Inovio Pharmaceuticals Inc. (NASDAQ:INO) has responded to questions from the FDA regarding INO-4800 and the Cellectra vaccine delivery device. The FDA had imposed a partial hold to Phase 2/3 clinical trials of the company’s experimental DNA COVID-19 vaccine candidate in late September.
Inovio expects a response from the FDA in 30 days
The FDA now has 30 days to respond after receiving the answers from Inovio to inform the company if it can progress with late-stage trials of the INO4800 vaccine. Although Inovio didn’t say exactly what the answers were, the company’s statement indicated that they are looking forward to a response from the FDA. The company is preparing for a planned Phase II/III clinical trial of the COVID-19 vaccine candidate. It is important to note that the partial hold of the clinical trial was not a result of the occurrence of any adverse events related to the expansion of the ongoing Phase I study. The study has continued and doesn’t affect the advancement of the company’s other product candidates currently in development.
The company reported a delay of the planned Phase II/III INO-4800 study on September 28 because of additional questions raised by the FDA. The FDA raised questions regarding the investigational COVID-19 vaccine candidate and the company’s Cellectra 2000 device employed in the delivery of INO-4800. Inovio is among the over 125 pharmaceutical companies across the globe that are developing a potential COVID-19 vaccine. The company had hoped to commence a late-stage clinical study by the end of September.
Other companies also saw a halt of clinical trials
Other pharmaceutical companies such as Pfizer Inc. (NYSE:PFE), Johnson & Johnson (NYSE:JNJ), and AstraZeneca (NYSE:AZN) are also developing COVID-19 vaccines. AstraZeneca and JNJ also had to temporarily halt their late-stage clinical trials due to subjects’ unexplained illness. Independent committees and regulators have since determined that the trials are safe to resume.
Inovio’s DNA-based vaccine candidate was developed in partnership with Wistar Institute in Philadelphia. The proprietary Cellectra delivery device delivers the vaccines through an electrical pulse to the skin.