Genprex Receives Safety Review Committee Approval to Advance to Highest Dose Group in Phase 1 Portion of Acclaim-3 Clinical Trial of Reqorsa® Gene Therapy in Combination with Tecentriq® in Extensive Stage Small Cell Lung Cancer

Rhea-AI Summary

Genprex (NASDAQ: GNPX) has announced progress in its Acclaim-3 clinical trial for Reqorsa® Gene Therapy combined with Tecentriq® in extensive stage small cell lung cancer (ES-SCLC). The company has completed the 0.09 mg/kg dose group and received approval to advance to the highest dose group of 0.12 mg/kg. Key points include:

- No dose limiting toxicities observed
- A partial remission noted in the first patient treated
- The combination therapy has received FDA Fast Track Designation and Orphan Drug Designation
- Phase 1 dose escalation is expected to complete in the second half of 2024
- Phase 2 expansion will enroll 50 patients at 10-15 U.S. sites

Preclinical data showed the combination therapy provided better tumor control than either agent alone in SCLC mouse models.

Positive

• Approval to advance to highest dose group in Phase 1 trial
• No dose limiting toxicities observed in 0.09 mg/kg dose group
• Partial remission noted in first patient treated
• FDA Fast Track Designation and Orphan Drug Designation received
• Preclinical data shows better tumor control with combination therapy

Negative

• Disease progression observed in first patient after initial partial remission

Insights

Medical Research Analyst

This news is significant for Genprex's REQORSA development program. The Safety Review Committee's approval to advance to the highest dose group (0.12 mg/kg) in the Phase 1 trial indicates a favorable safety profile for REQORSA in combination with Tecentriq for extensive stage small cell lung cancer (ES-SCLC) patients.

Key points:

• No dose-limiting toxicities observed in the 0.09 mg/kg dose group
• A partial remission was observed in the first patient treated, with a 30% decrease in tumor size
• The trial is progressing to the highest planned dose group
• Phase 2 expansion is anticipated to start in H2 2024

This progress is promising for Genprex, especially considering the FDA's Fast Track and Orphan Drug designations for REQORSA in SCLC. However, investors should note that this is still early-stage research and further studies are needed to confirm efficacy and safety.

Financial Analyst

From a financial perspective, this news is positive for Genprex (NASDAQ: GNPX), a small-cap biotech with a market cap of about $890,000. The advancement to the highest dose group in the Phase 1 trial is a de-risking event that could potentially increase investor confidence.

Key financial implications:

• Potential for faster time-to-market if safety profile remains favorable
• Possible increased interest from institutional investors or potential partners
• Reduced cash burn rate if trial progresses efficiently

However, investors should be cautious. Genprex will likely need additional funding to complete clinical development and potential commercialization. The company's small market cap suggests it's a highly speculative investment. While this news is positive, it's important to consider the overall financial health and cash position of the company in relation to its development timeline.

Demonstrated Favorable Safety Profile of REQORSA

AUSTIN, Texas, Oct. 15, 2024 /PRNewswire/ -- 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 that it has completed the 0.09 mg/kg dose group of the Phase 1 dose escalation portion of the Acclaim-3 clinical trial of Reqorsa^® Gene Therapy (quaratusugene ozeplasmid) in combination with Tecentriq^® (atezolizumab) as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC). In addition, the Safety Review Committee (SRC) has approved escalation to the highest dose group of 0.12 mg/kg. The combination of REQORSA and atezolizumab previously received U.S. Food and Drug Administration's (FDA) Fast Track Designation for the treatment of the Acclaim-3 patient population and the FDA has also granted Orphan Drug Designation to REQORSA for the treatment of SCLC.

"We believe the SRC's recommendation to advance to the highest dose group of the Phase 1 portion of the trial is another clinical validation for our REQORSA development program," said Ryan Confer, President and Chief Executive Officer. "We are proud of the achievements so far in the Phase 1 portion of the trial, which has demonstrated a favorable safety profile for REQORSA in the first trial to use REQORSA for SCLC patients. We look forward to continuing to treat these patients while we work toward bringing new therapies to lung cancer patients with unmet medical need."

