“Diagnostics For The Prevention & Treatment Of Disease” w/ James Rolke of Revelation Biosciences

Nathan (1s):
Welcome back radio entrepreneurs, listeners and fans. I’m producer Nathan, Gobes filling in for Jeffery Davis and Jonathan Freedman this morning. Excited to be back with you in the studio. And I’m excited to introduce you to our next guest James Rolke, director and CEO of revelation bio-sciences welcome, James.

James (19s):
Hi Nathan. Thanks for having me.

Nathan (21s):
It’s great. It’s great to have you. Thanks for joining. Why don’t you start by just telling, telling us about revelation bio-sciences overall, we’ll get into your background and what the company’s up to after that, but start by giving the listeners and viewers an overview of the company, if you don’t mind.

James (37s):
Sure. So revelation bias science was founded in may of 2020. We actually started a company at the, you know, just as the COVID-19 pandemic was starting to get going, but we didn’t want to be a COVID-19 specific company that we were, but we wanted to develop products that would have potential as a, as therapies and, and, and, and utility and tools for the pandemic. But again, we wanted it to be pan viral in nature, meaning working across multiple virus types. And so we actually started the company on the diagnostics, the Reverend kit, which is our universal screening tool that gives you a yes, no answer.

James (1m 17s):
It tells you what, if you have a respiratory viral infection period, regardless of virus types. So if you have influenza COVID or some other virus type, it’ll tell you if you have a, if you’re sick or not. In terms of the therapeutics, we, we set out to develop, again, pan viral. We have our flagship program it’s known as rev <inaudible> and that works as well as a, or we’re developing it as both a prevention and a treatment for a respiratory viral infection, regardless of virus type. We also think that the same technology which led to rev TX 99 B, would be useful as a treatment for chronic nasal congestion due to allergies and other underlying conditions.

James (1m 59s):
And then lastly, an earlier stage program called rev, TX to hunter also based on the same platform, technology is useful as a, as an adjunct, an intra-nasal adjunct and intramuscular vaccine to produce an overall better immunization. And that one’s actually becoming frankly very important because it’s, it, it improves the existing intramuscular vaccines. All the COVID vaccines are intramuscular vaccines. And what happens is when you give an intramuscular vaccination, you get a really strong body responses, systemic response, but you don’t get a strong mucosal response, meaning in your nose. And since most viruses enter through the nose, it would be advantageous to have that mucosal protection as well.

James (2m 46s):
And rev TX 200. When you give it concurrently with an intramuscular vaccine will give you the best of both worlds in bold over overall. I’ll give you a better immunization and protection.

Nathan (2m 58s):
Interesting. Well, those are some really exciting products that you guys have, and I definitely have some more questions on those, but before we get into all that, I’d love to hear a little bit about your background. What got you into this? What led you to be leading revelation? Bio-sciences

James (3m 15s):
Sure. So, so my background is I’m actually a chemist, but I’ve been working in the pharmaceutical field for about 30 years. My experience really spans all areas and phases of drug development from discovery all the way through to approval and commercialization. Prior to revelation, I was actually chief scientific officer at LA Jolla pharmaceutical company, where we brought to life saving drugs, <inaudible> for severe hypertension and our designate for malaria, from discovery through approval. And so when, when I left Lloyd, I actually was in the, it was interested in starting a, you know, a new company and COVID-19 occurred.

James (4m 3s):
And it interesting. It’s an actually interesting story. We started the company again on the diagnostic and it was because our chairman, Dr. Jordan, Dr. George Tidmarsh was having a conversation with one of his colleagues at Stanford. And his colleague was pining on the fact that when did breast cancer surgery become elective. And he was, he was, he was really pining on the Zack that there weren’t enough tests to allow people to come in, to have necessary necessary procedures done, you know, in a medical environment. And so we put our heads together and said, well, gee, there’s gotta be a better way. We could develop a universal screening tool that just simply allows one to screen themselves, but you don’t really care what you have cause you, you, you don’t want to go to visit your grandmother in a nursing home for example, or go out if you are influenza, influenza is, is, is a very deadly virus as well.

James (4m 56s):
And so we wanted to develop a universal screening tool that allowed us to, to screen large numbers of people very rapidly. And that led to the, the diagnostic. And I can tell you a little bit more about more of that, about that later on. So yeah, that that’s, that, that’s how I got into starting revelation.

Nathan (5m 18s):
Yeah. I mean, I think maybe a, that would be a good segue to, to talk more about the diagnostic tool, how it works and, and some of the other things you mentioned earlier as well, you know, what stage are each of these at? What stage is the company at overall?

