PART One

PROVIDENCE — The announcement that Isaac Stoner has been selected to serve as the new CEO of MindImmune comes at a momentous time for the enterprise, as it prepares to move into the clinic with its new drug development candidate, MITI-101, in 2026.

At the same time, MindImmune will soon be moving into its new corporate headquarters as part of the new cluster of five companies chosen to inaugurate the RI Life Science Hub, boosted by an $800,000 investment from the RI Life Science Hub.

Earler this fall, MindImmune was featured in ConvergenceRI in a two-part series, talking about the research and breakthroughs that culminated in what Founder Stevin Zorn called a 30-year scientfic journey to success.

"MITI-101 represents a first-in-class strategy to stop harmful innate immune cells from driving brain inflammation in Alzheimer's and other neurodegenerative diseases,” Zorn said. “By blocking the infiltration of innate immune cells into the brain, MITI-101 offers a new way to target neuroinflammation, bringing new hope to patients and families facing these devastating illnesses.”

“We think that Alzheimer’s disease is a chronic inflammatory disease,” Zorn continued. It is one that is associated with the process of immune cell recruitment – immune cells that originate in cells that originate in the blood,

Here is PART One of the ConvergenceRI interview with CEO Isaac Stoner and Founder and CSO Stevin Zorn.

STONER: It is good to have the financing closed. I have been working with Stevin for a couple of months now. But I have been in this kind of limbo, secret, hiding in shadows. It’s good to be out, speaking to the world now.

ConvergenceRI: it’s an exciting team that MindImmune has put together. You have great potential for your developing drug.
STONER: It is very, very exciting. For a decade of experience, these guys have been working the field for a long, long time. In fact, MindImmune has been in existence for what, six or seven years now, correct, Stevin?

ZORN: Since 2016.

STONER: And when it started out, the hypothesis of the company was very much controversial. These guys were pushing the boulder up the hill. Nobody would believe the discovery they had made was real. It was too “out there.”

And now, people are really on board, picking up what it is we are telling the world, which is: this is an immune disclosure; Alzheimer’s starts in the periphery. It starts with peripheral blood cells. The fact that people are starting to accept that is very exciting for us.

ZORN: I don’t know if you remember, Richard. When we first started talking, we talked about those who believed in Beta-Amyloid, and those that believed in Tau. And the Beta-Amyloid story just hasn’t played out to the way that everybody thought it would.

And, there is some data that is being reported this week that is showing that the Tau story is not playing out the way everybody thought it would.

Our inflammatory story is really getting attraction. And, as Isaac said, the cells that we think are critical here come from outside of the brain.

And, I think the analogy he gave about rolling a boulder up the hill is exactly right. I don’t know if we got into that before, but we had to convince the world that what they were working on was wrong — that immune cells actually get into the brain and that they do bad things.

And, as Isaac said, we’ve been able to convince the community now that we are really onto something here.

There is a whole lot of data that supports this. Now, it’s a very, very hot field, and as the traditional focus in the area disappears, or becomes “out of favor,” where do we go for cures and treatments for Alzheimer’s disease? We are working in a very, very ripe vein right now, to really make a difference.

ConvergenceRI: Let me start by asking you, Isaac, what may seem like a very obvious question, but obvious questions are often the most difficult ones: “How will you define success?”
STONER: I think it is so important to keep patients front and center as we build the company. It’s very, very easy for a company at our stage, especially when you are at the preclinical stage, to get lost in biology, to get lost in molecules, and animal models, and beta.

What we are focused on is lives; Alzheimer’s touches everybody. Everybody knows someone who has lost someone who has suffered with this disease.

Success for us will be a positive impact on patients. We are not going to rest until we get there.

There are a bunch of immediate milestones that have to happen between now and when we are truly benefiting patients.

What is really exciting about joining the team at MindImmune at this point is: we have a line of sight towards the clinic. We are going to be in humans next year at this time. It’s becoming more and more real to us, that mission of positive patient impact.

ConvergenceRI: It is a huge step, to be able to address Alzheimer’s disease, and come up with something that works. But it also opens the door, I think, to lots of other scientific endeavors, redefining what we mean by autoimmune diseases.
STONER: I think that’s right. So, Stevin and the team have already started to to begin to explore some other diseases, other neurodegenerative conditions. And, we are seeing the same sort of phenomenon existing in diseases such as ALS or Macular Degeneration — diseases, right, that people don’t tend to think of, again, as immune disorders, where the same or similar processes are occurring. We will have a pipeline of different indications where we are going to be focused.

