Genprex Announces First Patient Dosed in Phase 2a Expansion of Acclaim-1 Clinical Study of Reqorsa® Therapy in Combination with Tagrisso® to Treat Non-Small Cell Lung Cancer
- Completion of Phase 2a expansion study by the end of 2024
- FDA Fast Track Designation for the Acclaim-1 study
- Promising efficacy results observed in Phase 1 portion of the clinical trial
- Extended progression free survival seen in patients treated with REQORSA
- REQORSA being evaluated in three clinical trials for NSCLC and SCLC
- None.
The recent enrollment and dosing of the first patient in Genprex's Phase 2a expansion study of REQORSA® Therapy in combination with Tagrisso® represents a significant advancement in the treatment of non-small cell lung cancer (NSCLC). The prior Phase 1 results, indicating tolerability and potential efficacy, are promising for a disease known for its limited treatment options post-progression. REQORSA's mechanism, presumably involving gene therapy, could offer a novel approach to NSCLC management, especially for patients who have progressed on first-line treatments like Tagrisso®.
Partial remission and extended progression-free survival (PFS) in patients at varying dose levels suggest that REQORSA may have a dose-responsive effect, which is a crucial factor in determining optimal dosing strategies for maximizing patient outcomes. The focus on PFS as a primary endpoint aligns with the goal of improving the quality of life by extending the period patients live without disease progression. However, it is essential to await the completion of Phase 2a and subsequent Phase 2b trials to confirm these preliminary findings and to better understand the toxicity profile when used in a larger cohort.
Genprex's announcement of the Phase 2a expansion study's progression is a noteworthy development for stakeholders. REQORSA's Fast Track Designation by the FDA underscores its potential to address an unmet medical need. This status often expedites the review process, potentially leading to quicker market entry, subject to positive trial outcomes. It is crucial to monitor interim analysis, expected in 2025, as it will provide investors and medical professionals with data on efficacy and safety, which could influence the company's valuation and strategic partnerships.
REQORSA's evaluation in three separate clinical trials for both NSCLC and SCLC and the additional FDA Orphan Drug Designation for the SCLC program, highlight the strategic approach of Genprex to target multiple facets of lung cancer therapeutics. For investors, these designations may signal a competitive edge and market exclusivity benefits, which can be financially advantageous. However, the success of REQORSA is still contingent on forthcoming clinical outcomes and the biotechnology sector's inherent risks should be factored into any financial analysis.
The progression into the Phase 2a expansion study of REQORSA Therapy by Genprex is a pivotal event that may influence the company's market positioning. The NSCLC market is highly competitive, with several established players, but the introduction of novel gene therapies like REQORSA could disrupt current treatment paradigms. The combination therapy approach, leveraging the established efficacy of AstraZeneca's Tagrisso®, may enhance the marketability of REQORSA if the clinical trial results continue to show promise.
Investors should note that the clinical success of REQORSA could lead to partnership opportunities, licensing deals, or even acquisition interest from larger pharmaceutical companies looking to expand their oncology portfolios. The anticipation of interim analysis results in 2025 may also lead to increased stock volatility as the market reacts to new data releases. It is important to observe the industry's response to REQORSA's clinical progression, as it may set precedents for future gene therapy treatments in oncology.
Expects to Complete Enrollment of Phase 2a Expansion Study by the end of 2024
Acclaim-1 Study Has FDA Fast Track Designation
"We are encouraged by the very promising Phase 1 results in the Acclaim-1 trial, which demonstrated the combination of REQORSA and Tagrisso was well tolerated at all three dose levels with evidence of efficacy observed in patients with non-small cell lung cancer (NSCLC) whose disease has progressed on Tagrisso," stated Mark Berger, Chief Medical Officer of Genprex. "We are excited to begin the Phase 2a expansion portion of Acclaim-1, which will examine the toxicity profiles of different cohorts as well as efficacy and other clinical endpoints."
Data from the Phase 1 dose escalation portion of the Acclaim-1 study were presented at the 2023 AACR-NCI-EORTC International Conference for Molecular Targets and Cancer Therapeutics Meeting in October 2023. The data reported results from twelve patients with advanced, epidermal growth factor receptor (EGFR) mutant NSCLC whose disease progressed after Tagrisso treatment. REQORSA was generally well tolerated, as there were no dose limiting toxicities.
While the Phase 1 portion of the clinical trial was designed primarily to assess safety, promising efficacy results were also observed. One patient at the 0.06 mg/kg dose level, previously treated with carboplatin, pemetrexed, and Tagrisso, had a partial remission (PR) by investigator evaluation and treatment is now ongoing in the trial after 28 cycles, which is approximately 19.5 months. Another patient who is at the 0.09 mg/kg dose level, previously treated with Tagrisso, had stable disease and treatment was ongoing after 14 cycles, or approximately 10 months. And a third patient previously treated with cisplatin, pemetrexed, carboplatin, and Tagrisso at the 0.12 mg/kg dose level has stable disease and is continuing to receive REQORSA after 14 cycles, or approximately 10 months. The extended progression free survival (PFS) of each of these patients is consistent with long-term PFS seen in several patients in prior early stage clinical trials of REQORSA, and is not expected with treatment with Tagrisso alone after progression on Tagrisso1. PFS is the primary endpoint of both the Phase 2a expansion portion and the Phase 2b randomized portion of the Acclaim-1 study.
"Advancing Acclaim-1 marks an important milestone for Genprex. We are proud of the progress we have made thus far and are encouraged by REQORSA's potential to improve outcomes for patients battling NSCLC. We look forward to an interim analysis from the Phase 2a study in 2025 and expect those results will further validate our novel gene therapy approach to treating lung cancer patients," said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex.
REQORSA, the Company's lead product candidate, is being evaluated in three clinical trials as a treatment for NSCLC and small cell lung cancer (SCLC). Each of the three lung cancer clinical programs has received a Fast Track Designation from the
About Acclaim-1 Clinical Trial
The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company's lead drug candidate, REQORSA, in combination with Tagrisso in patients with late-stage NSCLC with activating epidermal growth factor receptor ("EGFR") mutations whose disease progressed after treatment with Tagrisso.
The Phase 1 dose escalation portion of the Acclaim-1 trial has been completed. The Phase 2a expansion portion of the study is expected to enroll approximately 66 patients, half of whom will have received only Tagrisso treatment and the other half will have received Tagrisso treatment and chemotherapy, to determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. There will be an interim analysis following the treatment of 19 patients in each cohort. The Phase 2b randomized 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 platinum-based chemotherapy. The primary endpoint of the Phase 2b 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 28 events.
About Reqorsa® Therapy
REQORSA® (quaratusugene ozeplasmid) for NSCLC and SCLC consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules (Genprex's ONCOPREX® Nanoparticle Delivery System) with a positive electrical charge. REQORSA is injected intravenously and specifically targets cancer cells, which generally have a negative electrical charge. REQORSA is designed to deliver the functioning TUSC2 gene to cancer cells while minimizing their uptake by normal tissue. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells.
Genprex's strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA's unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.
Tagrisso® is a registered trademark of AstraZeneca plc.
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 systemic, non-viral Oncoprex® Nanoparticle Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.
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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 for the year ended December 31, 2022.
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: Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications; the timing and success of Genprex's clinical trials and regulatory approvals; 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, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex's commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up 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.
Genprex, Inc.
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1. Cortellini A, Leonetti A, Catino A, et al. Osimertinib beyond disease progression in T790M EGFR-positive NSCLC patients: a multicenter study of clinicians' attitudes. Clin Transl Oncol. 2020;22(6):844-851. doi:10.1007/s12094-019-02193-w
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