Jason West on the 1,100-Year-Old Middle Eastern Tea Now Helping Fight Cancer

Jason West, co-founder and EVP of NextGen Scientific, joins Mookie on Bald Ambition to talk about a cancer drug with an unusual origin story. Instead of starting in a billion-dollar lab, it started with a weed growing wild across the Middle East, a plant people have brewed into tea and used as a folk remedy for cancer since at least the 9th century.

NextGen's founder, chemist Gene Zaid, grew up in the Middle East watching family members use that same plant, Arum Palestinum, as a traditional treatment. Curious why an 1,100-year-old remedy was still in use, with one study finding roughly 22 percent of Palestinians with a cancer diagnosis still drinking it today, his team isolated three naturally occurring molecules from the plant, found the specific ratio that made them work together, and synthesized a new compound out of them. The result, GZ17-6.02, is what's known as a super-enhancer modulator, a drug that acts on the master genetic switches sitting above individual genes rather than targeting one mutation at a time. Jason walks through why that approach has shown activity against a striking range of biologically unrelated cancers in early testing, and why it's designed to work alongside existing chemotherapies rather than replace them.

The conversation gets expansive: how a drug actually moves from a lab observation through animal testing into human trials, why every patient in a cancer phase one trial receives the real drug rather than a placebo, and the genuinely humbling moment their own scientific advisor, a leading oncologist, questioned why they'd included a third molecule the existing research said shouldn't work, only to watch it turn out to be essential. Jason and Mookie also get into why AI, for all its strengths, couldn't have found that third ingredient on its own, and take a harder look at the broken economics of clinical trial costs, where identical procedures can run five times more expensive simply because they're labeled as part of a trial.

The Drug

GZ17-6.02 is currently investigational and has not yet been approved by the FDA for any use. The formulation is being studied in an ongoing Phase 1b trial for advanced prostate cancer at Virginia Commonwealth University, with a second trial for a precancerous skin condition set to begin in Sweden and the Netherlands.

The Guest

Jason West is co-founder and Executive Vice President of NextGen Scientific, a clinical-stage biotechnology company developing novel cancer therapeutics derived from naturally occurring compounds. He holds a JD and MBA.

More from NextGen Scientific: https://investinnextgen.com

Transcript

SPEAKER_00 0:04

Welcome to Bald Ambition. I'm your still very bald host, Mookie Spitz. And the one with all the ambition today is Mr. Jason West. He's co-founder and EVP from Next Gen Scientific. I'm thrilled to have you on the podcast.

SPEAKER_01 0:24

Thanks for having me. I appreciate it very much. And I'm catching up to you quickly, so maybe I can come back later on when I'm uh even closer.

SPEAKER_00 0:32

You, sir, are still winning ahead of the game when it when it comes to being follically challenged.

SPEAKER_01 0:41

I've got four daughters, so I'm I'm uh I don't know how I still have what I have.

SPEAKER_00 0:45

Oh my gosh, I have two boys, one one adopted daughter, and look what happened to me.

SPEAKER_01 0:52

I get it, completely understand.

SPEAKER_00 0:55

Right. So so talk about life challenges. Cancer has been described as the emperor of all maladies. It's so complex. People don't realize that every cancer in every patient is pretty much a unique mutation. And science, medicine has come a long way from the rough and tumble chemotherapeutics of the past into immunotherapies. And now NextGen has its own armamentarium of the super enhancer. Can you set this up for us in terms of what you're exploring, some of the uniqueness of your approach and the excitement surrounding where you are and where you're headed?

SPEAKER_01 1:44

You bet, you bet. I uh so super enhancer modulator is what we think of ourselves as. And um it's a it's a relatively new area. Um I think it was first identified maybe back in 2013 as the first paper uh that came out uh noticing this behavior. Um essentially there are super enhancer genes, which I think of as kind of almost a, if you think of it in terms of a family tree, um it's up at the top, the kind of the granddaddy gene that controls a lot of downstream processes. Um it controls other genes, some of which are tumor suppressor genes, some of which are uh proto-oncogenes. And the idea is that um we are affecting that super enhancer gene area uh in a strand of DNA, for instance. Um what's happening is we say modulator, uh, meaning that you almost think of it like it's a bit of a rheostat, you're turning up or turning down certain activity. Um and so some of the testing that we did early on, some of the preclinical testing that we did, uh essentially was to generate some heat maps identifying what what areas of uh genetic activity were affecting. And what we found is that we are both upregulating the tumor suppressor genes, so we're actually kind of boosting the body's natural uh normal uh anti-cancer activity, and we're also downregulating the proto-oncogenes, uh, meaning we're kind of helping the body essentially downregulate or or uh fight cancer in the ways that it normally would. And it's fascinating, you know, the research that we've been doing so far to see that because it starts to explain why we're seeing effect against a variety of different uh biologically unrelated cancers, uh so several cancers in our phase one trial that don't normally uh respond to the same drug. And so we saw effect um several stable diseases in our phase one. Um very interesting, and um what we're ultimately trying to accomplish is let's get this into the hands ultimately of the oncologist. But we know that at some point we'll need to hand it off to a bigger pharma company to take it that last mile, get it across the finish line, and into the hands of the oncologist so they can put it in their toolbox and use it as they see fit.

SPEAKER_00 4:24

Now, some diseases like Hodgkin's is a classic example where you have an individual mutation on an individual gene that causes this disease. What you're saying is, in a sense, the opposite of that, that above the individual gene level, there's this other reality on the DNA molecule, essentially. And by tweaking multiple genes through your treatment, you're able to impact not only an individual cancer, kidney cancer, uh lung cancer potentially, but multiple different types of cancers because you're operating on, if you will, a macro level of therapeutics. Is that I know that that's super high level, but I'm trying to get our viewers and listeners to understand the qualitative difference of your approach to treating cancer.

