BTI 65 | Cancer Therapy

 

Bryan Kobel decided to pursue a career in biotech after seeing its massive opportunities to change the world. He sits down with Ammon Rivera to share how he translated his background as an investment banker into his role as the CEO of TC BioPharm, a company that develops cancer therapy. He opens up about finding his purpose in this space that allows him to save lives and molds him into a compassionate leader. Bryan also talks about their allogenic Gamma Delta T Cell therapy platform, which involves injecting isolated Gamma Delta T Cells to treat cancer-stricken patients. He explains how they are continuously evolving this method to make it cost-effective and easily accessible to underserved and economically disadvantaged individuals.

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A Journey From Investment Banker To The CEO Of A Biotech Developing Cancer Therapy With Bryan Kobel

You will read about our guest who is Bryan Kobel, the CEO of TC BioPharm. Bryan has an interesting background as many of my guests do because I love interviewing people with interesting backgrounds. Bryan started in the investment banking space. Through some connections that he made there and getting involved in funding biotech companies, he got the opportunity to be the CEO of TC BioPharm. Let me tell you a little bit about TC BioPharm itself.

It is an early-stage biotech company that is publicly traded. They’re working on an “off-the-shelf” allogeneic gamma delta T cell platform. With this off-the-shelf platform, you are potentially looking at fewer side effects, treating more cancers, and working more efficiently. I will allow Bryan to give you a better explanation of the company and what it is they are working on. I’m giving you a quick rundown on it.

Their broad platform technology allows them to design specific therapies that treat a broad range of cancers and infectious diseases with their “off-the-shelf” allogeneic gamma delta T cell or GDT products. Unlike other CAR-T platforms, destructions of target cells are controlled by the innate killswitch augmented by parasympathetic transgenes for more effective targeting and armoring. Tolerance of tumor-targeted expressions allows for targeting tumor-associated antigens previously considered impossible.

Bryan gives a good explanation of this. I am looking at their website and trying to give you some detail on this. I would also encourage you to check out TCBioPharm.com. At their very early stage, we are talking about phase one that Bryan has announced. He announced $5 million in funding. That’s pretty exciting. We should see how this moves forward. Also, they do have some CAR-T programs that are solid in hematological malignancies, and those are in pre-clinical stages. It is undisclosed in terms of the programs at this point.

I love talking to Bryan. He is a great person to talk to. We have some interesting discussions on funding biotechs, which is also a topic that a lot of people will find interesting. Bryan and I have been kicking around the idea of doing some type of panel interview discussion with a few other individuals to discuss funding, venture capital, how to raise money, and all these things. I know there are a lot of early-stage individuals or people that are in the startup stages reading this.

With that being said, thank you again for being here. I do want to encourage each of you to please like, share, and subscribe. For those of you reading, I much appreciate if you leave a review that helps the show quite a bit. If you are on other platforms, for example, Google, or even Spotify, you can’t leave a written review of the show, but you can do a five-star or something like that. I appreciate that.

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We’ve got individuals that work on the scientific side of things, dealing with pre-clinical stage companies and all the way up through commercial. You can reach out to me. I tend to specialize more on the clinical side and drug safety, although I do recruit into clinical operations, clinical development, clinical QA, and regulatory. Reach out to me directly because I can still work with you and my team that can help you on other roles that I may not cover directly.

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Welcome to the show, Bryan Kobel.

I appreciate it. It’s great to be here. I’m excited to chat with you.

I’m excited too. For the audiences out there, you should know I had a great discussion with Bryan. Unfortunately, we had some audio issues when I went to pull his episode to post. We’re redoing that. What’s interesting is he and I had a chance to talk and discuss things in the past. We got a little more chemistry going on. That being said, let’s kick this off, Bryan. Tell us about your background. How did you end up in biotech?

I started my career on the capital market side of the business at a healthcare-focused investment bank, which is where I cut my teeth with micro-cap funding of these businesses, getting to know them, and advising them. I moved into investment banking. I was there for a while. Lastly, I was at EF Hutton as their de facto Head of Healthcare investment banking. I loved the opportunity. I helped these companies that were advancing these amazing technologies that had an opportunity to change the world, save lives, and do incredible things.

My personality is a little bit more OCD-extended where once I got to know these companies and got to know what their goals were, I had all these other things I wanted to help them do, whether that was expanding the clinical trial focus, whether that was bringing in other assets, or whether that was M&A type of scenarios and all these other advisory things.

That got me thinking about being a little bit more on the corporate side of things, leaving the dark, side and going to the light. It was fortuitous. The Founder of TC BioPharm, Dr. Mike Leek, who’s now our CTO called me up one day. We had a board call. They were a client at the time. He said, “This IPO process is best led by you. Don’t answer the question, but how do you feel about coming on as CEO of TC BioPharm?”

