Business Of Biotech
The Business of Biotech is the pod dedicated to leaders of emerging biopharma firms. SUBSCRIBE to our new newsletter at www.bioprocessonline.com/bob. We bring you insight into organizational, finance and funding, HR, clinical, manufacturing, regulatory, and commercial challenges you’ll face as you navigate your company from an idea to success in the clinic and beyond. Each episode features guest commentary and best practices from accomplished founders and biopharma industry luminaries. The Business of Biotech is produced by Life Science Connect.
Business Of Biotech
Innovating On The Frontier Of Radiopharmaceuticals With RadioMedix's Ebrahim Delpassand, M.D.
We love to hear from our listeners. Send us a message.
On this week's episode, Ebrahim Delpassand, M.D., founder, CEO, and chairman of the board at RadioMedix talks about his personal journey standing up and growing a radiopharmaceutical company focused on oncology. Dr. Delpassand discusses the current trends in radiopharmaceutical drug development, the differences between alpha- and beta-emitting isotopes, overcoming manufacturing and supply chain challenges and restraints, and building strategic partnerships with companies like Curium, Fusion (now part of AstraZeneca), and Sanofi. He also offers specific advice to physician-entrepreneurs interested in building their own drug development companies.
Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.
Subscribe to our monthly Business of Biotech newsletter.
Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.com
Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/
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 Dr Ebrahim Delpassand, founder, chairman and CEO at Radiomedics, a radiopharmaceutical oncology company developing new therapies and diagnostic imaging agents, both internally and in collaboration with other companies and organizations. Dr Delpassand is a medical doctor in nuclear medicine and pathology and worked at MD Anderson for more than a decade as chief of clinical nuclear medicine and deputy chairman in the department of nuclear medicine. Nuclear medicine and deputy chairman in the Department of Nuclear Medicine. Radio pharmaceuticals is a hot area of therapeutic development right now and I'm excited to speak with Dr Del Passant about how he built Radiomedix, the company's business model and clinical programs, and why Big Pharma is spending billions of dollars to acquire radio pharmaceutical drug candidates right now. Thank you so much for being here, Dr. Delpassand.
Dr. Ebrahim Delpassand, M.D. :Thank you so much, Ben, for the invitation as well as kind introduction. Yes, I mean, as you mentioned, radiopharmaceutical space has come a long way now and still a lot of excitements in the future has come a long way now and still a lot of excitements in the future. This is an area that is growing, in oncology especially, and it is based on significant knowledge and background that we have right now related to oncology, the process of oncological conditions and also improvement in isotope manufacturing, radiopharmaceutical manufacturing, including finding very specific ligands that can reach to a specific moiety, whether it's an antigen receptor or a metabolic pathway on cancer cells. And, of course, another portion is technology on the chelation technology, as we call it, which is a sort of a chain that attaches the radioisotope to the ligand and create and forming a diagnostic or therapeutic radiopharmaceuticals according to the isotope that is attached to the molecule.
Ben Comer:Yeah, lots to talk about there. We have a number of things to dig into, but I want to start with how you initially became interested in radiopharmaceuticals. You know why you chose that field nuclear medicine as a physician.
Dr. Ebrahim Delpassand, M.D. :Good question. I mean, obviously I'm a physician, nuclear medicine physician. We see patients every day and we firsthand we see the need of the patients for better treatments, better outcomes as well as more sensitive and specific diagnostic agents. So the idea of radiomedics really came from our clinic, seeing the patients every day, understanding the unmet needs that we have an area that we can improve. So the idea came from clinic but at the same time a good understanding of our field, understanding how we can address these unmet needs, going to our scientists, essentially putting the problem on the table and ask them to see how we can address this problem.
Dr. Ebrahim Delpassand, M.D. :So very organically, I can say, the idea of radiomedics came along. Of course, initially we started with founding our clinic Excel Diagnostics and Nuclear Oncology Center in Houston to give us the infrastructure needed to conduct any kind of research, clinical research. So we started with that full modality diagnostic medical imaging as well as therapeutic nuclear medicine. And then after that, Radiomedics was born with the intention of a very intimate sort of communication and understanding between our clinic as well as our researchers. So they can, we can have from bed to bench as well as bench to bed. So whatever we invent at Radio Medics for the first time is tried by our team at Excel in patients. So this created a very nice synergy and dynamics between our organizations which led to the actually approval of a drug by FDA, as well as several promising drugs that now they are maturing in terms of regulatory path, hopefully getting to the finish line very soon.
