Inovio Receives Positive Feedback from FDA for INO-3107 Trial Results
Biotech company Inovio received positive FDA feedback on its INO-3107 trial results, potentially supporting accelerated approval for groundbreaking DNA medicine. Investor confidence increases.
Troy D. Hanson
October 10, 2023
By Chris Wack
In a recent development, biotechnology company Inovio saw an 8% increase in its shares, rising to 39 cents. This surge came after the company received feedback from the U.S. Food and Drug Administration (FDA) regarding the data obtained from its Phase 1/2 trial of INO-3107. This trial focused on the treatment of recurrent respiratory papillomatosis, a challenging condition.
The FDA provided valuable guidance, suggesting that the data gleaned from the trial could potentially support Inovio's submission of a biological license application (BLA) for review under the FDA's accelerated approval program. Notably, the agency also stated that Inovio's previously planned Phase 3 trial, which was randomized and placebo-controlled, would not be necessary to support this particular BLA submission.
However, the FDA did stipulate that Inovio must conduct a confirmatory trial prior to submitting the BLA for accelerated approval. This requirement aligns with standard FDA filing regulations. It is important to note that the specifics of this confirmatory trial have not yet been finalized.
If successful in obtaining FDA approval, INO-3107 would enjoy the distinction of being the first DNA medicine available in the United States. Furthermore, it would be an exceptional milestone for Inovio, as it would mark the first time that one of their candidates has received regulatory approval.
INO-3107 occupies a prominent position in Inovio's portfolio, representing their lead candidate. It is among three clinical-stage DNA medicine candidates developed by Inovio, all of which specifically target diseases related to the human papillomavirus (HPV).
In conclusion, Inovio's positive interactions with the FDA have resulted in increased investor confidence. The potential approval of INO-3107 holds significant promise for both the company and patients who stand to benefit from this groundbreaking DNA medicine.