It was certainly a shock because Mike is an incredible person as is Angela Scott, our other Founder. He’s our COO. He has done incredible things. It also gave me a personal opportunity to dive in and get my hands dirty, as Mike would say, and have more of a day-to-day involvement on a corporate level. I had this opportunity to do well by doing good. This opportunity to help people while also having a purpose every single day and being paid a little bit of money has been a wild ride, but it has been one that I wouldn’t give up. It has been great.

I bet. There’s so much you’ve probably gone through and learned and so much knowledge you’ve gained in that process. I’m curious. Going back to your investment banking days, how did you end up in investment banking? From there, how did you end up working in the healthcare space? Do you think it was by chance that it happened?

I went to college. I created my major. I went to some tiny liberal arts college in the middle of Lancaster, Pennsylvania. To give you an idea, I took three different classes on Amish culture. If anybody wants to know about the Amish, I’m equally probably pretty close to being an expert in them as well. I came out of college. I didn’t know what I wanted to do. I studied political economics. The major’s basic was the encapsulation of political happenings and decisions in one country, how they affected the economies of others, and how economic collapses, for example, in Asia would affect political ramifications in Europe, the US, and North America.

It was a lot of fun, but it has nothing to do with what I do now. I was trying to figure out what I wanted to do. I got recruited to join an investor relations firm. There, we were exposed to a number of different companies in the small micro-cap space, technology, consumer-driven businesses, healthcare, and biotech. I was drawn to healthcare companies and biotech for a lot of different reasons. It’s not just this idea of being able to help people and what they’re doing, but initially, when you’re young, all you think about is, “How do I make money on this thing?”

To me, there seemed to be a pretty strong pattern. You can drill down and get an idea of management. You can build a good story around these companies. If you deliver the homework, you could start looking out at this pattern or this pathway relative to inflection points, what the market was going to do, and how the market rode those inflection points. It’s buying the rumor and selling the news type of stuff. I got fascinated with that. It’s a huge industry. From there, I started figuring out who are the investors in that space and whatever else and building up a Rolodex.

I weirdly enough ran into an old high school friend on the train. We’re going to New Jersey because another friend of mine lived out there. We started chatting, and he goes, “I’m a broker at this investment bank.” I said, “That’s cool. I know some of the guys there.” He said, “It’s a whole new thing. There’s new management. Why don’t you come in and meet with us?” He called me the next day, “Why don’t you meet us tonight at wherever the heck I am?” I went, met, and sat down with him and had a chat about ironically a mining company out of Nevada.

I got a phone call two days later from their Head of Capital Markets at the time. He said, “You’re not licensed yet. You haven’t ever been in this world and don’t know what your goals are here, but what would you think about coming to our capital markets as a partner and expanding our institutional sales process?” That was my entree into that capital markets world and equity sales, which then led me to investment banking. It was born early on out of this idea of a huge industry, in which you could see very clear patterns of trading and which was very definitive.

There are binomial trees. You can look at the average of a Phase 1 success versus a Phase 2 success versus a Phase 3 success. There are BLAs. There’s some version of value when you look at Phase 2 and license things out. It seemed like such an interesting space. The more you learned about it, the more it drags you down into the weeds of what’s the next evolution or what’s the next step.

Not to date myself, but those are the early days of immunotherapy. You started seeing this glimmer of hope around cell therapy and stem cells, and then you got into the CAR Ts and all those things. That was a fascinating time to be involved in healthcare despite my dad trying to scare me away by telling me a horrible story about biotech blowing up and then never returning his phone calls heading into a Phase 2 readout, but it was fortuitous. Biotech is a fascinating place. It’s always changing. There’s always fringe science that may or may not be a paradigm shift in how you treat patients.

On the flip side, when you’re public, there are all sorts of opportunities to reinvent yourself and create a brand-new world. That led me into the healthcare space. From there, it was about getting yourself and creating a monetization event, which for me was a Rolodex that I used in the capital markets desk. From there, you’re graduating up to investment banking to get a little bit more cerebral about how you structure things and how you create something out of nothing sometimes from an evaluation perspective and a funding perspective.

BTI 65 | Cancer Therapy

Cancer Therapy: Biotech is always changing. There is always a paradigm shift in patient treatment. And when you’re public, there all sorts of opportunities to reinvent yourself.

 

I find that an interesting topic. You use the term that you came from the dark side. That’s a loving term of an endearment joke. I see it as yin and yang. You can’t have one without the other. If you want to grow or bring a treatment to market, you need money to do that. There are the VCs and then investors and then at different stages your different types of ways of getting funding. You eventually went public. That’s interesting. One of the founders of TC BioPharm reached out to you and said, “Don’t answer, but would you consider being the CEO?” What would you say from your life in investment banking has translated into being the CEO of a biotech company now running clinical trials?

