INOVIO is a clinical-stage biotechnology company developing and commercializing DNA medicines for HPV-related diseases, cancer, and infectious diseases. Its platform combines DNA plasmids with the CELLECTRA delivery system to generate targeted immune responses.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05781542 |
Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV |
COMPLETED | PHASE1 |
| NCT05430958 |
Safety, Tolerability and Immunogenicity of INO-4800 for COVID19 in Healthy Volunteers |
WITHDRAWN | PHASE1 |
| NCT05293249 |
dMAbs for Prevention of COVID-19 |
COMPLETED | PHASE1 |
| NCT04906629 |
INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees |
COMPLETED | PHASE1 |
| NCT04642638 |
Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure |
TERMINATED | PHASE2/PHASE3 |
| NCT04588428 |
Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers |
COMPLETED | PHASE2 |
| NCT04447781 |
Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19 |
COMPLETED | PHASE1/PHASE2 |
| NCT04398433 |
INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP) |
COMPLETED | PHASE1/PHASE2 |
| NCT04367675 |
INO 5401 Vaccination in BRCA1/2 Mutation Carriers |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT04336410 |
Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers |
COMPLETED | PHASE1 |
