Lantern Pharma Inc. (LTRN) Earnings Call Transcript & Summary

My name is Igor Astsaturov. I'm a physician/scientist. I co-direct with the Greenberg Pancreatic Cancer Institute. My role as a physician/scientist is to see the patients and develop new ideas for treatment of pancreatic cancer. So what is concerning to me about pancreatic cancer is that its incidence is rapidly rising. The reasons for that rapid rise is not clear. But it's alarmingly becoming the third leading cause of death. And we see increased incidences of pancreatic cancer in younger individuals. The fact that we see more and more patients with this cancer raises the urgency to develop new treatment options, which are currently very limited. This is probably one of the most refractory and aggressive type of human cancer that we know. So with the limited number of options that are available for patients with pancreatic cancer, we're really focused at this point on understanding the cancer biology and what the vulnerabilities in this disease. And that creates the opportunity to apply certain treatments and certain medications based on the cancer mechanism. It is -- unfortunately, the majority of pancreatic cancers do not carry a druggable or drug amenable, I should say, mutations. However, there is a subset of tumors they do. And even for these patients, the treatment options are not indefinite. So any opportunity to develop new drug, new treatment modality, the new mechanism that we can exploit for therapeutic gains to improve their quality of life, cure rates, longevity will be highly beneficial. One of the potential vulnerabilities in pancreatic cancer is deficiencies, either somatic or inherited in DNA repair pathway genes. And this has been a focus of extensive research recently with new drugs coming to the market and to clinical use. And this is one of the opportunities that we are exploring in the laboratory and also in the clinic. The search for genetic vulnerabilities in pancreatic cancer continues. And one of the opportunities that came about to us was this collaboration that we established with Lantern Pharma. Lantern has been long time focused on exploring the opportunity to develop previously abandoned drugs because of the lack of understanding of their molecular mechanisms. And they brought to our attention this compound called LP-184, which is a precursor prodrug that will be converting to an active alkylating DNA damaging agent upon exposure within the cells inside the cancer cells by an enzyme called prostaglandin reductase. So that immediately was of interest to us. And we began a very productive collaboration, which led to not only to publications, but also to launching a Phase I clinical trial, which we're very excited about. Let me tell you in a very few words what LP-184 is and how it works. It is a prodrug. It's a derivative of isoflavone, an old drug that has been in clinical testing in 1990s. Lantern developed a more advanced version of this drug with improved pharmacokinetics, and we found through genetic manipulation that it absolutely requires the prostaglandin reductase or also known as PTGR1 to be converted to a fully activated rapidly active DNA damaging agent. In the absence of PTGR1, these cells are completely insensitive to the drug, whereas a high expression of PTGR1 confers increased acceptability. And that offers yet another point of vulnerabilities because it turns out that PTGR1 is expressed at high level in many tumors, including pancreatic cancer. We also found one of the potential mechanisms how PTGR1 can be induced. It happens through oxygen deprivation mechanism called hypoxia, when it's upregulated becomes a point of vulnerability to the cancer cells. So not only damages DNA, so tumors that carry mutations that confer deficiency in DNA repair pathways, and also high expressing PTGR1 at high level are projected to be particularly sensitive to this drug. So we are excited about the opportunity to find which patients are likely to benefit whether the drug works and whether we can provide an additional treatment option for patients with this devastating malignancy. So this is a Phase I trial. It is designed to determine whether this is safe, whether patients can tolerate this chemotherapy drug. And we also are looking very intensively into a possibility that we find a subset of patients who might be potentially responding to the treatment because we know the mechanism, we know the biomarkers of -- that would predict the response to this drug. And we will look across multiple solid cancer types, including pancreatic cancer, where both PTGR1 and the incidence of DNA repair pathway mutations are frequent. So these are the areas of interest for us in both clinical development and also to understand the translational mechanism in the biomarkers. The patients we're looking for the ones that -- whose tumors that carry mutations in DNA repair pathway because the mechanism of the drug is DNA damage. We also are looking for patients who would express high level of PTGR1 from our preliminary bioinformatics exploration. There is a large variety of solid cancers that express PTGR1 on high level, including pancreatic cancer and other solid tumors. So this is a Phase I trial that will be open to any patients with incurable solid cancer. One other potential consideration is for patients with glioblastoma because of the history of use of alkylating agents. In fact, temozolomide is the only FDA approved alkylating agent that is currently widely used to treat this disease. We also know that glioblastoma expresses high level of PTGR1 that converts LP-184 to an active compound. And I think for me at least 2 main reasons, there should be some level of enthusiasm in GBM to see whether this drug has any activity. It has good pharmacokinetics and ability to penetrate to the brain. From my experience and serving as the medical oncologist, I know that oftentimes people and my patients live as long as they have options for treatment. So we are actively searching for clinical trials. I'm trying to do my best to help my patients to find suitable clinical trials for which they can be a good candidate. And it's this kind of exercise is reliant on understanding the cancer mechanism. So I do firmly believe that we will advance and improve the cure rates, and options for treatment will increase once we put patients -- more patients on clinical trials. So anyone who is a patient or who has a family member affected by pancreatic cancer or any other devastating malignancy should be interested in understanding clinical trials, why we do them and whether he or she can be involved in clinical research and enroll the patient to this clinical experiment. These are needs of our urgent and absolutely critically important. And there's always -- I firmly believe there is always a room for miracle. [indiscernible] drug, what is the mechanism of the tumor, we can win.

Thank you, everyone, for listening in -- to our webinar on LP-184 pancreatic cancer. If there are any questions, we are happy to answer those. The trials for LP-184 are ongoing at several sites and information on these trials is available on our website. Currently, we have enrolled over 19 patients in the Phase I study of LP-184, this is a dose escalation study. We are at dose level 6 at this time based upon -- look at the present data does appear to be pretty safe. There are not any concerns in terms of toxicities. A few patients have experienced nausea and vomiting, but beyond that, it does appears to be pretty tolerated well. Yes. So following the Phase I trial, we are going to initiate a Phase Ib, specifically in pancreatic cancers where patients with specific mutations, which are mutations in the DNA damage repair genes will be enrolled, including patients that may have been exposed to PARP inhibitors because our preclinical data has strong evidence that LP-184 works quite well even in tumors that are PARP insensitive or that have become resistant to PARP inhibitors. Much of this work was done on pancreatic cancer, PDXs, which are derived from clinical tumors that had become PARP resistent. No, there are several sites for LP-184 Phase I trial, and information on both the sites and the further details on the Phase I trial are available on our website. You can also send an e-mail to our VP for Clinical Trials reggie@lanternpharma.com. That is reggie@lantornpharma.com. Yes. Data readout will be done after all the dose escalation status is completed. So we expect to have some initial data readout in the next 2 to 3 months.