TechTalk: Unlocking the Power of Human Milk: A Biotech Startup’s Breakthrough in Immunodeficiency Treatment

Dr. Rik Mehta: 

It's my pleasure, Fritz. Thanks so much for having me. 

Fritz Spencer:

Well, to get us started, I would love if you could in a few sentences explain your startup's mission to our audience. 

Dr. Rik Mehta: 

Yeah, happy to. So at Lactiga, we sought out to pioneer the development of the first, what we call mucosal antibodies. Our body, it's such a unique and beautiful thing and we actually have two systems of immunity. We have a system of antibodies in our blood, in our systemic circulation, and we have a system of antibodies and immunity in what we call our mucosal compartments or the linings of our major organs. And to date, no company has ever developed antibodies to be delivered to fortify and bolster our barrier protection of our mucosal system. And so what Lactiga is doing, we're an early-stage biotechnology company focused in immunosciences to really re-envision how we develop antibodies to protect us against some of the worst pathogens, especially among our vulnerable patient populations, starting first with immunodeficient and immunocompromised patient populations. 

Fritz Spencer: 

Interesting. So if I'm someone on the street, tell me what exactly is the specific challenge that Lactiga is solving? 

Dr. Rik Mehta: 

Right. That's a great question. Let me see if I can break this down more simply. And it's an anecdote I don't frequently use, but it's the most visceral reaction is if you picture a while back, there were patients like the bubble boy, and these are patients where they were so sick that they had to be put inside of a sterile unit because there just weren't any treatment options. Now we've come a long way since that, but unfortunately for these patient populations, they have a shorter lifespan, especially among the pediatric population. And it's primarily because their body continues to be bombarded with pathogens that they're unable to fight off. It's like missing an entire layer of your army. And so, while there's been advancements in antibody replacements in the blood, your first line of protection is the antibodies in your mucosal system. Now, think back a couple years to the time of COVID, in fact, that's where Lactiga got its start. SARS-COVI-II is actually a respiratory infection of the mucosal layer and that's where it starts. And so we thought, well, if we can increase the in the mucosal compartments and other areas where there's mucosal linings, well, wouldn't that provide a protective layer, a shield from these pathogens from infiltrating your body? And the answer is yes, that's exactly what we're working on. And what we're looking to do is to give these patients that are unable to produce antibodies, a new line of defense, such that these pathogens don't proliferate into these full-blown diseases that end up making them hospitalized, sick, or in the worst case, death. 

Fritz Spencer: 

Yeah, that's exactly the words that came to mind was line of defense that you guys are building there. And as a founder, you must be pretty involved. Can you give me a little bit more about your background in this industry or in this area? 

Dr. Rik Mehta: 

Yeah. As a founder, you really are forced to wear many hats. Fortunately in my career, I've had the opportunity to learn a few of those hats. I started my career as a clinical pharmacist working in intensive care units, here in New Jersey at the Robert Wood Johnson Hospital. And actually I used that as a way to put myself through law school going to Rutgers Law, Newark. And then upon graduating and becoming a pharmacist and a lawyer, I went to the Food and Drug Administration where I spent about a decade in government service and public health really working to help the United States fight against bad drugs that were being circulated through our supply chain. And then focusing and leaving the FDA as the former deputy director of medical policy before parlaying that experience into the private sector and industry and wearing the hats at large pharmaceutical companies. And then going to smaller companies, helping them navigate complex regulatory strategies to get drugs approved and create market access. And in fact, helping a company IPO even based on their first FDA approvals before taking all that experience and moving it into my own startup. And so really with me, I help to bring deeper experience in navigating and taking advantage of the regulatory environment for keeping clinical trials streamlined in order to get safe and effective biologics to patients as quickly as possible. 

Fritz Spencer:

Your wall in your office must be covered in degrees and accolades. I can only imagine. So let's move back to Lactiga. I want to talk more about your technology. We are TechTalk here. We want to learn about what you're building, how you're building it, and maybe even how you're implementing it to your customers or patients. 

