TC BioPharm Holdings PLC (NASDAQ: TCBP)

TC BioPharm Holdings PLC (NASDAQ: TCBP) is a clinical-stage biopharmaceutical company pioneering the development and commercialization of gamma-delta T cell therapies for the treatment of cancer, with a particular focus on acute myeloid leukemia (AML). Gamma-delta T cells are unique immune cells that possess characteristics of both the innate and adaptive immune systems, allowing them to distinguish between healthy and diseased tissues. This dual capability makes them a powerful tool in the fight against cancer, and TC BioPharm is at the forefront of harnessing this potential to develop innovative therapeutics.

As the leader in gamma-delta T cell therapy development, TC BioPharm is the first company to advance to Phase II/pivotal clinical studies in oncology. The company is currently conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line, including a Phase 2b/3 pivotal trial for the treatment of acute myeloid leukemia. This trial utilizes TC BioPharm's proprietary allogeneic CryoTC technology, which enables the production and distribution of frozen gamma-delta T cell products to clinics worldwide, ensuring broader accessibility and consistency in treatment.

TC BioPharm's commitment to advancing gamma-delta T cell therapies reflects its broader mission to develop cutting-edge, immune-based treatments that address significant unmet medical needs in oncology. By leveraging the unique properties of gamma-delta T cells, the company aims to revolutionize cancer treatment and improve outcomes for patients with difficult-to-treat cancers like acute myeloid leukemia. With its pioneering approach and robust clinical pipeline, TC BioPharm is well-positioned to become a leader in the field of immuno-oncology.

TCB-008

TC BioPharm's lead candidate, TCB-008, is an innovative allogeneic gamma-delta T cell therapy currently being evaluated in the ACHIEVE UK clinical trial, a Phase II study targeting patients with acute myeloid leukemia (AML) or myelodysplastic syndromes progressing to AML (MDS/AML). The trial is designed to assess the efficacy and safety of TCB-008 in two distinct patient cohorts: those with relapsed/refractory disease and those in remission but with detectable residual disease. Recently, the trial advanced to a higher dose level, with the sixth patient receiving treatment under the amended protocol, which includes up to 230 million cells per dose—a significant increase from the previous 35 million cells. This dose escalation aligns with the medium dose cohort proposed for the company's FDA trial in AML, highlighting the company's commitment to optimizing treatment efficacy.

The ACHIEVE trial represents a critical milestone in TC BioPharm's development of TCB-008 as a potentially transformative therapy for AML. The ability to advance either cohort independently to a Phase III Pivotal Trial upon meeting primary efficacy endpoints underscores the trial's flexibility and the potential for rapid progression. With plans to enroll up to 24 patients in each cohort and interim data expected within the next six to nine months, TC BioPharm is likely to achieve key inflection points in 2024. The promising safety and efficacy data generated so far, combined with the company's strategic efforts to refine and escalate the dose of TCB-008, reinforce the candidate's potential as a monotherapy and support ongoing discussions for potential combination therapy partnerships.

Market Opportunity

From an investment perspective, TC BioPharm is uniquely positioned within the rapidly expanding field of immuno-oncology, a market projected to grow substantially in the coming years. The company's focus on gamma-delta T cell therapies, particularly in the treatment of acute myeloid leukemia (AML), sets it apart from competitors in the oncology space. As traditional cancer therapies continue to face challenges in terms of efficacy and patient tolerance, the novel approach of utilizing gamma-delta T cells offers a compelling alternative that could potentially capture significant market share. Investors looking for opportunities in breakthrough cancer therapies may find TC BioPharm's innovative platform and clinical progress highly attractive.

Additionally, the company's strategic use of its proprietary CryoTC technology, which facilitates the global distribution of its gamma-delta T cell products, positions TC BioPharm to scale rapidly upon successful clinical outcomes. This technology not only enhances the company's operational efficiency but also broadens its potential reach in the global oncology market, including in regions where access to advanced therapies is limited. With the oncology sector experiencing continuous demand for new and effective treatments, TC BioPharm's unique approach and scalable technology platform offer a promising investment opportunity with the potential for significant returns as the company progresses toward commercialization.

Leadership Team

Bryan Kobel is the Chief Executive Officer of TC BioPharm, having joined the company in June 2021. Before joining TC BioPharm, he held various senior positions in healthcare investment banking, including Managing Director roles at EF Hutton and the Alberleen Group, where he led deal origination and structuring across the healthcare and technology sectors. Mr. Kobel has a BA from Franklin & Marshall College and previously held several FINRA licenses, including Series 7, 63, 82, 79, and 24.

Martin Thorp has been a member of the Board of Directors of TC BioPharm since March 2016 and has served as the company's Chief Financial Officer since March 2019. He is the founder of Copernican Capital Partners Limited, a life science financial advisory firm, and has an extensive background in corporate finance, having been a partner and global managing partner at Arthur Andersen & Co. Martin holds a BA in business finance from the University of Kent and qualified as a Chartered Accountant in 1977. He served in various executive roles throughout his career, including co-founding NCL Technology Ventures, a life science advisory and investment firm.