Ben Comer:So you noticed this clinical need. That was while you were at MD Anderson and you mentioned Excel Diagnostics and Nuclear Oncology Center, a research center, what you know what kind of prompted you to set that up as a practicing physician. You know what was the kind of catalyst that got you started on, you know, company formation.
Dr. Ebrahim Delpassand, M.D. :You know, I think part of my brain was more thinking very entrepreneurial and trying to be thinking out of the box. I mean, when I was at MD Anderson, I had a secure job and you know I could easily essentially do whatever I was doing over there go to different parts of the world, give a lecture, et cetera, and, of course, training residents, which was very close to my heart. That was probably the area of the work that I was most interested in Anderson and the institutional capabilities. I thought that probably outside I can probably move faster and more efficiently. I should say this is what I did.
Dr. Ebrahim Delpassand, M.D. :Initially Many of my friends they thought I'm crazy, but while you're losing a very safe and secure position in a big institution, one of the best cancer centers in the world, absolutely. You know, I have this idea, I have this opportunity and I would like to go after this and I think history of radiomedics in the last close to 20 years proves that I was right. But of course we have to know a lot of work, a lot of weekends, holidays, nights, more early morning. This is what you need really to put down if you want to accomplish this and, of course, anybody who, any of you you want to go after your dreams, you need to be prepared for that. There is a lot of sacrifice that needs to do.
Ben Comer:So you founded Excel Diagnostics and Nuclear Oncology Center a couple of years later. I believe was the founding of Radiomedics. Can you talk a little bit about how you actually started it up and who your co-founders were?
Dr. Ebrahim Delpassand, M.D. :Right. Well, I'm blessed to have a very supportive family. My wife and I, we had an exit from another company that we had, so we felt that, at least for a while, financially we can afford to do this. The rest of my family I have three daughters. They were all supportive of me and one of them right now is working with me, aida. Aida Del Pasen started with the quality assurance, setting our QA department together and now transiting to more public relation and business development in our company. For a while she was actually the head of our manufacturing site, which is in north of Houston. So I think having, of course, a family or, in some cases, even friends that are supportive of what you're doing and understand your sort of idea, I think is extremely helpful, and I was blessed to have to have this on my side.
Ben Comer:Are there any negatives to having a family business, so to speak? I mean any kind of tense conversations at the holiday dinner table, or is it all good for you?
Dr. Ebrahim Delpassand, M.D. :No, it's not always rosy, as you can imagine.
Dr. Ebrahim Delpassand, M.D. :There is always. You know, there are differences in approach if you have different issues that you want to resolve in the company and approaches that you want to have. But one thing I've always believed and my belief was that none of us is as smart as all of us, meaning that if you have people that they care about a goal in this case about the company, about its future, as long as they are caring, as long as they want the best for the company, I think we must listen to everybody and try to gather basically all the information before making any decision, and I think this is the highlights of this. You know, yes, it's not always easy to work with family members, but at the same time, if you look at it from this aspect, that they all want the best. So why don't we be open-minded and listen to everybody's mind and then have a dialogue? Have a dialogue, discuss it and at the end, when we make a decision, everybody is going to be aligned and everybody is going to be, you know, supporter of what the decision you have made.
Ben Comer:So you had some exit money to get Radiomedics off the ground and fortunately had some talented family members that could pitch in as well. There were, you know, members of just your network at MD Anderson, so it's fairly easy to reach out. Or if you had to do something else to bring the right people into the company at the right time.
Dr. Ebrahim Delpassand, M.D. :No, absolutely. I mean no, actually not all of them from MD Anderson. I think I had initially our four scientists One was from MD Anderson, another one was from Rice University, another one was from industry and another one from totally different areas. That we thought is going to be a good fit. So, yeah, I mean these are the people that made our initial team, but at the same time, always I mean this is one of the challenges of any companies you need to have right talents with the right knowledge and also passion.
Dr. Ebrahim Delpassand, M.D. :I think it's very important when you interview people to come to your company, describe to them your intention of doing this. I always tell whoever we are hiring that you know this company is a patient-centered. I'm a physician, my wife is a registered nurse. The company was born by clinicians who wanted to do better for the patients, and we are looking for people with this kind of a passion.
