Business Of Biotech
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Business Of Biotech
Biotech Collaboration Strategy With IGI's Cyril Konto, M.D.
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On this week's episode, Cyril Konto, M.D., president, executive director, and CEO at Ichnos Glenmark Innovation (IGI) talks about the promise of multi-specific antibodies, funding the company during the 'biotech winter,' closing a $700 million upfront licensing deal with AbbVie, the impact of China's rising biotech sector, and the keys to successful collaboration. Cyril also discusses IGI's focus on developing innovative therapies for emerging markets, and the shift from animal models to in silico modeling in preclinical research.
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Welcome back to the Business of Biotech. I'm your host, Ben Comer, Chief Editor at Life Science Leader, and today I'm speaking with Cyril Canto, MD, President, Executive Director, and CEO at Ichnos Glenmark Innovation, or IGI for short, a clinical stage biotech developing multi-specific antibodies and headquartered in New York City. Cyril is an oncologist and has worked in big pharma clinical development at BMS and Pfizer. His team developed El ranatamab, a bi-specific T cell engager approved by the FDA in 2023 as Elrexfio. And he also led Allogene's early development of allogeneic CAR T cell therapies for lymphoma. Cyril became CEO at Ichnos Sciences in 2011 and CEO at IGI in 2024. And I'm excited to hear about the IGI business model, which is unique, and how the company scored a $700 million upfront deal with AbbVie for ISB 2001, a tri-specific T-cell engager for multiple myeloma. We'll also talk about why IGI is focused on bringing innovative therapies to emerging markets and how capital flow in China is changing the way IGI communicates externally. Cyril, thank you so much for being here.
Cyril Konto, M.D.:Thank you, Ben. It's a pleasure to be with you today.
Ben Comer:I'm glad to have you on. I mentioned in the intro you are an oncologist by training. You've worked at two of the largest pharma companies in the world. How did you first become interested in uh biologics specifically? And what could you tell me about your past career experiences, either successes or failures that led you to Ichnos Sciences?
Cyril Konto, M.D.:Um I'm an oncologist by training, and early on I saw firsthand the limitation of traditional therapeutics in complex cancers. Um, biologics opened the door to precision, modularity, and combinatorial biology. The ability to engineer molecules that solve problems, small molecules simply can't. So that's how I got interested. My time at companies like BMS and Pfizer grounded me in the rigor of large-scale RD while teaching me what flows innovation and really made created the appetite to join the biotech world. Um my successes, among them development of ipilimumab, supporting the development of nivolumab, anti-CTLA for first, PD-1, second, you mentioned elranatamab, BCMA C D 3 biospecifics. Those successes taught me discipline. The failures, they were many, taught me humility and the importance of platform thinking. We touch upon many technologies, we build up a portfolio of allogenic CAR T through collaborations with Cellectis and Servier that we spawn off to uh Allogene, and Allogene is running the registrational trial for those allogenic RT. So those are the different elements of drug development in biotech world, in pharma at a larger scale. You sometimes win, but we have to face many failures. IGI represented the the perfect inflection point, a chance to build a company around multi-specific science with the agility of a biotech and the scale readiness of a global alliance.
Ben Comer:That's great. And I I want to get into uh IGI's business model in just a second. But before we we could get to that up to 2024, you were CEO at Ichnos Sciences in 2021, uh the very beginning, you know, of the biotech winter, a very difficult time that's only starting to thaw out now. I wonder what you could say, you know, about, and I believe this was your first uh CEO role uh as well. But I wonder, Cyril, what you could say about how you managed through that period of time and you know what what the difficult decisions were uh that you had to make to keep the company alive and growing.
