Latest / Zero Friction / Transforming Cardiac Care & Heart Failure Innovation with Ayla Annac || Zero Friction Podcast
Transcript
- Terry Coutsolioutsos/RevRx AI: Well, welcome audience. My name is Terry Kuchaluchis. with the Zero Friction podcast. Today I have the honor of speaking with Ayla Annac She is the co-founder and CEO of Invivo Sciences, which is breaking out with a brand new therapy for treatment of heart failure. And Ayla is here going to give us a little background on her career, talk about some of the opportunities that she sees in the heart failure marketplace and where Invivo Sciences will be moving towards in the near future. So, Ayla, thank you so much for being here. Why don't you give us a little background on yourself and the company. So thank you. Ayla Annac: Thank you, Teri. I appreciate being here as your guest and appreciate the opportunity that you bring to us. name is Ayla Annac as you mentioned, and I am a co-founder and CEO of a small-scale biotech company called Sciences since 2001. With my co-founders, Dr. Wakar Suki and Dr. Elliot Elson, we established the company initially in St. Louis, Missouri. And ⁓ the as a technology development company for enabling the precision medicine in heart failure. And the of the technology that we developed or platform we develop combines ⁓ AI-driven certification with patient-specific biological heart tissue that we create three-dimensionally and what call biological tipping. So very layman ways that we are able to to get a sample through the stem cell technology from a patient or patient specific and create outside of the body the three dimensional heart tissues or disease models and we are able to screen the drugs or targeted drugs on those specific human cardiac tissues. and we are able to identify not only targets but also toxicity of those molecules for the target population and through AI integrations out of a large scale of population we can even go to the subcategories of the population. That means we can do smaller scale clinical trials the heart failure precision drugs and that is not very available yet in industry. and that is why we are excited to do but when you ask how I came to this world is question I will go backstop from where we are. lost own father to heart failure ⁓ in Turkey, in Istanbul long years ago, more than 33 years ago. He died at at age 53 for heart failure and it was very as a young child and family. to understand why he died suddenly at work and it was a very young man and this became a mission in myself, in my heart and I said I want to make something happen so that nobody experiences pain and nobody go through this again and I didn't know at that time how big of a scale of a disease is heart failure around the world and when I talked to the doctors at that time for my father when we went to visit the the doctor, they told me that there is no technology available. He needs a new heart and there is, you know, millions of people in the line to get a heart. So we cannot, he needs to be in a list. He will not make it. So such information for a little mind is very hard to grasp. Later on in San Luis, Missouri, when I was working for Nestle Prina and I had the pleasure to meet with the two scientific founders, Dr. Wakar Usuki and Dr. Elliot Alson and their project, I was very excited because they were talking about to create from the heart directly by the utilizing stem cell technology which they have, which is creating a three-dimensional ⁓ to screen the drugs and to be able to identify precision approach a drug that is curing or at least the disease, underlying disease, or a specific patient population. And they said they can help to do so. And that excited me when I was working for a corporate and I said, I'd like to help because I lost my father. I can help you to put the business side of it, business plans. And I talked to the Washington University Medical School and suddenly Medical School ⁓ this is very nice, ⁓ but need take on. because we need somebody to lead the project. And if you lead that, if you put together the business plans and the concepts, and if it is reasonable, then we fund partially. And the scientists can go and apply for grants, and we see the scientific validation. And it goes, I didn't know that it will take very large years. I didn't know how difficult it will be to funding. to validate scientific standpoint to get NIH and American Heart Association's validations behind. And these are different paths and they come together but you have to validate each step and then go to the pharmaceutical companies like Pfizer that time to if they have an interest. But that time they said we are ahead of time. We need to, you know, develop and then bring them as we develop more concept to, you know, stage of the data and platform technology. So they kind of guide me with the sets of paths, but each path takes years and requires investment. So these are technologies that require funding and require a consistent effort of promoting and not giving up on the technology till development stages and everything is proven, data came. So teams cannot give up even though people are not there to match with your or you some solution but they are saying, ⁓ I data or nobody is doing it. This is ahead of time. Many people responded that way and investors were not excited ⁓ to invest at the early stage or too risky. So we have only groups like SPIR grants that they fund ⁓ early risky technologies or universities. So we were in that ⁓ gap and now we had to persevere and have loss of grit. So I think the way I came into that because of loss of a father had a mission and the scientific partners also are idealistic and really really sharp individuals that they also want to help humanity. So they have this humanitarian aspect of it because they do know that it's a difficult path. heart failure had a solution by now My father died 34 years ago, many many drugs will come. Right now there is still no precision medicine in the heart