It’s interesting because you touched on it a little bit in your comment about the dark side. There is a lot you learn in that world of capital markets and investment banking that you can carry over into this role, especially when you get to later stages. Early on, for companies, it’s hard to have a finance type of person like me in that CEO role because there’s so much you have to know about the development of the asset and the molecule and so much of the science that needs to be wrapped into who you are, but once you get to later stages and move on to later life cycles as a biotech, it comes about a bunch of different things.

One, it becomes about managing people. That’s important to this job. You’ve got umpteen personalities. It’s a high-stress environment. It’s wrought with failure. We could do everything right, make all the right decisions, and solve all the complex problems that we’re working on every single day, and we still have upwards of a 95% chance of failure. That’s a pretty stressful environment, thinking that tomorrow something could happen, and you no longer exist as an asset or as a company.

You have to learn how to manage that stress among people. You have to be a very good communicator. You have to be clear and concise. That’s all part of the investment banking sales process, being able to take a very complex problem, distill it down, and communicate that directly to an investor in a short snippet. That’s effectively a call on his sales on a deal. The guy has got 30 seconds at the end of the phone. You got to get through to him and make sure he understands what you’re saying.

Biotech is a pretty stressful environment. Tomorrow, something unexpected could happen. Learn how to manage stress and be a good communicator. Share on X

That’s a real core to hear what we do, speaking to people at the company and his groups, “What are your problems? Let’s solve those problems. Here’s our strategic vision. Here’s what we’re going to do.” Communication is a core. It gets down to your point. How do you fund companies? How do I fund myself or our company without throwing the baby out with the bathwater? Every transaction can be positive and negative in the sense that you would be taking in new money, but putting yourself in a position to never have access to the capital again for the next 6, 12, to 18 months based upon what those terms are.

We’re avoiding all those pitfalls and understanding what is acceptable within a term sheet or funding, what is a non-starter, and what’s a gray area. All of that is valuable to us. It also helps that some of these investors we talked to have a preexisting history. They have done deals with us before. They understand how we think. There’s a little bit of a known factor there. The core here is understanding how to lead people in a positive manner and understanding how to communicate with them in a positive manner, which you have to do when you’re leading teams in investment banking.

It’s horribly long hours. You got 22-year-old kids, 23-year-old kids, and 24-year-old kids that are struggling and working for 18 hours and 20 hours. You have to keep them motivated. You have to understand when are you going to yell at them and when are you going to cajole them and tell them that they’re great. All that management process comes in.

How do you fund this business? How do you communicate with investors in a manner that you’re getting your point across, distilling it down appropriately, and being able to toggle up and down? As you start drilling into what’s more of the detail, you have to be well-versed enough to be able to answer a lot of those questions. An important piece of our puzzle as we start talking to investors is making sure that we’re giving them the full honest truth and telling them all the things that we know as best we can. That has enabled us to garner a substantial amount of funding in a nuclear biotech winter, frankly.

It’s a very interesting time that we have been in for a while here now, especially with biotech. I hear it every day as a recruiter. I’m an executive search headhunter. GQR has got a great reach and great delivery capabilities in terms of what we can do for our clients, but I hear it every day, “Such-and-such company is running out of money. They’re laying off X amount of their force or all of it.” The dark side of recruiting is we’re a vulture that swoops in, “We’ve got talent. We can take them somewhere else.”

It’s not just you that does that. I can tell you the number of emails I sent out to Magenta people or Jounce people. Mnemo went down and cut out a bunch of people. From my perspective, this gets back to a little bit of what you bring from the dark side, which is when things are in dire straits as they are now for biotech, this isn’t the time to start becoming a turtle and pulling your head into your shell. This is the time to start getting aggressive. What assets are out there that we can pull in here and get for frankly on the cheap? What employees are now without a job that we think might have high value to what we’re doing to help us advance our company?

BTI 65 | Cancer Therapy

Cancer Therapy: When things are in dire straits in biotech, do not become a turtle and pull your head into your shell. It is the time to start getting aggressive.

 

This is an interesting time because you’re seeing almost the antithesis of what has been biotech dogma for 30 to 40 years. You’re seeing companies go out and say, “We’re going to slim down to a single clinical trial, and that’s going to be our focus.” I’ve been doing this for twenty-some-odd years. I can’t remember a time when people weren’t saying multiple shots on goal. That’s how you de-risk. That’s how you manage your risk. We want companies with multiple shots on goal. We want platform companies. All of a sudden, you want one clinical trial. You’re going to bet all your eggs on that basket, knowing full well that your percentage chance of failure is exponentially high.

I understand the idea of extending cash one way because that’s part of this survival game, but I also don’t understand wanting to survive to the point of a single readout, knowing that is make-or-break, “Get a bad readout. See you later.” It’s a fascinating time because you’re seeing an opportunity if you can be bold as a company and as a management team to rebuild potentially a behemoth in whatever your focus is because there are going to be a lot of assets that are valuable, but that can’t be developed because of a lack of funding. There’s going to be a lot of great talent out there. You can build the next big Genentech.

