Reimagining Bone Marrow Transplants... Kevin Caldwell, Co-Founder & CEO, Ossium Health
Often the next thing we hear after learning that someone needs a bone marrow transplant is that they have to find a living donor that matches them to give it. When no family member is a match, this can take months and many challenges before the transplant is complete. Today we're talking with Ossium Health and its new technology which cryobanks bone marrow, all with the hope that eventually only a few will be left without a ready match. Kevin Caldwell is its cofounder and CEO. Kevin, welcome to the program.
Kevin Caldwell:Thank you for having me, Moira.
Dr. Moira Gunn:Now we've all heard of bone marrow transplants. They're permanent life saving treatments for various kinds of blood cancer, be it leukemia or lymphoma or multiple myeloma. And to be clear, the clearing of your unhealthy bone marrow and giving you new bone marrow, either from a match in your family, which can just be a few more weeks or more likely an unrelated donor, which can take months, all includes being in a medical setting or a hospital. So let's start there. How many bone marrow transplants are there in The US today?
Kevin Caldwell:So there are two major types of bone marrow transplants. There's autologous bone marrow transplants which is where a person gives a transplant to themselves and then there are allogeneic bone marrow transplants which is where one person gives bone marrow to another person. And what we're really working on at Ossium is the second kind of bone marrow transplant where you need a donor and there's about twenty thousand people who go looking for one of those transplants each year in The United States and we only do about ten thousand of those transplants.
Dr. Moira Gunn:Now if someone's a family member, you know, frequently they're right there with you, co located, so that can happen in the same place. But many times the donor, even in your family, but certainly an unrelated donor found somewhere in the system somewhere that matches you, they may not be co located with you. How do you maneuver or navigate that disparate geographic distance?
Kevin Caldwell:Right. So today, bone marrow donors are found through registries. And so many countries, including The United States, have national registries of bone marrow donors. And these are basically people who have volunteered to be potential donors for someone else who needs a transplant who happens to be a close genetic match to themselves. And when a person requires a transplant and doesn't have a match readily available in the family, these registers are called upon.
Kevin Caldwell:It's true that usually the donor and the recipient are not in the same location. The donor could be anywhere in the country or even elsewhere in the world. And so when that happens, the donor goes to a bone marrow collection center that is typically geographically close to where the donor lives. Their bone marrow will be removed, at that center, and then it's transported to the bone marrow transplant center where the patient, resides. It's typically, shipped overnight fresh.
Dr. Moira Gunn:And so within twenty four to thirty six hours, you've connected the donor with the, recipient. Although this may have taken months to find the right person to get that all set up, everybody's gotta be in the in a medical setting to make that happen.
Kevin Caldwell:Exactly. There's a lot of logistics and coordination that have to be done in order to make a transplant possible. It's really a herculean effort on the part of both the patient's team, the registry, the team recovering the cells from the donor. Everyone has to coordinate perfectly in order to make the transplant happen.
Dr. Moira Gunn:Now, Ossium has come up with the technology to make an impact here. What has Ossium Health done?
Kevin Caldwell:So Ossium has developed the capability to recover bone marrow from organ donors. And these are the same deceased organ donors that we rely upon for hearts, livers, lungs, kidneys, etcetera. OssiaM has developed a process for obtaining bone marrow from those same individuals and then cryopreserving or banking that bone marrow so that it can be used later. This allows someone who is an organ donor today to provide a transplant for and ultimately save the life of someone who needs a bone marrow transplant in the future. One of the things that we've really worked on is the ability to maximize the lifesaving value of every donation that we get.
Kevin Caldwell:And so unlike living donors, sort of volunteer donation where one donor saves the life of one patient, we were able to obtain many more bone marrow stem cells from a deceased organ donor, and this allows us to save multiple lives from each donor. For an adult transplant, a typical organ donor could provide enough bone marrow for two or three transplants. And if the patients are pediatric patients and leukemia is the most common cancer that children do get, then we could do four to six transplants from a single donor.
Dr. Moira Gunn:Now I know that the US government under its administration for strategic preparedness and response and specifically its agency called BARDA, and listeners may remember BARDA from during the COVID pandemic. It supported all the development of vaccines and COVID diagnostics and anything to do with the pandemic. BARDA has awarded Ossium Health a hundred and $25,000,000 contract. What is that contract for and why is the US government interested in this?
Kevin Caldwell:Right. So one of the goals that HHS is charged with, and in particular the Biomedical Advanced Research and Development Authority, or BARDA, is preparing The United States for catastrophic events, mass casualty events that would significantly harm large numbers of U. S. Persons. And within their mandate is nuclear and radiological countermeasures.
