Rich McCormick: [00:00:00] Hi, I’m Rich McCormick, Executive Vice President of CRO Operations here at Vial. Today, I have the pleasure of welcoming CEO of CTMC, Dr. Jason Bock to our First In Human podcast. Jason, thanks for joining us today.
Jason Bock: Thank you, Rich.
Rich McCormick: So, we’ll jump right in. Can you share the journey that led you to co-founding CTMC? And, how did the joint venture between Resilience and MD Anderson come about?
Jason Bock: It’s been an interesting journey and one that, at least for me, wasn’t predictable at all from the start. I did my undergraduate training at MIT in biology and then cell biology and physiology at Stanford. This was right during the early part of the genomics boom when we were busy sequencing the human genome.
I jumped into that field where we were trying to use this novel technology, in terms of sequencing the genome, and turn that into a more efficient way of coming up with innovative therapeutics. That’s been the story of my career, using technology or infrastructure to attack unmet medical needs.
Over the last 25 years, I’ve done that in small, medium, and large size biotech and biopharma. My last role was at Teva Pharmaceuticals before coming to Houston, where we developed a group of about 600 people that focused on innovative biologics. We brought more than 10 products into clinical testing and several through to global commercialization.
This was around the 2017 time frame when the first CAR-Ts were being approved. I became really fascinated with cell therapy as this new paradigm for single dose potentially curative treatments for patients. Yet the manufacturing for these products was extremely challenging.
Based on my experience with solving complex biologics’ manufacturing challenges. I thought, “This might be an interesting area to get involved with.” Coincidentally, and in parallel, some of the leadership through friends of friends at MD Anderson got in touch with me. We started talking and conjecturing about what we could do together and decided to do something pretty unique to attack this challenge.
I moved from the East Coast down to Houston next to the Texas Medical Center. I started a new department called, Biologics Development that essentially was a biotech within MD Anderson. The concept was to pull together a group of people with industry experience who had capabilities and competencies in developing therapeutics, specifically cell therapies, and work with MD Anderson researchers on their novel ideas. Then we can industrialize those, manufacture them, and bring them into the MD Anderson clinic to evaluate them in early phase clinical studies.
This was a pretty novel concept to do this at an industrial level. The way we went about doing it was a facility and the team are critical to doing this in a very robust way. We were fortunate to become aware of a local cell therapy company called Bellicom Pharmaceuticals that was looking to divest their fairly new cell therapy development and manufacturing facility.
In a very unusual move, MD Anderson purchased this facility from a biotech company. Some of the people in that group transferred into our group. Thus we began, this sort of like internal biotech. We were busy working with MD Anderson-invented products when news spread about what we were doing. Some CEOs and venture capitalists who sat on boards of biotechs, reached out and said, “What’s MD Anderson doing buying manufacturing facilities, what exactly are you doing?”
We told them the story. They said, ” That’s really interesting because we’re a n early stage research biotech company who had some innovation that we maybe spun out of an academic organization. We’re developing that product. We now have a clinical candidate and we have to decide how we’re going to get this into patients. For self therapy, there’s particular challenges of running autologous self therapy trials and logistics and requirements of the clinic interacting with the manufacturing in a different way than for all other therapeutic modalities.
We brainstormed with them and came up with a model where we would co-develop products with biotech companies where we would leverage, essentially, our infrastructure in CMC, both process and analytical development, even regulatory affairs, and the clinical infrastructure at MD Anderson to move products from early stage research, or preclinical proof of concept through IND-enabling studies through an IND, to first in human study where we could get clinical data.
We signed several of these co-development partnerships with biotech companies and got pretty good at [00:05:00] leveraging this connected infrastructure to move these products very rapidly through that into the clinic. Interestingly, I know this was, Rich which maybe you bit off more than you could chew when you just asked me this simple question and I told you a five year journey here,
Rich McCormick: No, it’s very interesting. (laughter)
Jason Bock: Things were going so well at MD Anderson, the group was growing, and we were signing more and more biotech partnerships. Then, this interesting organization, National Resilience, heard about what we were doing. And talked to us about what they were doing. They were a company founded by very ambitious venture capitalists who wanted to reimagine complex biologics manufacturing.
In some ways, similar vision to what we had. We wanted to do something connected with them, but we didn’t want the group to also lose our connection with MD Anderson. What we thought we could do is create an organization that could be the best of both worlds. We spun the group out of MD Anderson as a standalone company, a single LLC, but that’s 50 percent owned by MD Anderson.
And 50 percent owned by Resilience. We could have the connectedness to MD Anderson on the innovation, research, and the clinical capabilities. And from Resilience on the innovation that they were bringing to manufacturing technology and processes. It’s been really interesting that we spun out about a little more than 18 months ago. I’ve been off to the races ever since.
