Rob Hill, Tae Life Sciences - Accelerator-Based Neutron Beam Technology | LSI USA '24

Rob Hill  0:04  
I want to tell you a little bit about our company and what we're focused on today. So first, we're focused on developing a new way to treat cancer with radiation therapy, and our approach is different. Our company is very different than many of the companies that would have presented here today, our challenge and my background has been in optimizing radiation treatments. I've done it for the last 30 years. Many of the innovations in the field have been developed by teams that I was part of or LED. But one of the big challenges in radiation therapy is you're treating a region of the patient. So the a patient get gets imaging scans that defines for the clinician where the tumor volume is, and then they develop a treatment plan to target that tumor volume. The challenge is, there's that that volume of tissue includes healthy tissue and includes tumors, because quite toxic. So radiation therapy today is delivered five days a week, typically four to six weeks long, a very grueling and difficult regimen for patients. So we're focused on a different approach. Rather than treating a region of the patient, our focus is in treating cancer at the cellular level, but instead of across the whole body, only in the region that the physician elects to treat. So the particular approach that we're focused on commercializing is called boron neutron capture therapy BNCT. To give you some details around the company, we're based here in Southern California. My office is 25 minutes from this wonderful venue. We founded the company in May of 2017 we have raised we've been successful in raising capital. It is enormous undertaking, as you'll see in the coming slides. We've raised over $100 million from outside investors to date, and we've had a lot of support from our parent company as well. Our parent company is the world's largest privately funded fusion energy research company. They're focused on changing the climate and reversing climate change through the use of sustainable energy. The company has, we're chock full of innovators in the field. We have over 135 patents. We have around 100 people working on this project. And our solution entails a drug device combination. The device is a particle accelerator that generates neutron irradiation. And the drug is there's a series of different drugs that we have under development that delivers boron to cancer cells as selectively as possible. Those items combine to deliver the therapy. So here's how the therapy works. A patient is infused with a drug, the drug delivers boron to cancer cells as selectively as possible with the current drug, that process takes about two hours. Then you take a patient to a special radiation facility, and you irradiate the region of the tumor with low energy neutron irradiation. The drug itself has no biological effect, and low energy neutrons aren't very damaging to cells in the patient's body. But when boron atom meets a neutron, an alpha particle and a lithium ion is unleashed, those daughter particles are charged to a million volts of energy, and they deliver all of that energy over a range of five to 10 microns, approximately half the size of a typical human cancer cell. So the idea behind the therapy is, if you can load enough boron into the tumors, hit them with enough neutrons, you can destroy a tumor cell from the inside and even sparing a healthy cell nearby. So that is an extraordinary approach, and it has certain implications. One implication is that, because the therapy is well tolerated by patients, we can treat patients in a single treatment session, 75% of the time. This is extremely rare in oncology. Those of you who've had family members treated with chemotherapy, you know that process may take months, multiple cycles. The story is true. That story is similar with immunotherapy, with standard radiation. As I said before, it's a multi week, grueling process for patients to get that therapy. For 75% of patients, it's a single patient treatment, and they're done. So this is a big advancement in the field, and our status is We've now entered the clinical stage. Over the last little bit more than a year, we've now treated the number as of today is up to 20 patients. Patients, we treated more patients this week. For those patients, we have follow up data on the first 14 patients that have been treated. Seven of them are recurrent head and neck cancer. Seven of them are recurrent gliomas. These are very, very difficult to treat patients with very poor outcomes. The response rates you can see on this slide quite favorable, and you can see the first two patients that were treated on the right hand side, the really significant and a rapid anti tumor effect with this technology. To give you some perspective on clinical data, BNCT at two year survival, shows about a 62% survival rate for these recurrent head and neck cancers versus the standard approach of treating them with radiation therapy and chemotherapy, around in the 20s percent to your survival, depending on the study that you look at. So a significant number of these patients can survive if they get BNCT, and if they don't get BNCT, a significant number of these patients will die of their disease. So we've got a lot of interest from clinicians around the world. We're building a global research consortium to study this technology and get it approved around the world. In the United States, we've signed MOUs with two of the top cancer centers in the United States. We also have a strong research collaboration with MD Anderson Cancer Center and a research team in Argentina that also specializes in this approach. In Europe, we've signed MOUs with now five hospitals. We just signed one this past week, the top cancer centers in their respective countries, and we have a signed contract to install our first system in Europe, starting in August of this year. To do this therapy. We also have a collaboration with University College London in the United Kingdom, in Asia, we have our first system installed in China. We've created a joint venture with a Chinese company there to commercialize the technology. We also have strong collaborations in other countries, in Asia as well, and a research relationship with Kyoto University. So our strategy is in 2024 2025 we're really gearing up to run the clinical studies in the United States and Europe. We're starting the full clinical trial in China at our first installation in about two months. We anticipate by 2026 we will achieve approvals in the United States and Europe. The China approval will probably come a little earlier than that, and this is all with the existing drug, BPA that's been used to treat these patients. To date, we also have a new pipeline of drugs that we're developing, which I don't have time to share with you all the details about, but they're far superior to the current drug. So we have a small molecule program, an antibody program and a nanoparticle development program to develop new boron carrier pharmaceuticals to treat these patients. Our lead compound is called BTS borano tyrosine, and it's been shown in animal models that we can deliver more than two times the amount of boron to the tumor, and we can do it more than two times more selectively than the current drug, BPA that we're using in the clinic, this will revolutionize the field. Allow us to deliver 30% more radiation dose to the tumor, and we can reduce the dose in half to the normal tissues the patient will receive. This slide shows the first animal test that we did with this drug, where we have different cohorts of mice, the control group, the group that gets the existing drug, BPA, and the group that gets our new drug, our new drug, was able to completely eradicate very fast growing tumor in these mice. So I've spoken to many biotech investors and many medtech investors. Biotech investors are all interested in the bet. What's the probability of success? How can I handicap it? And what we've demonstrated is the bet is strong. The probability of success is very high. We have the right commercial backing. We have the right clinical backing, and we have the right strategy as well. Medtech investors, by contrast, want to see commercial progress. We have partnerships with many of the top hospitals around the world, representing total deals in excess of $50 million to date, but we have to convert MOUs to sign contracts in order to book those as orders. So we think it's a great opportunity and significantly de risked for investors, we have a strong leadership team, veterans of the medical device, radiation oncology, industrial particle accelerators, business and biotech and pharma as well.

So we're raising our Series C round 75 Ms. Million dollars in funding. We've already closed 15 million and This funding will be enough to get us through FDA approval in the United States and Europe. So that's our focus. That's our mission, reinventing radiation therapy and providing new hope to patients around the world. Thank you. Applause.