TCBP Announces First Patient Completed the Full Fose Regimen in ACHIEVE Clinical Trial

Rhea-AI Summary

TC BioPharm (NASDAQ: TCBP) has announced significant progress in its ACHIEVE Phase 2b clinical trial for TCB008, an allogeneic gamma-delta T cell therapy for cancer. The trial, focusing on patients with AML or MDS/AML, has reached a important milestone with the first patient completing the full dose regimen of approximately one billion cells. Importantly, no TCB008-related adverse events have been observed in any of the restart patients.

Key highlights include:

• 6 patients received a second dose
• 3 patients received a third dose
• 1 patient received a fourth dose
• 3 more patients expected to complete the full regimen by September's end

The company anticipates enrolling 24 patients in Cohort A and expects to announce a full data set, including primary and secondary endpoints, in the first half of 2025.

Positive

• First patient completed full dose regimen in ACHIEVE Phase 2b trial
• No TCB008-related adverse events observed in restart patients
• Preliminary safety data indicates 5mL dose of TCB008 is well tolerated
• Strong recruitment and enrollment at active trial sites

Negative

• Full efficacy data not available until first half of 2025
• Trial still in progress, final outcomes uncertain

Insights

Medical Research Analyst

The completion of the full dose regimen by the first patient in the ACHIEVE Phase 2b trial for TCB008 is a significant milestone for TC BioPharm. The absence of drug-related adverse events in restart patients is particularly noteworthy, suggesting a favorable safety profile for TCB008 at the increased dose level of approximately 1 billion cells.

The progression of multiple patients through the dosing schedule (6 receiving second dose, 3 receiving third dose and 1 completing all four doses) indicates consistent patient retention and trial adherence. This is important for accumulating comprehensive safety and efficacy data. The expected completion of full dosing for three more patients by September's end will further solidify the safety dataset.

However, it's important to note that while safety data is promising, efficacy data is still pending and will only be available after cohort completion and data cleaning, as per regulatory requirements. Investors should remain cautious and await the full data set, expected in the first half of 2025, for a complete assessment of TCB008's potential in treating AML and MDS/AML patients.

Financial Analyst

The positive safety profile of TCB008 in the ACHIEVE Phase 2b trial is encouraging for TC BioPharm's financial outlook. The absence of drug-related adverse events could potentially accelerate the trial process and reduce associated costs. Moreover, it may enhance the company's attractiveness to potential partners or investors.

The projected timeline for full data set release in H1 2025 provides a clear milestone for investors to anticipate. However, it's important to note that clinical success doesn't guarantee commercial success. The company's cash position and burn rate will be critical factors to monitor, as biotech firms often require substantial capital to bring products to market.

While the news is positive, investors should consider that TC BioPharm is still in the clinical stage and revenue generation is likely several years away. The stock may experience volatility based on trial updates, but long-term value will depend on successful completion of all trial phases and eventual market approval.

Oncology Doctor

The preliminary results from the ACHIEVE Phase 2b trial for TCB008 in AML and MDS/AML patients are promising from a clinical perspective. The tolerability of the 5mL dose, equivalent to approximately 1 billion cells, is particularly significant for this patient population, who often struggle with treatment-related toxicities.

The ability to administer multiple doses (up to 4) without drug-related adverse events is noteworthy, as it may allow for more sustained treatment effects. This could be especially beneficial in refractory or relapsed disease settings, where treatment options are

However, it's important to emphasize that while safety is important, efficacy remains the key determinant of clinical success. The upcoming data on primary and secondary endpoints will be critical in assessing TCB008's potential to improve outcomes in these challenging hematological malignancies. The strong recruitment and enrollment at active sites bode well for timely completion of the trial and comprehensive data collection.

• No TCB008-related Adverse Events seen in any of the re-start patients
• 6 Patients received second dose, 3 Patients received third dose, 1 Patient received fourth dose

EDINBURGH, Scotland, Sept. 12, 2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announces the first patient has completed the full dose regimen in the ACHIEVE Phase 2b trial ongoing in the UK with no drug related Adverse Events seen in any of the re start patients. As previously stated, patients are eligible to receive up to 4 total doses of TCB under the ACHIEVE protocol. Based on the amended dosing, this patient received approximately one billion cells in the TCB008 dosing regimen.

One patient in Cohort A has successfully completed the full dosing regimen having received all 4 doses. Preliminary safety data indicate the 5mL dose of  TCB008 is well tolerated, with no TCB008-related Adverse Events. These data outputs are indicative of TCB008's safety profile, in support of the ACHIEVE study safety objectives and endpoints. New patients will continue to be identified, screened, and enrolled into the study.

It's expected that a further three patients will have received their 4^th and final dose by the end of September. 14 patients in Cohort A are initially expected to receive TCB008 and, pending confirmation of primary endpoints, a further 10 patients will be recruited into the cohort for a total of 24 patients.

"We are extremely pleased to announce that the full dosing regimen is completed by the first patient to receive the increased dose of TCB008 under the ACHIEVE trial. Including the fully-dosed first patient in the ACHIEVE Phase 2b trial, we have observed no drug related Adverse Events in any of the restart patients," said Bryan Kobel, Chief Executive Officer of TC BioPharm. "This initial feedback speaks to the safety and tolerability of TCBP's drug. An additional three patients will receive their 4^th and final dose by the end of September. While we are able to see safety and tolerability in the immediate aftermath of dosing for ACHIEVE to update investors, the measurement for efficacy and the release of that data will be after completion of the cohort and the data clean per regulatory mandate. We are seeing strong recruitment and enrollment at our active sites and expect to be able to announce a full data set in the first half of 2025 inclusive of primary and secondary endpoints"

The ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with AML or MDS/AML, with either refractory or relapsed disease.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Company's intent or ability to affect any budget savings or execute on any M&A or capital raising strategy. These statements are based on management's current assumptions and are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. For other important factors that could cause actual results to differ materially from the forward-looking statements in this Current Report on Form 8-K, please see the risks and uncertainties identified under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, and our other reports filed with the SEC, all of which is available on the Company's Investor Relations website at www.tcbiopharm.com and on the SEC website at www.sec.gov. All forward-looking statements reflect the Company's beliefs and assumptions only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to update forward-looking statements to reflect future events or circumstances.

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 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 in treatment of acute myeloid leukemia using the Company's proprietary allogeneic CryoTC technology to provide frozen product to clinics worldwide.

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SOURCE TC BioPharm

FAQ

What is the current status of TC BioPharm's ACHIEVE clinical trial for TCB008?

The ACHIEVE Phase 2b clinical trial has reached a significant milestone with the first patient completing the full dose regimen of TCB008. Multiple patients have received second and third doses, with no TCB008-related adverse events observed in restart patients.

How many patients are expected to be enrolled in the TCBP ACHIEVE trial?

TC BioPharm (TCBP) expects to enroll 24 patients in Cohort A of the ACHIEVE trial. Initially, 14 patients will receive TCB008, and pending confirmation of primary endpoints, an additional 10 patients will be recruited.

When does TC BioPharm (TCBP) expect to release full data from the ACHIEVE trial?

TC BioPharm (TCBP) anticipates announcing a full data set, including primary and secondary endpoints, from the ACHIEVE trial in the first half of 2025.

What is the target patient group for TC BioPharm's TCB008 therapy in the ACHIEVE trial?

The ACHIEVE trial is targeting patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome/AML (MDS/AML), who have either refractory or relapsed disease.