SPEAKER_01 5:28

Yes, and that's well stated. I think uh you know, I think of it as uh one of our colleagues uh in here referred to it as broadly specific, um, which I thought was a great way of describing it, uh frankly, just because yes, it does affect that one you know genetic uh mutation, let's say, with Hodgkin's lymphoma. Um, but something caused that mutation to begin with, and so we are essentially going maybe one or two levels above that genetic mutation in Hodgkin's. And uh by definition, if you control that one, then you're controlling everything that's going on downstream, or if uh if not controlling, then certainly affecting. Um and so to a degree, and this might get out uh maybe a little outside of the question that that you were asking originally, but I think it's interesting to think of the idea of cancer treatment today predominantly is uh you know, multiple different drugs almost in a cocktail, uh, oftentimes that you you might hear the oncologists prescribing. Um that's where we view ourselves. We're going to be part of a cocktail. We seem to work better in conjunction with other chemotherapies, for instance. Um, and so it's kind of this becomes a one-to-punch. We're affecting certain things, uh, carboplatin is a is affecting certain things, and then together we are better than we are separate.

SPEAKER_00 6:58

That's part of the challenge of treating cancer in general. So many different things have gone wrong to basically embolden the cancer to be so successful. It's essentially a mutant cell or cells within the human body that are replicating at an exponential rate, creating this tumor and becoming essentially this other species in a human body. I mean, in the crudest way, that that's how to look at it. So the replication mechanism has been tweaked, how the tumor gets fed has been tweaked, and every way that cancer has transformed that original cell to basically become this monster in a human body, our angles of attack for science and medicine to combat it. So, what you're saying is that we've developed these cocktails of treatments that address all of these different ways that cancer flourishes and ravages a human body.

SPEAKER_02 8:06

Exactly.

SPEAKER_00 8:07

And with your super enhancer modulators, you're taking yet another tack. It's yet another arrow in our quiver to attack cancer, to mitigate its growth, and hopefully get rid of that tumor. Is that is that a way of looking at it?

SPEAKER_01 8:25

Very much so. And and I think the arrow in the quiver idea is actually that's a a phrasing that I use as well. Um it's just one more tool that we can use. And uh if you think about it, I think about it in terms of mechanisms of action, um, you know, the platinating, platinating agents and so forth, uh, is a great example. Um we're just one more example of a different mechanism of action, a different route to get to the same result, which ultimately is to combat the cancer's activity. Um and one of the things that we see, you know, kind of a as a an outcome is, and you mentioned it just a second ago, this proliferation of cells, this you know, kind of unchecked proliferation of cells, and ultimately you end up with a tumor and and uh and so forth. And what we've found is that our drug does seem to do several things. Uh so that tumor begins to kind of take on a life of its own. It's a mutant, as you say, and it it starts to send out signals of its own. It asks for its own blood supply. Um and so it starts building essentially routes of uh vessels that that it's now starving the tissue around it for blood and uh feeding itself. And so we found that we actually uh can help curtail that those signals that it's sending out for its own blood supply. Um we found that we're actually uh uh reintroducing or reinstating apoptosis, um which is that pre-programmed cell death. Uh so every cell is supposed to have a normal life cycle, it's supposed to die at kind of an appointed time, and a lot of times in cancer that process gets hijacked. And so we're what we found is that we're actually re-establishing that that normal cellular process uh to occur again, and uh just another mechanism of action, if you will, uh, of our drug. So hopefully we're we're going to be a really meaningful part of the conversation when it comes to knocking off cancer's ability to uh evolve and replicate and and cause problems for people.

SPEAKER_00 10:41

So starve the tumor so it doesn't get the blood supply that it has hijacked from its host. Yep, and remind the tumor that it doesn't have immortality, take away its vampirism, both figuratively and literally, yes, I like it, and basically just die already. The other cells have a normal life cycle. You've you've hijacked our food and you've hijacked our clock, too. Yep, that's right. To basically promulgate in this voracious and damaging way through the human body, and your enhancer modulators are able to do multiple things with that tumor, much like some of the other drugs, but as you point out, it's really about the mechanism. Yes, what aspect of the tumor are you, in a sense, attacking?

SPEAKER_02 11:35

Yep.

SPEAKER_00 11:36

And how is that coordinated with the other drugs in the cocktail to maximize the impact of the therapeutics overall?

SPEAKER_01 11:44

Yes, yes, very well said, very well said. You understand it so beautifully uh after a very short amount of time. I can guarantee you it took us a long time to get here to really truly tease out all the understanding that we've got. And we're still not done. You know, we had a lot long way to go still yet.

SPEAKER_00 12:01

It's challenging when you have complicated science and medicine, clinical data to translate it into a very simple story. And I I think Einstein famously or at least apocryphally said that if you can't express something simply, then you're either confused or it's wrong. And and I think that's true. And and what's great is is the impact that that has and the benefit for all your audiences, which is ultimately patients are empowered with an understanding of what's going on within their own body. Physicians need to understand how to differentiate and utilize these complex treatments. In the field of oncology, it's unmatched in terms of this of this choosing and mixing and trying. Oncologists are usually tinkering with all these options that are available to them. And many oncologists have that scientific experimental spirit. They want to bring maximum value and benefit to their patients in this wild, wild, wild, wild west evolving field of oncology. I think that that's wonderful for the field. And amidst all this, there's been really a transformation in our understanding of treatments. So I think a major milestone was getting beyond this idea that you have kidney cancer or lung cancer or brain cancer, because obviously what we discovered is not only are all cancers unique in their own way, but it's more about the tumor type, the type of cancer, than the organ that has happened to have been taken over. And that change in mindset is central to this idea that we need personalized, customized therapies that are tailored to the individual patient.