Dr. Ebrahim Delpassand, M.D. :It doesn't matter what you're doing, if you're doing only QA, lots of paperwork, or if you're just hands-on and pipetting certain drugs, or doing radio labeling, or even somebody who cleans the lab at the end of the day, et cetera. All they need to understand what is their role in this, and many times, actually I bring patients that who have received the therapy with their permission, to our team and say talk to them, tell them about your story, how you were feeling before treatment and after treatment, and to me that's the biggest sort of a motivation for people who are working in our space. Things don't happen overnight. It takes time, it takes a lot of work and therefore you need passionate people that they look at the endpoint of this. If you don't see that endpoint, sometimes the job might be extremely difficult to conduct. So providing that kind of vision and insight and motivation to people who are working for your company, I think is one of the best ways to keep your employees actually.
Ben Comer:And to your point on finding passionate individuals to join the company, and I guess I'm thinking you know at the beginning I mentioned at the top of this conversation that radio pharmaceuticals is a very exciting area, lots of growth, lots of deal making happening at the moment. I don't think that was necessarily the situation when you got started with radiomedics and I wonder you know what the talent pool was like in terms of individuals that could actually, you know, discover and develop new radiotherapeutics, radiopharmaceuticals? Was it difficult to find people, and is that talent pool expanding now?
Dr. Ebrahim Delpassand, M.D. :We had just started actually understanding the, I think, the value and potential of nuclear medicine, and especially on the therapeutic side. You know we had a PET scan at the time, just a, you know, fdg PET scan that is used for more than 80%, 85% of the oncology conditions right now. But we had just started seeing drugs like Zevalin, for instance, bexar, so they were targeted therapies against certain, let's say, cd20 antigen for lymphoma patients, et cetera. So with that kind of introduction, gradually you could see that scientists, they are getting interested in the field.
Dr. Ebrahim Delpassand, M.D. :Yes, initially the knowledge was limited, but what we needed, we needed, let's say, radiochemists that they knew how to handle radioactive material, how to do radio labeling with different ligands. We needed obviously people, experts in quality assurance, because one part is drug development. I mean QA is the backbone of drug development. So maybe the insight was not perfect at the time but at the same time we knew what kind of a talent we need for this space. And of course, on training, I mean one of the main emphases that we have had at Radiomedics is that we really would like our team to take advantage of any conferences. I mean we haven't missed any, except during COVID. We haven't missed any, let's say, major nuclear medicine meetings in US or, you know, in the entire North America or even in Europe. So and, of course, allowing our scientists to get trained to participate in these meetings, giving allocation financial help so they can attend to these meetings, et cetera. So learning and training is an integral part of what we're doing.
Ben Comer:Excellent. I want to ask you next about Radiomedics' business model, In terms of you know what you decide to develop internally and what you license out. There have been some big deals and now collaboration deals with Sanofi, with Fusion now, which has been bought out in a blockbuster deal with AstraZeneca. How do you think or how would you describe Radiomedics as business model and, I guess, specifically how you develop what to out-license and what to develop internally?
Dr. Ebrahim Delpassand, M.D. :Yeah, good question and a very important question. You see, initially number one you have to see what you do best and what you can collaborate, and you think some other doing, some other companies, do that best. In case of our first drug that received approval by FDA in 2020, the diagnostic drug copper 64, dotatate or Detecnet we knew how to develop the study. We knew how to perform the clinical trials. We thought that for commercial launch of the drug, we need to align and we need to partner with another big company that has done this many times with other drugs. This is why we went to Curium. Curium had cyclotron facilities in San Luis that they could make copper 64 for us and they had experience in commercial launch. You know, developing drug is one thing, but you know navigating. You know insurance companies, third party payers, contracting with them, having a strategy in terms of the public awareness of the drug, as well as then manufacturing of the drugs and making sure that you can deliver the commercial phase. It's a totally different ballgame than, let's say, you make a drug during investigational trial. So this is why we didn't have cyclotron and we didn't have experience in commercial launch. This is why we went to a company like Curium and told them that we are willing to license this drug to you. And they were very well positioned. It's not like out of the blue we found Curium or asked Curium to do that. This company had the first drug in neuroendocrine cancer diagnostic, which I told them. When I met first time with them I said that guess what? You have been a gold standard for diagnosis of neuroendocrine cancer. I have a news for you the G is dropping, so it's going to be an old standard now. So they were initially puzzled what I'm talking about and I said, yes, we have a diagnostic pet agent which has much better contrast resolution. It's a better, you know drug for this same condition. But at the same time why I went to Curium? Because they already had their boots on the ground. They had their people already selling Oxyurea scan, which was for neuroendocrine cancer. So this was the best fit and this is why the commercial launch was so successful and now actually Detecnet has more than 70% of the market, although there was another competing drug which was approved much earlier, but now we have a majority of the market. Although there was another competing drug which was approved much earlier, but now we have a majority of the market because of its ease of use centrally manufactured and available throughout the country. Wherever there is a PET scanner they can ship the drug and patients can benefit from that.