There were no dose limiting toxicities (DLTs) in this dose group and the SRC recommended moving up to the highest dose group planned in the trial.  As previously announced, the first patient treated in the Phase 1 dose escalation portion of the Acclaim-3 trial had a partial remission, which is defined as at least a thirty percent (30%) decrease in tumor size, from prior to the start of maintenance therapy to the time of the CT scan performed after two cycles of maintenance therapy. A CT scan performed after four cycles of maintenance therapy (three months), confirmed that the patient had a 30% decrease in tumor size in measurable lesions; however, one lesion not previously measurable had grown in size, thus leading to a conclusion of disease progression at that time. As the maintenance therapy consists of REQORSA and Tecentriq, and the patient had already received four cycles of Tecentriq during induction therapy and thus responses to Tecentriq would likely have occurred earlier, the Company believes this suggests that REQORSA may be providing clinical benefit.

The SRC is comprised of three physicians who are principal investigators in the trial. The SRC may recommend that the trial continue at the same dose or at a lower dose, that it escalate to a higher dose, or that the study be terminated altogether due to safety concerns.

In the Phase 1 dose escalation portion of the Acclaim-3 clinical trial, patients are treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The primary endpoint of the Phase 1 escalation portion is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D).    

The Phase 1 portion of the trial has two dose groups: 0.09 mg/kg, which has been completed, and 0.12 mg/kg which will now be enrolled. After the Phase 1 portion is complete, the Phase 2 expansion portion will enroll 50 patients at 10 to 15 U.S sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq 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. The Company continues to anticipate completion of enrollment in the Phase 1 dose escalation portion of the trial and to start the Phase 2 expansion portion in the second half of 2024, dependent on the number of patients needed to be enrolled in the 0.12 mg/kg dose group.

Data presented at the October 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics from studies in humanized mouse models of SCLC show that the combination of REQORSA and atezolizumab provides significantly better control of xenograft tumor growth than either agent alone. The data from these studies also demonstrated increased immune cell infiltration in the tumors with the combination of REQORSA and Tecentriq compared to Tecentriq alone.

About Acclaim-3
The Acclaim-3 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company's lead drug candidate, Reqorsa® Gene Therapy, in combination with Genentech, Inc.'s Tecentriq® (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment.

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^® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's 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, such as REQORSA in combination with other therapies in SCLC; the timing and success of Genprex's clinical trials and regulatory approvals, including, but not limited to, the Phase 1 dose escalation and the Phase 2 expansion portions of the Acclaim-3 trial; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; the effects of any strategic research and development prioritization initiatives, and any other strategic alternatives or other efforts that Genprex takes or may take in the future that are aimed at optimizing and re-focusing Genprex's diabetes, oncology and/or other clinical development programs including prioritization of resources, and the extent to which Genprex is able to implement such efforts and initiatives successfully to achieve the desired and intended results thereof; 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

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SOURCE Genprex, Inc.

FAQ

What is the current status of Genprex's Acclaim-3 clinical trial for REQORSA?

Genprex has completed the 0.09 mg/kg dose group and received approval to advance to the highest dose group of 0.12 mg/kg in the Phase 1 portion of the Acclaim-3 clinical trial for REQORSA in combination with Tecentriq for ES-SCLC.

When is Genprex (GNPX) expected to complete the Phase 1 portion of the Acclaim-3 trial?

Genprex anticipates completing enrollment in the Phase 1 dose escalation portion and starting the Phase 2 expansion portion in the second half of 2024, depending on the number of patients needed for the 0.12 mg/kg dose group.

What were the results of the first patient treated in the Acclaim-3 trial for GNPX's REQORSA?

The first patient treated in the Phase 1 portion of the Acclaim-3 trial had a partial remission, showing a 30% decrease in tumor size after two cycles of maintenance therapy. However, disease progression was observed after four cycles due to growth in a previously unmeasurable lesion.

What designations has the FDA granted to Genprex's REQORSA for small cell lung cancer?

The FDA has granted Fast Track Designation to the combination of REQORSA and atezolizumab for the treatment of ES-SCLC, and Orphan Drug Designation to REQORSA for the treatment of SCLC.