failure, even though it is number one killer and 20 million people each year dying from it. so I think the reason I did it is very I would like to be a solution to a really large scale problem. And I also understand that this is big, I will would like to be more leading the collaborative effort. because no one company can make this happen. You need pharmaceutical partners, need investors, experts, you need people understand how difficult space is this. Because oncology has been supported, ⁓ medicine in oncology has been supported with the large scale government funding and people's efforts and right now than 500 drugs available, precision drugs available. Terry Coutsolioutsos/RevRx AI: Mm-hmm. Ayla Annac: oncology space is a precision medicine approach but heart failure is five or six drugs for all around the world and no precision medicine yet and no funding equivalent to the oncology space. Terry Coutsolioutsos/RevRx AI: So do those drugs actually cure heart failure or do they just fix the symptoms or provide a solution for the symptoms? there a cure or is it curative? Ayla Annac: Secondary symptom management is the right now. are providing ⁓ quality life for the patient. Maybe they can relax, they can breathe. Maybe they walk, they can sit on a chair and they can read things, but none of them is curing. So they are becoming in the medical system and in the area that we are working, heart failure preserved ejection fraction is one of the most debilitating one. rehospitalization occurring so they are at home they cannot exercise even because there is no drug there is no innovation in the space and that rehospitalization cost is enormous without curing the patient. Terry Coutsolioutsos/RevRx AI: You know, I think it's a real good place to maybe even highlight, like, what is the impact of heart failure on our society today? Like, so there's obviously the qualitative component of somebody's life, right? So when you get heart failure, you can barely walk down the street, you know, across the house, with your children, play with your grandchildren, get to the mailbox, right? Those types of things ⁓ those activities are taken for granted that they just don't happen with the same quality that you used to have, correct? Ayla Annac: think you ⁓ well explained ⁓ able to play with your grandchildren, not able to go to the mailbox or exercise as a man or not able to ⁓ correctly and you are dependent on someone else because you our societies, know, men been for the family and when you take that main provider sometimes there's not much left for that society. Some people go into poverty levels when the main figure can no longer work. In the area of what we work, preserved ejection fraction, 51 % is female. The situation is much more worse because at least in the male figure, when they go down, there is a partner, there is a sister, there is someone that's feminine caregiver. But if, yes, caregiver, yes, and... Terry Coutsolioutsos/RevRx AI: Right. A caregiver, right? A caregiver. Ayla Annac: It's a big burden on the caregiver because they are not sometimes been compensated. But if the caretaker or the neater is a feminine, now needs to work, male needs to work. Terry Coutsolioutsos/RevRx AI: Yeah. The male, the person who's not the natural caregiver now needs to be the caregiver. It's hard, Ayla Annac: Yes, are. It is 51 percent. That means our society collapse ⁓ this heart failure is not going to be having solution. Nobody is looking into that from that ⁓ standpoint. is not good idea. But if there is no solution and bold genders are affected in this, long-term effects on our communities ⁓ is disastrous. So we need to understand maybe ⁓ a cancer patient is not a fun thing. Nothing is fun in any way, but heart failure, you cannot breathe, you have one heart. The moment you stop breathing, it is done. Terry Coutsolioutsos/RevRx AI: Yeah. And so the other thing I think our audience, you know, highlight for is that, you know, I think heart failure has the same mortality rate of a lung cancer. So I think, you know, the mortality rates, what, five, 50 % within five years or something along those lines. ⁓ So catastrophically, know, from a mortality perspective is there. Economically, I think it's the number one ⁓ Ayla Annac: Yes. Correct. Exactly. Terry Coutsolioutsos/RevRx AI: cost burden that we have on Medicare. So when you look at our Medicare spend, think heart failure has the number one expense tied to it. the problem from a qualitative life perspective is huge. The problem from a mortality perspective is huge. And the problem from an economic perspective, just with the healthcare cost ⁓ huge. So the problem is massive. So ⁓ out here trying to fix this massive problem. And so And your solution is designed to be a curative solution, correct, as well? Ayla Annac: Yes, the two area we are helping, number one, to decrease the trial cost, clinical trial cost of heart failure drug development through the patient stratification, because our technology has two sides. Number one is that we are able to go targeted patient specific cardiac tissues. can develop a disease model outside and they can test the drugs. But the other side is that we are able to bring the right patient to the right drug, to the clinical trials, so smaller scale clinical trials like cancer. Yes. Yes. And right now, one of the problems of investors shying away, because clinical trials of heart failure is very, very large, 2,500 people, very costly, and the failures are at the phase three. So once you have a failure in phase three, Terry Coutsolioutsos/RevRx AI: Precision, more of a precision medicine. Nice. Okay. Ayla Annac: billions of dollars is like at risk, nobody likes to be investing there. So they're expecting government investments coming in so that they can de-risk. And in the cancer area, the incentives in precision medicine was significant while in the heart failure area, it is almost very not equivalent. So that means that we need not only the from the