Cyril Konto, M.D.:Um so first icon sciences inception was in late 2019. Um it was uh a spin-off of the biologic research unit at Glenmark Pharmaceuticals. Um it was created with the idea that a biotech would uh um bring the right ecosystem for drug innovation, especially with biologic and biologics, in what was back in time uh a generic-driven pharma company, Glenmark Pharmaceuticals, which remain uh the sole investor. We are a fully owned subsidiary of Glenmark Pharmaceuticals. We, and just to to complete the picture on why we're speaking IGI today, um the good work we've done, and I'm going to respond to your question in a in a few minutes, uh made Glenmark decision to allocate their small molecule for portfolio to Ichnos Sciences, and to make sure that every employee recognized themselves in in this new structure, we decided to uh create a new branding, a new corporate name, Ichnos Glenmark Innovation. So now how did I kept the company alive during the biotech winter? 2021 required decisive leadership. Capital tightened, science became more competitive, and investors shifted sharply toward dearest assets. My priority was to focus the pipeline, make evidence-based decisions, and allocate capital with discipline. We exited areas that were not strategically aligned or insufficiently differentiated. For as example, for areas, inflammation and immunity, we were more experts in cancer. We decided to out-license our portfolio for those assets in this specific area and focus on oncology. When it comes to assets insufficiently differentiated, we had a CD38, CD3 bi-specific in a crowded space with standard first generation bi-specific T-cell engager. We decided to eliminate this asset. We also were running low in capital, we couldn't spend in too many um programs. We doubled down on assets where IGI had a true competitive advantage. Multi-specific, so multi-specific antibodies with validated biology, and a pipeline with line of sight to clinical differentiations, like ISB 2001, a first in class, CD38, PCMA, CD3, Tri-specific, T Cell Engager. Survival required both operational austerity and scientific ambition. We executed both. Last, in this spin-off I mentioned earlier, we also had a manufacturing plant allocated to Ichno Sciences. In this difficult environment, with also the need to make sure that we acquired the ability to scale up, we decided first to divest this asset, which was certainly not the right time in the post-COVID era. It was extremely difficult to find uh buyers for our manufacturing plant. And without finding the right buyer, we decided to shut down our um manufacturing plant and tech transfer our technologies to reputable large-scale commercial C DMOs to enable the next phase of development for our atmosphere mark innovation.
Ben Comer:And that that was an antibody manufacturing center or small molecule?
Cyril Konto, M.D.:A biologics manufacturing center where we did where we did cell line development, manufacturing uh operations, analytics, and also uh uh uh QAQC.
Ben Comer:So it was actually um more affordable than to close the internal manufacturing and and transfer over to uh a C DMO as opposed to running it yourself. That's interesting.
Cyril Konto, M.D.:More affordable, more flexible. Realize that when you we are an emerging biotech company, those are molecules that we administer first to patients. We don't know whether they're gonna be drug products, marketable drug products. So there were substantial operational expenditures allocated to manufacturing those molecules without really knowing whether one day one of them would uh would cross the finish line of uh marketing approval. So it's also a lot of investment. And by shifting from in-house manufacturing to an outsourced CBMO model, we were also um uh complying to the to the risk model of biotech company in general.
Ben Comer:Right. And um multi-specifics, multi-specifics uh is uh a term that has been trademarked uh by Ichnos or by IGI, uh, which is uh fascinating. I'll let you tell tell the the story of that. Um but was uh in terms of finding a CDMO, transferring you know that that process over to a third party, was did you find that um that there were plenty of CDMOs out there that that could handle you know that particular type of prop manufacturing process, or was it difficult to find a partner that could essentially you know do what you wanted them to do?
Cyril Konto, M.D.:I I say the skills were there. We had um all we discussed with um mid-sized C DMOs, uh mostly, not large C DMOs. Um but the the risks in this post-COVID where a lot of CDMO had started to produce vaccine and biologics. Right.
Ben Comer:Where the capacity issues.
Cyril Konto, M.D.:Indeed, we so we had to make some level of commitment to purchase our supplies from the buyer, a significant commitment over uh multiple years to make sure that the buyers can also on its own grow, find new customers, replacing progressively our own purchases. So there was also a financial commitment, um, and very few capital to expect from selling a CDMO. So the the environment was overall less permissive than switching directly to um a lot a large-scale CDMO like Thermo Fisher or Catalant. Right.
Ben Comer:Um, getting back to IGI, I want to ask you about um the business model. You mentioned you know, IGI is formed through an alliance between Ichno Sciences, which was originally a spin-off from Glenmark Pharmaceuticals, which was traditionally uh a generics uh manufacturer. Um what what more can you say, Cyril, about you know, why maybe you didn't just stay as Ichnos Sciences? Uh why did you then need to create the Ichnos Glenmark Innovation Company that's separate and that is now uh headquartered in in New York City? What was the the thinking behind that particular model?
