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Inovio Pharma (NASDAQ: INO) up 50% on FDA decision - no Phase III required

This shows how vital FDA decisions about testing and licence paths are in pharma development

Update : 11 Oct 2023, 12:10 PM

Inovio Pharmaceuticals (NASDAQ: INO) stock is up 50% on news from the FDA about the company’s lead candidate. INO stock jumped on the news that Phase III testing will not, in fact, be required. Instead it will be possible to follow an alternate pathway to approval. This reduces costs substantially. It also increases the likelihood of approval of course, that the FDA is willing to allow this other approval path.

The base business at Inovio:”Inovio Pharmaceuticals, Inc., a biotechnology company, focuses on the discovery, development, and commercialization of DNA medicines to treat and protect people from diseases associated with human papillomavirus (HPV), cancer, and infectious diseases. Its DNA medicines platform uses precisely designed SynCon that identify and optimize the DNA sequence of the target antigen, as well as CELLECTRA smart devices technology that facilitates delivery of the DNA plasmids.”

At one point this technology was to be used for a Covid 19 treatment, that rather failed. Then there was a hope that it would work on certain cervical cancer actions: “Eight months later, Inovio is repeating the cycle. The details have changed, but the outline is the same: Inovio is laying off staff because of a setback to a key pipeline program. This time around, the biotech is reducing its head count by 30% in relation to its decision to stop work on VGX-3100 in one indication. In March, VGX-3100, a DNA vaccine encoding human papillomavirus genes, failed to improve lesion regression and viral clearance in a biomarker-based subpopulation of women with high-grade squamous intraepithelial lesions, abnormal cells that form on the cervix and can turn cancerous. Further analysis of the data has persuaded Inovio to stop investing in the indication.”

States and the first commercial product for INOVIO”

inovio

This isn’t a slam dunk even yet but it is a definite step forward. Costs to market will be much lower, approval now has rather good odds. There’s also the point that assuming they do get this one product to market, even for a rare disease, then there’s the platform to continue developing the same underlying technology for other treatments.

Like all pharma development this is still highly risky. But there’s at least some light at the end of that tunnel now.

 

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