What's Happening?
Genprex, Inc., a clinical-stage gene therapy company, has announced the publication of data from its Acclaim-1 Phase 1 clinical trial in the journal Clinical Lung Cancer. The trial evaluated the Reqorsa® Gene Therapy in combination with Tagrisso® for
patients with advanced non-small cell lung cancer (NSCLC) who have EGFR mutations and have progressed after treatment with osimertinib. The study aimed to assess the safety and efficacy of the therapy, establishing a Recommended Phase 2 Dose (RP2D) of 0.12 mg/kg. The trial showed promising results, with no Dose Limiting Toxicities (DLTs) and early signs of efficacy. Among the 12 patients treated, three experienced prolonged time to progression, including one with a continuing partial response. The therapy was generally well tolerated, with manageable infusion-related reactions.
Why It's Important?
The publication of these trial results is significant as it highlights a potential new treatment avenue for patients with advanced NSCLC, a group with limited options after progression on existing therapies. The promising safety and efficacy profile of Reqorsa® Gene Therapy could pave the way for further clinical development and eventual regulatory approval, offering hope to patients and potentially improving survival rates. This development underscores the importance of innovative gene therapies in addressing unmet medical needs in oncology, particularly for diseases with high mortality rates like lung cancer.
What's Next?
Following the successful Phase 1 trial, Genprex plans to advance to Phase 2, where the efficacy and safety of Reqorsa® Gene Therapy will be further evaluated. The company aims to continue its collaboration with world-class institutions to develop its pipeline of gene therapies. Future steps include seeking regulatory approvals and expanding clinical trials to confirm the therapy's benefits. Stakeholders, including patients, healthcare providers, and investors, will be closely monitoring the progress of these trials and any subsequent regulatory submissions.