Cyril Konto, M.D.:So IGI was intentionally designed as a focused innovation-driven biotech with the skill advantages of global pharmaceutical company, big brother Glenmark in pharmaceuticals being backing us up. Glenmark carved out its biologics unit to create IGI, a company with its own governance, PL, RD autonomy, while still benefiting from Glenmark's infrastructure and global reach. This model gave IGI the space to innovate boldly while ensuring stability during economic turbulence. So that's really, I am to my mind, what supported every scientist, every clinician, supportive function in IGI to focus on innovation, drive innovation through research lab to clinic. Why did we shift it from ICNOS to IGI? I think this is this is more making sure that we have a cultural harmonization. Everyone, every Ichnos genius can recognize themselves in in the IGI. We are headquartered in New York. We're doing research in Lausanne, Switzerland, plus some uh manufacturing oversight um in Neuchâtel, Switzerland, and we have a supportive RD hub in uh in Mumbai, India. So you see, we're we're a multi-location field, um, hence the need to harmonize culture. We have different ways of thinking, of interacting, of formulating comments. US is very entrepreneurial, um, Europe is more reserved when it comes to comment and criticize uh others, India is very respectful of hierarchy. So we had to create a common denominator, denominator, excuse me, that that is our uh multicultural.
Ben Comer:From a people perspective, Cyril, how how do you bridge those gaps between three you know very different regions culturally? And you as the leader at IGI, you know, what what can you say about how you bring those very disparate groups together and uh you know under one mission?
Cyril Konto, M.D.:I think our greatest achievement is our culture. We created scientific rigor, transparency, and the courage to make hard choices. We've learned to pivot when needed, terminate when doesn't deliver, and invest where data leaders. And and with that and the importance of repeating this um at multiple occasions. Every quarter, we're we're broadcasting a town hall from the New York office where all the other locations are connected and realize that we have nine and a half hour time zone difference from the earliest to the latest uh time zone in our organization. So everyone, every single Ichnos genius in my organization is also committed to connect attention stone halls where we repeat our strategy, where we communicate um our achievements, where we are learning also through some of the failures that every biotech has to face. So all of this is uh is the support to a great culture that that makes IGI so special today.
Ben Comer:Um the top of your uh investor presentation uh that I that I looked at when I was just looking through your website, uh it says collaboration propels innovation uh at the very top. And I I it's sort of related to what you've what you've just been saying. Um what would you say about IGI's mission uh collaboration, really focus on on collaboration? How did how does that differ from maybe some of the the previous companies that that you've worked at? And is there a clear advantage to this focus on collaboration?
Cyril Konto, M.D.:Um our tagline, as you said, is collaboration propels innovation, and we feel that alone we will not be able to deliver a high-scale innovation relative to having a biotech to biotech collaboration, biotech to big pharma collaboration, going back to the AbbVie deal you mentioned in the intro, or even biotech to academia uh collaboration. I'd say IGI works differently because collaboration isn't a slogan, it's an operating model. It's in our DNA. Um, I took the helm uh of uh Ichnos Sciences at the beginning of uh 2021. We signed our first licensing agreement with Almirall, a Spanish dermatologic company to uh develop our entire L1 wrap monoclonal antibody for hydrodynitis suppurativa, a DEM disease. They are the specialists going back to my prior comments on focusing in cancer and out-licensing our assets to other experts. So that was in December of 2021, and we all just announced that this asset is now moving to phase two.
Ben Comer:And that was discovered internally.