James (5m 37s):
Great question. So, so the diagnostic, all of our products are actually based on measurement or modulation of what’s called the innate immune response. So just very briefly, the innate immune response is our body’s natural first line of defense against any type of infection or, and it works through the upregulation of proteins known as cytokines and chemokine. And so when, when a pathogen, such as a virus enters your nose, it’ll interact with receptors in your nose, activating the innate immune response, which ultimately leads to recruitment of what’s known as the adaptive immune response.

James (6m 19s):
The adaptive immune response is what leads to the production of antibodies. And that’s sort of a little bit of a background, just so your, your, your listeners understand the context of the biology 1 0 1. And so, so the, the, the, the diagnostic is based on measuring the body’s response to an infection. So that’s why it’s able to detect multiple virus types. So we don’t care if you have influenza, or if you have COVID or if you have RSV or insert virus name here, what we actually care about is whether or not you’re sick. And so the way the test works is as you swab the lower portion of your nose, to just an Aries, you take that sample, you apply it to a sample application pad.

James (7m 2s):
It looks very similar to a pregnancy test kit. It’s a, is a lateral flow as a device, you apply it to a sample application pad. You wait 15 minutes. And at the end of 15 minutes, you get a visual readout that says, yes, I have an infection, or no, I don’t have an infection. And so you can, you can see the utility of that, that would allow people to test themselves on a regular basis and make informed decisions about whether or not they can, God, okay, I’m sick today. I probably should stay at home and not spread my germs around, or I’m not sick. I can go about my daily business. And again, you, you, you don’t want to go out if you have the flu any more than you want to go out, if you have COVID. And so then flip, flip.

James (7m 42s):
And so where we are with that is we are actually just to wrap up the diagnostic as this we’ve completed the development work, and we’re in the process of doing the, the, the, the, the final clinical in product evaluation, to be able to fly all for, for marketing approval, which we plan on doing in the early part of 2023, just one other thing on the diagnostic, the, we did some preliminary testing where we, we collected samples from 190 different subjects. And what we showed in that a hundred nineties different subjects is, is that we had a hundred percent correlation with, with PCR, for COVID meaning no one with an act of replicating SARS, cov, two virus was allowed to slip through our tests.

James (8m 29s):
On the contrary, we actually had a 15, or excuse me, a 14% false positive rate. Meaning what it says is our test says you’re sick PCR for COVID says you’re not, but if you then test those people for additional virus types, what you find out is in fact, they are sick. They have the, they have either influenza, a rhino virus or another coronavirus. And so our kit is actually working the way we had intended it. And when we developed it as a universal screening tool,

Nathan (8m 57s):
That makes sense.

James (8m 59s):
So, and then just very, just going on to the, the, the, the therapeutic products. So, same thing, what we, what we set out to do is develop products that stimulate your innate immune response. So it basically creates a biologic shield to infection. And so the way rev, TX 99 works as the active ingredient is a molecule called fad. Fad is short for phosphorolated hex ACLA to dissect, right? That’s a mouthful, but the way it works is it stimulates, it stimulates receptors known as toll, like receptor four, that’s widely expressed in your nasal mucosa. So you give it, you give it intranasally as drops, and you stimulate the toll like receptor for that activates a particular pathway in the innate immune response that leads to the production of multiple protective cytokines, protective cytokines, being interferons, interferon, really to proteins and other protective cytokines and not inflammatory cytokines, which I think if people have heard or read about in the news, which, you know, such as <inaudible> that lead to bad outcomes.

James (10m 7s):
And so we actually conducted a phase one clinical study with rev DX 99 in healthy volunteers, where we looked at not only the safety, but we also had the opportunity to look at the activity of the drug as measured by cytokine up regulation. And what we showed in that study is in fact that the drug is very well tolerated from a safety perspective, there were no significant or serious adverse events. Everything was mild. And then the other thing we showed us is we showed, we showed significant up-regulation of key protective cytokines versus placebo. So based on that, we actually are, we actually have started and actually completed enrollment of a phase two B virus challenge study.

James (10m 50s):
And just so your, your viewers understand what a virus challenge study is. It’s when you have basically healthy volunteers come in and they, they, they volunteer to allow us to make them sick. And so in that particular study, we give rev TX 99 prophylactically. So you give the, you give the drug prior to inoculation with a virus type. And in this particular case where inoculating people with the age three and two influenza virus, and so we’ve completed. And so the outcome from that study, I should say is, as you’re looking for a reduction in the rate duration and severity of the viral infection for those treated with rev, TX 99, versus those treated with placebo.