Kevin Caldwell:And in particular, one scenario that they want us to be prepared for is one where, God forbid, there's a a nuclear weapon that detonates on US soil. Were that to happen, tens of thousands of people would be exposed to enough radiation that they would be at risk of what we call hematopoietic acute radiation syndrome. And that just means that the stem cells in their bone marrow sort of mutate, and this puts them at risk of death within about a month, unless those people are treated. One of the best treatments for someone who is at risk of sort of radiation poisoning is a bone marrow transplant because that allows us to permanently replace their blood and immune system, in this case the disease or radiation poisoned immune system, with a new healthy immune system from a donor. So we mentioned earlier, Moira, that there are only about ten thousand bone marrow transplants per year in The United States.
Kevin Caldwell:In this scenario, we would need to do 50 or 100,000 transplants in just a few weeks. The system would be overwhelmed in this scenario unless there was a way to do the transplants much more quickly, unless it were possible to get the bone marrow immediately on demand without needing to identify thousands of donors in real time. This requires banked bone marrow that's already been collected, tested, sort of characterized, and it's ready to deploy on demand. That, of course, is exactly what Osteum does. And this is an example of what we think of as dual use.
Kevin Caldwell:And so we're building the bone marrow bank so that we can treat patients with blood cancers who need a transplant under sort of conventional medical circumstances, but the same capability that we're building that will enable many of those patients who are currently going unserved to receive a transplant would also allow us to respond far more effectively doing one of these catastrophic events.
Dr. Moira Gunn:Now I know that this bone marrow transplant procedure, which Ossium has available today and is in use, does not need any more approvals to go forward. You could just continue from here. But I was interested, Ossium has decided on its own to conduct clinical trials. What are you studying and why are you doing this?
Kevin Caldwell:So it's true, Mora. Bone marrow transplants have been around for about seventy years. The earliest bone marrow transplants were done in the 1950s and 60s, and more than one and a half million of these procedures have been done around the world. We often think of stem cell therapy as twenty first century medicine, but bone marrow transplants are really the original stem cell therapy, and Ossium is building upon that sort of deep clinical history. Although bone marrow transplants themselves have a lot of precedent, our process where we are obtaining bone marrow from organ donors, cryopreserving it, and then using that bone marrow for transplant, is a novel process that we've developed.
Kevin Caldwell:We have a lot of confidence in that process based on the quality of the data that we're seeing so far from the initial transplants that we've done, and we want to make sure that physicians have access to that data. And so in order for physicians to develop confidence that our product can be used to reconstitute the blood and immune systems of their patients, they need a data set to rely on. And so the purpose of this study is to produce that clinical data set. And so we are measuring the rate of engraftment, how much time passes between when the bone marrow is transplanted and when the patient's blood and immune system is reconstituted. We're also measuring the amount of time the patient spends in the hospital and a variety of other metrics and really, really trying to show that they have excellent outcomes.
Kevin Caldwell:And so far, that's bearing out.
Dr. Moira Gunn:Now Osteum Health is in a period of building this donor bank. What if you need a bone marrow transplant today, especially if you don't have a match right now?
Kevin Caldwell:So if you're looking for a bone marrow donor, can go to ossiumhealth.com and go to our HOPE program, which is a program that we established for people who are looking for a bone marrow donor and don't have one readily available, and just provides information, a little bit of information about the diagnosis and contact information. Our team will review that and then someone from our clinical team will ask to be put in touch with your doctor. And if you are a good candidate for for the study or for the expanded access program, then our team would work with your doctor from there.
Dr. Moira Gunn:What if you wanna donate?
Kevin Caldwell:The way to become an Osteum donor is to become an organ donor. So if you just sign up for organ donation at the DMV, then you'll be a potential Osteum donor.
Dr. Moira Gunn:So where do you go from here, Kevin? There's a lot of work to be done.
Kevin Caldwell:Well, we are looking forward to the completion of our PRESERVE clinical trial for the treatment of blood cancers. We hope to bring the number of patients who go looking for a donor and ultimately receive a transplant much closer to one hundred percent than it is today so that fewer and fewer people die from this treatable disease. Beyond that, there's an enormous number of applications of banked bone marrow and stem cells, including enabling organ transplants without immunosuppression, people who receive solid organs from the same donors that we rely upon for bone marrow. Our hope is that one day they can live without needing to have their immune systems suppressed with drugs. There are opportunities to use some of the bone from the donors to make orthopedic products to expedite the healing after orthopedic surgery and really just a vast number of other applications.
Kevin Caldwell:We're looking forward to dramatically expanding our blood cancer treatment program from the nine centers that are currently participating in our clinical trial to the hundreds of bone marrow transplant centers around The US and world that treat patients every day.
Dr. Moira Gunn:Well Kevin, thank you so much for joining us. I hope you come back, keep us updated.
Kevin Caldwell:Thanks for having me, Moira.
Dr. Moira Gunn:Kevin Caldwell is the co founder and CEO of Ossium Health. More information is available on the web at ossiumhealth.com. That's O S S I u m o c m health dot com. And remember, you can become an organ donor simply by registering at your local DMV.
