Hello everyone, and thank you for joining the HC Wainwright 27th Annual Global Investment Conference. My name is Sara Nik, and I'm a VP of Equity Research here at HC Wainwright. It's my pleasure to welcome our next speaker, John Yu, Chairman and CEO of Kairos Pharma, a biopharmaceutical company developing therapeutics to reverse cancer drug resistance and immune suppression. With that, the floor is yours, John.
Thank you, Sara. My name is John Yu. I'm the CEO and Chairman of Kairos Pharma, and it's my pleasure to be with you today. As a neurosurgeon, one of the difficult parts of my job is to give the patient a diagnosis of brain cancer. As difficult as that is, it pales in comparison to when their tumor comes back several months later, as it becomes resistant to the chemotherapy that they're on. I'm dedicated to reversing cancer drug resistance in a host of cancers. These are our forward-looking statements. Kairos is a Greek term for opportune moment, and we seek to intervene at the opportune moment when a patient has become resistant to their standard-of-care drug and their immune system has become suppressed by their cancer. Resistance develops to even blockbuster drugs like anti-androgen therapies and EGFR therapies in non-small cell lung cancer.
We identify that this is because CD105, which is a cell surface protein that does several things, including increase BMP4 and decrease TGF-beta, becomes elevated during resistance. We developed an antibody that reverses this resistance, and this is a large opportunity in widespread cancers of prostate cancers, non-small cell cancers. We showed that it's also relevant for other cancers like colon cancer and breast cancer. There are three clinical programs that are in progress. Our lead drug, ENV105, is in a randomized multi-institutional phase II trial treating prostate cancer. This is funded by an NIH grant for our biomarker study, which confirms a biomarker that we identified in the previous phase II study. EnV-105 is also in a phase I trial for non-small cell lung cancer. This is supported by non-dilutive donor funding. KROS 201 is an immunotherapy that's cleared for an IND for glioblastoma.
We have an experienced team at Cedars-Sinai to drive enrollment, and grant funding has created non-dilutive value for the company. The problem is that cancers become resistant to standard-of-care drugs as they make CD105 on the cell surface. This mediates tumor cell survival and therapy resistance. CD105 is elevated in resistant cancer cells that recur or are incompletely treated by their standard-of-care drugs. The solution is ENV105, which is a therapeutic antibody that blocks CD105 and restores sensitivity to an entire class of hormone therapies for prostate cancer, including enzalutamide, amiodarone, and apalutamide, and EGFR-targeted therapies for lung cancer patients like osimertinib or Tagrisso, or gefitinib. These are broadly applicable for resistant cancers, and we showed that it's relevant for colon cancer, breast cancers, and head and neck cancers as well. In a published phase II trial, ENV105 was used after androgen receptor treatment failure.
It was used to antagonize CD105 when it became expressed in patients with prostate cancer that became resistant to their anti-androgen therapy. Patients that had progression on either amiodarone or enzalutamide had the same therapy continued with the addition of ENV105. We followed PSA and CT scans, and patients stayed on therapy until progression. In this trial, we showed a remarkable safety of the agent with no Grade 3 or 4 toxicities from ENV105. Therapeutically, there was a 62% clinical benefit rate in terms of PSA response and radiographic response at two months versus a 0% expected response after resistance. Many of these patients were treated for over a year, and this was in a group of patients that were treated previously with anti-androgen agents up to 2x , rather than patients that had been treated repeatedly for over 5x .
In this trial, we identified a biomarker, a three-gene assay that identified those patients that could respond to the treatment versus those that were non-responsive. These could be identified in patients prior to treatment. We received a $3.2 million NIH grant that tests this or confirms this biomarker in our present randomized phase II trial. This is important because we know that when a biomarker is in place, this improves the likelihood of success of a pivotal phase III trial from 55%- 76%. It, in essence, allows us to stack the deck in favor of patients that will respond to our therapy, thereby allowing us to do a smaller trial and also to get a more positive response from that trial. This is our present phase II trial.
There was a safety lead in the 10 patients that were all treated with apalutamide and ENV105 after they had recurred on anti-androgen therapies, one of among several treatments, including Lupron, enzalutamide, amiodarone, and apalutamide. These patients were treated with apalutamide and ENV105, and we reported the safety results in July. We plan to report the efficacy results from the safety lead-in on September 18th in association with a KOL discussion of the findings, which will be led by Joe Pantginis from HC Wainwright. In this trial, the primary endpoint is progression-free survival, which is the accepted pivotal trial endpoint, and the secondary endpoint is the validation of our biomarker. Patients that have failed anti-androgen therapy will be randomized to receive either apalutamide alone or apalutamide plus ENV105 with the goal of showing a difference in progression-free survival of these patients.
Moving on to non-small cell lung cancer, EGFR-driven non-small cell lung cancer comprises approximately 20% of non-small cell lung cancer, or approximately 45,000 patients per year. Tagrisso is a standard of care for these patients, and despite the tremendous response patients get from this drug, 80% of patients still only have a partial response to the drug, meaning that they have circulating tumor DNA. CD105 is elevated with Tagrisso treatment, and we are adding ENV105 in a group of patients that have failed Tagrisso treatment, or alternatively in a group of patients that are incompletely treated with Tagrisso. AstraZeneca's Tagrisso is a $6.6 billion drug per year with tremendous responses in this disease group, but a partial response in 80% of these patients.