SPEAKER_01 14:05

That's that I would agree with that statement very much. You know, it's such a highly differentiated disease, and it is uh in many ways very personal. You know, there's so many different subtypes and permutations of that. And then beyond that, whenever you start going through different rounds of therapy, that cancer evolves quickly and develops you know unique uh resistance mechanisms, which make it even more challenging because it's more differentiated than it was to begin with. Um so yeah, it's a it's a very challenging scenario. And I don't envy the oncologist because uh you know they have to continually try to stay one step ahead of this emperor of all maladies. Uh great book, by the way. Uh, you know, very very good book.

SPEAKER_00 14:54

The the other aspect of your therapeutics, and I'd love to hear more about it, is the nature of the treatment itself. And I'd like to provide a little bit of context. There's a tendency in the sciences to go big or go home. An extreme example in another field is in fundamental physics, for example, where we need to build bigger and bigger multi-billion dollar colliders to essentially measure things that we already know to be true to an increasing number of decimal places with the hope that we're gonna find something new and unexplainable, and it'll it'll create crisis and then we'll get our paradigm shift. And that hasn't always worked out. And I think there's a similar analogy to be had even in medicine where where there's this notion that if we that if we think of something exotic and unfamiliar, then we're cutting new ground. And if I understand your therapies right, you haven't so much gone forward, but you've gone backward into exploring traditional medicines and extracting the most value from substances that are already present in nature, combining them and recombining them, and then synthesizing newer, better versions of them. Do I more or less have that right in terms of what you're what you're bringing to bear?

SPEAKER_01 16:29

Yeah, I think that's a good good way of thinking of it. Um, of course, you know, from our vantage point, uh, we just observed something that we thought was interesting, uh, you know, at a very basic level, and said, why? Why might this be happening? Why might this be the case? Um, and so you know, it kind of gets into the early, earliest phases of our research. But um we we basically did go back to maybe how it used to be done back in the day, quote unquote. Um and so you know, started with a plant. Um, this plant, you know, and and there's multiple examples, as everyone knows, of drugs that we are using today that you know have it have their uh have their roots, no pun intended, in in the botanical world. Um aspirin is the probably the most common example. Um and so when we when we notice this behavior, you know, this long-standing kind of traditional usage of this plant that grows wild uh in the Middle East. Um and and it's it's been used in uh continuously for about 11 centuries. So we did a literature search and found references all the way back into the ninth century A.D. uh of this plant called Arum Palestinum. That's the Latin binomial for it. Um, you know, over there in that part of the world they might call it Solomon's lily or black callal lily. Um it's a just a weed. It grows wild over there in that part of the world. And um people have been using it as a tea. So they'll they'll go harvest the plant, the roots, uh, and then they'll uh chop it up and and brew it on the stove. Very um, you know, very traditional preparation, of course. Lemon juice, olive oil, garlic, you know, the things that they have over there in that part of the world. Um and uh what really caught our attention though is why on earth would this still be going on 1,100 years later? If there wasn't, if there was no efficacy to it of some type, um, you would think that it would have died out to history a long time ago. And so, you know, just from a kind of basic curiosity standpoint, we said, what's going on there? Um this is where the the part of the story gets a little bit uh, I guess very specific to our situation. We're in uh central Kansas uh is where we're headquartered. Um and as people know who've ever been here, there's very little to do in central Kansas. There's not uh you know a whole lot of nightlife or or anything exciting uh uh to do. And so, you know, boredom, I think, is probably what drove it as much as anything else. Um and Gene, our our uh our founder and uh chief scientist, he's a PhD medicinal chemist, and uh took the plant, identified what was in it, uh, found naturally occurring molecules that looked interesting, and said, okay, let's take this a little further. So we isolated three of the molecules in this plant that uh just what the good Lord gave us in this plant, and said, let's let's start here. Um, and then eventually figured out the right ratio of those three to one another, synthesized them, and uh, and voila, you've got a drug. Uh, did all the preclinical testing and so forth. And and at every turn, kind of we're we're expecting it to fail, you know, just from a scientific standpoint, you're just trying to make it, trying to break it. Um, and so that's that's kind of the background there of the story.

SPEAKER_00 20:11

That's fascinating. And again, as I was citing before, this isn't the output of a hundred million dollar proactive research initiative. It's basically being curious and looking at folk remedies and discovering that beyond it being maybe a helpful supplement or grandma's curative, there's actually efficacy lurking in the Solomon's tea time.

SPEAKER_01 20:43

There there is, and I think it's a great example of you know, some of that call it ancient wisdom. I I'm not sure what to refer to it as, but there's a reason that that people uh have been using it for that many years. In fact, there's a study out there, uh, can't quote you chapter and verse right now, but uh 22% of Palestinians with a cancer diagnosis, even today, use this T still as part of their treatment regimen, whether it's uh in conjunction with chemo or uh or by itself. Um and so it's very it's very specific uh culturally to the Palestinian population. Um but uh yeah, it's it is still very much in use. And so that's really, as you said, kind of just staying curious and looking at uh the question of why, um, and just continually coming back to that question.

SPEAKER_00 21:41

Now the internet is rife with misinformation, conspiracy theories. There's truly a swirl of overwhelming content. When when the World Wide Web first launched, there was this belief it was Pollyanna and proven retroactively not. Naive that instantaneous global communication would engender truth and justice and uh and uh and happy happiness for the human race. Now that hasn't exactly happened. As we know, there's a lot of swirl out there. So can you assure our viewers and listeners that the efficacy and safety profile of this these agents, these three chemicals that you have identified and then synthesized actually have an impact? Uh usually we would think of clinical trials, we would think of an FDA approval process. Can you take us through the legitimacy of your downstream approach? For sure.

