TC BioPharm (TCBP), is a clinical-stage biopharmaceutical company that is developing platform allogeneic gamma-delta T cell therapies for cancer treatment. Earlier this year, the Company became the only Scottish biotech listed on the Nasdaq.
TCBP CEO, Bryan Kobel attributes their success and growth to the amazing things done by incredible people, tireless, ferocious, and relentless scientists and operational experts at the Company. “They are TCBP, they make the Company what it is and are responsible for the growth and success of the Company every day,” he says.
Started Small, but Quickly Grew Big
Dr. Mike Leek and Angela Scott co-founded TC BioPharm in February of 2014. Dr. Leek is considered a “pioneer” in regenerative medicine, and in a career spanning 30 years, he has taken 10 different cell-based products from laboratory to clinic, while Angela has 37 years of experience in cell therapy production and regenerative medicine. She played a key role in creating the first animal clone, Dolly the Sheep in 1996, and she was also part of the team that clinically developed the first-in-man treatment for stroke in the UK.
During their travels following Dr. Leek’s exit from his previously founded company, Dr. Leek and Angela came to know that gamma delta T-cell was being used as a broad therapeutic in Asia. It piqued their interest, and soon they began working on a business plan around proprietary manufacturing and expansion processes.
“The Company is really derived from two cell therapy experts wanting to provide the world with an effective and non-toxic therapeutic for cancer. They believed in the cell, its innate function in the immune system as the first line of defense, and their personal expertise in creating a standardized therapy out of that cell which could help people,” says Bryan.
Starting with two co-founders, TC BioPharm increased its employee roster to 54 in January of 2018. It has now around 80 employees, and the Company has gone from the pre-clinical phase to having multiple clinics trials planned for the next 12 months. “This is all a credit to everyone at TCBP,” says Bryan.
Developing Therapeutics for Cancer Treatment
TC BioPharm develops therapeutics for cancer treatment by tapping into its allogeneic gamma-delta T cell platform. Bryan explains that they take donor-derived gamma deltas, the immune system’s first line of defense, and expand them into billions. After that, they infuse these billions of cells into cancer patients, which helps them fight the disease efficaciously and safely.
“Specifically, we’ve shown complete responses in relapsed/refractory Acute Myeloid Leukemia (AML), which means patients in palliative care, on death’s doorstep, responded to a remission state or better after one dose of our cell therapy, and saw no toxicity or adverse events” Bryan says.
These cells are the immune system’s “bouncer.” They sense, react, and kill sick or diseased cells, including all tumors ever discovered, as they respond to a specific phosphoantigen expressed by these cells called isopentenyl pyrophosphates (IPP). Healthy cells are not targeted by them because healthy cells do not emit IPP. This mechanism of action makes these cells potent to a number of cancers while also being non-toxic and safe for patients.
Bryan also points out that by using donor-derived cells, and because the company’s product is frozen/thawed, they can give sick patients the cells of a healthy immune system, reinforcing their immune system to fight. “And with our lead product OmnImmune, we don’t modify or edit the cell. As nature is undefeated, we just ask the cell to do what it does naturally,” he adds. “We make sure there’s an army of billions to overtake the disease, reinforcing the immune system with its innate killer cell.”
Setbacks Teach Lessons
Like almost all biotech companies, perseverance has been a part of TCBP’s journey – from the start to getting listing on the Nasdaq. “There were many hurdles to overcome,” Bryan says. “Mike and Angela have more stories on this front than I could even recount.”
The core challenge, which changed the direction and focus of the Company, was the initial trial that the team ran in tumors using an autologous approach. Kobel points out that the issue was not with the data they generated, as they saw responses in melanoma that were significant including the tumor shrinkage. They, however, realized that the autologous approach just was not going to work in cell therapy, both economically and functionally for patients.
“These are very sick patients in early trials, their immune systems are exhausted and suppressed, just beaten up really, and the cells act accordingly.” Bryan explains, “Imagine a boxer after 15 rounds of a prize fight, he is beaten up, one eye is swollen shut, and completely drained of energy, and then someone asks him to go another ten rounds! For us, that’s what the autologous approach was equivalent to. Maybe 1 in 10 patients we apheresed had enough activated cells to where we could expand them to the billions, and even then, these cells were inert.”
TCBP noted that not only was autologous not a viable product economically – it is costly due to the process and ancillary costs – but it was also limiting when attempting to treat large swaths of patients. The team felt TCBP was not giving the patient the best possible product. As the autologous approach resulted in many inert and “exhausted” cells due to the nature of the weakened systems of patients, it was not their best chance at a successful therapeutic course with that product, so the team at TCBP revamped their approach.
The Company had to find a way to get young, activated, healthy gamma deltas into the sickest patients, so they could be treated efficiently, economically, and effectively. Realizing that, Dr. Leek and Angela pivoted the business, and they developed the allogeneic manufacturing process and later Angela and her team in operations and development developed a frozen/thawed product.
Today, an autologous approach for patients takes weeks to deliver, and it is also not necessarily available to all patients due to how sick or diseased they are and other limiting factors. TCBP firmly believes that allogeneic is the path forward for patients, something seemingly echoed in the cell therapy community lately. “We can deliver our therapeutic at the point of care, within an expedited time frame, truly off the shelf,” Bryan says. “This is due to a combination of our universal cell bank technology, our expertise and ownership in our manufacturing process, and our team having moved OmnImmune to being frozen/thawed. Being frozen allows us to ship and store our therapeutic for an extended time and then, when needed, OmnImmune can be thawed and delivered to the patient rapidly.”
