INOVIO’s INO-3107 BLA Accepted with October 2026 PDUFA Date
FDA accepted INOVIO’s BLA for INO-3107 under the Accelerated Approval Program with a PDUFA date of October 30, 2026, though it flagged potential eligibility issues. The company published Phase 1/2 and long-term safety data showing T-cell induction and reduced surgeries, and launched a GBM trial collaboration with Akeso.
1. BLA Acceptance and FDA Review
In December 2025, the FDA accepted the BLA for INO-3107 under the accelerated approval program, setting a PDUFA target date of October 30, 2026. The agency noted potential eligibility issues for accelerated approval and agreed to schedule a meeting to discuss the appropriate review pathway.
2. Clinical and Safety Data Publications
INOVIO published Phase 1/2 trial results showing that INO-3107 induced new populations of airway-homing T cells correlated with significant reductions in surgical interventions. A retrospective safety study demonstrated sustained clinical benefit beyond 12 months, with most patients requiring fewer procedures after treatment.
3. GBM Collaboration and Next-Gen Programs
The company signed a clinical trial collaboration and supply agreement with Akeso to evaluate INO-5412 in combination with cadonilimab in a Dana-Farber Cancer Institute-sponsored GBM Phase 2 adaptive trial. It also advanced proof-of-concept data for DNA-encoded monoclonal antibodies and presented DPROT Factor VIII preclinical results at a global hemophilia forum.
4. Commercial Readiness and Financial Planning
INOVIO conducted market research to shape a differentiated product profile, developed pricing and go-to-market strategies, and selected logistics, distribution, and specialty pharmacy partners. The company is prioritizing cash discipline and resource allocation to extend its runway toward a potential commercial launch in October 2026.