#United States #Austin #Genprex #Reqorsa #TAGRISSO

Promising Outcomes from Genprex's Acclaim-1 Trial

Genprex, Inc., based in Austin, Texas, has recently made headlines with the publication of results from its Acclaim-1 Phase 1 clinical trial in the journal Clinical Lung Cancer. This study investigates the effects of Reqorsa® Gene Therapy, also known as quaratusugene ozeplasmid, used in combination with the drug Tagrisso® (osimertinib) for patients suffering from advanced non-small cell lung cancer (NSCLC). As a clinical-stage gene therapy company, Genprex is dedicated to creating transformative therapies, and this publication marks a significant milestone in their efforts.

Details of the Acclaim-1 Trial

The Acclaim-1 trial is designed as an open-label, multi-center study primarily focusing on patients with late-stage NSCLC, specifically those who have activating epidermal growth factor receptor (EGFR) mutations and have seen their disease progress following treatment with osimertinib alone or alongside other therapies. The initial safety assessment in the trial revealed promising results, showing no dose-limiting toxicities (DLTs) and establishing a recommended Phase 2 dose of 0.12 mg/kg.

With a total of 12 patients treated in this study, it became evident that Reqorsa, when combined with osimertinib, exhibited potential for efficacy. Notably, three patients experienced an extended time to disease progression, highlighted by one case where a patient maintained a partial response for over 32 months while undergoing treatment.

Encouraging Efficacy and Safety Profile

Ryan Confer, the President and CEO of Genprex, expressed his optimism about the results, asserting that Reqorsa represents a novel approach in the battle against lung cancer, bringing both a strong safety profile and early indications of effectiveness. The clinical trial's data suggests that the combination therapy could revolutionize treatment options for patients who have limited alternatives after failing previous therapy lines.

The absence of DLTs during the trial is promising; however, some patients did experience infusion-related reactions, which included muscle aches, fever, and chills. These reactions were managed effectively with common medications such as prophylactic steroids and acetaminophen, showcasing the manageable nature of the treatment's side effects.

Patient Cases Illustrating Potential

Further analysis of individual patient outcomes sheds light on the potential efficacy of the combination therapy. For instance:

• - Patient A: Treated at the 0.06 mg/kg dose level, had a partial remission after being treated with carboplatin, pemetrexed, and osimertinib. Remarkably, this patient continued treatment for 47 cycles over 32 months and is still participating in the trial after more than three years.
• - Patient B: Involved at the 0.12 mg/kg level, who previously underwent treatment with cisplatin and others, experienced stable disease for 24 months before eventual disease progression.
• - Patient C: At the 0.09 mg/kg treatment level, this patient had stable disease after 14 cycles for approximately 10 months before showing progression.

These cases illustrate extended Progression-Free Survival (PFS), a notable outcome that typically wouldn't be expected solely from osimertinib therapy after disease progression.

Conclusion

Genprex's dedication to developing life-altering therapies for both cancer and diabetes remains resolute. The promising results from the Acclaim-1 trial not only provide hope for NSCLC patients who have limited options but also pave the way for further innovative treatments in oncology. As the scientific community takes notice, Genprex continues to commit to its mission, supported by data that can significantly impact patient care and outcomes in fighting aggressive lung cancer. Investors and stakeholders are encouraged to stay informed with ongoing developments through Genprex’s official communications and social media channels.