Cyril Konto, M.D.:Yeah, it's our our internal research. We deliver we we had an IND already asset, and we are run around the phase one, first in human trial. Uh, we we even had proposed a draft protocol of this uh for this study. Two years later, we out-licensed our entire sort of monoclonal antibody to Astria Therapeutics, um, a company specialized in rare disease and dermatology. Um, and they've run the dose escalation in healthy volunteers for our uh monocle antibodies. They also uh enhanced the uh the antibody we delivered to them with the YT half-life extension uh technology to make this asset a best thing class. So, two examples of experts we decided to partner with our scientists, clinicians, translational teams, and external partners engage early and often. We have those joint steering committee. With AbbVie, we went even beyond the standard joint steering committee. We created subcommittees to enhance the collaboration. In contrast to Big Pharma, we run a flat, integrated R&D environment where decisions are fast and evidence-driven. The advantage is speed, clarity, and accountability, and our partners love that from us. Um the keys to collaboration are transparent goals, early scientific alignment, data discipline, respect for each function's expertise, and cross-functional ownership. So that's uh that's what defines our operating model. We encourage everyone in IGI to put themselves into the shoes of our partners. Partners have sometimes different priorities, different imperatives than the one we have foreseen for our assets, and and projecting ourselves into our partner on the on the partner side is also helping understanding and speeding up clinical development. Something we've done extremely well with Astria, with AbbVie, and and Almirall.
Ben Comer:Yes, you have certainly done very well uh with the the collaborations. And I want to get back to ISB uh 2001, a tri-specific antibody uh targeting multiple myeloma. Uh AB last summer licensed that for $700 million uh up front. Um, and you mentioned already, you know, the two other uh deals that that IGI has done for a company that has not been around for very long, you know, that's that's quite a solid performance. I I wonder if you could talk a little bit maybe about the the AB deal in particular. Um, you know, how did you make that deal? And also, you know, what does it mean uh for IGI from a financial standpoint?
Cyril Konto, M.D.:So it um we we started the first union travel with uh ISB 2001 in November of 2023. Uh we designed a dose escalation sufficiently agile to move quickly to top doses, uh, while also uh preserving a limited number of patients treated at suboptimal therapeutic doses. That's why we get in December of 2024 an oral presentation at the American Society of Hematology, where we presented preliminary results of the first 12 subjects treated with ISB 2001 showing early clinical efficacy at uh low doses as low as 50 microampere kg. So it became for us critical to make sure that we put ISB 2001 into a BD track to find a partner who can accelerate clinical development and enable optimized commercialization for this asset with our ambition again and strong hope behind these assets with the limited data we had back in time. So for I for ISB 2001, all the big pharma players in myeloma came to our data room uh different stages of uh of our bidding process. We, IGI, did a thorough strategic fit assessment. They were not all the same for us. Some had bi-specific already in their pipeline, some had some one has a tri-specific in its pipeline, heavily involving myeloma. We were a little bit scared about this one. We didn't want our asset to land in the hands of a big pharma, just like shutting the program down to protect its own portfolio. We created significant FOMO with all those key players in the data room. But that was not enough. We also put in place an external publication plan, making sure that we would receive um uh either good news uh in terms of regulatory uh achievement or good news in terms of podium presentation during the bidding process and especially during the negotiation phase of this bidding process that lasted from December 2024 to July 2025 with the execution of the deal with AbbVie. Those regulatory motions, they were we received fast track designation for ISB 2001 in March of this year, when companies were sending us their term sheets, and and we would only open our data room to serious companies with significant terms in the term sheet to protect ourselves because we are small and we cannot address questions from too many big pharmas. We wanted to have meaningful and high-quality responses to serious bidders, and also to protect the confidentiality of our data. We didn't want to let anyone get into the data room, get access to our data, and then leave without being really serious on the licensing of this molecule. And the last thing is in January we filed the abstract to ASCO. We never thought that we could get an oral presentation at ASCO, but here we were helped by some luck. This year, ASCO started a rapid oral presentation for drugs like ISB 2001, and we were lucky enough to be granted a presentation, a podium presentation for ISB 2001 next to our direct competitor, JNJ 5322, uh Jensen Tri-Specific, targeting BCMA, GPRC5B, and CD3, which would help also our bidders to compare and contrast the two the two tri-specific in development for myeloma. And lastly, um when it comes to this deal, it's very important to receive the right counsel. So we we haven't been cheap in in selecting our legal firm. We picked Covington and have been extremely uh satisfied with uh with the deep service we received from them. The the builds were to the extent of the work done, definitely, but this really helped because as a small biotech dealing with big farmers, we can expect that on the other side of the table, we have the big firms. And when it comes to uh to other partners, they were Latham & Watkins uh are very famous as well. So that also helped us anticipate all the scenarios of the lifecycle management of this molecule in our licensing agreement, and at the same time protect the emerging market rights that we wanted to keep for ourselves and license out to Glenmark Pharmaceuticals, our parent company, with the prospect to become the leader of therapeutic innovation in emerging markets. So that's also um guided us in our choices.
