Genprex Doses First Patient in Acclaim-3 Clinical Study of Reqorsa® Immunogene Therapy in Combination with Tecentriq® to Treat Small Cell Lung Cancer
Genprex announced the first patient dosing in its Phase 1 Acclaim-3 clinical study of Reqorsa Immunogene Therapy in combination with Tecentriq to treat extensive-stage small cell lung cancer (ES-SCLC). This trial, which aims to determine the maximum tolerated dose for a Phase 2 expansion expected in the second half of 2024, is supported by FDA Orphan Drug and Fast Track designations. Genprex highlighted the poor prognosis of ES-SCLC and the benefits of current treatments, emphasizing the potential of their therapy. Positive outcomes from the Phase 1 Acclaim-1 study in non-small cell lung cancer have enabled an accelerated timeline for Acclaim-3.
- First patient dosed in Phase 1 Acclaim-3 study, showing progress in clinical trials.
- FDA Orphan Drug and Fast Track designations for the therapy could expedite development and approval processes.
- Accelerated timeline due to favorable Phase 1 Acclaim-1 study results in non-small cell lung cancer.
- Potential for improved clinical efficacy due to the re-expression of the TUSC2 tumor suppressor gene.
- Phase 1 study is only starting, meaning the therapy is still in early stages of development.
- Current treatments for ES-SCLC have benefits, highlighting the high-risk nature of the disease treatment market.
- The timeline for initiating Phase 2 is still conditional on successful completion of Phase 1.
- No financial or revenue data provided, limiting the assessment of the company's financial health.
Insights
The announcement from Genprex about dosing the first patient in their Acclaim-3 clinical study is noteworthy. The therapy, REQORSA, in combination with Tecentriq, targets extensive-stage small cell lung cancer (ES-SCLC), a form of cancer with very limited treatment options and poor prognosis.
By re-expressing the TUSC2 protein—a tumor suppressor gene that nearly 100% of SCLCs lack—REQORSA has the potential to improve treatment outcomes significantly. Tecentriq is already used as maintenance therapy, but the combination with REQORSA aims to offer a more effective solution. Past studies in non-small cell lung cancer (NSCLC) patients have shown encouraging results, which justifies the expedited timeline for Phase 1 completion by the second half of 2024.
If Phase 1 determines a safe and effective dosage and subsequent phases confirm efficacy, REQORSA could substantially shift the treatment landscape for ES-SCLC. Retail investors should watch for Phase 1 results and any early efficacy signals, which would be pivotal for future valuation.
Genprex's progress on the Acclaim-3 clinical study represents a potential financial inflection point. The FDA Orphan Drug and Fast Track designations not only expedite the approval process but also provide certain market exclusivities and benefits that could translate into significant revenue upon commercialization.
Drug development is capital-intensive and advancing to Phase 2 by late 2024 could potentially attract additional funding or partnerships, given the high unmet need in ES-SCLC treatments. Investors should monitor the company’s financial health to ensure they have the resources to complete ongoing trials while mitigating dilution risks. Success in these trials can lead to substantial market opportunities, given the aggressive nature and high mortality rate of ES-SCLC.
The clinical development of REQORSA in combination with Tecentriq for ES-SCLC is particularly exciting from a medical perspective. The current median progression-free survival (PFS) for ES-SCLC patients is dismally low, with or without Tecentriq. REQORSA aims to alter this by reintroducing TUSC2, a critical tumor suppressor gene absent in nearly all SCLCs.
This gene therapy approach could potentially revolutionize how we treat ES-SCLC if proven effective, given the significant unmet need. Clinical outcomes from Phase 1, such as tolerated dosage and early efficacy signals, will be important in shaping future therapeutic strategies and can offer hope where few options currently exist.
Expects to Initiate the Phase 2 Expansion Study in the Second Half of 2024
Acclaim-3 Study Supported by FDA Orphan Drug and Fast Track Designations
"We are excited to take this next step in our fight against lung cancers as we work to advance an innovative therapy that we believe provides hope to patients suffering with ES-SCLC, an especially aggressive form of lung cancer that has extremely limited treatment options," said Ryan Confer, President and Chief Executive Officer at Genprex. "With a median progression free survival (PFS) of 5.2 months, ES-SCLC has a particularly poor prognosis. Additionally, patients receiving Tecentriq as maintenance therapy have a median PFS of 2.6 months after the start of maintenance therapy. With such limited benefit from current treatments, we believe the combination of REQORSA and Tecentriq can provide a promising new therapeutic option for the treatment of small cell lung cancer."
"The Phase 1 dose escalation portion of the Acclaim-3 study is expected to determine the maximum tolerated dose for the Phase 2 expansion study," stated Mark Berger, M.D., Chief Medical Officer of Genprex. "The favorable results from our Phase 1 Acclaim-1 study in non-small cell lung cancer (NSCLC) enabled us to shorten the Phase 1 portion of Acclaim-3. This should allow us to complete the Phase 1 portion of the study during the second half of 2024 and to advance more quickly into the Phase 2 expansion portion of Acclaim-3 in the second half of 2024. We look forward to providing study updates as we advance this potentially life-saving therapy to benefit patients battling ES-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 contains a plasmid that expresses TUSC2, a tumor suppressor gene protein. Nearly
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 is expected to enroll up to 12 patients at approximately ten
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 Reqorsa® Immunogene Therapy
Reqorsa® (quaratusugene ozeplasmid) Immunogene Therapy for NSCLC and SCLC consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid-based molecules in a lipoplex form (Genprex's Oncoprex® 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. In addition, REQORSA disrupts the metabolism of cancer cells by decreasing glycolysis and ATP production in cancer cells with decreased TUSC2.
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 current therapies for patients with NSCLC, SCLC, and possibly other cancers.
Tecentriq® is a registered trademark of Genentech, Inc.
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® (quaratusugene ozeplasmid) Immunogene Therapy, 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.
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website, registering for Email Alerts and by following Genprex on Twitter, Facebook and LinkedIn.
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.
Genprex, Inc.
(877) 774-GNPX (4679)
GNPX Investor Relations
investors@genprex.com
GNPX Media Contact
Kalyn Dabbs
media@genprex.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/genprex-doses-first-patient-in-acclaim-3-clinical-study-of-reqorsa-immunogene-therapy-in-combination-with-tecentriq-to-treat-small-cell-lung-cancer-302144415.html
SOURCE Genprex, Inc.
FAQ
What is Genprex's Acclaim-3 study?
When was the first patient dosed in the Acclaim-3 study for GNPX?
What designations has the FDA given to Genprex's Acclaim-3 study?
When is the Phase 2 expansion of the Acclaim-3 study expected to begin?
What is the purpose of the Phase 1 portion of the Acclaim-3 study for GNPX?
