INO-3107 is an investigational DNA medicine candidate for recurrent respiratory papillomatosis (RRP) associated with HPV-6 and HPV-11. Clinical data from a Phase 1/2 trial showed reductions in post-treatment surgery burden in many participants. The program has FDA Breakthrough Therapy and Orphan Drug designations and was being prepared for BLA submission under accelerated approval pathways.
Class action lawsuits allege securities violations by Atara Biotherapeutics and Inovio Pharmaceuticals related to FDA submissions. Atara faces claims over manufacturing issues with its tabelecleucel BLA, while Inovio is accused of misleading statements about INO-3107 regulatory timelines and manufacturing deficiencies.
Inovio Pharmaceuticals faces a class action lawsuit alleging false statements about manufacturing deficiencies affecting its INO-3107 drug candidate. The lawsuit claims the company exaggerated its ability to file a BLA by mid-2024 and misled investors about accelerated FDA review prospects. Following FDA acceptance for standard rather than accelerated review, Inovio's stock dropped 24.45%.
Inovio Pharmaceuticals trades as a speculative micro-cap biotech on NASDAQ, with DNA medicine candidates in oncology and infectious disease facing binary clinical risks and ongoing capital needs.
Multiple law firms have filed securities class actions against Inovio Pharmaceuticals after the FDA accepted its INO-3107 BLA for standard rather than accelerated review, following earlier manufacturing delays with the CELLECTRA device.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT04398433 |
INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP) |
COMPLETED | PHASE1/PHASE2 |