In preclinical models, we show that ENV105 can overcome resistance and shrink tumors, and that ENV105 not only reverses resistance to Tagrisso but allows it to have a more complete response. We are accruing a phase I study of these patients that have failed Tagrisso or who are partial responders to Tagrisso with persisting tumor cell DNA. This is the Bayesian design of the study with the safety lead-in, and then patients who have become resistant to Tagrisso or incompletely treated. The determination of safety and effective dose of ENV105 will be tested, and the secondary endpoint is to identify biomarkers for these patients. The results so far will be reported at the World Lung Cancer Meeting in September, and this will be reported by Karen Reckamp, the principal investigator of the study. Moving on to immunotherapy, immunotherapy is a $118 billion market.
Despite this, there's only a 17% response rate in patients. The problem for this is that cancers comprise billions of growing cells. However, our immune system seldom generates enough T cells to kill all of these cancer cells, and only tens to hundreds of thousands of antigen-specific T cells. Our solution is KROS 101, which is a GITR ligand, meaning a glucose-induced tumor necrosis receptor-like ligand. What this allows us to do is change the lever to increase T effector cells that can kill the cancer cells and decrease the T regs that inhibit this immune response. By pushing this lever towards expanding T cells that are cytotoxic against the tumors, we're generating more T cells that can fight the cancer and increase the ratio of these cells. In addition, we've generated KROS 201, which received an IND from the FDA.
This generates autologous T cells outside of the body that can target cancer stem cells. KROS 401 is a small molecule that converts pro-tumor macrophages that are in the tumor microenvironment into cancer-killing macrophages. KROS 101 targets the GITR ligand and enables T cells to increase. By increasing these T cells, it can complement other checkpoint inhibitors like pembrolizumab from Merck and nivolumab from Bristol Myers Squibb. Using the same mechanism but antagonizing the GITR ligand, KROS 102 reduces T cell numbers and is a new class of agents for autoimmune diseases and transplant rejection. This is KROS 101. This was identified by Ram Murali, our VP of Research and Development.
He first reported the structure of the GITR ligand in two papers in PNAS, or Proceedings of the National Academy of Sciences of America, and found that a small molecule can stabilize this primer, allowing it to signal the receptor. This works much more effectively than the AstraZeneca or Merck antibodies that were developed that target the receptor instead of the ligand. We feel that this is because by targeting the ligand, we impact the antigen presentation of dendritic cells to the T cells and impact the immune response in a much more effective way. KROS 102 is an antagonist that breaks up this primer, and it allows T regulatory cells or the suppressor immune cells to increase to decrease the impact of an autoimmune response against the patient's own organs or against an organ that was transplanted. These are our drugs that are being developed.
ENV105 is in a randomized phase II trial. The market opportunity is significant with the anti-androgen agents that are there. ENV105 is also in a non-small cell trial, phase I trial, and this is a large market as well, a $14 billion market with Tagrisso alone representing $6.6 billion of this. The activated T cell therapy of KROS 201 received an IND from the FDA, and we're rapidly developing KROS 101 and 102 for an IND for small tumors and for autoimmune diseases. These are large market opportunities as discussed, a large $11 billion prostate cancer market, a $14 billion EGFR-dependent lung cancer market, and a head and neck cancer market of $1.5 billion, which we're targeting next with a head and neck cancer trial.
All these trials are designed to show that ENV105 really targets a central mechanism of cancer drug resistance that's relevant for widespread cancers and for many drugs that are designed to treat these cancers. The fact of the matter is that we have very good drugs for cancers until they don't work. ENV105 is designed to reverse the resistance that develops to standard-of-care drugs. For the immunotherapy market, the checkpoint inhibition market is a $47 billion a year market, and KROS 101 and 102 targets this checkpoint inhibition as well as our other Kairos agents that target different aspects of the immunotherapy market. Our company, Kairos, was spun off from Cedars-Sinai Medical Center, which is the number two medical center in the United States based on the U.S. News and World Report. We've pushed the therapies forward through non-dilutive NIH grants.
Through the present, we got an IND for our phase I and II trials and began enrollment in 2024. We just reported the safety results from the safety lead-in of our phase II prostate trial in July and plan to release the efficacy results from this cohort in September with the KOL discussion on September 18th. The interim data for the phase II trial will be discussed then, and safety results from our phase I cancer trial will be reported in a national meeting or international meeting in September by Karen Reckamp, our PI from Cedars-Sinai Medical Center. Significant catalysts are coming in the near term that we're excited to release. Our patent protection is good with regard to the composition of matter and methods of use and extends through 2040.
We have a small team of investigators and our CFO, and people often ask us how we can compete with Merck or Pfizer with hundreds of scientists each. The reason is that we've developed technologies that don't compete with their technologies but actually make their technologies work. We see it more as a collaboration with large pharma as we develop this therapy that allows their drugs to work better. We've composed our independent directors based on their expertise in partnering assets from biotech, and they have expertise both from the biotech standpoint as well as from large pharma. We're relying on their expertise to develop partnering strategies across the board. In summary, we're a clinical stage company with an antibody that impacts a central mechanism of cancer drug resistance. We have an extensive pipeline that targets immune suppression.
We're enrolling in a phase I and phaseII trial with interim efficacy data out in September 2025, as well as safety data from our lung trial coming up then as well. We have a strategic relationship with Cedars-Sinai Medical Center, which is ranked number two in the country, and this provides medical expertise and drives clinical efficiency and provides the intellectual capital to translate some of the findings into clinical trials and back again into the lab. We're a small company with a technology that could impact large pharma therapeutics in widespread cancers. Thank you very much for your attention.
Thank you so much, John, and the Kairos team for an informative presentation. We appreciate the time and effort that went into preparing this, and thank you again from the HC Wainwright team.
Thank you, Sarah.