SPEAKER_01 22:49

You know, it's uh that's a great question because it's kind of where we start, right? Um first you identify, you know, what is what is it that you have, you know, from a chemical standpoint. Um and then you know, you you do some of those early tests just to determine uh things like uh mutagenic uh properties. Does it cause genetic mutations? That's one of the earliest tests that you would do in in this uh scenario. Um satisfy yourself that there's no genetic mutation problems, uh then you go on to is there any efficacy whatsoever? You know, you you're testing against uh cancer in a petri dish, essentially. And if you're seeing efficacy there, then you uh then you graduate on to uh you know more of the in vivo studies where there's mice and rats and and so forth. Um that's kind of the general pathway. Now, all along the way, also you are uh conducting a host of different um what they call toxicity studies, and you're looking for signs of toxicity in animal tissue and so forth. Uh so there's a whole battery of tests, and it varies depending upon the type of drug. Um, but in our case, um we're looking for a variety of different toxicities. Um and then you correlate that data to what you believe will happen in a human based on the differences between metabolism of, let's say, the the mice, the rats, the dogs, and then the humans. Uh, and that's the path that we that we followed. And and it's very prescribed by uh you know kind of standard uh FDA required protocols.

SPEAKER_00 24:33

Phase one, phase two, phase three, going from safety considerations to human safety considerations, and then the verification of efficacy and the identification of side effects and other risks.

SPEAKER_01 24:49

Yep, exactly. And what I'm describing actually is it happens long before you ever get to phase one and that actual first inhuman study. Um, and that's why I though I've described it before the the first inhuman study or that phase one, these are these are typically late-stage cancer patients. Um nobody gets a placebo in the cancer test, you know, cancer world. It would be considered unethical. So everybody in a phase one is is getting the drug, um, but they have failed on all other regimens that they've tried thus far. And so this is somewhat of a Hail Mary. Um, and that's why I describe those folks as probably the heroes of the story, because when they do that, they're they're taking the risk because this is, as I said, it's a first-in human study. No human has ever taken it. We think we know what's going to happen uh when it when a human takes it based on extrapolation from data from animal models, but nobody really knows. And so it's a bit of a uh of a of a scary moment there, that first dose. And everybody's watching very closely, of course, and and hoping and praying that there's no you know negative side effects. And uh luckily in our case, we we saw very minimal side effects in our phase one. Um it was really good to see because everybody's expecting side effects. And in our situation, we saw um the I think the worst that we saw was some elevation in liver enzymes, which that's not nothing, but it's you know, on the on the scale of cancer drugs, these are that's a pretty uh manageable side effect. Uh we saw no grade four, no grade five uh toxicities in that phase one. Um so it was very encouraging to see that. Um, and then we saw uh our ability to what they call dose escalation. Um we're we're increasing the dose with each cohort uh to really explore uh essentially how much can a human take. Um and that's a bit of a mirror image uh from what other drugs uh and and studies would typically do. You you you usually want to use as little Tylenol as possible to cure your headache. In our situation, from a cancer standpoint, you want to use as much drug as you can possibly tolerate in order to maximize the the effect uh of the drug. So you dosed escalate in in our trials, and um we found uh that that we could hit a dose that was efficacious but also still safe for humans to take, which was good to see.

SPEAKER_00 27:38

So this is legit, folks. This isn't just some Middle Eastern tea supplement. This has been translated into real testing through the legitimate authoritative framework for testing any and all drugs that are meant to treat cancer in particular. And you're jumping through all the hoops, you're getting all the data, both in terms of safety and efficacy. And how are things looking at this point? We're recording this around mid-August 2026. Where where does it stand in terms of its potential viability?

SPEAKER_01 28:21

Yeah, it's uh it's going very, very well, actually. Um, so right now we're actually in a clinical trial at Virginia Commonwealth University uh for advanced prostate cancer. And so this is a what they call a phase one B. It's still considered technically phase one, um, but in this particular you know situation, we're focusing very specifically on that advanced prostate cancer. And again, you know, very, very difficult patient panel. Um these are folks that have uh these are what they call castration resistant uh prostate cancer. Um again, they've failed on uh all or almost all of the therapies they've had before. Um you know, tough situations. Um and so far so good. Um, you know, we it's a very narrow subset of prostate cancers, of course, so the enrollment rate is very slow. Um it there's a reason some of these trials take several years. Uh, and so essentially we're kind of in a waiting game uh to a degree, but so far so good. Um and then we're also about to start a clinical trial in uh Sweden and the Netherlands on um it's essentially it's it's the same active ingredients, the same uh active pharmaceutical ingredients, they call them APIs, uh, but in a topical cream form. My brother is a dermatologist, and so he actually helped develop the dermatology version of this drug, um, whereas the prostate trial is actually an oral capsule. Um so this topical trial is intended to explore uh what's called actinic keratosis. So it's the uh red kind of lesions that are on uh you know guys' foreheads sometimes they spend a little too much time out in out in the sun. Maybe they're fishing or or uh golfing too much, if there is such a thing.

SPEAKER_00 30:16

Or if they're high risk, like your your podcast host here.

