INOVIO gets FDA nod to use Phase 1/2 data for INO-3107 BLA under accelerated approval; Phase 3 waived

INOVIO PHARMACEUTICALS, INC.

FDA confirmed that completed Phase 1/2 trial data for INO-3107 in RRP can support BLA under accelerated approval; previously planned Phase 3 trial no longer required.
Confirmatory trial must be initiated before BLA submission; design not yet finalized.
If approved, INO-3107 would be first DNA medicine in the US and INOVIO's first commercial product.
Phase 1/2 results: 81.3% (26/32) of patients had fewer surgical interventions; median reduction of 3 surgeries; strong T-cell immune response with durable memory.
Cash runway guidance may change; company plans to provide updated cash guidance on Q3 2023 earnings call in November.

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