James (11m 38s):
And again, we have completed that study and we’re actually anticipating the top line results from that study in early Q2 of this year. So we’re very excited as a company about that. If, if the results from that study are positive, you, then we’ll, we’ll move into those later stage studies, probably an additional phase two B study to further understand and optimize the dose and dosing regimen, and then move into a phase three registrational study to get the drug approved.

Nathan (12m 9s):
Interesting. That’s all very exciting. And some, some really groundbreaking stuff would, would love to have you come back at a later date and talk to us about the, the progress of everything before we, we wrap, I did want to ask as well, you know, we are on our show. We love to try to impart impart knowledge upon other business owners and entrepreneurs that may be watching and listening. Everybody knows launching a new businesses is, is difficult launching during the pandemic. I’m sure. Doubly. So do you want to talk about any of the possible, you know, trials and tribulations that you’ve gone through over the past few years to bring it to where it is today?

James (12m 49s):
Sure, sure. So it’s also a good question and I can give you a reasonably good answer. So, you know, when we, when we started the company, we actually started on it about w we had a $1 million seed round for financing and, you know, you have to stretch and make every dollar count when you’re starting a business, right? And so that’s, that’s really, really one of the keys. And so with that million dollars, you know, we identified and developed in-house some did the formulation technology that rent, it led to the rev, TX 99, as well as advanced the, the diagnostic, which again, is where we started the company.

James (13m 31s):
And based on the four or five months worth of work that we did with that million dollars, we were able to then go out and raise an additional amount of money. I think it outfits at about 12 million, roughly dollars. And we used that money to complete the phase one clinical study that we had, or actually originally started with it, with the seed money until we need to that data that I just described. And then from there, from there, we, we, we w we, our ultimate goal was to eventually go public. And we, we explored a number of avenues from IPO to reverse merger, to, to merging with, with a special purpose acquisition company.

James (14m 16s):
And we ultimately wound up merging with a speck known as Petra acquisition and corporation. And that, that occurred late fall. Actually it occurred early this year. Unfortunately, timing is everything. And I guess that’s one of the things you just have to, you just have to stick to your knitting. So we, you know, we, we reverse merged right at the beginning of the year, and we really couldn’t have picked the worst time to become a publicly traded company, because as I’m sure all of your listeners are patently aware the stock market in general, yes, the biotech market in particular took a massive hit, you know, losing, losing greater than 60 to 70% of its value in a lot of companies.

James (15m 2s):
You know, so we were not immune to that, even with good data where we were not immune to it. And my advice to everybody is a steady hand on the tiller, as a, as a sailor would say, it’s, you have to just, you know, believe in what you’re doing, you know, be creative and just keep working at it right until you get to, you know, until you get to the next, you know, until you weather the storm, when you get to the next value inflection point. And that’s what we’re doing as a company is, is we believe in our products and we’re going to continue to work towards them. And, you know, I’m not keeping them, I don’t watch the stock price on a daily basis because if I did, I would drive myself insane. So what I do best, which is developed products

Nathan (15m 43s):
Well, great. I think that’s great advice for entrepreneurs and business owners at any stage of their, their business James world director and CEO of revelation. Bio-sciences James, if people want to find out more about revelation, bio-sciences about some of the products you guys are working on, things like that, what’s the best way for them to reach out.

James (16m 5s):
Yeah, it’s the best place to go is to go to our website. It’s rev bio-sciences dot com. That’s R E V B I O C Fiona, B B B I O S I C E I N Z E S. Rev bio-sciences dot com. And there’s all kinds of information on there about the technology that goes into our products, some of the data, as well as our corporate presentation and corporate context.

Nathan (16m 32s):
Great. Well, thank you, James. I really appreciated you joining this morning. And like I said before, hope that you can come back, you know, and maybe six, 12 months tell us how everything has progressed. And we, we always love to get updates.

James (16m 45s):
I would love, I would love to do that. You know, hopefully by the end, we’ll have the drug, you know, well through the next clinical study and, and, and have demonstrated the utility of the products that we’re working on. And hopefully there’ll be, you know, well on their way to approval.

Nathan (17m 1s):
Excellent. Awesome. Well, thanks again, James. This has been radio entrepreneurs, and we’ll be back with more I’m radio entrepreneurs.

James (17m 10s):
Don’t you like.