TC Biopharm is set to begin the Phase IIb/III clinical trial of gamma-delta T cell therapy, OmnImmune, to treat acute myeloid leukaemia (AML).

The move comes after the UK Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee have granted approvals to commence the trials.

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Subject enrolment in the trial is anticipated to begin in the first half of this year in the UK and will be subsequently extended to the US.

An allogeneic unmodified cell therapy, OmnImmune comprises activated and extended gamma delta T cells.

The therapy previously obtained orphan drug designation from the US Food and Drug Administration to treat blood and bone marrow cancer patients. 

TC BioPharm CEO Bryan Kobel said: “We are extremely pleased to receive MHRA and Research Ethics approvals, which marks the final step in our protocol submission and commencing through the clinical trial process of our proprietary AML therapy. 

“On the heels of announcing our Orphan Drug Designation from the FDA, we have now further demonstrated our ability to run parallel processes for clinical trials in both the US and UK/EU. 

“The positive results demonstrated by OmnImmune in Phase Ib/IIa clinical trials are encouraging and bolsters our belief in its potential as an effective therapy for acute myeloid leukaemia.”

Naturally occurring immune cells, the gamma-delta T cells, possess traits of the innate, as well as adaptive immune systems. They can distinguish healthy tissues from diseased tissues. 

To detect, act on and destroy liquid and solid tumours, TC BioPharm leverages an allogeneic approach in unmodified and CAR-modified gamma-delta T cells.

Currently, the company is carrying out an investigator-initiated Phase I trial of an unmodified gamma-delta T cell product, ImmuniStim, to treat Covid-19.

In April 2019, TC BioPharm started a Phase I trial of new allogeneic cell therapy, TCB002, to treat AML.

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