Dr. Ebrahim Delpassand, M.D. :The other deals we were kind of looking at again our capabilities, I think Fusion deal. We looked at Fusion as a company that has already secured several contracts for procuring Actinium-225. Procuring Actinium-225. And at the same time our company was kind of more partial to what led to 1,2 because of other reasons that we had and we thought they're going to be most suitable company because they had Actinium. Having the source of Actinium available is a big and very important factor in developing Actinium therapies. So this is why we agreed to talk to them and license the drug and I'm very happy for them that they had a great exit actually with, as you mentioned, blockbuster deal with AstraZeneca and we are waiting for the phase three clinical trial. That of course Radiomedics has its own incentive and milestone payments et cetera for that licensing.
Dr. Ebrahim Delpassand, M.D. :On the Sanofi side, the Alphamedics drug that we licensed to Sanofi was again licensed to Sanofi was again the result of our collaboration with Oranomed, a French company with presence in Texas.
Dr. Ebrahim Delpassand, M.D. :They were the manufacturer of the drug and they had a good source of lead 212 at the time. And of course, phase three trials comes with a lot of expenses. It doesn't come cheap and we thought that this is very good, that again we partner with a big pharma that they have a lot, of, a lot of good experience in the phase conducting phase three trial trial and at the same time financially can back this effort. The whole idea was to have the drug the sooner the better, available to the patients because of the results were so promising as compared to a standard of care that is available. So this is why we did that. We have other drugs in our pipeline that we think we can do it ourselves, taking it to higher phases, even conducting a phase three if necessary. So a combination of those. I think you have to know your strength and you know your weaknesses and, based on that, make a decision how you want to approach and design your strategy basically for drug development.
Ben Comer:Yeah, and I want to ask you about your internal development candidates. But before I do, you've alluded to you know the sourcing issue with Actinium short half-life, inconsistent sourcing issues those have been long-standing challenges you know, for the field of radiopharmaceuticals I'm curious about. You know what is changing and maybe what you might say about how radiomedics is managing source materials and supply chains?
Dr. Ebrahim Delpassand, M.D. :you know, with that kind of forward-looking view Of course, yeah, we have three armaments needs in nuclear medicine as of today. One is sourcing of radioisotope. Another one is basically having sites for conducting clinical trials because, as you know, there are lots of clinical trials ongoing, so you need to have good sites that they know how to run these clinical trials and, of course, you know. The third one is manpower. We really need good experience, knowledgeable manpower. So, on the supply of the radioisotopes, yes, nuclear medicine always has had challenges about the half-life, and this is something you cannot change it. You cannot change it had challenges about the half-life, and this is something you cannot change it. You cannot change gallium-68 half-life, or, you know, lead-2, 1, 2's half-life, et cetera. So, but we have addressed this challenge. The most common isotopes that let's say fluorine-18 for doing a PET scan, has a half-life of about two hours. This has the challenge has been responded by having a regional sort of a cyclotron facilities that they can manufacture the isotope to the radio labeling and deliver within about two, two and a half to three hours distance, driving distance. You can deliver the dose easily. In case of, of course, actinium half-life is very accommodating. I mean, it's more than 10 days half-life, so that's no problem. There are other issues about actinium which we can talk later. In case of lead 2.1.2, specifically, we are talking about a 10.5, 10.6 hours half-life. So you need to have enough activity at the dispensing time and you can calculate that, how much at the calibration time at the end user, how much activity you're going to have, and then, if you can solve this problem, you can easily have a centralized manufacturing and ship it by even commercial carriers like FedEx and the next day end users. They're going to have that and they're going to have enough activity to give to the patients. So these have been solved. There are shielding issues that we have resolved that.
Dr. Ebrahim Delpassand, M.D. :And then there are other issues. Let's say, in case of lead 2.1.2, parent isotopes, you want to make sure that they are available. In case of lead 2,1,2, there is abundant availability of thorium 2,2,8. Of course you need to secure your sources for this still, but there is no shortage, like I think, like actinium-225, especially the pure actinium-225. So each of these isotopes, they have challenges I'm pleased to. I'm sure you have seen our press release.