SPEAKER_01 30:23

Uh and so the goal there is just to um to try to help prevent that precancerous condition, or to address it, I should say, rather than prevent it. Um and there's 60 million cases of actinokeratosis per year. Um so it's a big issue and and something that's continually, you know, uh a battleground for uh dermatologists uh all over the country and the world. Um and so we've seen already preclinically uh some indications that we should be very effective in that environment. Um this is a great example of a scenario where what we're trying to do is offer the dermatologists another tool in that toolbox, another arrow in the quiver, if you will. Um but in this case uh the the accepted treatments right now are they're common. Um you know, they're just uh you know, burn them off, um, which is sometimes painful and and uh it's it's quick and effective, but not as very desirable. Um and then the other one is uh uh a cream called effudex, which is very, very hard on the patients. And um, so consequently, there's a lot of um difficulties with what they call patient adherence. Uh the patients don't like to take the drug and it hurts and it's um kind of turns your for lack of a better term, it it turns your face into a hamburger. It's it's really tough. Um our our drug by comparison is very effective, we think, or or will be shown to be effective, and also very tolerable. It's not going to cause the burning uh that that uh the other drug can. So we think we can be just as effective and or more effective and safer, which means you've got yourself a drug uh and a very viable treatment option for the uh for the dermatologist.

SPEAKER_00 32:20

And you've got yourself a drug which seems efficacious but also is advantageous in terms of administration. So you know the chemotherapies, the immunotherapies are all injectable. So they need to go right into the bloodstream because they can't go through the GI tract. They get interfered with, they get broken down. And and simply being an oral agent, and to your point, even a topical one for the dermis is a huge advantage in and of itself for for treating something like cancer.

SPEAKER_01 32:58

Yeah. We do hope that you know that instead of having them go to an infusion center that the patient can just grab the pills, take them on home, you know, uh, and and take them at you know in the comfort of their own home. That's a big deal. Um, you know, it may not necessarily make the drug company quite as much money or the treatment center as much money, frankly. Um there is a very real component to you know the the what they call the routes of entry, you know, whether it's IV or oral or topical, if you will. Um and and it it varies and it changes the the economics of of a drug drastically. Um but we're hoping that we can you know show that we're effective and also be a very uh you know easy-to-take drug, like you like you mentioned.

SPEAKER_00 33:49

That's the cynical side of science, and especially medicine and healthcare, where the where companies might be pursuing opportunities which ostensibly come across as frankly more profitable. And then when other options are available that are frankly cheaper and faster and more efficient, but yes, less beneficial to the shareholder, there might be a lack of incentive. So that's a yet another reason that exploring these new medicines from what we would consider unlikely sources is helpful and refreshing and hopeful to remind us that a chemotherapy and immunotherapy, maybe in the future we don't need to spend five hundred thousand dollars per cycle per patient to extend life by two, three months when there might be innovative ways to explore other mechanisms of action through other sources that are a little bit closer to home, easier to administer, and frankly, far cheaper for the patient and for society.

SPEAKER_01 35:06

Yep. That it's certainly part of the goal for sure. And and uh I would hope that nobody says, hey, I can make this as an oral, but I'm going to make it as an IV just to make more money. I I think most of the time you know the idea is to optimize you know the effect of the drug and the safety of the drug and so forth. Um, but you know, there it's there's definitely very real practical outcomes, you know, to IV versus oral versus other routes of entry. And um at some point, you know, it is challenging to turn an oral drug into an IV or vice versa. Um but you know, our our role is just to try to come up with the best molecule, and we'll let others uh that are much more capable figure out you know the the other routes if they want to.

SPEAKER_00 35:56

Yes, you guys are upstream, as they say, with many, many steps to go through, many hoops to jump through before any patient can actually be prescribed this medicine. You know, in a way, again, that's that's beneficial to the patient and society. The prostate cancer angle is interesting too. Uh, you probably remember the drug Provenge, which was the trailblazer in personal therapeutics and in immunotherapy. And it was super complicated in terms of administration, but it did focus on pretty much your cohort, which is the prostate patient who was almost on their last legs. Let's see what we can do for them.

SPEAKER_01 36:45

It's interesting, you know, prostate cancer is a really, really uh common uh diagnosis. There's 800,000 cases um a year, just a prostate in general. Um but nobody hears about it.

SPEAKER_00 37:00

Um almost every man will eventually get it. So you you live long enough and you're gonna get prostate cancer, and many of the cases just we don't even need to treat it. You're gonna die before it could really metastasize. And there's such a range of severity and impact for the disease, making it even more complicated.

SPEAKER_01 37:23

Yes, that's very true. They they say most of the time, you know, you you will die with it, not from it, uh, which is good, but it's certainly, you know, there's you know quality of life issues that come along with just having it, that if we can help, you know, root it out, uh, let's do it. You know.

SPEAKER_00 37:43

Yeah, absolutely. I have one question from uh almost an IP point of view and and from a developmental point of view. Uh I don't know if you're familiar with the story of a corda therapeutics, and they had a drug for MS patients called Empira. And and they had issues with their patent fairly later in life because the the molecule itself was so simple. It was a potassium inhibitor that helped MS patients walk just a little bit better. But the legal case was made that it was just a pyramidine ring with an extra little atom attached, you can make it in your bathtub. So come on, guys. And they lost the patent earlier than they thought, based on this argument that the drug was just so common. Is there is there any concern that you have that Solomon's tea is basically already being used by millions of people in the Middle East that you're you're purifying it and synthesizing it? But because the the elements of the treatment are are fairly rudimentary, is there is there a concern from even an investor point of view, a patent point of view?

SPEAKER_01 39:12

No, it's a it's a good question. Uh really good question, actually. They I think um our situation probably is quite different from a patentability standpoint. So uh so uh full and fair disclosure, I'm actually an attorney.

SPEAKER_00 39:26

I'm not a patent attorney, but I uh I I do practice uh you know, I saw the J the J D on your alphabet soup after you came.

