Hello and welcome back for the [Next Company webcast. We welcome Kairos Pharma, who trades under the ticker KAPA on the NYSE American. Joining us from the company is John Yu, the company's Chief Executive Officer, and Neil Bhowmick, the company's Chief Scientific Officer. John and Neil will be taking us through the slide presentation, and if time permits, we'll have a brief Q&A session. With that, John, Neil, let me go ahead and turn the floor over to you both to begin.
Thank you, Robert, for inviting us to this conference. It's our pleasure to be here. As a neurosurgeon, one of the most difficult things that I have to do as part of my job is to give a patient the diagnosis of a brain cancer. But as difficult as that is, it pales in comparison to when I have to tell the patient that their tumor is back with a recurrence because of the resistance their tumor has developed against the chemotherapy that they're on. Kairos Pharma is focused on developing therapeutics to reverse this cancer drug resistance. These are forward-looking statements. Kairos is a Greek term for the opportune moment or perfect time. And so we seek to intervene at the opportune moment when a patient has become resistant to the cancer drug that they're on or when their immune system has become suppressed because of their cancer.
We have three clinical programs in progress. Our lead drug, ENV105, is in a phase II trial treating prostate cancer. This is a randomized trial, which is supported by an NIH grant. ENV105 is also in a phase I trial treating non-small cell lung cancer when patients have become resistant to TAGRISSO. This is supported with non-dilutive donor funding. KROS201 is a cell therapy that's been cleared for IND for glioblastoma. We have a strategic relationship with Cedars-Sinai Medical Center from where the technology was derived. It is the ranked number two hospital nationally and number one in California. This drives clinical trial efficiency because, as investigators here, we have the efficient enrollment of the largest cancer center west of Mississippi. The costs for the trial are also decreased significantly as investigators here.
This streamlines therapeutic innovations as we work with investigators both on the clinical side as well as on the research side at Cedars. Our drugs reverse cancer drug resistance, and these are de-risked with extensive safety studies. We also have a biomarker identified to treat the most responsive patients. Our extensive pipeline of drugs has been shown to reverse immune suppression, and our IP portfolio is valid through 2040. Our technologies target a large market of a fast-growing $11.3 billion anti-androgen therapy market, and a $14 billion lung cancer market, and a $118 billion immunotherapy market. Neil, our CSO, will present our lead drug, ENV105.
Hi. I'm Neil Bhowmick, and let's dig a little bit deeper into ENV105. This is a neutralizing antibody that blocks a cell surface co-receptor called CD105. CD105 promotes bone morphogenetic protein or BMP signaling and inhibits TGF-ß signaling. We were interested in this protein since we found it to be elevated in prostate and lung cancer tissues when patients receive standard of care either hormone therapy or EGFR inhibitor therapy, respectively. The elevation of CD105 caused an induction of this BMP signaling that I just mentioned, and that supports tumor survival and thus therapy resistance. Importantly, ENV105 has no effect on the tumors as a single agent, yet has been shown preclinically and in clinical trials to, when combined with either hormone therapy or radiation or EGFR antagonists, it restores sensitivity to the otherwise insensitive tumors. If we can move on.
This is an example of enzalutamide, a hormone therapy standard of care for prostate cancer patients. You have an angry tumor on the left-hand side when it's given as a single agent. When it's given in combination with ENV105, not only is the tumor smaller, it's more differentiated, meaning that it's more responsive to ENV105. That's quite evident by the histologic image that's shown. If we can keep going there. With this combination that I just mentioned with enzalutamide and ENV105 and another hormone therapy called abiraterone and ENV105, we performed a phase II trial that we recently published. In that publication, just to summarize, we showed a 62% clinical benefit in these patients.
Importantly, these patients had been taking abiraterone or enzalutamide, these two hormone therapies, prior to enrolling to the trial, and they were shown to be resistant to these drugs. And what we did was we told them, "You can stay on these same drugs, but we're going to add the ENV105 on top of it." And that's where we saw the 62% observed benefit, where if you left them on abiraterone or enzalutamide alone, they would have had progression on these drugs. And importantly, there were no grade three or four toxicities we observed in this small trial. So if we can go to the next slide. An important finding in this trial were biomarkers. So biomarkers, as you know, when you combine a companion biomarker with the therapy, it improves FDA approval significantly over having a drug without a biomarker.
In this, we identified three in these patients that were predictive of response. This is going to really help us when we go into phase III and selecting our patients efficiently. We can run a much cheaper, much smaller phase III trial since we'll be selecting the patients most likely to benefit from our drug combinations. Next slide, please. The trial that we have ongoing, as John mentioned, it's a phase II trial. We're taking patients. Currently it's accruing. It's a multi-center trial. Patients that are on various generations of hormone therapy, first, second generation hormone therapy. What we're doing is we're taking these patients that are recurring from these drugs, and we're allowing them to either take, in a randomized fashion, the third generation hormone therapy called apalutamide as a single agent. That's that green line on the bottom there.