It’s something for people to keep in mind. It’s a fascinating discussion to talk about. You and I have talked in the past about doing some type of panel interview where we could talk about funding biotechs. You were talking about the term sheets. I remember talking to some companies and hearing them make a comment, “We’re working on our funding. We got offers, but the terms aren’t favorable.” They’re trying to make that decision, “Do I take this now and stay alive? Do I find another way? If I take this, then I lose everything a few years from now.”

To your point about multiple shots on goal, I’m not in a biotech company. I don’t understand the scientific side of things, but I can understand the business side of things. That makes a lot of sense. If you are scaling down from a conservation mindset, “We could conserve what we have and keep things going,” then you also have to realize that your chance of this going somewhere could be fairly low. You have to have ways to pivot and move around.

You have to have real conviction. It also depends on when your readout is. Maybe people are betting, “It’s eighteen months until my next big readout. If I can extend my cash to that time, maybe the market has turned around, and I can pull in some capital in twelve months.” I don’t know everybody’s internal decision-making process, but this is an interesting space to be in and an interesting time. Terms are what they are at this point. It’s a buyer’s market. You have to make a decision on what’s palatable to you and what’s not. Can you take this money, survive, and then fix whatever you did to where you can still have exit matters for existing investors?

BTI 65 | Cancer Therapy

Cancer Therapy: Biotech is a buyer’s market. You need to make decisions based on what’s palatable to you or not.

 

It’s an unfortunate time, but companies have survived through difficult times and come out the other side. Actinium is a good example. They have survived. They have a Phase 3 readout for SIERRA, and they have hit it. Sandesh has been incredible in managing that process. I’m envious of him. I’m also trying to follow in his footsteps. There are tons of other companies that have been down that road. Anavex is another one. I haven’t looked at it recently, but at one point, they went from a penny stock to an almost billion-dollar valuation. There are examples of being able to survive those types of reinventions of your capital structure. We’re looking to be a part of this. It’s exciting.

It’s interesting you mentioned Actinium. I’ve done some work with them for recruiting. It was before GQR, but I’m sure other recruiting firms have as well. Let’s shift the conversation. I’m going to keep going in this direction. I like it, but let’s talk about TC BioPharm. What’s your allogeneic gamma-delta T cell therapy platform? Tell us a little bit about that.

Our allogeneic gamma-delta T cell started years ago. We ran an autologous trial in gamma-deltas. Gamma-deltas are between the innate and adaptive immune systems. They have unique methods of action in the sense that they’re your offensive linemen. They’re these behemoths. They react to a phosphoantigen called isopentenyl pyrophosphate or IPP. The hardest part of my job has been learning how to say isopentenyl pyrophosphate.

We ran the autologous trial. What ended up occurring effectively was because the gamma-deltas are such a small percentage of cells in your body and because these patients were immunosuppressed and immunocompromised, we weren’t getting activated big volumes of gamma-deltas that could proliferate. We were getting very inert cells. We can serve probably 1 in 10 patients or something like that.

We drew a line under that and said, “What’s the next step?” We developed an allogeneic platform, meaning we can take donor blood from a young and healthy 25-year-old. We isolate this gamma-delta T cell, expand it into the hundreds of millions, and then inject that into sick patients. What we’re getting now are highly activated, highly excitable, and healthy big-number gamma-deltas that we’re now putting back in the system to fight back against cancer.

BTI 65 | Cancer Therapy

Cancer Therapy: TC BioPharm developed an allergy genetic platform that injects highly activated and excitable Gamma Delta T Cells into the body of a cancer patient.

 

What we know is all tumors ever discovered in the study emit IPP. We started in blood cancers because the premise was it’s injecting our therapeutic directly into the tumor for blood cancers and specifically went after AML. What we saw in our first trial was effective in six patients, we saw two complete responses and an MLFS, which includes a morphologic leukemia-free state. The bone marrow started regenerating and creating a remission state for the patient. These are patients in palliative care.

The platform has proven that it’s efficacious and safe. We haven’t seen any drug-related serious adverse events, but it’s a bold step in cell therapy to say, “We don’t need the autologous patient decision.” There is a space for autologous for sure. It’s a small percentage of patients you can treat because those patients are immunosuppressed and immunocompromised. When you try to get healthy cells out of them, there’s going to be a small percentage that can proliferate and are active, maybe 20% of patients.

We’re looking at this from another angle and saying, “We want to be able to serve everybody. We want to serve the underserved and the economically disadvantaged because, at scale, we should have a relatively cost-effective solution.” We want to be able to do this at the point of care with a frozen-thawed product and deliver it immediately versus having a patient come in, get him frozen, ship his blood somewhere, create the product, and ship it back.