First Movers in Biotech Space
Innovation and integrity are pretty close to TCBP’s core values. And, at every turn, it seems the Company is “the first” to do whatever it is in the middle of doing. For example, first gamma delta cell therapy human trial, first allogeneic gamma delta product, first frozen/thawed gamma delta, and the list goes on and on.
Bryan thinks that they have introduced multiple innovative products largely because Mike and Angela instilled a maverick-type culture into TCBP. They encouraged people to not be afraid to challenge norms, not be afraid to take a chance and innovate, to pursue an idea even if it seems impossible and to push through boundaries of the norm as if they were not constrained. This even extends to social issues.
Angela is one of the very few female founders in STEM, 25 percent of the Company’s senior-level employees are female, and over 50 percent of its employees are female, which is rare in biotech and STEM. “Companies are trying to catch up from that perspective, so TCBP is an unheralded leader again, something that stretches back to our inception,” Bryan says.
“It’s truly remarkable to see what Mike and Angela have built, both from a cultural standpoint at TC BioPharm, as well as results that the company has delivered,” he adds.
Role and Responsibilities of CEO
In June of 2021, Bryan joined TCBP to take up the mantle of Chief Executive Officer and lead the Company through the IPO process and beyond as a public company. He has more than 15 years of experience in healthcare and life sciences, investment banking, and capital markets, and under his stewardship, the Company successfully listed on the Nasdaq in February of 2022. When Mike proposed to Bryan the idea of joining TC BioPharm, the culture of the Company and maverick style of Mike personally aligned well with his own values and personality. This made his move to the new company much smoother than expected.
“The core culture and values of the Company were already ingrained in me, they were already part of my personality. I didn’t have to adjust to the culture, and more importantly, the team at TCBP didn’t have to adjust to a new brand of values or vision,” Bryan says. “I think it’s probably something Mike saw in me and one of the reasons he felt comfortable with the transition.”
As CEO of TCBP, Bryan focuses on a number of strategic initiatives, communication strategies, clinical trial plans, and programs, empowering the team at TCBP, and making sure they are well-capitalized to fund their clinical trials and R&D efforts. As the Company recently completed its Initial Public Offering, or IPO, on the Nasdaq, Bryan has been lately focusing more on supporting the employees at TCBP with their projects and on strategic initiatives with medium and large pharma companies. “At the end of the day, I’m really here to make the rest of the teams at TCBP successful,” he says. “We have a number of exciting projects ongoing and my job is to ensure that our people have the resources and help they need to continue to do incredible things.”
The Company employs “extremely intelligent people” who work “unbelievably” hard. Bryan says that his job is to give them the tools and opportunities, and space to do their jobs to the best of their abilities. For example, if the Company’s clinical team needs to connect with a potential US clinical partner, Bryan does everything possible to ensure that it happens. If the R&D team needs additional capital for a project, he takes the lead to find that capital. “That’s really my main role and responsibility, hire smart people and let them do what we hired them, to do and make sure I help however I can in their endeavors,” Bryan says.
With him at helm, TCBP announced and completed its IPO. Bryan calls it “a seminal moment” in the biotech ecosystem of Scotland. “It was arduous, but we were able to complete our transaction in arguably the worst broad market for IPOs in a decade and one of the worst markets I can remember for biotech,” he says.
A true leader, Bryan credits his team, the value of the Company’s gamma delta platform, and bankers at EF Hutton for the successful IPO.
Health and Competition
TCBP is not competing against any company in the traditional sense, or rather the Company doesn’t view the market in those terms. It believes in rooting for all its competitors, as every company in the biotech space undertake herculean efforts to cure terrible diseases. “This is not easy work. It’s a lot of failure and few successes, after long hours of solving complex problems that end up not working many times despite all that effort,” Bryan says. “So, I don’t think we view it as competition so much as we see it as camaraderie.”
TCBP supports and cheers the successes of companies in the space. And it tries and stays connected to these other companies via conference attendance, market news organizations, and old-fashioned networking. “Certainly, glad many of these events are back after the Covid hiatus,” Bryan adds.
What Is Next?
The future of the company is predicated on generating results in its clinical trials. The Company intends to continue to advance its therapeutic in Acute Myeloid Leukemia, which showed incredible promise in a Phase 1b/2a trial in relapse/refractory patients. This time, Bryan says, they plan to do that as a second-line treatment, and look at other potential areas of expansion in AML. Additionally, the Company is looking at other blood cancers it might be able to treat with its therapeutic, presuming that if its product works in AML, it will work well in other blood cancers given the universal mechanism of action.
Bryan points out that they are also actively looking to move into solid tumors, both with their unmodified gamma delta product and also with a co-stimulatory CAR version. He explains that the co-stimulatory approach acts as an on/off switch for the CAR, which means that they can generate a CAR that kills only tumor cells and does not have on-site/off-tumor toxicity associated.
“It’s an exciting time for TCBP, we’re busy moving our product into multiple oncology indications, and it’s a testament to the team that we are primed for such success in 2022 and beyond,” says Bryan.