We are starting out in the biggest and the baddest. We are starting out in Alzheimer’s disease, which has been so, so difficult. There are just so many patients suffering with this disease; there is a really huge opportunity for us.

ConvergenceRI: How rapidly do you see the company growing?
STONER: In terms of personnel, we are going to keep it pretty lean. The reason being because much of the work we are going to be doing is going to be outsourced through different contract research organizations or these will be clinical centers.

These are the hospitals and other centers who are running our clinical trials. So, for at least the next couple of years, we are going to maintain a pretty small footprint of no more than 20 people.

And then after that, after we get some of these early clinical results back, we’ll see. We might start to grow pretty rapidly as we chase down other opportunities, based on the same hypothesis.

ConvergenceRI: In terms of entering the clinic, I assume you are still in negotiations regarding where the CRO work is being done. Is that correct?
STONER: Pre-clinically, we’ve got a number of CROs that are supporting us. A couple in-state; a couple right here in Rhode Island. We are also using a CRO that is in Oklahoma; we are also using a couple that are, I believe, overseas. We are making use of a number of these contract research organizations already.

As we move into the clinic, Stevin, how are we thinking about where our clinical sites are going to be. Are any going to be close to home?

ZORN: Yes. So, the CROs that we are working with that run clinical trials draw from various clinical centers around the country.

And so, while we haven’t defined which hospitals we are going to be recruiting patients to yet, you can just like think about what are the big Alzheimer’s centers in the U.S. and that’s probably where we will be.

We are not working with fly-by-night CROs; we are working with the best of them. We’ve negotiated with several. We actually haven’t chosen the one that we are going to go with, but we are actually very close.

STONER: And, Richard, it won’t be at one place.

ConvergenceRI: I assume that they will be at various locations and centers. (Pause.) How will the new location — you weren’t really able to talk about it during our last interview — you are essentially moving to downtown Providence as part of the RI Life Science Hub, is that correct?
STONER: Yes.

ConvergenceRI: When will that move officially. take place?
STONER: In March.

ConvergenceRI: Have you inspected the new facility? Are you happy with it? Have they officially opened the doors for you?
ZORN: They are making it happen right now.

The building is up. I don’t know whether you’ve been inside to tour it yet.

The actual laboratory is still framed out. They are fitting out the walls. We’ve seen the plans; we have actually walked through the space. It will be more than adequate for us and for a variety of other companies to come in.

I’m looking forward to the proximity to Brown University next door, and their animal facilities that we will be able to work with.

And plus, we will maintain our affiliations with the University of Rhode Island. And the George and Ann Ryan Institute. As well as the pharmacy school.

This is a great opportunity for MindImmune to expand its wings and to be taking even more advantage of the ecosystem in the state.

While we are now 30 minutes closer to Boston.

STONER: I have been working right next door to the new (RI Public Health) Laboratory (the home of the RI Life Science Hub) at the CIC Providence for the past year. So I have seen the new building start as a hole in the ground, and it is looking pretty spectacular right now.

So, we are very excited for that to be ready. We will be one of the first folks to move in.

And, like Stevin said, proximity to Brown — some of the smartest people in the world come out of Brown University, my alma mater.

ConvergenceRI: How will you maintain your relationship with URI? How have you worked out the specifics of that?
ZORN: We haven’t worked out the specifics of that. We are just starting to have those conversations now.

ConvergenceRI: Do you think that Brown, in turn, will follow the model that you helped to develop? It was a very innovative model where you were imbedded at URI, a for-profit drug development company, and you became an integral part of the URI ecosystem. Is that something that can be replicated at Brown?
ZORN: No, I don’t think so. Because we were part of the fabric of the university at URI. We are going to be part of a biotech life science Hub in Providence. It’s a very different game to play. And, one of the tenants, and one of the neighbors, is Brown University, a world-class, Alzheimer’s disease-focused university that we will be able to collaborate with.

So, we won’t need to come up with the same kind of arrangement with them that we had with the University of Rhode Island.

STONER: There is a huge interest at Brown in entrepreneurship, in figuring out how to spin out (research), in figuring out how to build companies and incubate companies and then release them into the wild.

During the last year, I have been giving talks, plugged into student groups, trying to teach them how this whole process of company formation works.

I think we will continue to do that. We want to be the model they can follow.