We want them to show up and have a doctor go, “You’ve got AML. Let’s immediately freeze-thaw and inject you with some gamma-deltas. Let’s start the process and keep being able to deliver that.” That’s a pie-in-the-sky dynamic. Maybe we never get there, but that’s what the promise of an allogeneic cell therapy is and for us, a promise of an allogeneic gamma-delta cell, knowing how aggressive that cell is and how reactive it is to existing tumors.

You’re seeing a real pull now, more so lately, of companies going into the gamma-delta space and having good success. There’s Lava Therapeutics and Imcheck. Both companies are trying to light the cold tumor hot to draw gamma-deltas in. Adicet and IN8Bio are both doing great things in different variants. We use the gamma-delta variant too. The gamma-delta is a bit of an orchestrator. One of the functions it has in the body is once it gets to a tumor, it will bring with it other immune responders. It brings with it the NK cells, the macrophages, and all the other parties to that tumor.

If we can find donors that we can build these cell banks for that are young, that have activated gamma-deltas, and that have a healthy immune system, then we can use that to bolster other people’s immune systems off the shelf like that. We can ship the product. It lands. It’s frozen. It’s at centers of excellence around the world, MD AndersonCity of Hope, and Dana-Farber.

When these patients present with blood cancers, they get an injection, and because of a lack of toxicity, you’re not going to have drug-on-drug interactions. You could give them any number of other treatments along the way. You’re talking about a seismic shift in the treatment of cancer using allogeneic cells. Gamma-deltas can slide into a number of different areas within the paradigm.

What is the biggest hurdle you think you face on that? You mentioned, “The off-the-shelf availability of this therapy is our vision.” What do you foresee as the biggest potential challenge of getting to that point?

That’s like asking me, “Which hurdle are you worried about in the 100-meter hurdle?” It’s all the hurdles. The most obvious is funding. Let’s put that to the side and say we’re a pie in the sky. This is fictitious. We’ve got unlimited cash. For us, there are a couple of big hurdles. One of them is regulatory. The regulators are putting in an ungodly amount of effort to try and get up to speed on cell therapy in general. You’ve got 1,200 active INDs at the FDA in cell therapy. In gene therapy, there are another 1,300. They hired 300 people, but people are also leaving CBER for higher-paying opportunities in the private sector.

They’re going to you.

I can’t afford them, but they’re going somewhere. Within the FDA versus the MHRA versus the EMA, they haven’t created any universal regulations. That makes it a little bit difficult to operate. I can give you a prime example. We’re filing our US IND in Q3 to launch an allogeneic gamma-delta trial in AML in the US. One of the hurdles we faced there was the donor hurdle, which is if I want to treat a patient in the US with donor blood and if I get them out of Europe, they’ve got to be effectively a needle in a sea of haystacks. There are all these crazy requirements that we have to meet.

They can’t be in Europe for a certain period. They can’t have certain CMVs and all these other things that would factor in that you wouldn’t need to worry about if it was a non-US donor and that you don’t worry about in Europe. That was difficult. We said, “We will get a US donor.” The UK government has the Human Tissue Authority or the HTA. The HTA stood up and said, “We think it’s unethical how the US compensates donors. You can’t ship blood in here if you compensate donors and buy a leukopak in a normal way.” That’s an interesting quandary that you have to figure out if you want cell therapy to proliferate other than me building places all over the world to manufacture their products.

You probably have to figure out some version of uniformity across these areas. That’s one issue that we face that we’re solving and have found ways to solve and been a little bit inventive around. Eventually, there are going to be some ply constraints. If there are a lot of cell therapy companies and we’re all buying leukopaks, at some point, there are only so many donors in the world. Commercial scale down the road becomes a question. I don’t know if we have to answer it yet, but something we think about a lot is campaign manufacturing and commercial scale. What does that mean? What’s the solution to that? Some of that is a technology-driven answer.

For cell therapy to proliferate places all over the world, experts have to figure out some version of uniformity across all of its areas. Share on X

If you look at the acceleration of technology and manufacturing of these cells over the last few years, it’s exponential. You will only see that accelerate over the next 3, 5, or 10 years to the point where some of our concerns about a commercial manufacturing process will be solved outside of our four walls, and we will sort it. CDMOs have accordioned out. Every day there’s a new CDMO popping up and saying, “I’ll sell you whatever cells you want.” It’s a little bit more specialized than that.

I do think you will see a contraction in that industry and a little bit more specialization. What benefits us is we make our products. We know we have a best-in-class gamma-delta allogeneic V2. We don’t have to go outside our four walls, but you hear horror stories of people going to a CDMO to buy gamma-deltas, alpha-betas, or NK cells, spending $500,000, getting a bad batch, and having to go back, buy another $500,000, and throw out what they bought. That’s a dynamic you can’t survive.

That’s a hurdle not necessarily for us, but for companies that are out there buying a product from somebody else. That can be a dangerous situation. The biggest concerns we have are making sure we’re communicating with the regulators, working with them, and getting ourselves in a good position. How do you get to a commercial scale once you’ve developed these assets to where they need to be? What does manufacturing look like for us and everybody else?