Ben Comer:Uh you made several, I think, really important points just then, Cyril. Um, you know, protecting your communication and and and data to make sure that that's not getting into the wrong hands. You anticipated a potential catch-and-kill and avoided that. Uh, you you mentioned FOMO, fear of missing out. Uh, that that podium presentation, I suspect really, really helped uh build up uh build up that FOMO. And then you you mentioned um the emerging markets focus too, which I think is also very interesting. The out-licensing deal, I believe, with Ab V covers the US and Europe, uh, Japan and China. Am I right about that? But but you you still have the rights to other emerging markets. Can you talk a little bit more about um, you know, I guess Glenmark's role in potentially um commercializing those and and why you wanted to maintain those emerging market rights and what the opportunity is there?
Cyril Konto, M.D.:You absolutely. You're absolutely right. We granted AV exclusive licensing rights for ISB 2001 in North America, Europe, Japan, and Greater China, retaining the rest of the world territory's rights in IGI for subsequently licensing those rights to landmark pharmaceuticals. It was also bold from AVI to accept this type of deal. But what we did within IGI is making sure that we were protecting AbbVie's territory and commercialization more importantly. When you think of global revenues, Abbvie's territories represent roughly 85 to 90 percent of the sales and emerging markets, the remaining. So it's also in the interest of IGI to make sure that AbbVie can develop ISB 2001 fast, efficiently, and get this product to market as soon as possible. Not mentioning the $1.2 billion milestone payments plus the royalties on itself that IGI will benefit from this strategy. So we also created within our licensing agreement mechanism to protect AbbVie in their development and commercialization plans for not for preventing them from being affected by some wrong moves that could happen in the emerging markets. And that is until commercialization in the US. So that's that's also when ourselves projected into AbbVie's position on what could make the partner less uh excited by striking a deal with IGI given this this context. That being said, we also believe that uh Glenmark pharmaceuticals operations footprint in emerging market is large at scale and probably the best fit for developing eventually out of what ABVI is doing in the Western world by creating some bridging studies to match uh local uh requirements in emerging market and more and more importantly for commercializing ISB 2001 in those emerging markets. So, from an IGI standpoint, we have uh the best of both worlds taking care of ISB 2001.
Ben Comer:So um just so I'm I'm clear, in order to avoid any potential missteps in emerging markets, those bridging studies, other development work in the emerging markets that will be conducted by IGI or or Glenmark, those will happen only after uh AbbVie receives approval and begins to commercialize in in the West. Is that right?
Cyril Konto, M.D.:Not necessarily after, but if it happens before, it will be uh under AbbVie scrutiny and and and and nothing will be done to harm advisability in their development and commercialization.
Ben Comer:Right, got it. The other the other, I think, important point that you made previously that I didn't mention in my recap is the importance of contracting and having a strong partner who can help out a small biotech to match the kind of uh firepower that that big pro big pharma would have. That's an incredibly important as well. I didn't want to leave that out. Um IGI, uh we've talked about this, is focused on on multi-specific um antibodies. Your background is in biologics, but you also have a small molecule candidate. Um what can you say, Cyril, about your development strategy uh across those two different, very different modalities?
Cyril Konto, M.D.:While our core strength is multi-specific antibody, biology does not respect modality boundaries. Some targets are best addressed with protein engineering, others with small molecules. Our strategy is to deploy the right tool for the right biology, not force biology into a single modality. This dual modality approach allows IGI to build a pipeline that is both scientifically coherent and commercially diversified. We have inherited a single small molecule candidate from Glenmark Pharmaceuticals. It's the code name is GRC65327. It's on our pipeline slide uh on the website. This is a CBLB inhibitor. I'm not going to make a case for the CBLB pathway. Um, in essence, CBLB inhibition supercharges the immune synapse by enhancing activation of T cells and NK cells. So when you think of this biologics biotech company developing multi-specifics, engaging T cells and NK cells, there is an opportunity for combination by enhancing the effective cells responsible for tumor killing. Of course, all of this will be upon confirmation of the safety of GRC65327, which is planned to enter a clinic at the end of 2026. Okay.