Dr. Rik Mehta: 

So this is what I think is super cool. So a few years back, about let's say five or six years ago, a really good friend of mine who's our chief scientist, and while I was at the FDA, he was a postdoc fellow at the NIH, kind of this idea. And ironically, the two of us both became parents at the same time and our refrigerators were chock-full of breast milk. Probably asking, well, what's the correlation here between antibodies and breast milk? And well, the truth is that breast milk is chock-full of antibodies and no company has ever taken breast milk to see how you can purify the polyclonal secretory IgA out of that milk. And again, we're very familiar with this type of process with looking at human plasma and human blood. And in fact, they're very well circulated therapeutics right now. Intravenous immune globulin is the mainstay therapeutic for immunodeficient patients. But again, IgA is your most common antibody in your mucosal layer. And so putting two and two together to say, well, breast milk happens to have the most ample supply of secretory IgA, exogenous for patients that are not producing it endogenously, what if we took it and replace their missing IgA? And so we sought out very early in this journey to fund some studies, patent enabling studies. Now we have a very robust patent portfolio being the only company that can take breast milk and purify secretory IgA for the development of therapeutics for any patient population really. And so that really was the kind of seminal start to our company was looking at breast milk and seeing if we can lead the development of human therapeutics out of it. Now, breast milk is used a lot right now looking at multiple facets of it, the nutritional value, the lipids, the fats, et cetera. But Lactiga is highly focused on just the antibodies. And we're very fortunate to have partnerships with breast milk banks all throughout United States and North America that believe in our cause, that want to use unused breast milk for the purposes of treating vulnerable patient populations with life-threatening diseases. 

Fritz Spencer:

It's so very interesting and I thank you for sharing the tech side, the product side. And I'd like to move on now to a little bit more about the venture side. Every startup has its product, but it also has its equity. What's it raising, what's it doing? So can you tell me a little bit more about your investor adventure, if you want to call it that? 

Dr. Rik Mehta: 

Yeah, and it's been a journey. Fortunately, we are backed by investors that believe in the technology and really believe in two things. One, of course, we're creating a transformative therapeutic for an underserved population where there hasn't been any meaningful medical innovation for an unmet medical need for better half of 50 years and especially in children. And the second is that Lactiga is really seeking to formalize the framework, in fact, the regulatory framework of using breast milk as a supply, not just in the United States, but across the world. And it creates such a unique opportunity where the therapeutics that can be developed out of breast milk can be life-changing, especially in low and middle income developing countries. And so for us, our venture journey really started with friends and families that believed in us, that wrote the first checks, which then parlayed into institutional investors. And we were fortunate to get the backing of Checkmate Capital and 1517 Fund early on. And so we raised about two and a half million, and that allowed us to do really what I call the most pivotal non-clinical studies to create the data sets that showed that, hey, in fact, there's something here. And we have a great publication with an entire team of different collaborators and a special shout out to Mount Sinai, Hackensack University, University of Georgia, Rutgers, and so many others that have partnered with us to do these studies that are showing such promising display of evidence of efficacy for these patients. So between our grants and our non-dilutive funding and our venture capital, we've raised just enough to complete the non-clinical data sets and go to the FDA, present our data, and develop a very clean pathway to regulatory approval. 

Fritz Spencer:

Yeah, I noticed just by looking at your website that you guys have patents across the globe, it would appear. Can you tell me more about your global strategy and maybe how that process went for you? 

Dr. Rik Mehta: 

Yeah, absolutely. So again, our primary market we looked at was Canada and the U.S. And once we were able to establish those patents, we took advantage of the PCT, what they call the patent highway that allows for filing in multiple jurisdictions. We were backed by a great legal team. DLA Piper prosecuted our first patents successfully. This was despite so many... And as a founder, I'll tell you Fritz, you hear a lot of negatives, right? And the most common one we heard as, well, you're using a natural product, you're never going to be able to patent that. Well, for the purposes we were using it for, and I'm glad I never listened to naysayers, we got a very solid established with the freedom to operate letter on our entire patent portfolio. Again, filing in multiple jurisdictions, looking at the European Union and many other countries beyond that. And that was really important because as an early-stage company, really the strength of your value, we don't have any products out on the market. We're not generating revenue. Our value is based on our data and our patent portfolio and our team of course. And those are really the three most important elements for an early-stage company, and we've really nailed all three of them. 

Fritz Spencer:

It really sounds like it, and I love to hear it. You have a robust portfolio of patents as well as your team, and obviously what you guys are developing in IP is clearly fundamentally important. I'd love to know, it sounds like you have a lot of experience in not only the public and private sector. Is this your first personal venture into entrepreneurism? And if so, what has been the biggest surprise that you have hit along that path? 

