TC BioPharm Announces Successful Dosing of Final Patient in ACHIEVE Safety Cohort

Rhea-AI Summary

TC Biopharm (NASDAQ: TCBP, TCBPW) announced the completion of dosing its final patient in the safety cohort for the phase 2B trial of OmnImmune (TCB008) aimed at treating Acute Myeloid Leukemia (AML).

The trial transition from donor matching to a universal donor model is a significant advancement. The company anticipates a positive review from the Data Safety Monitoring Board (DSMB) in February, enabling open enrollment for 37 patients.

CEO Bryan Kobel expressed confidence in the trial's progress, highlighting recruitment success and upcoming interim reviews to assess dose levels, projecting significant market potential as the global AML market is expected to reach $2.6 billion by 2027.

Positive

• Completion of dosing for the safety cohort in phase 2B trial indicates progress.
• Transitioning to a universal donor model enhances patient recruitment and trial efficiency.
• Expecting a positive review from DSMB, paving the way for open enrollment.
• Strong market potential for AML treatments, with projected market size reaching $2.6 billion by 2027.

Negative

• Minor unforeseen delays reported during the trial, which could impact timelines.

Phase 2B Clinical Trial Evaluating Omnimmune^® in AML Patients

EDINBURGH, Scotland, Feb. 7, 2023 /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 official dosing of its final patient from the safety cohort for ACHIEVE, its phase 2B clinical trial of OmnImmune^® (TCB008) for treatment of Acute Myeloid Leukemia (AML).

TC BioPharm's trial involved administering TCB008, the Company's novel drug to treat AML, to pathologically confirmed diagnosed patients afflicted with this type of cancer. The initial 5 patients of the trial were spaced two weeks apart with safety review by an oversight board.

This safety cohort is in line with TCBP's stepwise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient. Pending the final review of the Data Safety Monitoring Board (DSMB), the Company will move to open enrolment of the trial, and expect a positive formal review from the DSMB in February.

"Completing dosing of the safety cohort is yet another step in our efforts and firmly plant TCBP as the leader in the allogeneic gamma delta space in regards to clinical data points and clinical stage," said Bryan Kobel, CEO of TC BioPharm. "I am extremely impressed with the effort of our clinical and operational teams, working collectively throughout the early stages of the trial to coordinate and successfully complete dosing our Safety Cohort. While we experienced minor unforeseen delays, as can be expected with trials involving very sick patients, we secured good visibility into positive levels of recruitment from our sites as we move towards open enrolment."

Kobel continued, "The next several months continue to be highlighted by various catalysts, including moving to our interim review to gauge our dosing levels of these patients. At the 19 patient review we will have the opportunity to increase the dose size for treatment based upon our review of the efficacy and the economies of scale. Additionally, we will be opening new sites to expand the reach of the trial and to increase recruitment success. We look forward to moving quickly to the next stages of this trial and continuing our leadership position and creating shareholder value."

The global market for AML is expected to reach $2.6 billion by 2027, growing at CAGR 15.2% over the forecast period, driven by introduction of high-priced products and strong pipeline of upcoming drugs. The Phase 2B clinical trial is ongoing and is expected to enroll approximately 37 patients. TC BioPharm will report additional results as they become available.

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 recent update regarding TCBP's clinical trial?

TCBP has successfully completed dosing the final patient in the safety cohort for its phase 2B trial of OmnImmune for AML treatment.

When will TCBP move to open enrollment for its trial?

TCBP expects to move to open enrollment following a positive review from the Data Safety Monitoring Board in February.

What market potential does the AML treatment have?

The global market for AML treatments is projected to reach $2.6 billion by 2027, growing at a CAGR of 15.2%.

What does the safety cohort in TCBP’s trial involve?

The safety cohort in TCBP's trial involved administering TCB008 to pathologically confirmed AML patients with a focus on safety evaluations.

What challenges has TCBP faced in its clinical trial?

TCBP reported minor unforeseen delays related to trial timelines, which are common in studies involving seriously ill patients.