And the blue line is the apalutamide with ENV105 as a combination. And so since it's a randomized trial, we allow those patients that are on apalutamide alone, single agent, to cross over when they fail. And we expect them to fail in about two months. And so it's important that I mention this because that means these patients are going to be accrued and go through the trial in a pretty rapid fashion. So the primary endpoint, of course, is progression-free survival, and this is the standard for prostate cancer patients, castration-resistant prostate cancer patients. And the secondary endpoint we'll be measuring is, of course, validating the companion biomarkers that I just mentioned. If we can go to the next slide. Yeah. So the next trial that we have ongoing is currently accruing at Cedars-Sinai Medical Center and its affiliates, and is for non-small cell lung cancer.
A very specific kind of non-small cell lung cancer is those that are EGFR-driven. These are those patients that are actually nonsmokers. That's a growing population, not just in California, but nationwide. These patients develop lung cancer despite having no smoking history, but they respond very well to EGFR inhibitors like TAGRISSO, which is the standard of care currently. TAGRISSO inhibits EGFR signaling, and it works fantastically until it doesn't. For these patients, what we did was if you go on the next slide, we have preclinical data to suggest that the combination with ENV105 was quite beneficial, and we started this trial that you can see here. We're currently accruing into the safety arm where we're combining TAGRISSO with ENV105.
And then we're going to go into the two other arms that you see where these are patients that are resistant to TAGRISSO completely or partially. And it's interesting that we looked at this partial resistance group because that's actually 80% of the patients on TAGRISSO today. They are partially responsive. And so we're going to be looking to improve their efficacy of TAGRISSO when they're in combination with ENV105. This is a phase I trial looking at safety as the primary endpoint, but we'll be also identifying biomarkers here. If we could go to the next slide.
So I'll be talking about our immunotherapy assets, the Kairos Therapeutics . And immunotherapy is a $118 billion market. However, despite the size of this market, patients only demonstrate a 17% response rate with immunotherapy in general. And the problem here is that cancer is comprised of billions of growing cells. However, the immune system seldom generates enough T cells to kill all of these cancer cells. And so it's a numbers problem. The solution that Kairos has developed is to increase the number of T cells by affecting a lever for T cell generation called the GITR receptor or glucocorticoid-induced TNFR-related receptor. What this does is it changes the lever to increase killer T cells and decrease the immunosuppressive Treg cells.
And by doing so, we increase the number of T cells that can kill the cancer and also allows these T cells to become more cytotoxic and be better killers of these cancer cells. KROS201 uses KROS101 and is a T cell therapy that is designed to kill the cancer stem cells from glioblastoma. And this is received in IND. KROS401 converts pro-tumor macrophages that are the resident immune cells and converts them into cancer-killing macrophages. So KROS101 targets the GITR ligand, enables T cells to increase in number and kill cancer cells more effectively. And this can be used to complement present checkpoint inhibitors like pembrolizumab from Merck and nivolumab from Bristol-Myers Squibb. In addition, KROS102 uses the same mechanism of T cell growth, but in the opposite direction. It reduces T cell numbers and can become a new class of agents for autoimmune diseases and transplant rejection.
KROS101 is a small molecule that's designed to stabilize the GITR ligand, which trimerizes or makes a three-pronged component to signal the GITR receptor, which then trimerizes itself. This three-pronged receptor can then signal other receptors, bring them together, and cause a signaling for T cells to grow significantly. This is very different from antibody approaches from AstraZeneca and Merck, which were limited in efficacy because of the autoimmune gastritis that was developing in these patients and also because it was not a physiological means of causing T cell growth. KROS102 prevents the trimerization of the GITR ligand, thereby preventing the GITR receptor from being signaled.
This decreases the number of T cells and can be a very effective means of treating autoimmune diseases like Crohn's disease, multiple sclerosis, rheumatoid arthritis, et cetera, and also organ rejection, which is caused by T cells that are generated to kill off the organ. This is our pipeline of drugs that are in clinic and development. Again, ENV105 is in a randomized phase II trial at multiple centers for prostate cancer. It's also in a phase I trial with TAGRISSO for non-small cell lung cancer. KROS201 received an IND from the FDA for glioblastoma as an autologous activated T cell therapy to target the cancer stem cells of glioblastoma. KROS101, again, is a small molecule that increases T cell growth. KROS102 is a small molecule that decreases T cell growth.
