3 Patients Already Dosed In TC BioPharm's Phase 2b Trial Of A Cutting Edge T Cell Therapy For Hard-to-Treat Cancers

This week, TC BioPharm Holdings PLC TCBP, a clinical-stage biotech working on cutting-edge immunotherapies for some of the most difficult-to-treat cancers, announced that the first three patients in a Phase 2b trial of its lead drug candidate have been dosed. The Phase 2b trial represents the next step in bringing the company’s off-the-shelf T cell therapy, OmnImmune®, to the market. 

OmnImmune Uses Cutting-Edge T Cell Technology to Fight Cancer 

OmnImmune is a novel cell therapy that hopes to make immunotherapy effective for a wider range of cancers. Unlike other immunotherapies which use engineered T cells to target specific tumor-associated antigens, OmnImmune uses gamma delta T cells.

Rather than looking for a single antigen, these less specialized T cells look for signs of stress or abnormalities that are found across all cancers. Many researchers believe that a more generalized approach makes gamma delta T cells better equipped to target multiple cancers. 

That broader potential application paired with TC BioPharm’s development process means OmnImmune has the potential to become a much more affordable off-the-shelf cell therapy for cancer patients. While most cell therapies available right now are autologous, made from cells taken from the patient who will receive the treatment, OmnImmune is made from healthy donor cells. 

By using donor cells, TC BioPharm is better able to manufacture OmnImmune at scale rather than custom-creating the therapy using each individual patient’s own cells. Plus, thanks to the company’s banking and freezing process, OmnImmune has a shelf-life of up to 18 months, making it even more scalable. 

The Phase 2b Trial Moves Gamma Delta T Cell Therapy Closer to Market

The three patients who have been dosed are part of a five-patient safety cohort. Spaced two weeks apart, clinical researchers and an oversight board will review the safety and tolerability of OmnImmune in these initial patients to confirm that there aren’t any toxicity issues. 

After that, TC BioPharm can move on toward open enrollment for its Phase 2b trial. Dubbed ACHIEVE, the Phase 2b trial will ultimately enroll about 37 patients with either acute myeloid leukemia or myelodysplastic syndromes – a set of bone marrow cancers. 

After being treated with the allogeneic gamma-delta T cell therapy, patients will return for periodic follow-ups to measure their overall response rate, or the number of patients who achieve complete remission of their cancer.

That Phase 2b data will add to an already strong collection of preclinical and clinical data on the safety and efficacy of OmnImmune. Patients in earlier trials who received just one dose of the cell therapy saw cancer levels in their bones decrease from 38% to 6% on average, according to the company. 

“The next step in the study is a 19 patient interim review, which will allow TCBP to review dosing and increase dosing to a higher level should our team deem it necessary,” Bryan Kobel, CEO of TC BioPharm said in a statement on the news.

With plans to finish the safety cohort review before the end of 2022, TC BioPharm is targeting January 2023 for the start of open enrollment in the trial. That represents just one of many expanded clinical efforts planned for the first half of next year. 

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