Dr. Ebrahim Delpassand, M.D. :We just introduced a desktop or benchtop lead 212 generator at the society of nuclear medicine in the orleans and this is essentially, by the way, the raha raha word of raha in persian means freedom and okay, having a freedom to have availability of lead 212 in your laboratory. This is an automated generator, automated synthesizer included in the generator, and you can refill the generator of lead just as needed on demand. Basically, you can fill up the column and ship it to the end user. So in this way, researchers or people even conducting phase one, phase two clinical trials, they will have access to lead 212 for radio labeling and this really opens up a great opportunity for our researchers.
Dr. Ebrahim Delpassand, M.D. :We wanted to democratize availability of lead 212 for the researchers. We experienced the sort of limitation when we started working with our partner, oranomet, that we were limited, of course, to their manufacturing, and this is why we embarked on a project to make it more available for our own preclinical and clinical studies, as well as sharing this technology with other companies and academic centers. So they have availability of lead 2. 1, 2 for developing of any of these exciting drugs that they have. They have very promising ligands that they need isotope. Isotope is like you know, the ligands are like a gun, isotope is like a bullet. So you make more sophisticated guns, but if there is no bullet it's not going to be useful.
Ben Comer:So this is why and this is an example coming from Texas, of course- and I did note the announcement of the Benchtop LED 212 generator, which is a unique innovation In terms of sharing it with other companies. Will they be able to essentially kind of pay for access to that, and is it something that you can give to multiple different organizations? Is it modular in a sense?
Dr. Ebrahim Delpassand, M.D. :Sure, yeah, we have different, basically, strategies for making this available to interested parties. This is modular, so you can scale up the amount of activity that you need for the project that you have. Typically for preclinical studies, you don't need as much activity as, let's say, if you want to manufacture several doses every week. You need a bigger generator. You need more of those modules that you need to order to have enough activity for making doses for human clinical trials.
Dr. Ebrahim Delpassand, M.D. :In terms of our business strategy, we will be somewhat selective, in a sense that we would like to see the promise of the ligand that companies or academic centers are working on but still is in the form of more guidance and partnership. We want to see if we can also transfer our experience to them in using this radioisotope, in using this radioisotope. But you know, the main thing is if we can expand the availability of this isotope, which, in our hand, has shown significant you know promise. I think it's going to be good not only for the field but, at the end, for the patients who need these drugs in the future.
Ben Comer:Right, and we're talking about the lead 212 radioisotope right now. You mentioned at the very beginning, with your first product, going to copper 64, away from gallium 68. What can you say about how you essentially choose new isotopes and evaluate them and how you kind of landed on copper 64? And I'll use that to you know. Move forward into a debate that I really want to get to, which is about, you know, beta versus alpha emitters.
Dr. Ebrahim Delpassand, M.D. :Awesome, yeah, of course. Again, this is a prime example of learning from the clinic and then going to the scientists to address a shortcoming of one isotope. For instance, in case of gallium, gallium-68 comes from germanium-gallium generator. Half-life is only 68 minutes, so the manufacturing is very fragmented. I mean you cannot make the drug and then ship it from Texas to California. That is impossible. At the time when it gets to California, no activity is going to be there. So it's a very, you know, a small radius, as I mentioned, maybe two hours driving distance. If you manufacture it, you can send it. Also, the number of doses that you can make from one single generator is very limited when you're using gallium. There were three times in a day that you could get only one dose in Houston, when this is the biggest medical center in the world.
Dr. Ebrahim Delpassand, M.D. :Just you can imagine. I mean they were delivering one dose at seven o'clock, another one at 12, another one at three to four o'clock. So, and also when we were getting the doses. Just imagine patient doesn't show up on time, or you have a problem starting IV for the patient which are common things, I mean or you have to reboot your PET scanner computer. All these things were causing so much anxiety and so much stress for our technologists and our staff when they were dealing with Gallium 68 labeled agents.
Dr. Ebrahim Delpassand, M.D. :We went to copper because of copper half-life, which is 12 and a half hours, almost half hours, almost. So that allowed us to have a centralized manufacturing, robust, high quality manufacturing and distribution across the country. And then, when they receive it our technologies they can wait three hours, even before injection of the patients or after injection. They have more time if they want to repeat PET scan, for whatever reason, if they want to have multiple time points on the patients, you can still use copper. So this was, although for the same indication, but this was superior to gallium and I think because of all these facts, because being so user friendly.
