’s clinical trials and regulatory approvals, including the extent and impact of the COVID-19 pandemic; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex’s future growth and financial status; Genprex’s commercial and strategic partnerships including the scale up of the manufacture of its product candidates; and Genprex’s intellectual property and licenses.
These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.
What is the objective of the Acclaim-1 trial by GNPX?
The Acclaim-1 trial aims to evaluate the combination of REQORSA™ and Tagrisso® for treating non-small cell lung cancer in patients whose disease progressed after Tagrisso treatment.
How many patients will be enrolled in the Phase 1 portion of the Acclaim-1 trial?
The Phase 1 portion of the Acclaim-1 trial intends to enroll up to 18 patients.
What is the primary endpoint of the Phase 2 portion of the Acclaim-1 trial?
The primary endpoint is progression-free survival, measured from randomization to disease progression or death.
When did Genprex receive FDA Fast Track Designation for the Acclaim-1 patient population?
Genprex received FDA Fast Track Designation in January 2020 for the Acclaim-1 patient population.
What are the expected outcomes of the Acclaim-1 trial for GNPX?
The trial aims to provide evidence of the efficacy of REQORSA™ in combination with Tagrisso® for patients with advanced NSCLC, which could enhance treatment options for this patient population.
