MedPath

INO-3112

Generic Name
INO-3112

INOVIO Advances DNA Medicine Pipeline with Focus on INO-3107 BLA Submission for RRP

• INOVIO plans to submit a Biologics License Application (BLA) to the FDA for INO-3107 by mid-2025, seeking priority review for recurrent respiratory papillomatosis. • Retrospective data showed that 50% of RRP patients treated with INO-3107 achieved complete response, requiring no surgery two to three years post-treatment. • INOVIO aims to initiate a confirmatory trial for INO-3107 at approximately 20 U.S. academic centers, enrolling around 100 patients. • The company is progressing with its commercial readiness plans, targeting a potential launch of INO-3107 by the end of 2025, pending regulatory approval.

Iparomlimab/Tuvonralimab Plus Chemotherapy Shows Promise in Recurrent/Metastatic Cervical Cancer

• Updated phase 2 DUBHE-C-204 trial data shows iparomlimab/tuvonralimab with chemotherapy, with or without bevacizumab, yields a 75.9% objective response rate in recurrent/metastatic cervical cancer. • The combination therapy demonstrated a disease control rate of 98.3% and a median progression-free survival of 15.1 months in the efficacy-evaluable population. • Survival benefits were observed regardless of PD-L1 CPS status, suggesting broad applicability of the iparomlimab/tuvonralimab combination in this patient population. • A phase 3 trial is ongoing to further evaluate the efficacy and safety of iparomlimab/tuvonralimab plus chemotherapy with or without bevacizumab in this setting.

Inovio's SWOT Analysis: Biotech Stock Faces Manufacturing Hurdles Amid Pipeline Progress

Inovio Pharmaceuticals, Inc., a biotechnology company focused on developing treatments for infectious diseases and cancer, is navigating through clinical advancements and operational challenges. Despite a promising product pipeline, including its lead program for recurrent respiratory papillomatosis (RRP), the company faces manufacturing setbacks that have delayed its regulatory timeline. Inovio's financial stability is under scrutiny as it burns through cash reserves, despite having a healthy current ratio. The company's future success hinges on resolving manufacturing issues, advancing its clinical trials, and navigating the competitive biotech landscape.
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