Dr. Ebrahim Delpassand, M.D. :So this is why we have a majority of the market now, and so these are the things that you learn from the clinic, you learn from your technologists. They come and talk to you that you know. Is there anything better than this? This is causing a lot of, you know, anxiety for us, and it's. These are expensive doses. I mean, if you can't use the drug, you're going to lose several thousands of dollars for that drug and of course, I don't think any administration would like that, so right. So these are. This is an example I'm glad that you brought it up that you can actually use the clinic experience toward making better drugs.
Ben Comer:So, going back to lead 212, which is an alpha emitter, and my sense is that that is the direction that radiopharmaceuticals is moving to toward alpha emitters and away from beta emitters is moving to toward alpha emitters and away from beta emitters. You know way more about this, so I'd love to hear your explanation as to why alpha emitters may be an improvement upon beta emitters.
Dr. Ebrahim Delpassand, M.D. :How are they different? Yes, the differences are in two folds. One in terms of path length, of between 10 to 80 microns. So if you look at these differences, it tells you that you know when you have a two millimeter in case of lutetium. There are other beta emitters like yttrium-90, it's more than a centimeter actually. So you're going to have a lot of side effects or, you know, radiation to the cells that are not necessarily abnormal. So that is one difference.
Dr. Ebrahim Delpassand, M.D. :The other difference is in energy. The energy of alphas are between 100 to 400 times higher than different beta emitters. So you're talking about highly energetic with the short path length versus lower energy and longer path length in the case of beta emitters. Therefore, how this plays in treating cancer, the importance of alphas because of a higher energy and shorter path length it's more targeted and with the higher energy it can break the DNA more effectively. Typically, majority of the breakage of the DNA caused by alpha emitters are double strand DNA damage, which leads to the apoptosis and cell death majority of the cells. On the other hand, on the beta emission you have more single strand DNA damage. That gives the opportunity to the cancer cells to repair themselves and therefore we see more, you know, recurrence in the patients who are treating with beta emitters as well, as obviously it can translate into less effectiveness, if you will. The objective response, for instance, in the case that we have, which is very parallel comparison, comparing lutetium dotatate, which is a beta emitter for neuroendocrine cancers, with lead 2,1,2 dotamtate, which is a lead-labeled alpha therapy for neuroendocrine cancer. In the same cohort, in the patients who have not received prior any kind of radionuclide therapy, the beta version has objective response of 13%, ours has more close to 70%. So all these talks that I said earlier might be hypothetical, but here we have objective evidence in patients to see the difference.
Dr. Ebrahim Delpassand, M.D. :I don't want to go into too much detail about activation of immune response et cetera, which is so fascinating actually, that part. We think that alpha emitters like lead 212 actually stimulates and activates the immune system which can actually continue the effectiveness of a drug. We have patients that six months after the last treatment still they show response to therapy. That's not radioactivity for sure. I mean the radioactivity is already decayed. This is the radioactivity is already decayed. This is the response of immune cells into the cancer after damage of the cancer cells and this is continued actually. So it's a very fascinating field, multifactorial. But in summary, these are the differences between beta and alpha.
Ben Comer:Yeah, and correct me if I'm wrong, but I think the vast majority of approved radiopharmaceuticals in the past have been beta emitters. Now you know there's some incredible data coming out about alpha emitters. Is there still a role for beta emitting therapies? You know new ones going forward, or is it your sense that alpha-emitting therapies will completely supplant the use of beta-emitting therapies in the next what couple of years? So here is my bias.
Dr. Ebrahim Delpassand, M.D. :I feel that beta-emitters are a stepping stone coming to alpha-emitters. However, having said this, I think both isotopes will have a role in the near future. Definitely the amount of research that is ongoing on beta emitter drugs lutetium-177, even terbium is coming right now. These are beta. You know, copper-67, for instance. These are all beta emitters and they will have a role in medicine, but alpha emitters for sure. I mean, because of what I just described, it is very exciting If we can resolve the issue of supply of the alpha ameters, different alpha ameters, whether it's acetine-211 or actinium-225 or lead-212, we need to have a good supply supply and we need to expand the research in this area.