Rich McCormick: It seems like definitely off to the races. In those last 18 months, CTMC has helped multiple companies file INDs. Can you elaborate on how your company facilitates the acceleration of cell therapies from development to testing?
Jason Bock: Yeah, absolutely. In the last 18 months, we’ve had the honor of driving six projects through, to IND and to initiate clinical studies on those both from biotech partners as well as MD Anderson-invented products. What we found is through offering comprehensive connectedness on basically everything that needs to be done from a research project to let’s say 15, 20, 25 patients of clinical data, CTMC connected with MD Anderson can do everything a company needs to do that.
Whereas, if you go with a more traditional route, where you hire a CMO, a contract manufacturer to make a viral vector for you, and then one to make the cell therapy, and then you hire a CRO to open up multiple clinical sites. Then, you hire a logistics company to move the product back and forth between those sites. Just all of that interaction in that complex network, there’s time lost there. Through tightly integrating the manufacturing, the CMC development, and the clinical development, we’re able to save quite a bit of time.
In one instance, a company came to us and said, ” We think it’s going to take us about two years, we have a detailed plan, we have a network of contracting groups we’re going to work with. We can do it in about 24 months to get to some X number of patients’ clinical data.”
And we looked at their plan and said, “I think we can do it in 18 months.” That sounds good. They signed up with us. Now, anyone can say anything. It’s about what can you actually deliver? What was very gratifying to me is that we didn’t hit 18 months. We actually did that in 16 months, and got them to that milestone early. We looked for every opportunity we could to accelerate that product development, and really helped that company get to various milestone inflections, much sooner.
Rich McCormick: Anything in this industry, especially in the space happening ahead of projected timelines is impressive. Your model is described as biotech friendly. You have unique access to patients at MD Anderson. What makes that model stand out and what’s significant, digging into that manufacturing center, just being within steps of MD Anderson?
Jason Bock: There’s a number of aspects that differentiate the model from other ways of bringing products into the clinic specific to cell therapy. The most distinctive is the tight relationship with MD Anderson, where even when we’re evaluating a potential partnership, we identify a key opinion leader, from MD Anderson, who would be interested in running that clinical study, and they evaluate a potential product to the potential partnership alongside us.
What’s amazing about MD Anderson is almost everything in oncology, at one stage or another, goes through MD Anderson. These guys have an amazing view of the landscape. It carries a lot of weight with us if one of these KOLs says, ” This product is really interesting. I would put my patients on that clinical study,” As opposed to them saying, “you know, there’s a lot of other things out there. This isn’t so exciting. [00:10:00] Then we tend not to work on this because we really want to focus our resources on these really impactful, game changing, cell therapy projects.”
So we evaluate those projects In connection with, and then the energy KOl. And then, all throughout the processes of us doing the IND-enabling studies and FDA interactions. This investigator is along with us for that ride. They are getting the clinical study ready. They’re working with the company and writing the protocol, putting that all together, so that, by the time we get to the IND clearance, they’re raring to go.
Lots of times, there’s this unfortunate white space between IND clearance and, “CMC is already, manufacturing is already, and off the clinic, okay, we’ve got to get CTAs in place and clear IRBs and all their things.” Because this investigator has been primed and literally working on the project for a year before, they’ve got everything lined up because they’re the ones actually pulling the products and saying, “Look, I got patients waiting for this. I want to get people on this study.”
That allows us to quite rapidly activate MD Anderson as a clinical site, usually in less than 100 days. Actually, every study we’ve done has gotten to activation in less than 100 days, which is quite fast for an institution the size of MD Anderson. The next thing that helps with the acceleration is just the volume of patients that MD Anderson sees that come through. The patients who are actually coming to MD Anderson, to be on the latest, greatest, clinical trial. 80 percent of the patients who are seen at MD Anderson are on a clinical trial. Very few people are getting standard of care and they think it’s what they want. There’s a massive volume that goes through MD Anderson. If you look at the number of patients on cell therapy clinical trials at MD Anderson versus all other organizations in the U.S., MD Anderson is number one. It’s not just number one. If you add together number two and three. They don’t add up to the number of patients that MD Anderson sees. What that patient volume allows us to do is make sure that we find the right patients for the right clinical study, and enroll them quickly so we can get to a clinical proof of concept as quickly as possible.
Unfortunately, not all the therapies we work on will be efficacious, but we’ll drive to that answer as quickly as we can.
Rich McCormick: Being so close to the staff, to the KOLs that you mentioned, is there any interaction with actual patients that are being treated?
Jason Bock: Of course, we’re very careful about HIPAA laws and keeping patient confidentiality in mind at all times. We have quite robust safeguards around that. But, self therapy is such a, personal therapy, not only because it’s personalized and specific for that particular patient, but patients get very engaged in the therapy themselves because they go through a process where we take out some of their blood or tumors and cells to bring that into the manufacturing facility, engineer it, and then give it back to them.