Ben Comer:Um, I wanted to ask uh kind of following on this question about multi-specifics. You have uh what's called the beat platform uh at IGI, and I wonder if you could just describe what that is, if it's possible at a high level uh sterile, and kind of at which I don't know if that's possible or not. We're not a scientific podcast, so I won't ask you to go or I'll ask you to stay out of uh getting too far into the weeds, but can you can you at least uh give us a sense of um of what makes the beat platform unique?
Cyril Konto, M.D.:Um beat is IGI's proprietary multi-specific engineering platform. Um without getting into too much protein details, I'd say it enables precise modular assembly of antibodies with multiple arms. When you think of uh ISB uh 2001, we have three arms where and three different arms whereas a standard monoclonal antibody has only two arms and they are similar arms. So that's different specificities, different effective functions as well, it solves long-standing challenges such as chain pairing, geometry, and stability or multi-specifics. Bits allows us to design molecules that engage multiple tumor antigens, selectively activate T cells, NK cells, myeloid cells, so a broad spectrum of immune cells, avoid off-tumor toxicity, that's very important, because some of those targets can be expressed on the tumor but also on healthy tissues, and deliver stronger immune synapse formation. So in short, it's more biology in one molecule engineered for real-world clinical impact.
Ben Comer:There has obviously been some success already with bi-specific antibodies. You're now working on on tri-specific. I mean, it what why do you think that, you know, there are there, there, I guess um, you know, is the is the next thing gonna be, you know, quad-specific or you know, are are we gonna keep adding, you know, uh additional specifics to the antibody? Why, you know, I guess first tell me, you know, why there was a need to move from bi-specific to tri-specific, and then if you have any thoughts about, you know, what comes next after that.
Cyril Konto, M.D.:And that's we're at the core of the purpose of our beat multi-specific platform. Yes, you're right. There was a need. Tumors are extremely smart, they don't regulate antigens to avoid attack. Um so by having multiple binders targeting multiple antigens on the tumors, we avoid the main mechanism of resistance associated with uh antigen down regulation. The multispecific can also activate more deeply the immune cells. Um you can drag a T cell, but you can also enhance uh the activation of these T cells. You can hit NK cells on multiple activation pathways, which is critical to the NK cell biology. So those are the the benefits of adding additional binders, creating this multi-specificity on the bit platform. That being said, um there is there is a biological challenge. We create those molecules with multiple binders, we have to make sure that they do not bind to everything but the tumor because of those multiple arms. Um, we even invented this term in-house of penthopus. We have a platform that can deliver multi-specificity beyond trispecific. And I'm glad to report that uh we just nominated our first NK cell engager in our what we call immunite platform of NK cell engager because we believe in the power, uh immune power of NK cells to kill solid tumors. And we expect to bring this ISB 2301 NK cell multi-specific NK cell engager into clinic in early 2027. This will be our first example of delivering a molecule beyond the standard tri-specific. The bit enables this because the bit is stable. So far with ISB 2001, we are observing a half-life of more than two weeks in patients. It's close to the normal half-life of monoclonal antibodies, despite having this highly complex technology. So that the bit stability is a key component to the multi-specificity strategy we're developing in AGI.
Ben Comer:Um, when you start adding binders and going into more and more, you know, from from by to try-specific and even more multi-specific uh type of molecules, there's obviously, you know, you've we we hear a lot about personalized medicine and oncology and you know, creating almost individualized therapies for for patients that are specific to their cancer types. When you start adding these additional binders and get into the multi-specifics, are you also bringing down the size of the patient population that those drugs would potentially target? Are they getting more personalized, or is that not how it works? Is that not correct?
