Roy Buchanan

Sudan Loganathan

Jay Olson

Liang Cheng

Yi Chen

Gregory Renza

Anish Nikhanj

Cheng Li

Eduardo Martinez-Montes

Edward Tenthoff

Roger Song

- INOVIO announced the publication of **positive Phase 1 proof-of-concept trial results** for its DNA-encoded monoclonal antibodies (DMAbs) for COVID-19 in *Nature Medicine* on **October 21, 2025**.  **[1055726_20251021PH02916:0]** 
- The trial demonstrated **durable and tolerable expression of DMAbs** for up to **72 weeks** in all **39 participants**, with no immune rejection detected across approximately 1,000 blood samples.  **[1055726_20251021PH02916:0]** 
- The most common side effects were mild, temporary injection site reactions, and **no serious adverse events (SAEs) related to the study drug** were reported.  **[1055726_20251021PH02916:0]** 
- DMAbs were detected in **100% of evaluable participants**, confirming functional activity and effective target binding, with serum concentrations reaching a peak of **1.61 µg/mL**.  **[1055726_20251021PH02916:0]** 
- INOVIO's Chief Scientific Officer highlighted the **breakthrough potential of DMAbs** as a long-acting, scalable, and tolerable alternative to traditional monoclonal antibodies for a broad range of diseases.  **[1055726_20251021PH02916:0]**

INOVIO Publishes Positive Phase 1 DMAb Trial Results in Nature Medicine

- INOVIO has begun the rolling submission of its Biologics License Application (BLA) for **INO-3107**, a treatment for **Recurrent Respiratory Papillomatosis (RRP)** in adults, with the FDA agreeing to the timeline.  **[1055726_20250826PH58699:0]** 
- The company aims to complete the BLA submission in the coming months and seeks **priority review**, targeting FDA file acceptance by the **end of 2025**.  **[1055726_20250826PH58699:0]** 
- **INO-3107** holds **Orphan Drug** and **Breakthrough Therapy** designations from the FDA, enabling submission under the accelerated approval program based on Phase 1/2 trial data.  **[1055726_20250826PH58699:1]** 
- In the Phase 1/2 trial, **72%** of patients saw a **50-to-100% reduction** in surgeries after one year, increasing to **86%** after two years for a subset of participants, with **half** of those requiring no surgeries.  **[1055726_20250826PH58699:1]**

Inovio begins rolling BLA submission for INO-3107

INOVIO PHARMACEUTICALS (INO)