TC BioPharm Receives MHRA and Research Ethics Committee Approvals to Initiate Phase 2B/3 Clinical Trials for the Treatment of Acute Myeloid Leukemia

Rhea-AI Summary

TC Biopharm announced that it has received MHRA and Research Ethics Committee approvals to begin clinical trials for its OmnImmune® therapy to treat Acute Myeloid Leukemia (AML). The Phase 2/3 trials are set to start enrollment in the first half of 2022 in the UK, with plans to expand into the US afterward. Previously, OmnImmune® received orphan drug designation from the FDA. CEO Bryan Kobel expressed enthusiasm about progressing with their proprietary therapy following promising Phase 1b/2a results. The company is focused on developing gamma-delta T cell therapies with a strong pipeline for future indications.

Positive

• Received MHRA and Research Ethics Committee approvals for OmnImmune® trials.
• Phase 2/3 trial enrollment expected in the first half of 2022.
• OmnImmune® has orphan drug designation from the FDA.
• Promising results from Phase 1b/2a trials bolster confidence in therapy.

Negative

• None.

• Trial enrollment expected to begin during the first half of 2022

EDINBURGH, Scotland, March 23, 2022 /PRNewswire/ -- TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, announced that it has received MHRA and Research Ethics Committee approvals to initiate gamma-delta T cell therapy clinical trials of OmnImmune® for the treatment of Acute Myeloid Leukemia (AML).

OmnImmune® an allogeneic unmodified cell therapy consisting of activated and expanded gamma delta T cells has already received orphan drug designation for the treatment of patients suffering from the blood and bone marrow cancer.  Phase 2/3 trials will begin enrollment in the first half of 2022 in the UK with expansion into the US following shortly thereafter.

"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," said Bryan Kobel, CEO of TC BioPharm.  "On the heels of announcing our Orphan Drug Dsignation 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 1b/2a clinical trials are encouraging and bolsters our belief in its potential as an effective therapy for Acute Myeloid Leukemia."

About TC BioPharm, Ltd.
TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer and viral infections with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue. TC BioPharm uses an allogeneic approach in both unmodified and CAR modified gamma delta t-cells to effectively identify, target and eradicate both liquid and solid tumors in cancer.

TC BioPharm is the leader in developing banked allogeneic gamma-delta T cell therapies, and the first company to conduct ICH compliant phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial for OmnImmune in treatment of acute myeloid leukemia and Phase I trial for ImmuniStim® in treatment of Covid patients using the Company's proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide. TC BioPharm also maintains a robust pipeline for future indications in solid tumors and other aggressive viral infections as well as a significant IP/patent portfolio in the use of CARs with gamma delta T-cells and owns our manufacturing facility to maintain cost and product quality controls.

Forward Looking Statements
This press release may contain statements of a forward-looking nature relating to future events. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions. These statements reflect our current beliefs, and a number of important factors could cause actual results to differ materially from those expressed in this press release. We undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise. The reference to the website of TC BioPharm has been provided as a convenience, and the information contained on such website is not incorporated by reference into this press release.

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SOURCE TC BioPharm

FAQ

What is the purpose of TC Biopharm's OmnImmune® clinical trials?

The trials aim to evaluate the effectiveness of OmnImmune® in treating Acute Myeloid Leukemia (AML).

When will the Phase 2/3 trials for OmnImmune® begin?

Enrollment for the Phase 2/3 trials is expected to begin in the first half of 2022.

What approvals has TC Biopharm received for its AML therapy?

TC Biopharm received approvals from the MHRA and Research Ethics Committee.

What previous designation has OmnImmune® received from the FDA?

OmnImmune® has received orphan drug designation from the FDA.

What are the next steps for TC Biopharm after receiving trial approvals?

The next steps include initiating enrollment for the Phase 2/3 trials in the UK, with plans to expand into the US.