KROS301 is a small molecule that targets a growth center as well as an immune evasion mechanism for triple-negative breast cancer. KROS401 is a peptide that reverses the immunosuppressive macrophages in the tumor and allows them to kill tumor cells and allow T cells to come into these tumors as well. And ENV-205 is an antibody targeting mitochondrial DNA to reverse resistance to chemotherapy in a host of cancers. And so the cancer drug resistance market is a large one. The androgen therapy prostate cancer market is an $11.3 billion market. The EGFR-based lung cancer market is a $14 billion market. And chemotherapy-treated head and neck cancer is a $1.5 billion market. So large markets that we're targeting.
And the important thing is that not only does ENV105 work for prostate cancer and lung cancer, it's really worked for all the cancers we've tested so far, including head and neck cancer, breast cancer, and lung cancer, as well as colon cancer. The immuno-oncology market is a quickly growing and immense market. The different components of this market, from small molecules, peptides, checkpoint inhibitors, and T cell therapies, are the components of the therapeutics that Kairos is developing and the individual agents that are on the docket for clinical trial. And so we've really developed these therapeutics through academic grants that have been non-dilutive for the company and have allowed us to develop these drugs into large clinical trials that we're in now, a 100-patient phase II randomized trial in multiple centers and a phase I trial in lung cancer, and rapidly developing pre-IND candidates for clinical trial.
And so we have these trials that are ongoing and safety and efficacy endpoints that are near term over the next year to report. Our IP extends from 2035 to 2040 and protects both the composition of matter as well as the methods of use and the methods of development. We're a small team of investigators. Ramachandran Murali is a structural biologist who developed the small molecules with a very in-depth knowledge of the structure of these molecules, allowing him to develop the drugs to be used. And Neil Bhowmick, our Chief Scientific Officer, is a biologist who understands the deep mechanisms of resistance and tumor development and so has developed these therapeutics that counter these central mechanisms of resistance. I'm a clinician neurosurgeon as well as an immunologist and help to translate some of these findings from the lab into therapeutics that can be brought into the clinic.
And together, we've developed the clinical trials to test these molecules in the clinic. Our independent directors are deeply knowledgeable in the area of drug development and commercialization and are helping us partner some of our assets as well as to bring these to commercialization. So finally, we're a clinical- stage company with an antibody that impacts a central mechanism of cancer drug resistance. We have an extensive pipeline of agents targeting immune suppression. We're enrolling in phase I and phase II trials with interim efficacy data in 2025. We have a strategic relationship with Cedars-Sinai Medical Center that provides medical expertise and drives clinical trial efficiency, providing an acceleration to therapeutic innovation. And we're a small company with technology that could impact large pharma therapeutics in widespread cancers. So thank you for your attention, and we're happy to take any questions.
All right. Perfect. Thank you both so much for that very detailed presentation here. Have time for a couple of questions here. Maybe the first, just sort of talk about how you compete with pharma companies for the assets that you're developing?
Yeah. So we are a small company with three basic scientists and translational scientists and clinicians. But we're able to compete because the fact of the matter is we're not really competing with these large pharma companies. We've developed therapeutics that actually allow their drugs to work for a longer period of time and more effectively. And so we think we'll be able to partner with these large pharma companies to help their therapeutics work more effectively. And that's what we're really concentrating over the next year is to bring these trials to fruition, demonstrating the efficacy of our agents, and so allowing us to partner more effectively with large pharma to allow their drugs to work more effectively.
All right. Perfect. Makes sense. Maybe, Neil, this would be for you. Maybe how relevant is CD105, the mechanism of drug resistance, relevant to other cancers?
Right. I mean, as John stated, we have two trials ongoing for lung and prostate cancer, but we have preclinical studies, some published, some unpublished, for head and neck and colon, as well as even pancreatic cancer, looking at its progression as well as metastasis as far as inhibiting metastasis. At this moment, all our trials are looking at drug combinations, as I described.
Great. And maybe just final question here. And John, I know you had a slide up there earlier, but maybe talk about some of the near-term milestones for the company, something investors should be paying attention to here as we now enter 2025.
Sure. Some of the meetings that we'll be participating in will be at the JP Morgan Conference, talking with some of our partner candidates. We'll also be participating in the DealFlow Microcap Conference on January 28th in Atlantic City. And we'll also be presenting our translational data on KROS101 at the AACR-JCA joint conference on February 5th. And so we'll be reporting our very compelling data from our GITR molecule that allows T cells to expand rapidly. In addition, over the near term, we'll be reporting our safety readout for our prostate trial. And within that, we'll be the efficacy data that we've accumulated so far for patients with recurrent cancers that are castration-resistant. And also, we'll have our safety readout for our lung cancer trial as well.
The important thing is that after the safety readouts, then we can freely enroll in a more serial fashion rather than in a parallel fashion at our multiple centers and not just serially as with the safety data for these patients. So we're very much looking forward to reporting results of our clinical trials as well as our preclinical assets moving toward an IND.
All right. Fantastic. Well, we'll go ahead and we'll leave it there.