Cyril Konto, M.D.:It's more personalized to certain solid tumor indications when it comes to ISB 23 to 1. It's dedicated to myeloma, smoldering myeloma, and eventually some autoimmune indications for ISB 2001 because we designed the molecule to specifically target the plasma cells that are the problem of myeloma or autoimmune disease. So, in some way, we are creating a technology that is specialized and which hopefully will deliver enhanced anti-tumor activity due to the overspecialization we we brought to the technology against solid tumor indications. That being said, some uh some very dedicated technologies targeting one antigen requires to test patients for this antigen. Best example is Herceptin. We had to test patients for HER2, making sure that they had over expression of HER2, and those patients were the right candidates to receive a Herceptin. With the multi-specificity, if you're targeting multiple antigens, you have less of a need to check on the marker expression because we're creating this binding of multiple antigens, and the biology makes those antigen more or less expressed, but this is compensated by the multi-specificity binding to different tumor antigens. So it's kind of balanced, but you're right. We're designing molecules for specific tumor indications, not for not like chemotherapies with a very broad impact. Right.
Ben Comer:Excellent. Um a lot of capital, it's a big topic in the industry right now. A lot of capital is flowing into China and Chinese biotechs. Um, it's something that I heard FDA Commissioner Makary mention recently uh from a kind of speed and competition standpoint. Um he's obviously got a number of pilots uh going on at the agency to try to uh bring drugs to market uh faster. But I wonder if that trend of capital moving into China has impacted IGI's uh strategy in any way.
Cyril Konto, M.D.:It it did. And you're right. I think Chinese biopharma industry has come a long way. Uh the biotech sector is scaling rapidly, backed by capital, regulatory speed, large pools of patients. The number of biotech company uh listed in the Hong Kong or Shanghai, actually, has grown. It's it's five times between 2018 and and 2025. Um China's growing influence also uh in global biopharma innovation. They have seven times they fire seven times more INDs than the US today, and and almost twice the number of NDAs as in the US.
Ben Comer:That's amazing, yeah.
Cyril Konto, M.D.:Indeed, it it's it's very hard to compete. So the dynamics affects global time timelines and partnering expectations. Our kind company has announced multiple in-licensing deals from Chinese, uh settled with Chinese biotech companies, uh, angry being being the last one. So it's for us, it's um uh it's important to put this into consideration. How can we differentiate our innovation from what China is doing? And and China has clearly evolved into innovation-driven uh biotech sector. Um we believe that the market competition reinforces our need to stay ahead through quality science, differentiated platforms, and selective geographic partnerships. How did this affect us? First, a major flow of capital, US capital, to China, so less capital for biotech, hence a need to focus on non-dilutive capital through uh partnership deals like the one we struck with AbbVie. Second, we we are trying to avoid feed uh Chinese innovation with our internal work. And the best example, I think, was striking to me to see the pre-clinical data package of our main competitor, uh Johnson Tri-Specific, published only recently after about 200 patients have been treated in clinic, and the asset is already on a registrational path. So giving you enough leeway to get closer to BLA approval before informing the competition on the design of your molecule and the preclinical performance of your molecules. That's I think this this new peer review, late peer review publication model, is a model that we will we will implement in IGI, especially when it comes to ISB 201. And last is everything is about intellectual property. We're having we're filing our provisional certainly sooner than what big farmers are used to do, because we also have a need to communicate on our technology. We will seek licensing uh opportunities for ISB 2301 ex-US. We intend to keep the rights for this molecule in the US, not only development but also commercial rights for ISB 2301 in the US, and eventually, upon the success of this asset, transform our organization from an R&D biotech today to a commercial biotech in uh in a six to seven years uh horizon. So that's how we're being influenced, but um I think I think we have to also think of ways um of modernizing the way we do drug development uh today. The time to first patient those is a critical time. Um can we enhance reviews at US clinical investigational sites in parallel of the FDA? Can we make sure that uh uh startup activities in the clinical operation space can also stop before the IND clear uh uh the FDA clears uh our IND. So those are ways of modernizing uh drug development in the Western world. There's also a significant cost of drug development um compared to China. We have to acknowledge that we have a different uh healthcare system model than China, and and it is more expensive to do drug development in the US, in Europe, and in Australia than it is in China. And I realize why uh some of my peers in the biotech sector are uh interested in in driving innovation in China or getting innovation from China.
Ben Comer:Um to your point on the need for modernizing the FDA, uh, another you know um initiative that that commissioner Commissioner Makary has been talking about, and and when I saw him speak a week or two ago, said that you know, very soon he would be announcing uh specific either disease areas or or modality types that would no longer require animal studies uh in in preclinical research. And I wonder, you know, what you think of that, Cyril? Um, you know, how has the technology in areas like in silico development reached uh a point that that animal studies um can can not can be avoided uh in certain areas? Um what what's your experience with that and what what are your thoughts on on getting rid of animal studies in at least in certain modalities or in certain uh disease areas?
