Innovation Pharmaceuticals Inc (IPIX)

[CallMeCrazy]

NIH assisting in development of fungal vaccine

We don’t currently have any vaccines for fungal infections, and as my colleague Keren Landman writes, “it’s not for lack of trying.” But the researchers working on preventive measures say that the rapid spread of Candida auris adds urgency to the mission for a drug-resistant fungal vaccine moonshot.

“There needs to be a vaccine. And it needs to be supported right now,” said Karen Norris, an immunologist at the University of Georgia’s veterinary school, who leads a team developing a potential fungal vaccine.

With the support of the National Institutes of Health, her team is designing a fungal vaccine to be cross-protective against several different fungal pathogens, potentially including Candida auris. They demonstrated in a paper published last year that the vaccine will induce an immune response in animals and particularly those that are immunosuppressed or immunocompromised.

They have yet to test it on humans. A phase one clinical trial would still be more than a year away, and that’s assuming they have the funding to undertake it.

“We are looking at the process for scaling up the manufacturing of this vaccine for development and for safety studies down the road in people,” Norris said. “We are hoping to partner [with the private sector] to advance this at a more rapid pace than where we are right now.”

https://www.vox.com/politics/2023/3/23/23653504/candida-auris-fungus-cdc-vaccine-prevention?fbclid=IwAR2aQEXNIF2m7GBqeH94_rvsJNI-w5eorcRKvE-sbkl_EjkgRWtpEYRqB0Y

NIH should not be confused with NIAID. NIAID is one of the 27 institutes and centers that make up the National Institutes of Health. There is probably more than one institute involved in fungal research, but the above research, IMO, doesn't involve NIAID because of the above-mentioned P-1 funding problems. NIAID develops designated drugs through P-2.

A successful phase 1 is not the end to FDA required safety data. The FDA requires safety data at all stages of drug development and even after the drug is on the market.

The criticisms of all the brilacidin testing reveals a lack of understanding of the drug approval process. Prior to drug approval, the FDA requires reams of all kinds of data.

The turning point for brilacidin will be when NIAID announces a phase1.

This is not a stock for the impatient.