Gene Therapy Company Announces Positive Clinical Study Results From Lung Cancer Trials
Gene Therapy Company Announces Positive Clinical Study Results From Lung Cancer Trials
Genprex Announces Positive Clinical Study Updates from Acclaim-1 and Acclaim-3 Phase 1/2 Clinical Trials in Lung Cancer.
Disclaimer: This article is intended for informational purposes only. It is not intended as medical advice and should not be taken as such. Please consult with a healthcare professional for medical advice and information.
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Genprex, Inc., a clinical-stage gene therapy company, has recently announced significant updates from its ongoing Acclaim-1 and Acclaim-3 Phase 1/2 clinical trials. These trials are focused on treating non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) respectively. The promising early results are seen as a potentially transformative development in the treatment of these challenging forms of lung cancer.
Genprex's Clinical Trials
Genprex’s lead drug candidate, Reqorsa® (quaratusugene ozeplasmid) Gene Therapy, is at the heart of these clinical trials. Reqorsa is designed to re-express tumor suppressor genes that are often inactivated in cancer cells. The Acclaim-1 trial is investigating the combination of Reqorsa with AstraZeneca's Tagrisso® in patients with late-stage NSCLC who have specific EGFR mutations. Meanwhile, the Acclaim-3 trial is exploring the combination of Reqorsa with Genentech's Tecentriq® as a maintenance therapy for patients with extensive stage SCLC.
The Acclaim-1 clinical trial has been designed to address a critical need for patients with late-stage NSCLC who progress after initial treatment with Tagrisso. Tagrisso is a treatment that targets specific genetic mutations in the cancer cells. However, over time, many patients experience disease progression, necessitating alternative therapeutic strategies.
The trial, which has received Fast Track Designation from the FDA, is structured in multiple phases. In the initial Phase 1 dose escalation portion, two patients have shown prolonged progression-free survival (PFS). One patient has been undergoing treatment with the combination of Reqorsa and Tagrisso for over two years, achieving a partial remission (PR) following the second course of treatment. This patient had previously been treated with both Tagrisso and chemotherapy. The other patient has had stable disease for more than 15 months without progression, continuing on the combination therapy.
Expansion and Focused Enrollment
Following these promising early results, Genprex has decided to refine its focus within the Phase 2a expansion portion of the Acclaim-1 trial. Initially designed to include two cohorts of 33 patients each, the company has decided to limit enrollment to the cohort of patients who have previously received only Tagrisso, excluding those who had also received chemotherapy. This decision is aimed at optimizing resources and focusing on the subgroup most likely to benefit from the Reqorsa treatment.
The Phase 2b portion of the study remains unchanged, where patients will be randomized to receive either the Reqorsa and Tagrisso combination or a platinum-based chemotherapy. An interim analysis will be conducted following the treatment of 19 patients in the Phase 2a expansion portion, anticipated in the first half of 2025. The Acclaim-3 clinical trial is evaluating the combination of Reqorsa and Tecentriq as a maintenance therapy for patients with extensive stage SCLC. This trial also holds an FDA Fast Track Designation and has been granted Orphan Drug Designation for the treatment of SCLC, presenting the significant unmet need in this patient population.
In the Phase 1 dose escalation portion, the first patient exhibited a partial response (PR) after commencing the combination therapy. This response was particularly notable as tumor regression rarely occurs during maintenance therapy with Tecentriq alone. However, after three months, the patient exhibited disease progression as detected by a CT scan. The initial positive response, combined with the fact that this occurred at a lower dose planned for the trial, suggests that Reqorsa may be providing a clinical benefit.
The Role of Biomarkers in Optimizing Treatment
In addition to the updates from the Acclaim-1 and Acclaim-3 trials, Genprex has made strategic decisions to streamline its oncology program. The Acclaim-2 clinical trial, which was evaluating the combination of Reqorsa and Merck & Co.'s Keytruda® in patients with late-stage NSCLC, will cease enrollment of new patients. Current participants will continue to receive treatment until disease progression.
This decision was driven by various factors, including enrollment challenges and competition from numerous other trials targeting the same patient population. By discontinuing the Acclaim-2 trial, Genprex aims to allocate resources more effectively and concentrate efforts on the most promising aspects of its clinical program. Genprex is also collaborating with an academic research partner to identify and develop biomarkers that can help select the patient population most likely to respond to Reqorsa. These biomarkers are crucial for predicting and measuring target engagement and making informed decisions on the progression of drug candidates.
The academic partner is currently analyzing biomarkers that could indicate a lack of response in lung cancer, which could enrich the population of responders in clinical trials. This collaboration aims to enhance patient screening and enrollment, thereby increasing the likelihood of success in the Acclaim studies.
The Science Behind Reqorsa
Reqorsa's mechanism of action involves re-expressing the TUSC2 gene, a tumor suppressor gene that plays a vital role in controlling cell growth and metabolism. In many cancers, including nearly all SCLCs, the TUSC2 gene is either deleted or inactivated. By reintroducing TUSC2 expression, Reqorsa aims to restore the tumor-suppressing functions that have been lost in cancer cells.
Nonclinical studies have shown that re-expressing TUSC2 in combination with immune checkpoint inhibitors like Tecentriq can lead to improved clinical efficacy. This combination approach is being tested in the Acclaim-3 trial and holds promise for enhancing outcomes in patients with extensive stage SCLC. With the positive early results from the Acclaim-1 and Acclaim-3 trials, Genprex is poised to continue advancing its clinical programs. The company is focused on completing the current phases of the trials and moving towards regulatory submissions for Reqorsa.
The strategic decision to concentrate resources on the most promising aspects of its oncology program reflects Genprex’s commitment to bringing new therapies to patients with lung cancer. By leveraging its gene therapy platform and collaborating with research partners, Genprex aims to make significant strides in the fight against cancer. The updates from Genprex's Acclaim-1 and Acclaim-3 clinical trials offer hope for patients with NSCLC and SCLC. The early positive responses to Reqorsa treatment, combined with strategic decisions to optimize the clinical program, position Genprex to make meaningful contributions to oncology therapy. As the trials progress, the potential for Reqorsa to become a new treatment option for lung cancer patients becomes increasingly promising.
Disclaimer: The information provided in this article is for informational purposes only. It is not intended as medical advice and should not be taken as such. Please consult with a healthcare professional for medical advice and information.
We are working endlessly to provide free insights on the stock market every day, and greatly appreciate those who are paid members supporting the development of the Stock Region mobile application. Stock Region offers daily stock and option signals, watchlists, earnings reports, technical and fundamental analysis reports, virtual meetings, learning opportunities, analyst upgrades and downgrades, catalyst reports, in-person events, and access to our private network of investors for paid members as an addition to being an early investor in Stock Region. We recommend all readers to urgently activate their membership before reaching full member capacity (500) to be eligible for the upcoming revenue distribution program. Memberships now available at https://stockregion.net