Dr. Ebrahim Delpassand, M.D. :And, of course, there are several mature clinical trials ongoing in the phase two, late phase two, completion, starting phase three. These are going on in alpha emitters. But to me this is the optimal tool that we have. I think we need to have higher energy to deliver any cancer cell. If you can safely deliver enough radiation, you can kill cancer cells. The issue is that safely, I mean we need to have basically to design the radiopharmaceutical that be so effective on the cancer cells but spares the normal cells, basically normal organs, et cetera. So this is something that I think the field is going to go toward more alpha therapy, but definitely there is a role for beta-amino therapies as well.
Ben Comer:And radiopharmaceuticals, historically, you know, have targeted a specific set of cancers, specific type of cancers thyroid cancer, prostate cancer, specific neuroendocrine tumors, which you've mentioned. But you're taking some big swings, you know. Beyond those specific cancer types, what you know, what can you say about the next therapeutic frontiers for radiopharmaceuticals and what you're working on?
Dr. Ebrahim Delpassand, M.D. :Well, radiomedic and Radiomedics, we are working on several unmet needs in oncology and the basically top one is brain tumor that we are working right now. I sincerely hope that we can make a big difference for these patients. Whatever we have done in the last 20 years for brain cancer patients has not really significantly changed the outcome or quality of life of our patients. Unfortunately, in the more aggressive type of brain cancer we lose the patients maybe in about two years, in spite of significantly affecting on their quality of life after surgery, chemotherapy and radiation therapy the brain by simple IV administration and deliver a big load of radiation to the tumor inside the body, without cutting the patient, without causing a lot of side effects for the patients. That is sometimes worse than the disease itself. So this is our goal.
Dr. Ebrahim Delpassand, M.D. :We have a drug that can cross broad brain barrier. This is one of the challenges of treating brain tumors. I mean it's different from solid tumors in the rest of the body. Brain has its own sort of a protective layer that makes it difficult for many drugs to cross that and gets to the brain tumor. So this drug that we are working on has this capability of crossing blood brain barrier. We are using our best available isot of crossing blood-brain barrier. We are using our best available isotope, which is lead 2,1,2, and the best ligand that has high affinity for GBM or brain tumor. So this is one. Interestingly, the same drug has affinity for pancreatic cancer. So this is the next unmet need that we have in oncology Again, very difficult disease to treat, and I'm talking about adenocarcinoma of the pancreas.
Dr. Ebrahim Delpassand, M.D. :There is a neuroendocrine version which is totally different than this type. So we are hoping that the next step to work on that. And of course we have other ligands, like GPC3, for instance, which works on hepatocellular cancer and some urogenital cancers, and also we have a ligand proprietary ligand for prostate cancer as well that we would like to radio label with L212 and use that for. So these are some of the areas that we are working and of course there are very exciting targets that scientists are looking at and we are hoping to improve that portion the ligand, the carrier of the isotope more, and I think that will be the future frontier of nuclear medicine. We need to have more ligands with more affinity to the target and higher residence time in the target. I think that will be the area of growth in nuclear medicine.
Ben Comer:Right and which internal candidate would you say is your lead candidate or is furthest along at this point?
Dr. Ebrahim Delpassand, M.D. :I mean, of course, AlphaMedix, which we have licensed to Sanofi, that is further along. But internally, the drug that I mentioned, we call it RMXVH. It has affinity for low-density lipoprotein receptor in GBM and pancreatic cancer. That is the highest one, followed by, you know, GPC3 and prostate cancer.
Ben Comer:At this point, and how are you thinking about scale up? I wanted to ask you about your Spica manufacturing center that you've built in Houston and maybe you could talk a little bit about how you think you know, how you think about scaling these programs up as they progress into, you know, larger clinical studies.
Dr. Ebrahim Delpassand, M.D. :Absolutely. I mean, that is another, as I mentioned, the third on my team, yes, besides the, you know people that really need to have knowledgeable and manpower in the field. Another one is actually manufacturing site. That's another thing that we need. Radio Medics started addressing this issue in 2019. We put together our Spica Center manufacturing site, which is close to the airport in Houston 27,500 square feet of manufacturing, seven large clean rooms equipped with all analytical. So that's the place that we do a scale up. That's the place that we run our let's say, we will have enough bandwidth to make our drugs required for, let's say, phase three trials. Of course, all our manufacturing, all the drugs that goes into human at this point, is manufactured at Spiker Center, but definitely something like this is needed when you're talking about tens of doses every day that you need to do for clinical trials, phase three trials, as well as, down the road, commercial launch.
