TC BioPharm Begins Dosing Phase 2B Clinical Study Evaluating its Lead Compound, OmnImmune®, in Patients with Acute Myeloid Leukemia

Rhea-AI Summary

TC Biopharm has initiated the dosing of three patients in its Phase 2b clinical trial of OmnImmune®, targeting Acute Myeloid Leukemia (AML). This trial includes a safety cohort of five patients, with results expected by the end of 2022. Following this, the study will move to open enrollment in January 2023, aiming to enroll around 37 patients, including those with myelodysplastic syndromes. The trial represents a pivotal step in TC Biopharm's strategy to advance its innovative gamma-delta T cell therapies.

Positive

• Initiated dosing in Phase 2b clinical trial for OmnImmune® targeting AML.
• Five patient safety cohort to enable safe progression to open enrollment.
• Expected completion of safety cohort by end of 2022, with open enrollment targeting January 2023.

Negative

• None.

• 3 Patients Dosed in 5 Patient Safety Cohort

EDINBURGH, Scotland, Nov. 22, 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 today announced the dosing of its first three patients within its Phase 2b clinical trial of OmnImmune®, an allogeneic unmodified cell therapy focused on treating Acute Myeloid Leukemia (AML).

The initial 5 patients in the trial are deemed a "safety cohort", spaced two weeks apart with safety review by an oversight board to confirm no drug related toxicity issues, subsequent to 5 patients being dosed the study will advance to open enrollment. This safety cohort is in line with TCBP's step-wise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient.

"The launch of our Phase 2B trial is a key milestone in the development of our lead therapeutic, OmnImmune®, for patients with AML and for TC BioPharm's emerging pipeline of 'off-the-shelf' gamma-delta T cell therapies," said Bryan Kobel, CEO of TC BioPharm. "This study design includes a 5 patient safety cohort prior to open enrollment, we expect to complete the safety cohort before the end of 2022. 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 for efficacy, or we can elect to maintain our current dosing level of 7x10^7 or 700 million cells per dose. We look forward to moving ahead with our Phase 2b trial with a target for open enrollment in January 2023, as well as our efforts to expand our clinical efforts in the US in the first half of 2023."

TC BioPharm's Phase 2B trial, dubbed ACHIEVE, will enroll adults diagnosed with AML who have either relapsed or are refractory to prior treatments as well as a cohort for patients with myelodysplastic syndromes (MDS), conditions that can occur when the blood-forming cells in the bone marrow become abnormal.  The trial is expected to enroll approximately 37 patients.

About TC BioPharm (Holdings) PLC

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 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 gamma-delta T cell therapies, and the first company to conduct 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 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 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 Phase 2b trial for OmnImmune®?

The trial aims to evaluate the safety and efficacy of OmnImmune® in treating Acute Myeloid Leukemia (AML).

When will the open enrollment for the Phase 2b trial begin?

Open enrollment is expected to start in January 2023.

How many patients are planned to be enrolled in the Phase 2b trial?

Approximately 37 patients are expected to be enrolled in the trial.

What are the key milestones for TC Biopharm's trial in 2022?

Key milestones include completing the five-patient safety cohort and progressing to open enrollment by early 2023.