They get very engaged in the process often asking, “Where are my cells? When am I getting them back?” For several trials, we actually deliver the final product right to the patient’s room. They’ve been given some pre-infusion preparation for several days before that. They’re waiting there for their cells. In contact with the staff there. Lots of our guys get selfies taken with them (laughing) right before the infusion, right before we get in there, and kick the cancer’s butt.
Rich McCormick: That’s really emotional and exciting. I would think, in that moment, in that room, it’s not happened to many patients around the world, let alone you’re sitting there with somebody.
Jason Bock: It’s quite powerful. That kind of connectedness is why we wanted to Connect with MD Anderson. Literally, it’s like, you get 2, 000 steps on your watch, bringing the product there because it’s so close. That really keeps that connection. We don’t load things on an airplane. We don’t put things in a shipping truck or anything. We bring it right to the patients
For subsequent trials we have, now, as we scaled up trials, expanded from just MD Anderson and can run and support multi center trials and have been doing that for a few years now, as well.
Rich McCormick: You mentioned CTMC. It’s a joint venture. Can you discuss the power of partnerships in biopharma development? What role do they play in moving these drug concepts from ideation to commercialization?
Jason Bock: Nobody can do therapeutic development on their own. It’s so important to be very intentional about how you pick your partners, how you create interfaces with them, and how you structure those relationships. Based on my 20-year history in biotech and biopharma, being on that side, we want to really think about how we structured that relationship with a biotech company.
A lot of what we [00:15:00] do could be classified as services. A lot of the CMO industry positions, like fee for service, here’s a menu of things, you check off the boxes, you order what you want, and then you pay us for service. The problem with that model is that you can have misaligned incentives.
The biotech company is trying to get their product into patients as quickly and robustly as you can. The service provider is trying to do a bunch of services. Some of those things overlap, but sometimes they don’t. When they don’t, that causes delays and anger (laughs).
What we do is set up a partnership with the main intention of aligning our incentives. We want to do things so that we are essentially biotech’s CMC and development arm. We are aligned with them in that we are incentivized to get products through FDA interactions to patients as quickly as we can. For biotech companies as much cost certainty as we can. It’s basically a fixed price offering that we put together. We participate in some of the downstream revenues if the product is successful. That aligns us to work as quickly as we can to get the product data and realize that value, as well as, give the biotech company some cost certainty and not have to deal with change orders and the like, which not only present financial uncertainty, but also lots of times impact timelines as people start negotiating over how much a particular change is going to cost and things.
Rich McCormick: How do you envision cell therapy or CTMC, in particular, influencing the future of cancer treatment?
Jason Bock: Humbly speaking, cell therapy is going to transform cancer treatment, as well as, how we treat other diseases. Over the last six months, we’ve seen some exciting results in autoimmunity. A lot of CD9 CAR-T’s or other CD9 therapies are being applied and having some pretty dramatic effects in autoimmunity.
This concept of utilizing the body’s immune system to produce a single dose, potentially curative, therapy is a game changer. It’s transformative in how healthcare is delivered. It’s such a different model than if you, for the rest of your life, have to take a certain medicine. Or if, for some cancer treatments, every six weeks you need to come back to the hospital for another cycle of treatment. Which only delays disease progression or creates stable disease or partial remission.
What is exciting with cell therapy is we’ve seen very late stage patients who have no other options, getting a single dose and being cured for a long time, as long as these therapies have been administered upwards of 10 and 15 years. That changes all of how healthcare is administered. Specifically, though, the relationship between manufacturing in the clinic and sponsor companies is very different with cell therapy. Because, all of the manufacturing for these autologous cell therapies that have this transformative effect are on demand. We can’t just store these products up in a warehouse. We can’t make 100,000 doses ahead of time and then just distribute them through a supply chain network.
While typically, the relationship between these three entities, like sponsor, manufacturer, and clinic is very arm’s length, right? Sponsor or biopharmaceutical company orders 10 kilos of a drug for the second quarter next year. They produce it, that gets processed into bottles, shipped to pharmacies, and then doctors just prescribe it and it comes off the shelf to the patient. Inherently, in autologous cell therapy, these three entities are inexplicably linked in real time.
That creates a different relationship that’s needed, a much more integrated relationship. Because in real time, the doctor is finding patients, shipping samples to the manufacturing site to produce those, and getting them back to the clinic. Overall, cell therapy has such a high potential. But it also requires us to rethink how we do a lot of things. That’s what I’m proud of that we’ve started that journey. There’s still a lot to be done in reimagining how we do this. But, if we want these therapies to reach their full potential for patients, we have to rethink how we do things.
Rich McCormick: Jason, it’s been a pleasure meeting with you today. Thank you for being a guest on the First In Human podcast. The team here at Vial wishes you and your team at CTMC nothing but future success.
Jason Bock: Thank you so much, Rich. I enjoyed the conversation.