investors to open the minds that there are new technologies that cost, there's the clinical trials can be small trials and effective, successful trials can be done because of the new technologies like what we have. But I think with the efforts, there will be incentives to create precision drugs and fund them. Terry Coutsolioutsos/RevRx AI: So your technology is not only designed to potentially one day actually be a cure, but it's actually designed to be precision diagnoser ⁓ heart failure so the right drugs can be delivered or the right therapy can be ⁓ Ayla Annac: Yes, in the future, yes. Because we can actually identify the diagnostic parameters of a specific patient population and then they can bring the drug from the disease model from the targeted population and when the drug is actually approved it is for the target population so the treatment is very specific so that is also a companion diagnostic area. So you are not only, you know, approving the drug but it's a companion diagnostic site so diagnostic companies as well as drug companies is going to be benefiting from partnering and because we are small we have one drug in in our library that we are working on a lead drug but the the technology can help many drugs development with collaboration Terry Coutsolioutsos/RevRx AI: So where do you stand today, like in terms of getting something that would be, is your goal to get something clinically approved or is it designed to work within the current research structure of a pharmaceutical company pathway? it like, is it standalone by itself or is it more like a strategic supporting tool for a company that's trying to develop a heart failure drug? Ayla Annac: Our platform can be support and can work with anybody like a CRO, specific needs CRO or collaborative effort. ⁓ can access the platform and develop their own drugs or smaller populations and can help them to develop the protocol for ⁓ which population to be brought to the clinical trials for the success of the drugs ⁓ that they attained or the diagnostics. Terry Coutsolioutsos/RevRx AI: Okay. Sure, yeah. Ayla Annac: But what we have is for heart failure preserved ejection fraction, we call IVS-201, we are trying to move that lead drug to the next stages of clinical trials we are trying to generate a successful meaningful phase 1 data and from biologically stratified patient population for that specific drug ⁓ because can stratify the population and when we do this one successfully, the drugs will validate. that how drugs can be, many, many drugs can be, you know, come out from a platform like what we have and so that ⁓ will not be shying away from developing precision medicine for heart failure. And they will join the efforts of many, many small scale drugs for subpopulations because heart failure prescription fraction says, large subpopulations. So, but currently everybody takes one drug and goes to the same. We are ⁓ focusing the group that has fibrosis on their and that is the reversal of fibrosis is our target for that population and that is why we are very targeted on where we are going for the clinical trials and that will a ⁓ drug candidate. Terry Coutsolioutsos/RevRx AI: Right. Mm. Ayla Annac: that pharmaceutical companies can come and collaborate and take on full commercialization and investors will continue working either with the sub libraries that we have, other drugs, or we can collaborate with helping others to develop their drugs. Terry Coutsolioutsos/RevRx AI: Well, that's quite a noble purpose. Sounds like a big list of things to do. Do you have time frame in terms of when all this might become viable or is that a topic you can discuss today? Ayla Annac: Yes, I think we are looking for the next 18 months for ⁓ successfully raising the of the funding we need for covering the cost of the Phase 1 trials, ⁓ which a smaller scale because we have human data already. And ⁓ ⁓ ⁓ we successful to show how small trials be done, that will open the floodgates for investors' mindset and also Terry Coutsolioutsos/RevRx AI: Okay. Ayla Annac: As I mentioned that there is a mindset of ecosystem that needs to change because there is not much incentives, government incentives behind the development of the precision medicine drugs for heart failure. maybe is one of the main sources, but they don't have sufficient funds for everybody. They don't have sufficient funds to give every innovation coming out. Terry Coutsolioutsos/RevRx AI: Mm. Right. Right. Ayla Annac: And so what is happening again, it goes to philanthropic groups that can fund individuals, family funds that have the legacy that they want to come and contribute because they are already in the space. And so those individuals are very important to bring the new precision medicines for the next 10 years to the society and to prevent the burden of the taxpayers and to bring the new solutions. Terry Coutsolioutsos/RevRx AI: Mm. Okay. Ayla Annac: that is effective solutions to the patients and this is going to happen with the groups. leadership will come through collaborative efforts. So not one company will be the queen or a king of the space like Cancer Field. will be many, many drugs will come. Everybody will win. There's enough money to make in this one. But I don't think expecting it, government trust will fund this. Currently, incentives are Terry Coutsolioutsos/RevRx AI: Okay? Ayla Annac: very low compared to the cancer field. It has to change. It will come. The changes and that funding will come. I think Europe already is aware because they declared in Davos, I believe, the precision medicine and cardiac is one of the critical challenges for European countries and they have to find solutions that will be effective for cardiovascular there are Terry Coutsolioutsos/RevRx AI: Mm-hmm. Ayla Annac: leaderships looking into that but funding even in Europe is way way behind to cancel the area. Terry Coutsolioutsos/RevRx AI: So the funding's been a challenge then, I guess, is a friction point. And I know that