Episode 56: Jason Bock- Founder and CEO at CTMC

Step into the future as Dr. Jason Bock, founder and CEO of CTMC discusses the company's unique approach to accelerating cell therapies from development to testing, and the power of collaboration in reshaping the future of cancer treatment. Listen in as we discuss how CTMC's partnership with MD Anderson is not just technical but deeply human in nature, with the patient and personalized medicine at heart

First In Human is a biotech-focused podcast that interviews industry leaders and investors to learn about their journey to in-human clinical trials. Presented by Vial, a tech-enabled CRO, hosted by Simon Burns, CEO & Co-Founder. Episodes launch weekly on Tuesdays. To view the full transcript of this episode, click here.

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Transcript

Speaker 1: 0:07

You are listening to First In Human, where we interview industry leaders and investors to learn about their journey to inhuman clinical trials Presented by Vile, a tech-enabled CRO hosted by Simon Burns, ceo and co-founder. Featuring special guest host Rich McCormick, evp of Clinical Strategy and Head of Oncology. In this episode we are joined by Dr Jason Bach, founder and CEO of CTMC. Join us as we explore the intriguing story of co-founding CTMC, its impactful collaboration between resilience and MD-eminent cancer center, and the evolving landscape of cancer treatment for cell therapies.

Speaker 2: 0:46

Hi, I'm Rich McCormick, executive Vice President of CRO Operations here at Vile. Today I have the pleasure of welcoming CEO of CTMC, Dr Jason Bach, to our First In Human podcast. Jason, thanks for joining us today. Thank you, rich, 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?

Speaker 3: 1:11

It's been an interesting journey and one that, at least for me, wasn't predictable at all from the start. So, to go back a little bit on my history, 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, and so it 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, and so over the last 25 years, I've done that in small, medium and large-sized biotech and biopharma. My last role was at telepharmaceuticals, 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 2017, timeframe when the first curtees were being approved, and became really fascinated with cell therapy as this new paradigm for single-dose, potentially curative treatments for patients. And yet the manufacturing for these products was extremely challenging, and so, based on my experience with solving complex biologics manufacturing challenges.

Speaker 3: 2:46

I was like this might be an interesting area to get involved with and coincidentally and in parallel, some of the leadership through Friends of Friends at MD Anderson got in touch with me and we started talking and conjecturing about what we could do together and decided to do something pretty unique to attack this challenge. And so I moved from the East Coast down to Houston, next to the Texas Medical Center you can actually see MD Anderson in the background and started a new department called Biologics Development. That essentially was a biotech within MD Anderson and the concept was to pull together a group of people with industry experience who had capabilities and competencies in developing therapeutics, specifically cell therapies, work with MD Anderson researchers on their novel ideas and then we could industrialize those, manufacture them and bring them into MD Anderson clinic to evaluate them in early phase clinical studies. This was a pretty novel concept to do to set 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.

Speaker 3: 4:01

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 and some of the people in that group transferred into our group. Thus we began this internal biotech. We were busy working with MD Anderson, invented products and developing those. When news spread about what we were doing and some CEOs and venture capitalists who sat on boards of biotechs reached out and said what's MD Anderson doing, buying manufacturing facilities and just kind of making some noise when it's actually done? We told them the story. That's really interesting because we're a 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 in the patients.

Speaker 3: 5:11

For cell therapy there's particular challenges of running autologous cell 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 a preclinical proof of concept through IND, enabling studies through an IND to first in human study where we could get clinical data. So we signed several of these co-developed partnerships with biotech companies and got pretty good at leveraging this connected infrastructure to move these products very rapidly through that into the clinic. And then interestingly, I know this was Rich maybe you bit off more than you could chew when you just asked me this simple question and I told you like a five-year journey here, right?

Speaker 2: 6:23

Definitely a journey question. So yeah, no, very interesting.

Speaker 3: 6:27

So things were going very well actually so well at MD Anderson.

Speaker 3: 6:31

The group was growing and we were signing more and more biotech partnerships. And then this really 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 manufacturer. It's always a similar vision to what we had, so we wanted to do something connected with them, but we didn't want the group to also lose our connection with MD Anderson. So what we thought we could do is create an organization that could be the best of both worlds. We spun a group out of MD Anderson as a standalone company, single LLC, but that's 50% owned by MD Anderson and 50% owned by resilience, so that 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. So it's been really interesting that we spun out about a little more than 18 months ago and have been off to the races ever since.

Speaker 2: 7:42

Yeah, it seems like definitely off to the races. So in those last 18 months CTMC has helped multiple companies file INDs, so can you maybe elaborate on how your company facilitates the acceleration of cell therapies from development to testing?

Speaker 3: 8:00

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've found is that through offering really 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 so thank you so much 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 and 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 loss. There. Through tightly integrating the manufacturing, the CMC development and the clinical development, we're able to save quite a bit of time.

Speaker 3: 9:24

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 number of patients with clinical data. We looked at their plan and said I think we can do it in 18 months. About time is really 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 help that company get to various milestone inflections much sooner.

Speaker 2: 10:11

Yeah, anything in this industry, especially in this space, happening ahead of projected timelines is impressive. So your model is described as biotech-friendly and you have unique access to patients at MD Anderson. What makes that model stand out and what's significant? Really, like maybe digging into that manufacturing center just being within steps of MD Anderson.