SPEAKER_01 39:37

I uh I I like to call myself a recovering attorney. I uh I don't don't practice every day, of course, uh and and uh use it really just to kind of help uh speed things along, you know, business-wise and so forth. But uh so I uh you know from a patenting standpoint, um you know, ours is is novel in terms of both the it's a it's a novel combination at the end of the day. And um whereas the plant itself is you know in in common use, um our our combination of the three APIs is is novel and is actually not found in nature. So what we did is we took the those three, and like I said, we we identified those as the most likely uh culprit behind uh helping you know combat the cancer um cycle. And so we uh you know, doing all the testing, what we found is an optimal ratio of those three together. Uh and that ratio is is you know, from a percentage standpoint, isn't found in what the plant gives us. Um so I think we kind of put our our human spin on it, if you will, um, and tried to take it a step further. Uh the other thing that we found is you remove one and the whole thing just craters. It doesn't work. So you need all three of those. And um the efficacy's there, the safety's there. Um, and so it makes it druggable, it makes it uh patentable in that scenario. I'm not too worried about um, you know, the problem that you described uh before being an issue for our situation, but you know, there's always risk. Um and and the attorney in me always kind of stays up at night going, what if, what if, you know. Um, but really we've we've got ourselves a this patent actually is extraordinarily complicated. It it actually looks more like the Encyclopedia Britannica than it does a patent. It's a it there's volumes uh that go along with it. Um be tough, it would be tough to penetrate.

SPEAKER_00 41:48

And and that all said, can you tell us a little bit more about the development process? So you guys went through a lot to get to where you're at and move forward from there. Uh the research, the development. I'm sure our viewers and listeners are saying hey, can you ask Jason if they use the AI?

SPEAKER_01 42:13

You know, it's funny. Um the the uh it's really funny you asked that. Uh, this is a great question because I was just talking to a uh gentleman here the other day that asked about AI as well. Um in our scenario, it was it was very, I would call it very exploratory. Um, you know, in those early days, you don't know what you don't know. And so you are just kind of throwing stuff against the wall to see what sticks. Um and that probably doesn't sound very uh uh exotic at all, and it's not. It's really just a broad-based approach where you say, what where could we go first? And so we sent these molecules off to um pretty much anybody that had a cancer cell line and would give us the time of day. You know, North Carolina State, Nebraska, Notre Dame. We were working with as many, you know, uh very reputable, usually universities uh and some independent laboratories, testing it against basically any cancer cell line we could get get a hold of. Um because we again trying to break it and trying to figure out what's the limitations of this thing. What really caught our attention, and these are all again in in vitro testing. So uh as they say, it's easy to cure cancer in a petri dish. You know, it really is challenging when you put it get it into a body. But um in our situation, we just kept on hitting the target every single time. Um it starts to explain maybe why we're effective against so many different kinds of biologically diverse cancers. And so it goes back to that again, that super enhancer modulation idea. Um But you know that's where it got a little bit challenging because when you work on everything, then it becomes a little challenging to figure out, okay, where do we turn first? What do we focus on first? What do we have the most likelihood of success against? And what is the most underserved disease that we can find as well? Um, because you want to you know you want to get across the finish line as cheaply and as quickly as you can. And so that's why a lot of times people will will focus on um those uh underserved cancers um just as a as a way to get a quick win. Um and so that may be something that we do do next uh because we did see some effect against uh it was a very strange um uvial melanoma is what it's called. It's an ocular cancer. Um very underserved, uh, could be an opportunity for us to be successful more quickly. Um and so that's coming, but this is still very much a developing story.

SPEAKER_00 45:08

So your broadly specific indication, how does this pragmatically roll out when you apply for FDA approval? It's gotta be for treating a particular condition. And although, as we discussed before, cancers are tumor types rather than technically associated with an organ, that's still how oncology treatments are essentially categorized. This is for kidney cancer, this is for melanoma, etc. What's your first salvo like? Which are these lowest of low-hanging fruit that you're zeroing in on?

SPEAKER_01 45:51

So I would say that's still still somewhat undetermined. I think we have good uh you know clinical data to show effect against uvial melanoma, which is one that, like I said, it might be our first salvo because it is underserved. Um you know, there's relatively nothing out there for it already. We'd be kind of uh uh you know one of the only ones. Um and then by definition, if we're the only one, then we're first line drug right then.

SPEAKER_00 46:19

Um that's a good place to be just from a launch point of view.

SPEAKER_01 46:24

Yes, yes, absolutely. And and there's some really practical reasons for that as well. You know, if you are first line then and you're the only kind of option for uvial melanoma, then you might very well be the the the one you will be the one that gets uh insurance approval more quickly as well. And that's a challenge. Uh, you know, getting insurance approval is itself uh a big job. And so, you know, we would look at that and say, well, if you if you can kind of get it in one indication, then that does kind of it's a it's a bit of a trailblazing sort of scenario there. And hopefully it makes it uh a little quicker and easier to get uh approval in other indications as well. Um but that is going to be and and a continuing conversation for us to try to identify the the best uh approach and the best uh target for us.

SPEAKER_00 47:21

Pharma companies take a lot of heat, especially in the press, popular opinion. When you do pew research or these surveys, pharma companies sometimes rank below tobacco companies in terms of levels of trust. Now, now some of that is deserved, but I think most of it is unfair. And the reason is what you're citing right now, in terms of the the sheer difficulty that is involved in getting a drug evaluated, tested, approved, marketed, and paid for.

SPEAKER_02 48:00

Yeah.

SPEAKER_00 48:00

Uh most most drug trials fail. And uh it's worse than Hollywood, where you need one blockbuster to support a dozen flops. In in drug development, you need a hundred tested for maybe one to make it, and I think that that's that's very generous. So what you're illustrating is a common problem, and it takes a lot of wherewithal and determination, especially on the part of a smaller company, to develop a novel agent to verify its safety and efficacy and to make it palatable for patients to eventually use and benefit from. It's this is hard, folks. People don't realize how how difficult this process is.

