Luke Fox, NEXT Life Sciences - AMOI Studio Interview | LSI USA ‘23

Transcription

Ben Glenn  0:11  

My guest is Luke Fox, LSI 2023. Luke, thanks for coming by the studio.

Luke Fox  0:18  

Thanks for having me.

Ben Glenn  0:19  

So tell me more about what your company is up to, you're coming into an exciting time of your clinical trial. Tell me more.

Luke Fox  0:25  

Absolutely. So NEXT Life Sciences, we're developing one of the world's first male birth controls. It's about time, it's about time. And it's really responding to the massive demand for men. They're saying, hey, we need something that's not just trying to replace hormonal birth control for women, and give that to men, but truly provide a sensible, effective and safe solution, which means something that's non hormonal, that's long lasting, right? So you set it and you forget it, and is reversible on demand whenever you want.

Ben Glenn  0:55  

But it sounds like the roots of this is not something that came out of the United States, or came out of one of our big research institutes, where the roots of your company said,

Luke Fox  1:05  

Yeah, the technology has been in development for a long time since 1979. This technology actually comes out of India through their labs there, where they've been trying to solve this problem. They have a massive need in India and around the world, say, how do we enable men to be able to participate in family planning. And so in that development, they found that there's a lot of ways to optimize that it was then brought to the United States 10 years ago. And it's been in preclinical studies over the last 10 years, including most recently, a two year baboon study, which is like the gold standard for non human primates, showing that this technology can be seen as both safe and effective.

Ben Glenn  1:41  

So have you happen to have one of these devices with you,

Luke Fox  1:45  

I just happen to have some here. So this technology is known as Plan A, like the name. So Plan A because it's really about showing that this should be the default solution. You can see it here. So it's a quick simple injection of this hydrogel. And you can see the hydrogel it's in liquid form. Now it's made up of mostly water over 90% water. And once it's injected into the vast difference, it's a quick simple 10 minute pain free procedure right after the injection to the best difference. And in doing so creates a flexible filter, that flexible filter filters out all the sperm allows all the other fluid to pass through, doesn't have any change to ejaculation. I like to say all the juice none of the seed.

Ben Glenn  2:30  

So it's it's literally a hydrogel that sets up and causes the blockage.

Luke Fox  2:36  

Exactly. And is it as it causes that we are we've seen studies of up to 13 years of effectiveness. So showing that this is should last well over 10 years for men to be able to have it injected. And it's a set it and forget it again, 10 minute pain free procedure, leading to what we're aiming for for 10 years of protection. And at that point, you can then renew it or get it get it reversed.

Ben Glenn  3:00  

And what's the reversal procedure look like? 

Luke Fox  3:03  

The reversal is again another just quick 10 minute doctor's visit of an injection of simple sodium bicarbonate. And that sodium bicarbonate baking soda, right it creates a chain reaction that then turns it from a solid in flexible solid back into this liquid form. And then it just gets flushed out and you're ready to go. And especially when you compare that to you know, people talk about vasectomy, and vasectomy is in order to get a vasectomy reversed costs on average about $10,000 And it's a three hour microsurgery that has a 50-50 chance of working most of the time. Whereas with this, it's safe. It's simple and effective.

Ben Glenn  3:39  

That's incredible. So Fox, where is the company right now? What stage are you in? And you're you're here at LSI? Are you raising money? Are you trying to get more people enrolled? But what's the state of the company right now?

Luke Fox  3:51  

Yes, right now we're raising our series seed in order to find our final clinical trial. And that clinical trial we're kicking off at the end of this year 2023.

Ben Glenn  4:01  

That's incredible. So tell me more about the the baboon study. Where was that conducted? How do you have so much confidence in that? That sounds like a great breakthrough?

Luke Fox  4:09  

Absolutely. This the baboon study was done here in the United States was and it was showing that you can take this technology that was done in India, and in India, they did it slightly differently. So when they inject into the vas deferens, they line the inside of the walls of the vast difference with the hydrogel is hydrogel in India was called reisberg. Here in the United States, it's called Vansel Gel. A lot of people probably have heard of the vassal jail. That is what next life science has the worldwide exclusive license to and that's what we're commercializing as Plan A. But in India, they line the inside of the wells the vast difference. So as the sperm passed by the sperm were destroyed, that made it classified as a pharmaceutical. What's so exciting about what we've demonstrated here working with various nonprofits, most prominently, the nonprofit that brought it to The United States which is Parsons Foundation, incredible pioneers in the space, they showed that instead of just lining the inside of the walls with the hydrogel, if you create an occlusion, it's even more effective, more safe. And it becomes then a medical device, which is a much clearer pathway through the FDA.

Ben Glenn  5:19  

Oh, you're kidding me of pharmacology has a more difficult pathway than a med device.

Luke Fox  5:25  

Right? Yeah. And about a billion dollars less

Ben Glenn  5:28  

About a billion dollars less than another 25 years on your life.