Dr. Rik Mehta: 

Yeah, again, great question. So I've always been an entrepreneur in spirit, and one of the reasons why I couldn't get past 10 years in the government. From a startup perspective, I've been fortunate to launch a different company prior to this as a SaaS software mostly focused on the delivery of healthcare and looking at ways to rationalize a broken state regulatory framework between licensing, credentialing for healthcare systems. And that went well. And beyond that, I've also been involved in politics and much like the startup of a business starting up a campaign is quite very similar of which at the end of the day, you have to get the respect of the people that you want to believe in you for something that you want to again achieve something for the greater good. And in this case, developing medical innovations has been my entire background, starting as a pharmacist and, well, actually well beyond that, probably inspired by my father who did spend 50 years doing cancer research. I've always had this kind of startup spirit. But at the end of the day, you really have to ask yourself why you're doing it. And the why really matters to me, whether it's to effectuate public policy for the betterment of our future generations or medical innovation that's going to be life-changing for very sick patients. Those are the whys that drive me. And I'll end on this point, Fritz. For me, and what's really important is that I'm actually a father of three boys. And so when I look at the importance of the things that we're doing, especially when we are first studying a disease state that has a very high mortality rate in the pediatric populations, that means something to me. I was at the Immunodeficient Patient Foundation meeting in Chicago over the summer, and I met with a lot of patients and their families, and it really touched me. And so to know that we're on a track that could really change families and how they deal with these diseases, I mean, these are really the strongest people I've ever met. And so that's what I think is really important, especially the reason why you want to drive it, which can get lost in your conversations with venture capital, raising money. And of course, at the end of the day, they're always asking, "Well, what's the market size? How much are you going to make? What's the revenue potential? And are you a unicorn?" And that unicorn doesn't mean are you going to transform patients' lives? It's like, are you going to create a billion dollars of revenue? So you got to look past that and really focus on the why. 

Fritz Spencer:

Yeah, it sounds like you've really found that why, and the impact is not only at home for you, but very close to home. So that's very nice to hear that it's not just about the numbers for you and it's more so about that why. So lastly, I would love for you to give some of the listeners out there that maybe on this same journey as you some advice, something that you found extremely useful whether recently or in the last few years. 

Dr. Rik Mehta: 

Yeah, so I'll end on this. Keep going, just keep going. When we started in 2020, 2021, the market conditions were more favorable. There's more liquidity and funding came pretty, I don't want to say easy, but it came and now the market's tightened up, the IPO has shrunk. And of course we're hopeful for a successful 2025, but it's so easy to say that's it, I'm out. But don't. Keep going. Don't give up and believe in yourself and believe in the why. That's really important. If you're doing it for reasons beyond what the revenue is. And if you truly believe that you're building something that's going to be transformative in people's lives, talk to those people. This morning I was on a call with a patient who's patiently waiting for our treatment, for our clinical studies to start, and I said, well, I apologize. We're at least a year out. And he's like, "Well, I'm following your journey and I'm rooting for you." And those kind of stories, those anecdotes are really what means the world. So for other innovators and entrepreneurs, build a good team, make sure you trust the people you're with and make sure you know why you're doing what you're doing. Otherwise, it's going to be a very hard journey. 

Fritz Spencer:

Thank you for that so much. I appreciate it. And speaking of going forward and not stopping, really quickly, tell us what's next for Lactiga. 

Dr. Rik Mehta: 

So for Lactiga, we're fortunate to have FDA feedback, have orphan disease designation, rare pediatric disease designation, all of this for our first asset that we're developing, and that's building on our platform of secretory IgA, whether it's an oral capsule, a respiratory product. We're about to kick off some research in lung transplant rejection studies as secretory IgA can unlock a lot when it comes to regulating the microbiota. So for us, we're hyper focused on finishing successfully our fundraise round and filing our IND to get into a clinic. And believe it or not, we have feedback from the FDA that may allow us to go straight to a phase two study bypassing phase one, really unique opportunity and getting our treatment to patients as quick as possible. And that's what we're laser focused on. So this time next year, Fritz, we will have our first patient enrolled. 

Fritz Spencer:

I can't wait to see it. And Rik, thank you so much for joining me. I greatly anticipate following Lactiga's journey and your journey and just being along for the ride and getting to witness what you guys accomplish. 

Dr. Rik Mehta: 

Thank you. Really appreciate that. 

Fritz Spencer:

And a special thanks to our listeners for tuning into TechTalk, the entrepreneurs and innovators who turn to EisnerAmper for accounting, tax, and advisory solutions. Subscribe to EisnerAmper's podcast to listen to more TechTalk episodes or visit eisneramper.com for more tech news that you can use. 

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