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TC BioPharm (NASDAQ: TCBP ) is a clinical-stage cell therapy company focused on the development of treatments for infectious diseases, including allogeneic chimeric antigen receptor (CAR) T cell therapy products for the treatment of cancer. Founded in 2014 in Edinburg, Scotland, the company recently reorganized and refocused its efforts to gain US FDA approval for OmniImmune, an unmodified allogeneic gamma delta T cell product initially targeted for the treatment of Acute Myeloid Leukemia.
In an email conversation with AlphaStreetTC BioPharm CEO Bryan Kobel provided insight into the company’s clinical programs and future plans:
Can you explain the importance/differentiator of your platform allogenic Gamma Delta T-Cell Based Immunotherapy?
We are developing safer and cheaper products to target cancer and save more lives – especially allogeneic therapy as the future of cancer and infectious disease treatment. The main advantage of allogeneic products is their ability to be stored and delivered to the point of care, or in short, than products of patient origin. Also, and this is the crux for oncology patients, cancer suppresses your immune system and damages your system. So the allogeneic approach allows us to take healthy cells, activated cells ready to fight, from a healthy donor and give them to a sick/unhealthy patient at the right time.
OmniImmune based on the technology of our platform for allogenic therapy that allows us to create and bank donor T cells, which is different from the autologous approach that uses the patient’s own blood for T cells. The allogeneic gamma-delta T cell therapy platform that is being developed for cancer indications has allowed us to share data low-cost and scalable human efficacy in Acute Myeloid Leukemia (AML) with reduced dependence on patient fitness. In the nucleus, gamma-delta T cells become less powerful and less common when people are old, sick, or immunocompromised. Our ability to generate young, active gamma-delta T cells using donor blood allows us to provide billions of healthy gamma-delta T cell populations to infuse cancer patients.
Clinical development to date has allowed us to take a logical, safer, and more agile approach to clinical trials. By launching an autologous, unmodified delta gamma product, we can assess safety before entering the clinic in 2018 with an unmodified allogeneic product. Currently, our focus is the clinical development and refinement of products based on GDT vehicles that are compatible with our exclusive genetic CAR-T arsenal to fight various cancers.
How is the clinical program progressing in TCB-008?
The past three months have been incredibly exciting and we will soon be down some tracks towards the commercialization of cell therapy. Most important are the steps taken to refocus clinical strategies on US FDA trials OmniImmunealso known as TCB-008.
Over the last 12 months, we have established various research collaborations and strategic relationships, the majority of which are based in the US and are beginning to bear fruit. Another key element in this strategy is the addition of Bree Harlin to the management team as Chief Clinical Officer to lead the Global Clinical Division with a focus on managing US clinical trials. He joined the team from Loxo at Lilly, where he worked on the clinical development of targeted therapies for various types of solid and hematological cancers. He has worked in clinical development and operations in many therapeutic areas at large pharma and small biotech companies for most of his career beginning in academia working on clinical trials at Mass General and Brigham and Women’s Hospital.
With Bree on the team, in February, we announced the final patient dose of the phase 2B clinical trial OmniImmune. The TC BioPharm trial involved administering TCB-008 to patients diagnosed with safety review by the supervisory board. Completing the safety cohort dose is another step in our efforts and firmly establishes TCBP as a leader in the allogeneic gamma delta space.
Regarding your initiative in the future FDA trial for TCB-008, what are the different stages and tentative time for approval?
The pending protocol submission will be a Phase 1b safety trial, with a relatively small patient population and a short timeline to completion. The first step is to file an Investigational New Drug (IND) Application with the FDA, which we anticipate for the third quarter of 2023. This trial will likely be a dose-escalation trial consisting of 9-12 patients, a safety trial being conducted. hope will show indications of efficacy. The trial was a departure from the ACHIEVE trial in that we increased the dose significantly, the lowest dose was about 700m cells, and the highest was about 2.2 billion. We expect an additional IND to be filed in early 2024 as well.
The US trial priority aligns us with our long-term goal of becoming a leading commercial stage company, with multiple oncology treatment applications for TCB-008 both as monotherapy and as combination therapy. We are very confident in the potential of our assets and the best way to achieve company success is to initiate this proposed US trial protocol and pursue future trials through the FDA pathway. TC BioPharm expects this US clinical trial enrollment to be relatively fast as America offers more patients with more than 20,000 AML diagnoses per year. This transition will allow TC BioPharm to become more economically efficient by simplifying its strategy and reducing manufacturing and production efforts.
Can you tell us about the partner program you are working on?
We are now better positioned for short-term success and sustainability, including the potential to read major data in 2024 stemming from the partnership announced in January with the University of Texas MD Anderson Cancer Center. This is a valuable component of FDA testing. We are excited about the new collaboration as an opportunity to expand our knowledge base on how gamma-delta T cells work in the oncology setting. This collaboration combines MD Anderson’s clinical trial infrastructure and immunotherapy platform translational research expertise with TC BioPharm’s targeted gamma-delta cell oncology pipeline clinical data.
The goal is for the research team to work together in preclinical and clinical studies to evaluate the therapeutic potential of gamma-delta T cells and better understand the behavior of these cells in patients. Ultimately, the steering committee will drive the development of datasets and subsequent effectiveness assessments for each study. This is a remarkable combination of the comprehensive ability to discover detailed insights into the behavior of gamma-delta T cells and their corresponding responses in patients. We expect this to be a big part of what happens next with TCB-008 as well as helping us design targeted cancer studies in additional blood cancers.
Do you need external funding as your clinical program enters advanced stages?
External funding and cost savings are essential to get closer to the finish line. External funding will help us address the current market realities and macro challenges facing biotech companies, as well as our plans to protect TC BioPharm’s long-term sustainability and ensure our growth plans are properly capitalized. Earlier this month, we announced a restructuring for cost savings of more than $3 million annually. It is linked to focus on US clinical trials to help reduce cost structure and streamline operations. As we continue to raise external funding, TCBP will continue to consider additional cost savings programs and non-dilutive funding options as well as strategic collaborations and partnerships. Cancer is an expensive disease to treat, so it’s an expensive drug development process, but we see TCB-008 as potentially significantly reducing treatment costs.
External funding, realigning our resources, and organizational restructuring will help us focus on critical programs expected to improve patient lives and establish long-term value for our shareholders.
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