TCBP Announces MHRA Acceptance of Amendment for ACHIEVE UK Trial

Rhea-AI Summary

TC BioPharm (NASDAQ: TCBP) receives MHRA clearance for dosing size increase and outpatient treatment in ACHIEVE trial for TCB-008 in Acute Myeloid Leukemia. The amendment allows for a dose increase to 12x10^7-23x10^7 gamma delta t-cells and patients to be treated as outpatients, impacting trial timing and FDA trial plans positively.

Medical Research Analyst

The acceptance of the amendment by the MHRA for TC BioPharm's clinical trial is a significant development in the progression of their lead product, TCB-008. This decision will likely expedite the trial process due to the shift from inpatient to outpatient procedures, potentially improving patient enrollment rates. The increase in dosing size may enhance the therapeutic effect, although it remains critical to monitor for any emerging safety concerns despite the current lack of such issues.

From a medical research perspective, the ability to administer higher doses of gamma delta T-cells could suggest a stronger immune response against Acute Myeloid Leukemia (AML), a severe cancer with limited treatment options. This approach aligns with the increasing interest in immunotherapy as a cancer treatment, where leveraging the body's immune system has shown promise in targeting and destroying cancer cells.

Healthcare Economist

TC BioPharm's amendment to conduct outpatient procedures instead of inpatient ones represents a strategic shift with economic implications. By reducing the need for overnight hospital stays, the company is likely to decrease the costs associated with the trial, which can be substantial in terms of bed occupancy and resource utilization. This change is particularly relevant given the current strain on healthcare systems like the NHS, where bed availability is a critical issue.

In the long term, if TCB-008 proves effective and safe, the outpatient model could set a precedent for cost-effective cancer treatment delivery. This could have a ripple effect on healthcare economics, potentially easing the financial burden on health services and improving access to innovative treatments for patients.

Market Research Analyst

The announcement by TC BioPharm may resonate positively within the investment community, as it reflects the company's ability to adapt and optimize clinical trial protocols. The ability to potentially accelerate the trial timeline and improve patient enrollment can be seen as a proactive measure to bring the product to market more swiftly. Moreover, aligning the dosing levels with the Investigational New Drug (IND) application for the U.S. FDA trials may streamline regulatory processes, which is often a critical factor in a biotech company's valuation.

Investors tend to look favorably upon companies that demonstrate operational efficiency and strategic regulatory alignment, as these factors can reduce time to market and increase the potential return on investment. The company's anticipation of using high-dose regimens across various settings suggests confidence in the scalability and versatility of TCB-008, which could be a key differentiator in a competitive oncology market.

• Increases dose level in line with Cohort 2 in IND
• Changes from "in patient" to "out patient" procedure

EDINBURGH, Scotland, Feb. 22, 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 announced that the MHRA has officially accepted its proposed amendment to the Company's clinical trial authorisation (CTA). The amendment allows for an increase in dosing size of TCB008 (unmodified expanded gamma delta T cell Lymphocytes) to 12x10^7-23x10^7 gamma delta t-cells.

Additionally the amendment allows for patients to be treated as "out patients", easing the burden on patients and lessening the burden on clinical sites as patients will not need to be monitored overnight after the first five patients are dosed. The ACHIEVE trial is a Phase 2b trial in Acute Myeloid Leukemia testing efficacy for TCBPs lead product TCB-008 (Omnimmune).

Medical and Healthcare Products Regulatory Agency (MHRA) is the UK regulatory authority, a government agency, for medicines and medical devices. The MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents.

Bryan Kobel, Chief Executive Officer of TC BioPharm stated, "Management is pleased to receive amendment clearance from the MHRA, this is yet another example of the team executing on plans we have laid out for the investment community. The changes to the protocol will substantially impact both the timing of data in the ACHIEVE trial as well as impacting the proposed FDA trial. Shifting to an out patient procedure means patients in the trial are not forced to spend a night in the hospital, increasing their quality of life in a difficult time, and also allows hospitals to not need to hold a bed for a patient in a time when beds are scarce in the NHS. We believe, after feedback from the clinical sites, that this was a material rate limiting concern in enrolment and are happy we can now provide them relief. Increasing the dose size, in accordance and discussion with our investigators, can increase the positive impact in patients with no safety concerns, furthering our stance that TCB-008 should be used in a myriad of settings at high doses. This step also aligns the dosing levels with the IND, where our second cohort would be receiving this dose, and gives us a window to approach the FDA with data at this level to potentially go immediately to dose level two in our US Phase 1b in relapse/refractory AML."

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 for OmnImmune^® 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

What is the purpose of the amendment accepted by MHRA for TC BioPharm (NASDAQ: TCBP) in the ACHIEVE trial?

The amendment allows for an increase in dosing size of TCB008 to 12x10^7-23x10^7 gamma delta t-cells and for patients to be treated as outpatients.

What trial phase is the ACHIEVE trial in for TC BioPharm (NASDAQ: TCBP)?

The ACHIEVE trial is a Phase 2b trial in Acute Myeloid Leukemia testing efficacy for TCBPs lead product TCB-008.

What is the role of the MHRA in the UK healthcare system?

The MHRA is the UK regulatory authority responsible for the regulation of medicines and medical devices used in healthcare.

How does the amendment impact patients and clinical sites in the ACHIEVE trial for TC BioPharm (NASDAQ: TCBP)?

The amendment allows patients to be treated as outpatients, reducing the burden on patients and clinical sites by not requiring overnight monitoring after dosing.

What is the significance of increasing the dosing size in the ACHIEVE trial for TC BioPharm (NASDAQ: TCBP)?

Increasing the dosing size can have a positive impact on patients with no safety concerns and aligns the dosing levels with the IND, potentially advancing to higher dose levels in future trials.