Luke Fox  5:31  

Yes, truly. And that's what's so exciting about this. And that's what parcelas Foundation, what they pioneered, is taking something that was a long, complicated regulatory pathway that was being done in India, and said, Hey, let's simplify this. Let's optimize this and design for manufacturability. That's what they've been doing for the last 10 years. And now, they said, we've de risked it. Now it's about commercializing. And that's where NEXT Life Sciences has stepped in, to bring our commercialization team to now bring it not just to the United States, but to bring it to many people around the world, there's half the world population is a man. And when we look at the problem set, right, half of all pregnancies are unplanned. Like, that's insane. And when we think about all of the amazing by all the amazing medical technologies, and machine learning, and all these crazy advances that are coming to the world, and yet we still no matter where you are in the world, half of all pregnancies are unplanned. And I believe that's because we've ignored half of the entire population, men, right men have been completely ignored by contraceptives. And that when you look at the amount of men that are trying to participate, over 80% of men are saying, hey, like, over here, I would like to be able to participate in family planning.

Ben Glenn  6:41  

I love the way that this the shift to go from, we're going to have this liner that's going to act like it's going to be a spermicide, basically,

Luke Fox  6:50  

Precisely

Ben Glenn  6:50  

to it's a filter. And I love that I remember it brings to mind one of my clients, you know, long time ago from Dr. Fogarty. And it was we don't have to stop everything to go in to the lungs, the lungs can handle a lot of material we discuss got to be small enough. So it doesn't have to be an inclusion, you know, don't have to block completely. You can let some material go by just it just can't be too big. So I love that that's a great thing about medical devices.

Luke Fox  7:19  

Yes, that's, that's exactly. So we allow all the seminal fluid to be able to pass through while still filtering out the sperm, until there's absolutely no change to ejaculation, or to volume or anything. That would be anywhere noticeable, except, again, none of the sperm. And that's what makes the clinical trials such a straightforward process, because many other male contraceptive devices and pharmaceuticals are doing things like confusing the sperm making them swim in circles, right decreasing to a technical level of infertility. Or as with Next Life Sciences with our Plan A technology, it reduces sperm count to zero. And so that by designing it to reduce the sperm count to zero, makes the clinical trials very straightforward. We don't have to prove fertility, we just have to prove there's sperm in the ejaculate.

Ben Glenn  8:06  

Yeah, that's that's, I think it's a great lesson for all the companies that are here. And I love what Scott Pantel does at LSI. This is a great lesson. No, you plan your you plan your trip through FDA, you to you, they're not going to tell you what the endpoint is, yes, you tell them what you're going to do and prove it and bring the evidence. And they'll tell you whether or not you met that or not. And I think this is a great story for it, pick this, pick an endpoint that is very easy to verify. Zero is very easy to verify,

Luke Fox  8:37  

Surely, and as we look at all the amazing companies that are here at LSI, it's really incredible to see the innovations and how they're really pioneering all of these new fields, and helping to not just not just be subject to the FDA, but truly partner with the FDA to create real innovation that solves these massive problems that millions of people face. And family planning being a massive one, especially when you look at the health consequences to women, when when they are subjected to only a single, single solutions that are primarily hormonal. 

Ben Glenn  9:11  

Yeah, I think that that's another one. It seems like what we've been doing for birth control, the women pay a very heavy price. Biologically, you know, there's the, you know, you're putting something into their body that they have to deal with. So you look at, you know, kidney load, liver load everything, it's got to be dealt with, it's not just doing that work, it's also a burden to the rest of their system. So this sounds like, you know, why not let the, you know, the men put their shoulder to the wheel, surely and

Luke Fox  9:36  

Let men be able to participate. Right? We believe that women should be able to freely participate and have that and be able to use birth control to great thing. Birth control was the economist actually said in 1999, the single biggest innovation of the 20th century was not the internet. It was not all of these other things you might think but it was female birth control. And I believe as we look back on the 21st centuries, our generation our lifetime, that many will say that the biggest, most significant innovation of the 21st century was male birth control. Because what male birth control allows is for that inclusive participation, not just for women, but truly for men to be able to not just share the burden, but to alleviate the burden, especially when we talk about safe, effective non hormonal, male contraception.

Ben Glenn  10:26  

Maybe you've touched on this, but hit me again, the economics between vasectomy, and your injectable.

Luke Fox  10:33  

So a vasectomy is a one time procedure. It's designed to be permanent. And the key thing is that the majority of men that are getting vasectomy, so are 45 to 65. People are child complete. The reason why we're called Plan A, and this technology is so exciting, is because it's we're focusing on men who are in committed relationships primarily who are saying right now, I'm not trying to have a child, right, or people who are going into college and saying, Hey, like I know I definitely for the next few years don't want a child. But at some point in the future, I may want one and enables them to be able to participate in ways that they can't. Right now, vasectomy is are designed for people who are child complete are saying I don't want any more children.

Ben Glenn  11:17  

Is there anything else you want to share with us today?

Luke Fox  11:19  

Well, I welcome to anyone to join us and sign up at our website for Plan A for men.com. Definitely check us out. We'd love to connect with anybody who is interested in learning more.

Ben Glenn  11:31  

Fox, thanks so much for coming by.

Luke Fox  11:33  

Thanks so much for having me. Really appreciate it. 

Production crew  11:36  

Luke Fox, take one marker