I talked to other founders and co-founders the med tech and the pharmaceutical space. And it's a very challenging period to raise money. And especially with a big problem like heart failure, those are things where government assistance is definitely probably Ayla Annac: Great. Terry Coutsolioutsos/RevRx AI: supported by a lot of folks, but it sounds like, was there some legislation that got passed for some new grant money too, think just recently possibly in the legislature? Ayla Annac: Yes, actually, I think SPAR companies, NIH funding reopened, reauthorized. And I would like to say that, you know, we are very grateful, one of the companies and initially we got funding to do the prototype development and technology platform development through the university partnerships. without those funding, investors doesn't come in very early stages. And Without those kinds of funding, the technology is like colossal and the number one killer in not only US, around the world, will not find a solution innovation. So we are grateful, but at the same time, I think is a ⁓ space where innovation, efficiency ⁓ strategic partnerships still need to come together. And we cannot wait everything from governments. We cannot wait everything that they will... be the solution and there will only be one funding. But I think there is a room for larger scale of incentives from the government because oncology, precision medicine only developed this far and this highly because of the government spending behind was proportionately significant, other than heart failure is not much. we have only Terry Coutsolioutsos/RevRx AI: Right? Ayla Annac: one or two philanthropic funds trying to do work on this space and so I think is competing for attention everybody is trying to get some ⁓ know funding and while this colossal problem taking lives daily and hospitalization is the big problem in the hospitals ⁓ if one percent of the rehospitalization which is 300 billion dollar cost paid back Terry Coutsolioutsos/RevRx AI: Mm. you very much. Ayla Annac: to the investors ⁓ the structures, I think more innovation will come. ⁓ I think technology is already here. All need to do to collaborate to bring the drugs together. And I think we have enough smart people out there, ⁓ very investors out there that ⁓ pulling the teams and making things happen in a collaborative manner shouldn't be a problem. But I think it is still... Terry Coutsolioutsos/RevRx AI: Right? Ayla Annac: It is not a challenge that has been solved. So I am just one of the individuals and soldiers trying to make something happen. Terry Coutsolioutsos/RevRx AI: Well, and it's a great purpose to have. think at the end of the day, heart failure is a big problem. You're trying to solve that big problem. And we understand there's a long pathway to go with that as well with funding, with large randomized clinical trials, all those things take time and money. And so getting as much support from a financial perspective is needed in order to solve these big problems. And so we definitely have an appreciation for that. So moving do you think ⁓ is a five year window of timeframe? Is it a 10 year? What do you think the window is before technology like ⁓ either or other technologies like yours gets to the market for us? Ayla Annac: I think there's no reason for this will be not a five years window because technology has been already developed. There is no funding needed for technology. So that means that only thing we need to do is that to target the subpopulations for heart failure with different drugs and not one company can have 500 drugs. And that is why every company, small companies will come up with their focus of drug development. But to our technology will be able to show that you can complete a phase one study with approximately 250 patient population. This is a huge economical scale difference from the larger clinical trial to a smaller, a very similar to cancer oncology approach. People who are in the field of oncology precision medicine development will notice economics. and investment and the returns but this is not happening in the heart failure. The moment few companies successfully start showing the drugs even those segments for a smaller population there is no reason for so many other drugs to do the same follow the path and you know to target the other populations and then drugs will start coming out in time. Terry Coutsolioutsos/RevRx AI: Mm. Ayla Annac: So five years, I think, is very reasonable by knowing that certification technology, medical records, AI integration, and also the three-dimensional cardiomyocytes and disease models for heart failure patients is already developed. ⁓ we only need to now focusing on specific diseases under the heart failure umbrella or cardiovascular. ⁓ Terry Coutsolioutsos/RevRx AI: Right? Ayla Annac: There needs to be more teams. So one team, as I said, one company can never be one. There will be pharma. Pharmaceutical partners are critical. They need to be opening more, I think, meetings ⁓ for smaller innovative companies and collaborate. Terry Coutsolioutsos/RevRx AI: Right? Right. Yeah. Anish, good have you today from Invivo Sciences, co-founder and CEO. You can go to their website. I know that they have ⁓ investor information there as well as a lot of the information on the technology. We wish you the very best. Thank you for joining me today and to discuss this huge that we definitely need our government and our resources to really begin to focus in on what heart failure does today. I have experienced myself with heart failure my history. I understand the problem that it brings and it mortality, has quality of life, and it has economic implications that definitely should addressed. thank you so much, Ayla. much appreciate your time today. Ayla Annac: Thank you. Terry Coutsolioutsos/RevRx AI: We wish you the very, best of luck. Ayla Annac: Thank you for including and thank you for bringing the attention to this important matter. Thank you very much.