Cyril Konto, M.D.:IGI remains compliant to all health authority regulations, and and we applaud the Animal Welfare Act that the FDA is is uh enforcing whenever it is possible. I say from from our standpoint, and think of ISB 2001 first, one of our binders did not cross-react to cynos, to cynomogus monkeys. And because this molecule cannot bind to uh some specific cell that's supposed to bind in human in monkeys, then those animal models become irrelevant. So we had discussion with the FDA. We presented the molecule, we presented the preclinical data package, and we also presented our in silico PK/PD modeling um in order to predict a safe dose range, but also an efficacious dose range through computed modeling. And um and the FDA really welcomed this uh this opportunity. We partnered with uh with the key player in the in the field of uh quantitative systemic pharmacology, SERPARA. We built this model, and interestingly, um our clinical data matched pretty well the predicted data by this in silico model. And you can you can already speak of AI here. That's that's a uh some of the ramifications of artificial intelligence. And we have a manuscript we submitted our uh QSP manuscript to explain the world how we how we thought through this exercise. So that was for ISB 2001 at a small technology scale in the very large scale that IGI aims at. Now think of ISB 2301. We have even more than three binders without disclosing too much. Then we are reaching such a level of biologic complexity that it's very hard to recapitulate the mode of action of this molecule in animal models. Of course, you multiply the binders so that you multiply the risk that binders will not bind um animal models in the right way, and that the data you're gonna collect in monkeys or other species will not be relevant to do uh pharmacokinetics or even non-clinical toxicology uh uh relevant experiments. So for us, it becomes even more important to partner with those companies and continue our endeavor in in silico slash AI pharmacokinetics, pharmacodynamics modeling of what our complex technologies will deliver in patients in terms of prediction models.
Ben Comer:Yeah, and it strikes me as really powerful to be able to validate the in silico data in your actual clinical trials later in the clinical data data later on, which will only make those models stronger over time. Um that's excellent, Cyril. Uh, we're coming up to the end of our time. I'd like to just end with your kind of top priorities uh right now, your next milestones at IGI. You know, what are you really focused on right now?
Cyril Konto, M.D.:We have kicked off our collaboration with AbbVie. We're uh uh focused on uh completing the Trigmite phase one study. Uh dose expansion is unrolling fast. We are aiming at uh providing a recommended phase two dose uh for monotherapy, but also for combination in myoma. We are enabling AbbVie taking over clinical development of ISB 2001, and we will meet with the health authorities to validate the um's proposal for clinical development plan. So that's for us a major priority. Obviously, we nominate we just nominated our first NK cell multi-specific antibody, ISP2301. We are now working hard on IND enabling studies to file the IND before the end of uh 2026 to enable a clinical start in early 2027. That's our uh second priority. We have enough cash runway to go through the phase one of ISP 2301, but we also have to turn to the future. We'll need to prepare for fundraising, and we have to transform IGI from a private company today to a public market-ready biotech company. So our third priority is the transformation of our organization. We've done already significant efforts to show future potential investors that uh we are a robust, compliant, uh, disciplined organization. We will continue to do so uh to enable IPO in a few years uh in the horizon uh of fundraising for IGI.
Ben Comer:Cyril, thanks so much for coming on the show. I really appreciate it. Thank you, Ben.
Cyril Konto, M.D.:It was a pleasure uh sharing ideas and also realizing that what I say can be uh put into a much larger biotech context. And uh I'm hopeful that this tiny experience can help my colleagues in the biotech sector and look forward to connecting with as many of my peers in this to make uh U.S. biotechnology sector a success.
Ben Comer:Absolutely. Uh we we've been speaking with Cyril Canto, MD, President, Executive Director, and CEO at Ichnos Glenmark Innovation or IGI. I'm Ben Comer, and you've just listened to the Business of Biotech. Find us and subscribe anywhere you listen to podcasts, and be sure to check out new weekly video casts of these conversations every Monday under the Business of Biotech tab at lifescience leader.com. We'll see you next week, and thanks as always for listening.
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