Ben Comer:Would you potentially consider commercializing your own therapies? Would you need to partner at that point, or have you mapped that out?
Dr. Ebrahim Delpassand, M.D. :It depends. Now we are, we have learned a lot, of course, in what it takes to commercialize the drug, but still we are very open to collaboration. We like to see that. You know companies that they have more experience than us. Come, and we definitely welcome you know companies that they have more experience than us. Come, and we definitely welcome you know communication with these companies and working together for the commercial phase. We have a lot of experience in conducting clinical trials, both on the regulatory strategy, both on the regulatory strategy, as well as enrollment of the patients, et cetera.
Ben Comer:But definitely we welcome any collaboration by big pharmas, by companies that they have a lot of experience in that area. Right, we've talked about this a little bit, but Radiomedics is now 20 years old as a company. Put yourselves in the shoes of a physician or an academic scientist, you know, with a bold idea for a new therapeutic approach, who wants to start up, you know, a biotech or a pharma, a life sciences company? Just thinking about your, you know, thinking back over your 20-year journey, the challenges you've had to overcome. What kind of advice would you give to someone like that, who maybe has, you know, a safe and comfortable academic job but really sees a need out there for patients?
Dr. Ebrahim Delpassand, M.D. :Ben, this is a loaded question. I mean a lot of stuff but I can't do it. Is that what you're going to say? But you know I can summarize some of my experience in the last 20 years since the inception of Radiomedic. So number one I think I would like to advise my young colleagues start by a good legal structure for your company.
Dr. Ebrahim Delpassand, M.D. :Think about because this is very important you need to align yourself with a legal firm. I know, initially, when you start, things are you know money is in shortage and these things are. They don't come cheap. These things are they don't come cheap. But there are good firms that actually understands our field and understand their startups and challenges that the CEO or a CFO of a startup company has. So they cooperate, they want to essentially lay the seeds so in the future actually be your partner and then at that time obviously there's not going to be a problem with money. So this is very important for your. You need to have a very solid structure. Think about where you want to, for instance, register your company and what would be the structure If you are, you know, having stock options, for instance. It should be all written, all very, you know, organized. Basically, this is one thing. The other thing is that you know, do not sign any agreement without really legal oversight. I think you will see that the money that you spent to build that agreement, you know, whatever you pay to the attorneys, 10 times higher for you if you have done a good job in terms of the legal agreements and having a nice, solid oversight by a legal counsel that they have experience in doing these things.
Dr. Ebrahim Delpassand, M.D. :Second, I think you know, hire talented and right knowledge people. These are the backbone of any company. This is the most valuable asset of any company People who are knowledgeable. They have good talent and also, as we discussed, passionate passionate about your goal. They understand, they share your vision, they share your you know future that you're thinking about. I think the other thing is that, as the owner of the business, I should say be ready to come first, to leave last and get paid last. That's the rule of the game. If you don't want to do that, I don't think you are right.
Dr. Ebrahim Delpassand, M.D. :For this, there is a need for a certain sacrifice and, of course, you need to have funding to do that. Look at the funding that is available to you and look at your goals and the sort of runway that you can have. Also, understand the unmet needs on your field. As we mentioned, it's very important to know where is itching to a scratch. You need to know the unmet needs and this is very important to be successful.
Dr. Ebrahim Delpassand, M.D. :We don't do in drug development. You don't do research for research. You do research to solve a problem for the patients and always have the end point inside what would label of your drug would look like? You need to go toward that and you need to look at it day one that you have this understanding your competition extremely important and also the last but not the least, patient's welfare. This is a business of helping patients with catastrophic illnesses. Always have that in mind. You want to help the patients and always when you are designing a clinical trial, when you are essentially even hiring people, when you are allocating resources, financial resources, look at see where you can use your dollars to the best of the way to help the patients.
Ben Comer:Excellent advice and, dr Delpasan, thank you so much for coming on the show.
Dr. Ebrahim Delpassand, M.D. :My pleasure, my pleasure, ben. Thank you for invitation and happy to come to your show anytime you feel appropriate.
Ben Comer:We've been speaking with Dr Abraham DelPassan, founder, chairman and CEO at Radiomedics. 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 videocasts of these conversations every Monday under the Business of Biotech tab at lifescienceleadercom. We'll see you next week and thanks for listening.