What stage of the process are you at now? Where are you with your pipeline in moving these clinical trials forward?

Ironically, the last time we spoke, we started the idea of dosing patients. We have completed our safety cohort from a dosing perspective. We have dosed the first five patients in our Phase 2B in the UK. We also have moved forward pretty substantively with a couple of different things. We announced our strategic collaboration with MD Anderson and the immunotherapy lab there. Jim Allison and Pad Sharma are wonderful and incredible. We have a joint steering committee. We’re excited to move to the US. We will file our US IND in Q3. MD Anderson is going to be the lead site there.

We believe the CI, as far as I know, is going to be Dr. Abhi Maiti, who’s amazing. There will be a couple of other sites around that. We have had some research collaborations that are moving forward with 3 or 4 different partners looking at our TCB008 in combination with their assets, whether that’s a bispecific antibody or a ligand pathway. We’re looking at 2024 having not just our monotherapy in the clinic, but we expect there to be an investigator-sponsored trial. We expect some fruit out of these research collaborations to equally be going into the clinic in 2024.

We continue to develop our CAR-modified gamma. Our target is B7-H3 with ovarian cancer as the indication within that CAR-modified. We have taken leaps and bounds in September 2022 since we last spoke, clinically being able to treat some patients. We’re weighing on the DSMB review as we speak and then additionally getting ourselves in a position to now expand into the US with multiple clinical trials and probably Europe as well with 1 or 2 since some of our partners are Europe-based.

How have you gone about patient recruitment? This question stems from a conversation I had with a clinical trial site owner I had interviewed on the YouTube channel. He also has a YouTube channel interestingly. We talked a lot about CROs because he deals with CROs quite heavily. His whole thing is, “Biotechs don’t need CROs.” We had this conversation. I’m curious. Do you rely on your CROs to help you recruit these patients? How have you gone about that?

We haven’t used CROs in our Phase 1Bs. We used the CRO in our Phase 2B, although not to recruit, interestingly enough. It was more for data management and things like that. We have a good relationship with our PI and CIs here in the UK. Emma Nicholson is our CI at Royal Marsden. Victoria Potter at KCL or King’s College London and then Anne Latif at Queen Elizabeth, which is around the corner from me in Glasgow, have all been incredible.

This might sound arrogant, but it’s easy to recruit patients when you’re able to articulate to that clinician the potential here for the gamma-delta and when you show them the Phase 1B data of palliative care patients responding the way they did. At the end of the day, clinicians want to help their patients. If you’re showing them a real potential path here to this patient having a quality of life and real life beyond what they’re expecting, they’re going to recruit for you and do a lot of work for you.

One of the things I was talking about earlier with an investor was this idea that it’s not an extension of life. That’s not what matters. That’s not what makes the gamma-delta and TCB008 impactful. It’s the extension of an actual life, not just an existence. If you’re extended to 6 to 9 months, but those 6 to 9 months are you laying in bed unable to move for 20 hours a day, getting injected with a bunch of things, and in pain, that’s existing. That’s not living.

What we’re providing people is an increased quality of life as well as an extension of life. They’re able to live their life, go out and play with their kid and their grandkids, and do all those things. We haven’t yet struggled with recruitment. A lot of that is the promise of TCB008. A lot of that is our relationship with our CIs and PIs. When we go to the US, we will probably use a CRO because you have to, but it comes down to being in a special space and being able to provide real benefits to these patients because that clinician then will do a lot of the work for you and the CRO, frankly.

BTI 65 | Cancer Therapy

Cancer Therapy: If your life is extended only for you to get injected with a bunch of things, that is not living. TC BioPharm helps people extend their lifespan while also achieving an increased quality of life.

 

It’s not that CROs are the devil. They provide an effort, but we’re also not a big fan of having a disconnect between us and our clinicians. We want to be in constant contact with them. We want to be communicating with them. That helps them want to help us. If you give a CRO that job, you’re outsourcing to some degree the core of who you are, which is the patient response. You’re seeing it as a clinical data sheet. You’re not seeing it as that clinician driving the value to it in the patients they’re seeing every single day and hearing in their voice the positives or negatives and all those things.

Recruitment a lot for us relative to patients gets to making sure that we’re doing everything we can to listen to and work with the principal investigators and chief investigators to make sure that their concerns are heard, that the protocols are put together appropriately, and that we’re meeting them in the middle and making sure that every week and every month, there’s a conversation, “How is recruitment going? What are you seeing?” We’re at the top of their mind.

I appreciate the time here. We’re near and close to the end of the time we set. I want to make sure we leave some time to talk about the final three questions I like to ask people. Let’s go ahead and shift the conversation to that. The first question is this. If you went back in time and gave yourself a piece of advice, what would that advice be?

Other than taking the red pill or the blue pill?

