Inovio Pharmaceuticals (INO) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Company and technology overview

• Focused on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases, with INO-3107 as the lead candidate for recurrent respiratory papillomatosis (RRP).

• INO-3107 BLA accepted by FDA under Accelerated Approval Program, with a PDUFA target date of October 30 and Orphan Drug and Breakthrough Therapy designations.

• Manufacturing established at commercial scale for DNA component and in-house for delivery device.

• DNA medicines platform enables strong T-cell immune responses and protein production, with proprietary CELLECTRA device for delivery.

• Platform versatility allows for both immunotherapy and therapeutic protein applications.

Clinical data and product profile

• INO-3107 targets HPV 6 and 11, aiming to reduce the need for repeated surgeries in RRP patients.

• Clinical data show 72% of patients had a 50–100% reduction in surgeries in year one, improving to 86% in year two.

• 28% of patients required no surgeries in year one, increasing to 50% in year two.

• Well-tolerated with mostly transient injection site reactions and no discontinuations.

• Office-based administration, no ultra-cold chain required, and no need for surgery during treatment distinguish it from competitors.

Regulatory and competitive landscape

• FDA granted standard review instead of priority review; company believes INO-3107 meets criteria for accelerated approval.

• Competitor product received full approval, influencing FDA's stance on accelerated approval eligibility.

• Company submitted an Assessment Aid to FDA and awaits a meeting to discuss review pathway.

• Revised confirmatory trial design submitted to FDA, shifting from placebo-controlled to single-arm study.

• European regulators require two placebo-controlled trials for approval, creating a disconnect with U.S. requirements.