TC BioPharm (NASDAQ: TCBP) has received approval from the Research Ethics Committee and MHRA to start a clinical trial on OmnImmune, which treats Acute Myeloid Leukemia (AML). The drug is a cell therapy with expanded and activated gamma delay T cells.
Regulators have already given OmnImmune orphan designations to treat cancer of the bone marrow and blood. The company will begin Phase II/III clinical research on the drug at the beginning of 2022. Moreover, the study will start in the U.K and later reach the U.S.
According to TC BioPharm’s CEO, Bryan Kobel, the company is excited to get approval. The authorization has enabled the company to finish its protocol submission. It has also enabled the company to studies in its therapy.
The company reveals that the U.S Food and Drug Administration (FDA) has given it Orphan Drug Designation. It has also proved that it could conduct two separate trials in the U.S and the U.K.
Nobel adds that the company’s OmnImmune Phase IIa/IIb study results were positive, thus encouraging it to continue developing a therapy for AML.
The company develops treatments for viral infections and cancer
TC BioPharm discovers, develops, and commercializes therapies based on gamma-delta T cells for viral infections and cancer. Their treatments have shown more efficacy in treating AML.
The treatment consists of gamma-delta T cells which are found in the body. These T cells have characteristics of the adaptive and innate immune systems. Furthermore, they can differentiate healthy from diseased tissue.
The company utilizes an allogeneic method in CAR-modified and unmodified gamma-delta T-cells for identifying, targeting, and eradicating solid and liquid tumors. It is also prominent among companies that develop this type of therapy.
The company currently has two projects
In addition, TC BioPharm was the first to carry out significant phase II oncology clinical studies on ICH compliance. It is now carrying out two separate studies on its therapies.
The first trial is a Phase IIb/III OmnImmune study for AML, while the second is a Phase I study for ImmuniStim. The latter is for creating COVID-19 therapies and utilizes TC BioPharm’s CryoT technology, which will ensure the company can distribute the drug in its frozen form worldwide.
