(Havre) – The Montana University’s Center for Translational Medicine is developing a vaccine for Fentanyl and Heroin. New Media Broadcasters talked with Director Jay Evans about what the vaccine is.
“No, absolutely its the vaccine program that we started a couple of years ago with a collaborator fro the university of Washington named Marco Pravetoni and he’s been working in this area for about 10 years of addiction vaccines. So, we developed a vaccine that allows us to generate antibodies against the drugs, either heroin or fentanyl, and those antibodies generated by the vaccine is when the subject then takes the drug will bind the drug in the blood stream and prevent it from crossing the blood brain barrier and there for you get no effect from fentanyl or heroin after taking the vaccine. So, the vaccine will help people quit and also prevent accidental overdose in those people in high risk of having accidental exposure.”
He continues by talking about the inspiration for the vaccine.
“The inspiration is that obviously there’s a really high medical need. each year here in the U.S. over a hundred thousand people are dying of overdose primarily from these synthetic opioids although it doesn’t receive the attention that things like covid or flu, or some of the other traditional vaccine targets you think about, but in reality, it’s not much different than developing a vaccine to an infectious disease. its an area we’ve been in for a long time a number of years ago we were involved in some clinical trials on a nicotine vaccine which used almost identical technology but because nicotine bloodstream concentrations are really high it take an extremely high antibody titer to be effective and promote nicotine or smoking cessation where as something like heroin or fentanyl the drug/blood stream concentrations are extremely low for it to be lethal and there for you don’t need as high antibody titer which is a much more achievable target.”
He also adds when they began working on the vaccine.
“Well, we’ve been doing vaccine research in our group for nearly 30 years Marco Pravetoni at the university of Washington has been working on ways to generate immune response against haptens which are these drugs like heroin, or fentanyl, or cocaine or nicotine or others. He’s been working on that for about 10 years, our group has been working specifically on the fentanyl, heroin vaccine for about 2 and a half years with Marco and our group specializes in both vaccine formulation in ways to make the immune response stronger and more durable by adding stimulants. So, his expertise in designing the actual haptens, what we call the fentanyl mimetic, that the immune system is going to respond to combined with our experience in formulating vaccines and immune stimulants together make a pretty powerful combination for developing a new vaccine targeting fentanyl.”
Jay goes on by talking about when they will reach human clinical trials.
“We hope to be in human clinical trials in January or February of 2024. We’re just now finishing up the manufacturing of the drug product to the specifications required by the FDA for use in humans and now were initiating our final toxicology tapping whihc is also require to make sure that the vaccine that your putting in people is also safe. we expect those will finish up during this fall, we’ll submit our initial drug application or IND to the FDA. Hopefully get approval around the end of the year or that first part of January that will initiate our phase 1 clinical trials.”
He finishes by talking about what’s next for his team once the vaccine is complete.
“So, we’re a large vaccine research team so we have programs in covid, monkey pox, influenza, pertussis, pseudomonas, e-coli, an oncology vaccines as well as immuno therapy and auto immunity. So, this is one of several vaccine clinical trials we have planned in the next two to three years, so once the fentanyl and heroin vaccine phase ones are done, we actually expect that in 2025 we’ll probably have an influenza super seasonal or universal influenza vaccine trial entering phase one after this one. So, we have a number of products lined up to move to clinic in the next years.”
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