Speaker 3: 10:33

There's a number of aspects that differentiate the model from other ways of bringing products into the clinic specific to cell therapy. I think 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 who will, from MD Anderson, who would be interested in running that clinical study, and they evaluate a potential product and a potential partnership. Alongside what's amazing about MD Anderson is almost everything in oncology at one stage or another goes through MD Anderson. So these guys have an amazing view of the landscape and it carries a lot of weight with us if one of these KOLs says this product is really interesting and I would click 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 that 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 an MD Anderson KOL and then all throughout the processes of us doing the IND-enabled studies and FDA interactions, this investigator is along with us for that ride and they are getting the clinical study ready. They are 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. And lots of times there's this I don't know unfortunate white space between IND clearance and like OK, cmc is already, manufacturing is already and off the clinic like OK, we've got to get CTAs in place and clear IRBs and all that kind of 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. And so 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 got to activation in less than 100 days, which is quite fast for an institution the size of MD Anderson.

Speaker 3: 12:51

And then the next thing that helps with the acceleration is just the volume of patients that MD Anderson sees that come through and the patients who are actually coming to MD Anderson to be on the latest, greatest clinical trial.

Speaker 3: 13:07

80% of the patients who are seen at MD Anderson are on a clinical trial. There are a few people getting standard of care and they think it's what they want. So 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 US, 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, and so 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 that 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 being so close to the staff, to the KOLs that you mentioned?

Speaker 2: 14:02

is there any interaction with actual patients that are being treated?

Speaker 3: 14:06

Yeah, of course we're very careful about the laws and keeping patient confidentiality in mind at all times and we have quite robust safeguards around that. But cell 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, and so they get very engaged in the process. Like OK, where are my cells? When am I getting them back?

Speaker 3: 14:44

And for several trials we actually deliver the final product right to the patient's room and they've been given some pre-infusion preparation for several days before that. So they're waiting there for their cells. Like we're in contact with the staff there and like I think it's going to be around four o'clock when we're going to come by as patients. Ok, when are they coming? And oftentimes they get very you know, ok, they're my cells. Lots of our guys get self-sacred with them Like hey, you're the guys who manufactured my cells, a lot of my cells, right before the infusion, right before we get in there and kick the cancer spot.

Speaker 2: 15:19

Yeah, like 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.

Speaker 3: 15:29

It's quite powerful. That kind of connectedness is why we wanted to create this. Connected with MD Anderson. Literally it's like 2,000 steps. You get too many steps on your watch bringing the product there because it's so close and that really keeps that connection. We don't load things on an airplane, we don't put things in a shipping truck or anything, just bring it right to the patients For subsequent trials. We have now, as we scaled up trials, expanded from just MD Anderson and Ken Rudd and support multi-center trials, and have been doing that for a few years now as well.

Speaker 2: 16:10

So you mentioned CTMC. It's a joint venture, so maybe can you just discuss the power of partnerships in biopharma development and what role they play in moving these drug concepts from ideation to commercialization.

Speaker 3: 16:26

Yeah, nobody can do therapeutic development on their own, and so it's so important to be very intentional about how you pick your partners and how you create interfaces with them and how you structure those relationships. So, 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, and a lot of what we do could be classified as services, and a lot of the CMO industry positions this as like feed for service. Here's a menu of things. You check off the boxes and you order what you want and then you pay us for a service. The problem with that model is that you can have misaligned incentives.

Speaker 3: 17:16

The biotech company is trying to get their product into patients as quickly and robustly as you can.

Speaker 3: 17:22

The service provider is trying to do a bunch of services. Some of those things overlap, but sometimes they don't, and when they don't, that causes delays and anger. So 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 a biotech 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 and for biotech companies as much cost certainty as we can, and so it's basically a fixed price offering that we put together and that we participate in some of the downstream revenues if the product is successful, and so that aligns us to work as quickly as we can to get the product data and realize that value, as well as gives a 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 timeline as people start negotiating over how much a particular change is going to cost them.

Speaker 2: 18:39

Right. So how do you envision cell therapy, or CTMC in particular, influencing the future of cancer treatment?

Speaker 3: 18:49

Humbly speaking, cell therapy has been a transform cancer treatment as well as how we treat other diseases. That's really over the last, I think, six months, maybe a little bit longer. We've seen some exciting results in autoimmunity and how a lot of CD9, car-ts 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 and is transformative in how healthcare is delivered. 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, and it only delays disease progression or creates stable disease or partial remission. What I think is exciting with cell therapy is that 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 up for 10 and 15 years. That changes all of how healthcare is administered.

Speaker 3: 20:12

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. You 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, give it to me second quarter next year. They produce it Like it's processed into bottles and then shipped to pharmacies and then doctors just prescribe it and it comes off the shelf to the patient.

Speaker 3: 21:08

Inherently in autologous cell therapy, these three entities are inexplicably linked in real time. That creates a different relationship that's needed, much more integrated relationship, because in real time the doctor is finding patients and shipping samples to the manufacturing site to produce those and getting them back to the clinic. I think overall it's going to sell therapy as such a high potential but 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. I think there's still a lot to be done in reimagining how we do this. If we want these therapies to reach their full potential for patients, we have to rethink how we do things.

Speaker 2: 21:54

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 Bio wishes you and your team at CTMC nothing but your success.

Speaker 3: 22:06

Thank you so much, rich, enjoy the conversation.

Speaker 1: 22:15

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