The red pill is the one that kicks you out of the matrix. The blue pill is, “Keep living the matrix. Enjoy it.”

It’s an interesting question. Early on in your life, you worry a lot about taking risks or making a decision. You tend to mull over it a lot and think, “If I fail at this, it’s the end of the world.” There are two quotes, one which I’ll butcher, but it’s from a great man, and one that I won’t butcher from a terrible movie. Winston Churchill at some point said something to the effect of, “Success is not final. Failure is not fatal.” You are going to fail. You’re going to make mistakes, but you should still make that decision.

Don’t think about the failure, what’s going to happen, and all the horrible things that could go wrong because things are going to go wrong no matter what you do, but if there’s an opportunity there that you can learn from it, go and do it. You will figure it out, pick yourself up, dust yourself off, and step forward. That gets to the terrible movie quote. Shia LaBeouf in Transformers opens the door, looks at Megan Fox, and says, “Don’t you want to look back in 50 years and say you had the guts to get in the car?” Get in the car. It will make your life better.

When you fail, things will go wrong no matter what you do. But if there’s an opportunity to learn from it, do it. Pick yourself, dust yourself off, and move forward. Share on X

Even if you fail, you will have taken that shot and you will find the next step. It will help you find your path. If you’re passionate about something, go for it. Even if you fail, it will be a win because you’ve been passionate about it. You want to live whatever you do. That’s an important lesson. If you love something and you want to give it a shot, go for it. Don’t worry about the failure. You will figure it out.

I like that. We all want to be successful and do certain things. I’ve put a lot into this show in the last few years, and I’m not where I want to be yet. There are certain things that I know that I need to do or things that I can do to make this more of a self-sustaining venture versus self-funding. I’m working on that. It’s interesting because I hit some pretty big snags on a few different things. One of the big things I learned from my personal situation is that I tend to try to do too much. I had these three big things that weren’t related to each other. I was self-funding everything.

Things shifted with some of my business. I had a drop in revenues and things like that. All of a sudden, it was like, “I can’t fund this out of my pocket anymore, but if I don’t find a way to fund it, it’s going to mess a lot of things up for me.” I’m working on it, but I’m saying that because it goes to what you’ve been talking about. Even if it’s a failure, it’s not final. It’s so cliché, but it’s not about how many times you get knocked down. It’s about how many times you get back up. It’s not about what happens. It’s about how you respond to what happens. It’s so true.

There are lessons in whatever happens where you look at that and go, “That venture failed, but those mistakes are valuable in whatever this next venture is that I do. I’ll learn not to make those mistakes.” It will lead you to something brand new that you hadn’t thought about. That’s an important piece of the puzzle. Nobody goes into a job and stays there or takes something, is there for the next 50 years, and retires. That never happens. Your average time at a job is less than five years. If that’s the case, you’re going to keep recycling. Chase what you’re passionate about. Get involved. Understand you’re probably going to fail, but you will learn from that, move on, and find something else that you’re passionate about.

You’re going to succeed.

Eventually, you will succeed.

That’s the thing. You’re going to either fail or succeed. Sometimes you’re going to fail at the moment but then still pull it out and succeed. If you don’t take the risk and you don’t risk the failure, then you also don’t risk the reward. I don’t remember what the percentages are in baseball. If you’re batting at 300 or something, you’re amazing. It’s 30% of 100%, and you’re amazing.

You’re in the Hall of Fame if you hit 300.

Let’s talk about books. I got some notes here from when you and I first originally talked. I wrote some books down, but I’m not going to say anything. I’m going to see if things have shifted with you. Are there any books that you recommend on life or business that you feel could be valuable for audiences?

Here are the three books that I recommend. Let’s see how close I got and if anything shifted. There’s More Money Than God, which is effectively a history of finance, the growth of hedge funds from the first hedge fund, all the people who changed it, the first guy who got into block trading, the first corporate raiders, and all that stuff. It’s a fascinating historical account of that.

I don’t know if I read Flesh Made New between when you and I met or if I recommended it yet. It’s a look at cell therapy, but everyone has written cell therapy books from the positive, “This thing is magical.” These guys looked at it from what were all the bad things that happened. There’s a guy who falsified data out of Japan. There was this idea that this chicken heart had lived forever, but it was all these other things. That was a fascinating book because they’re purporting and supporting the idea of cell therapy, but what they’re doing is looking at it from, “Something is great. It doesn’t mean that there weren’t missteps along the way.” Science can sometimes delay that.

You’ve seen in Alzheimer’s this idea of the plaque amyloid roundabout where everyone is chasing tau and amyloid. It was taken as dogma for years that it was what caused Alzheimer’s. Now, what you’re seeing is companies going, “It might be something else.” Two guys out of Australia proved that’s more of a symptom than an actual function of the disease or a cause of the disease. That stunted the development of Alzheimer’s treatment for years because people were afraid to veer from that.

