Genprex Expands Clinical Trial Sites for Acclaim-3 Clinical Study of Reqorsa® Therapy in Combination with Tecentriq® to Treat Small Cell Lung Cancer
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Insights
The expansion of clinical trial sites for Genprex's Acclaim-3 study is a significant development in the field of oncology, particularly for extensive-stage small cell lung cancer (ES-SCLC), an area with high unmet medical needs. The addition of multiple sites through a collaboration with a network of community-based oncology practices could potentially enhance patient enrollment rates. This is vital for the timely advancement of clinical trials, as patient recruitment is often a bottleneck in the drug development process.
From a medical research perspective, the combination therapy of Reqorsa and Tecentriq represents a novel approach in ES-SCLC treatment. The re-expression of tumor suppressor genes, such as TUSC2, could potentially address the underlying genetic dysfunctions in SCLC. Given that a high percentage of SCLCs lack TUSC2 protein expression, this therapy could fill a significant gap in the current treatment landscape. The FDA Orphan Drug and Fast Track Designations underscore the urgency and potential of this therapy to address a critical need.
For investors and stakeholders in Genprex, the strategic collaboration to expand clinical trial sites is a positive indicator of the company's commitment to accelerating its clinical program. The potential market impact of Reqorsa, if successful, is substantial given the orphan drug designation which often comes with benefits such as market exclusivity, tax credits and waiver of certain regulatory fees. These incentives can enhance the commercial viability of the drug.
Furthermore, the partnership with a network of oncology practices is a strategic move that could improve access to the trial for patients, which may lead to a more diverse patient population and potentially more robust data. This could be a significant advantage in the competitive landscape of oncology therapeutics. The company's ability to leverage existing relationships, as indicated by their previous collaboration on the Acclaim-1 clinical trial, suggests an efficient use of resources and a potentially expedited path to market.
The announcement from Genprex may have implications for its financial health and stock performance. The progression of the Acclaim-3 study into multiple new sites indicates a scaling of operations that can be seen as a growth signal by the market. The partnership with community-based oncology practices not only aids in patient enrollment but also helps in mitigating the high costs associated with clinical trials by potentially reducing the time to market for Reqorsa.
Investors should note, however, that the biotechnology sector is highly volatile and the outcomes of clinical trials are uncertain. The success of the Acclaim-3 study is pivotal for Genprex's future revenue streams and market capitalization. The stock market's response to such announcements is often speculative and while the long-term benefits could be substantial, the short-term financial implications are tied to the perceived success of the ongoing clinical trials and subsequent regulatory approvals.
Multiple clinical trial sites to be opened under collaboration with large network of community-based oncology practices
Acclaim-3 Study Supported by FDA Orphan Drug and Fast Track Designations
"With the majority of oncology patients treated by community-based oncology practices, this collaboration to expand our Acclaim-3 clinical study to additional trial sites is important as it may accelerate patient enrollment, provide access to our innovative clinical trial treatment for patients outside of major urban or academic settings, broaden the geographic reach of our study to more ES-SCLC patients in need and potentially benefit ES-SCLC patients who currently have limited benefit from existing treatment options," said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex. "This collaboration leverages the broad network of oncologists and enables patients to access our promising treatment at the office of their primary oncologist, while allowing Genprex to more efficiently and expeditiously accelerate our Acclaim-3 clinical trial."
ES-SCLC is an aggressive form of lung cancer that is presently incurable. ES-SCLC has a median progression free survival (PFS) of 5.4 months from the start of initial therapy. However, once patients start receiving maintenance therapy with Tecentriq they have a median PFS of only 2.6 months. The combination of REQORSA and Tecentriq as maintenance therapy may provide a new therapeutic option for the treatment of small cell lung cancer (SCLC).
Genprex has a novel cancer treatment platform that re-expresses tumor suppressor genes in cancers. Tumor suppressor genes are often deleted or inactivated early in the process of cancer development. REQORSA, the Company's lead drug candidate, contains a plasmid that expresses TUSC2, a tumor suppressor gene protein. Nearly
"We look forward to continuing our relationship with this large, nationwide network of oncology practices for our Acclaim-3 clinical trial in SCLC, which is the same partner we used for our Acclaim-1 clinical trial in NSCLC," said Mark Berger, M.D., Chief Medical Officer at Genprex. "Based on the success we experienced in patient enrollment from our other lung cancer clinical trial, we believe this collaboration will enhance our patient enrollment for Acclaim-3 and help us to expeditiously begin treating patients in need."
About the Acclaim-3 Clinical Trial
The Acclaim-3 clinical trial is a Phase 1/2 open-label, dose escalation and clinical response study of maintenance therapy evaluating Reqorsa® in combination with Tecentriq in patients with ES-SCLC. The Acclaim-3 clinical trial will enroll patients who did not develop tumor progression after receiving Tecentriq and chemotherapy as standard initial treatment, and who are therefore eligible for maintenance therapy.
The Phase 1 dose escalation portion of the Acclaim-3 clinical study was initially expected to enroll up to 12 patients at three to five
The primary endpoint of the Phase 2 portion of the trial is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq treatment in patients with ES-SCLC. Patients will also be followed for survival. A Phase 2 futility analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up.
Genprex has received
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® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. 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-002 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, 2023.
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.
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