The Exchanges

Q And so Orca's novel therapy, it's designed to replace conventional bone marrow transplant. Bone marrow transplant is, I guess it's one of the oldest cell therapies in a sense, but, but you're doing it in a totally different way. You know, every year right now, I think it's what, 20,000 Americans or so receive a bone marrow transplant. Why did you start there?

A I mean, you almost mentioned it in your, in your answer. It's one of the most well-established, oldest, most impactful cell therapies. Um, it's an impressive cell therapy because it ends up, Treating patients who have failed all other treatments, patients with really terminal blood cancer, and have no other option, and it actually does so trying to cure them. So the fact that you can cure patients at this late stage is really a miracle. There are very few, um, cancer treatments out there that are done with curative intent, and, and so it's incredible, and the folks who developed it got the Nobel Prize for it. Um, but it's also carries a lot of risk, just like other cell therapies. Maybe 20, 30% of people will die from the medicine itself.

AI assessment note: “It's one of the most well-established, oldest, most impactful cell therapies.”

Q the immune system is what you're doing. And then when you reboot the immune system, it turns out it can kill cancers. Uh, what other diseases could it possibly treat, right? There's, there's all sorts of Americans who have autoimmune diseases. Like, like what's, what's next here? Let's say that you get this approved and you're saving, you're helping with all these cancers. Like what else can you help with?

A Right, right. So, um, I think like you mentioned it earlier, um, The big challenge has always been when you reboot the immune system, how can you do that safely? Because otherwise, if you don't do it safely, you're sort of renegated to really the terminal end stage, most sick and ill patients out there, but there's way more people who aren't at that stage who could really benefit, and there are sort of serendipitous situations where people have had, for example, really severe autoimmune diseases like multiple sclerosis, happen to also have leukemia on the side. For the leukemia, they get an immune system reset, and, and then they, you know, magically see the Disease vanish, right? That also happened with HIV, which is pretty incredible.

AI assessment note: “severe autoimmune diseases like multiple sclerosis... That also happened with HIV”

Q Because originally you had like a subconductor plate, And there'd be, like, lots of little wells in the semiconductor plate, and you can scan each one, and, and certain things would drop through the plate, right, if it was the correct cell or not. But then, but are you, are you going to use that longer term, or, or, or what's the framework now?

A Right, right. So we would like to, um, so we have a whole stack of technologies that, uh, the technology you mentioned is sort of the, the accelerator to be able to broaden it out to really huge numbers of patients, where we're basically using lasers and light to move cells around and sort them, and, That can really speed things up by orders of magnitude. So we're really excited about that scalability opportunity. Um, but then around that, you also have to build all the other preparatory technologies and all the logistics technologies. Like we actually had to develop our own logistical system and our own set of medical couriers who will actually take the product and deliver it to the patient, our own tracking systems, and then, um, and ultimately also get the hospitals to be able to interact with these products and quickly get them into the patient veins. Rather than having them sitting around.

AI assessment note: “the technology you mentioned is sort of the, the accelerator to be able to broaden”

Q I think you have one big plant in Sacramento right now. And I mean, if this stuff works, you're gonna have to build more of these plants on the East coast as well to treat people and then around the world. Are you, are you thinking about it? Is that a few years from now you build, need to build more plants or how's that gonna work?

A Right. So we're, we built already one big plant that will sort of be the, the template. And hopefully we can use this template across multiple other areas. Uh, we are also right now exploring opportunities with, with partners to see if we can adapt some of the existing plants that are out there, uh, to our version of manufacturing so that we don't have to always start from scratch and go faster. Uh, so I think it'll be a mix of multiple solutions from, uh, partners, uh, and manufacturing support and our own plants, uh, that will again, it'll sort of case by case, but we're again, our, Principle here is go as quickly as possible, impact as many patients as possible, as long as it's effective and good.

AI assessment note: “I think it'll be a mix of multiple solutions from, uh, partners”

Q I think there's guys like, you know, I'm friends with Ro Khanna, who's like much to the left of me, and he says, well, we're already paying for all these things in academia. Shouldn't the government just tax most of them? Because we created them in academia. Like, like, what have you done to create something in the last eight years at Orca? Like, how is that different than academia?

A I mean, uh, I'm not sure about sort of, uh, uh, how you do ultimately, you know, build a country and how to make it most successful. But what I do know is that it's, it's, there's a huge step when you go from research and development and fundamental breakthrough to translation into impact, uh, on folks. And especially if you're doing something lifesaving, where you have to really demonstrate that it's scalable, that it works, that it can impact a lot of lives. That can fit into the existing system, both from the perspective of delivery and from a perspective of reimbursement and from a perspective of really getting to the right patients and giving access. I mean, those are pretty big challenges that you need to spend quite a bit of thought and effort onto it.

AI assessment note: “there's a huge step when you go from research and development and fundamental breakthrough to translation”

Q Interesting situation here because a bone marrow transplant originally was not FDA approved. It's a method or process existed. I think before the FDA started regulating these things, So that puts you in a unique position. How do you approach the first ever FDA approval in this space? What does that mean? What's that require?

A It's a, it's a good question. It's a tough question. Um, Basically being a pioneer is not easy. It's definitely hard, uh, but it's also exciting because you get to set the standards, uh, specifically how we deal with the FDA and, uh, and that whole process. It's been a huge learning curve for me. Um, but ultimately you have to go back down to basics, to fundamental principles, science and data, and really have a very open and direct and frequent conversation with the FDA. And I think when you're doing something pretty novel and exciting, Everyone gets excited by it. And ultimately, whether you're a regulator or whether you are a biotech, the goal is still the same thing. It's really help patients. And when that realization comes together, you basically begin to collaborate and, and you actually develop a really good, interesting, uh, kind of connection and, and you learn a lot from them and they learn from the science that you're building. And, um, and it's been basically going down to the fundamental principles of how do we regulate the space given the fact that it hasn't been regulated in the past. And how do we learn from whatever we can learn from other pseudo proxies? But ultimately, a lot of these decisions, you don't know if they're going to work out or not, and it is pretty scary.

AI assessment note: “have a very open and direct and frequent conversation with the FDA”