This book shows you within cell therapy that same dynamic. It’s interesting because it emboldens people like us and our company to be willing to think outside the box and attack a problem from a different perspective. People are saying, “This is the only way to do it.” That doesn’t mean that you’re wrong. It means that maybe they’re rigid in their beliefs. There are a lot of reasons for that.

Be willing to think outside the box. Learn how to attack a problem from a different perspective. Share on X

I’ve been recommending Surrounded by Idiots by Thomas Erikson. It sounds pompous, but I assume I’m the idiot surrounding people. It’s about human behavior and how to effectively communicate with people both in business and life. That was something that I wanted to make sure I was fully functioning in as best I could, given it’s a big part of what I do now. That was a fascinating read. It’s a quick read too. It’s a pretty short book. I recommended Die Wise last time, which is also a great book but morbid.

I got Flesh Made New and More Money Than God. You mentioned that. Surrounded by Idiots is new. You mentioned Die Wise and threw out two others. I’m the same. I’m like, “There’s this book you asked me to recommend. I got ten that you should read.” You mentioned Den of Thieves and When Genius Failed.

Those are phenomenal books. When Genius Failed is about long-term capital management, which is a good overlay if you look at money, pouring things into systems, and what can happen when you have too much money and you overload systems. You see it in finance. We see it everywhere else too. You have to be able to read those signs.

Den of Thieves is a classic. Everybody should read that book. Anybody in finance should read that book. I remember when I first started a company. Back in the day, I shifted over from capital markets and joined a firm. The first thing I did was buy all the young kids that came into work for us Den of Thieves and told them to read it because it’s a cool history. It’s not always rosy, but it’s a great indoctrination into the world of finance.

I had this founder team on the show a few episodes back. They mentioned Barbarians at the Gate.

It’s a great book.

These are good. We touched on this at the beginning. I want to ask you a final question. This is a unique question to your situation. What would you say is one of the most important things you’ve learned since becoming the CEO of a small biotech?

That’s a thoughtful question. It’s hard to whittle it down to one lesson because you feel like you’re constantly evolving and learning in this role. Every day something happens unexpectedly, and you have to deal with it. What I’ve learned is you have to shift your mindset in this role. You can no longer be a hard-charging taskmaster yelling at people and demanding certain things from them. You have to hold them accountable. You have to have accountability in an organization, without question. You have to give people direction and purpose and have them understand that there’s a process here.

Everybody has to be rowing in the same direction. That’s how you get there, but you need to do it from a humble perspective. People think the chief executive officer is a general, and maybe he is. I’ve never been in the army. Maybe generals think this way too. Once you get to this role, you’re more of a servant. Your job is to make the company successful. The way you make the company successful is by making the individual and the teams successful. Your job is to give them goals and hold them accountable for those goals. Your job becomes supporting those teams and individuals so they can then reach those goals.

When they’re hitting problems, your door should be open so they can come to you and say, “I’ve got an issue.” We say, “How do we solve it? What are the next three steps?” You have to start thinking long-term and be able to communicate with your team and have them feel free to communicate with you and not be barked at. They have to understand that you’re there to help them. We’re here to make you successful and give you an opportunity to drive this company forward as a group.

If you do that, people will want to stay and make you successful. Ninety percent of people in biotech are there not for the money necessarily. They’re there because they want to be able to help humanity. They enjoy science and this altruistic idea of being a part of something that saves lives. If that’s their mindset, they want to feel supported. They want to feel the camaraderie. They want to feel like they’re part of this team that’s pulling forward in a positive and borderline philanthropic way.

You can’t come in and start cracking a whip, yelling at people, and making these crazy demands. You have to listen to them. You have to be able to support them. You have to give them whatever it is they need and whatever it is of yourself that can make them successful no matter the time of day, the hour, or what they’re struggling with. It can be personal or professional, but your job goes from being a taskmaster, especially when you’re in investment banking where you’re screaming at people all the time to being more of a compassionate leader.

I hope everybody at the company feels like I have their back, that I’m going to be supportive, and that they can come to me. I can try and solve their problems for them. That was an interesting lesson to learn. You can’t come in and start swinging your sword around. You have to come in and let them know that this is a chance for them to come to you and say, “I need these three things.”

It’s my job to get those three things, “Here’s your goal. Here’s where the company is going. Here’s our strategic focus. Here’s what I want to do. For each team, here are your five goals for the next twelve months. Tell me what you need. Let’s figure it out.” That was a tough lesson to learn and one that I’m still learning. I’m not an expert at it. There are days when I’m good at it and days I’m not, but that’s a shift in mindset that I’ve had to learn.

With that, thank you so much for being on the show, Bryan. I appreciate you coming back and giving me a second shot for this interview.

Let’s keep it going. I’m happy to chat anytime. I appreciate our conversations and your super insightful questions. I’m looking forward to hearing other companies talk about themselves soon.

Thank you.

Thanks. Take care.

 

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