SPEAKER_01 48:52

You you are so correct. Uh it's hard, it's extraordinarily expensive. Um, you know, we're we're in the midst of a fundraising campaign right now. We've raised already 75 million. Um and and that's no small sum, but we still have more work to do and um and more funds are needed to you know conduct the trials and and do what we what we know we want to do. Um yeah, you're right. Uh drug companies have a bad rap, um, but I I think that is mostly undeserved, frankly, just because most folks I think don't necessarily know what goes into the entire process um and and the uncertainty of it. Uh it's almost every day is a new day. Uh you you have a really tough time kind of seeing around corners and knowing what's coming, and it's very difficult to anticipate. Um the other thing, and this is just a the fact of the matter is, you know, our drug development system that we have is uh, you know, you develop a molecule eight or ten years ago, and then you put it through its paces, apply for uh, you know, your clinical trial with the FDA, you're stuck with that molecule. You can't adjust and tweak based on what you find in that clinical trial, even though you know that that one tweak should uh resolve whatever problem maybe maybe has arisen, you've got to go all the way back to square one and start all over again. That's extraordinarily expensive. Um and I think in part that maybe is something that would be a good outcome. Uh hopefully that's a good thing that AI can deliver to the industry is to eliminate the uncertainty a little bit, uh, if possible. I would say this anybody that thinks that uh AI is going to be the only answer or or or the the panacea of of it all probably is wrong. Um because it's interesting. One of our uh uh advisors is a gentleman, his name is Dr. Daniel Von Hoff. He's a uh very well respected uh oncologist and researcher and and has his fingerprints on pretty much every uh drug that's currently in use in the oncology space. Um the guy is probably he's forgotten more about drug development than any of us are going to know. Um and uh he said why uh why are you guys using these three molecules? And he was asking some questions uh early on when we first met him. And uh finally he he revealed to us, he said, I was actually looking at two of these. Um, because the literature all would suggest that those two uh APIs that that we are in our current drug are uh should be effective. Um but the third, he said, the third, the literature says is not uh bioactive and is not bioavailable. Why on earth would you put that in there? And uh we gave him a very very transparent answer. I said, well, probably just because we're ignorant. We it was just it was prominent in the in the in the plant. And so we said, well, there must be something going on. Um and sure enough, there was. Now, AI would never suggest that third API, it just wouldn't have been in the database. So from that standpoint alone, you would you would then realize that, hey, AI doesn't necessarily have all the answers. You still need that human uh uh intuition, if you will, um, that I don't know that AI is ever going to uh be able to supplant. And uh so I think that when you get humans and AI working together, now you've got a magical recipe right there.

SPEAKER_00 52:55

Yeah, it's a generative pre-trained transformer, GPT, and the architecture is predictive. So the only way you predict is if you've got pre-trained inputs. And then when you got an agent, in this case an API, that comes completely from left field, the model hasn't been pre-trained on the data. So you need that real-world lived experience human element to pump the data into the transformer to do its inference. So you make a great point about novel agents, you make a great point about serendipity, and you make a great point about creativity in the drug development process, too, where sometimes you really need to throw stuff against the wall because the natural world is so unbelievably complex and verginated, and there's more we way more we don't know than what we do. And this goes back to the whole process being antiquated of drug development, just like you mentioned that you've got a molecule put into a clinical trial, and then it's like you know, Rick James, you can't touch this anymore. And and and science is iterative, yes, and and it's you know, folks in the future are gonna look back at this phase of humanity and our drug development process and be like, wow, that's Jurassic kind of stuff, where you have maybe one or two endpoints in your studies when how we're measuring patients and their interaction with these agents is also Neanderthal caveman stuff. We've we've got digital technologies to measure the 37 trillion cells in the average human body, right? We're not even at the tip of the tip of the tip of the iceberg in terms of the biometrics of our own patients. What are we doing? Measuring their blood pressure and asking them to keep a diary? I mean, seriously, this is this is caveman stuff. And it's not ignorance and it's not willful neglect, it's just the juggernaut of bureaucracy and regulation and compliance. Because once you create an infrastructure, a bureaucracy like this, it becomes self-perpetuating. And it's complexity for complexity's sake, ostensibly with this mantle of protecting the public. But protecting the public from what? We don't even know what we're working with yet. That's our that's my rant seeing this as technically an outsider and just scratching my bald head as to how how slow the process is and how anti-scientific drug development is because of all these guardrails. Now, I know we need to protect the public's health, but I'm just saying that there's so much we can do to expedite it and to make it more iterative and efficient, better measured and implemented.

SPEAKER_01 56:18

Yep. I I would agree. I think uh wholeheartedly, uh, you know, from your lips to God's ears, I think there's a major reform that is needed here. Um and I'll have to leave it to you know people much, much more intelligent to figure out what those reforms are. I couldn't tell you. I can tell you a few things that I think should be done differently. Um, but you know, for instance, you know, one thing that really just bugs me is and it and it increases the cost uh exponentially all the time. Um, you know, imaging, uh CT scans, PET scans, uh X-ray, and so forth, it's a big part of any clinical trial. You you got to get your eyes on the tumor and see what's happening and so forth. Um that same x-ray that is occurring just as a normal part of the that patient's care, let's say it costs $500. Uh in the context of a clinical trial, that x-ray will cost $2,500. Um same same exact x-ray, same reads by the radiologist and and so forth. Um why? Uh ostensibly it's because the cost of the clinical trial, you know, it's a burden on the on the trial site and so forth. But there are there are fees that are baked into the cost of the clinical trial at the clinical trial site that I would think should cover that. Um the extra costs of administration and record keeping and so forth. Why is that X-ray so much more expensive just because it's in a clinical trial? Now, do that over the course of a clinical trial that's uh let's say a year long, and uh that patient goes in for 12 different images or four different images, and there's 50 patients on trial, 200 patients on trial, and it's not just the x-rays, it's everything. Um now you're talking big dollars, and that's every single trial that's going on in America that don't like that. It shouldn't be that way. First of all, it keeps drugs from being developed except by only those who have the fortune of uh the literal fortune to raise a bunch of capital. Um but folks who don't raise a lot of capital also have good ideas too, and we're probably filtering them out as a result of that system. Not good for what we're trying to accomplish.

SPEAKER_00 59:00

Absolutely. That's just one of the many implications of this layered labyrinthine bureaucracy where everyone wants a little peace and the end result is pushing out the innovators, the entrepreneurs. And the definition of scientific innovation is the need for agility. You need to be iterative, you need to be responsive, and when you destroy that at its heart, you're just blinding yourself to so many possibilities, and it's all about the possibilities and it's about the exploration. So obviously, I'm just a solved podcaster, and uh, you know, you're you're a guy in Kansas.

SPEAKER_01 59:47

What do we know?

SPEAKER_00 59:50

But uh the good news here is you and NextGen are actually out there doing doing it. So you're you're trailblazing into new areas, you're doing it efficiently, you're relying on what would be considered folk medicine inspiration. So you're you're not creating a billion-dollar accelerator to uh prove what we already know. You guys are reaching into the canon of human knowledge and then tweaking it and optimizing it and seeing if it could be beneficial. That's exactly right.

SPEAKER_01 1:00:24

You bet.

SPEAKER_00 1:00:25

That's really inspirational. And then you mentioned funding, you're raising funding. I'll put links in the description below on the YouTube video or on Spotify, Apple Podcasts, wherever you're listening and watching. Can can people learn more about NextGen? Can they if they got some change to throw around? Uh, in that are you taking institutional investors, private investors? How does your VC situation look like right now?

SPEAKER_01 1:00:55

So thus far, we've not taken any uh venture capital funding. We've got a uh couple of like a family office, I guess I would call it a loosely described, and uh we have a private equity group that's in there as well. Um but mostly this is just interested people that have uh that we've reached out to and and that have reached out to us. And um so and this is just over the course of years, of course. Uh but uh yeah, we we're we're doing private in investment. Uh it's technically considered a regulation D uh for accredited investors. Um, but we are in the process of uh finalizing our paperwork with SEC to launch uh what's called a Reg A, Regulation A plus, which is more of a public offering, if you will. Um and so yeah, we're we're available. It's uh investinnextgen.com is the website, but uh we're also pretty old-fashioned around here. If you want my number, I'll just we can just post it too. You know, we can just give me a call.

SPEAKER_00 1:01:57

Um I don't want you to be spammed though. Okay.

unknown 1:02:03

Okay.

SPEAKER_00 1:02:04

Link is safer. Uh otherwise you're gonna have you're gonna get those texts like we haven't spoken in weeks. Where are you? I'm going to play golf.

SPEAKER_01 1:02:14

Right, that's true.

SPEAKER_00 1:02:16

I'll spare you that. And it sounds like you got enough on your plate already to not be burnt burdened by that kind of that kind of interaction. But I want to sincerely thank you for your time. I learned a lot. And frankly, I'm I'm inspired on a number of different levels. I'm inspired with the innovative science and the spirit of exploration, that throwing it against the wall and seeing what happens. But it's also betressed and and really supported and reinforced by the rigor, scientific rigor. And you guys, you guys aren't fringe, you're playing by all the rules, you're getting the approvals, you guys are legit in every way you can be legit, and uh, and putting it in the system.

SPEAKER_02 1:03:05

Oh, I appreciate that.

SPEAKER_00 1:03:06

The result could can speak for itself, and I'm also inspired by just the spirit of that, that you guys are smaller, more nimble, and thinking out of the box, because I think that's really the big part of the human future, which is not so much you know, just rehashing and being conservative, but taking some risks and and going for it.

SPEAKER_01 1:03:32

For sure. You know, there's there's uh there's only one way to do it, and that's the right way. Yeah, you know, from a just from a regulatory standpoint, of course. Um but yeah, we we if if we have one thing going for us, I guess that we do try to think outside the box and and always bring kind of new and innovative ideas to the table because frankly, it's needed. You know, if not us, then then somebody's gonna have to do this uh because we're we're facing something that's very serious and it's affected everyone. You know, everybody has a cancer story. So we just said, hey, we can help here. Let's see what we can accomplish.

SPEAKER_00 1:04:14

We've seen innovation even in clinical trials. Uh, one of the silver linings of the COVID epidemic was the virtual clinical trial where costs were cut, where patients could even measure themselves and participate at home. So we're even seeing innovation on the clinical trial side. It's just we wish it would stick a little bit better, but but at least on the drug development side, we've got trailblazers like you, which is great to great to see.

SPEAKER_01 1:04:44

We appreciate that very much. That's very kind of you to say.

SPEAKER_00 1:04:48

Thanks so much. Like, comment, and share. Thanks for listening and watching Bald Ambition. It's been a real joy having Jason West, co-founder and EVP from Next Gen Scientific, working on a new type of cancer treatment. They're in their early phases, and it's extremely exciting taking that fresh approach to creating new medicines and not breaking the bank doing it, and at the same time offering patients the possibility of of cures coming down the pike and the spirit of going for it. Thanks so much, Jason.

SPEAKER_01 1:05:33

Thank you as well. Appreciate it.