TC BioPharm Announces Complete Response in Minimal Residual Disease (MRD) Patient

Rhea-AI Summary

TC BioPharm announced a significant clinical milestone as the first patient in Cohort B with Minimal Residual Disease (MRD) achieved complete molecular remission after receiving their lead drug candidate TCB008. The patient responded after two doses of 250 million gamma delta t-cells each, totaling 500 million cells over two weeks. The patient remains in remission two months post-treatment at Guy's and St. Thomas' NHS Foundation Trust. This breakthrough is particularly significant for blood cancer patients, as MRD often leads to relapse. TCB008 shows promise as a potential foundational component of post-remission therapy and as a monotherapy alternative to bone marrow transplants.

Positive

• First patient in Cohort B achieved complete molecular remission after only 2 doses of TCB008
• Patient maintains remission status two months after treatment
• TCB008 shows potential as an alternative to bone marrow transplants
• Treatment demonstrates rapid response with only 500 million gamma delta t-cells total
• Therapy shows promise for both post-remission and newly diagnosed patients

Negative

• Limited data from only one patient response
• Long-term durability of response still unknown
• Complete efficacy profile across broader patient population yet to be determined

Insights

Oncology Clinical Trial Specialist

TC BioPharm's gamma delta T cell therapy achieved complete remission in an MRD patient after just two doses, showing significant clinical promise.

This is a significant clinical milestone for TC BioPharm's lead candidate TCB008. The patient with Minimal Residual Disease (MRD) achieved complete molecular remission after receiving just two doses (totaling 500,000,000 gamma delta t-cells) over a two-week period. Most importantly, the patient remains in remission two months after treatment.

The clinical significance here cannot be overstated. MRD represents a critical challenge in blood cancer treatment - these are cancer cells that remain after initial treatment and frequently lead to relapse. The patient in question had experienced molecular relapse while on low-intensity chemotherapy, with rising NPM1 transcript levels (a molecular marker for leukemia) detected on repeated samples.

What's particularly impressive is that after just two of a possible four infusions of TCB008, the patient achieved complete molecular response with no detectable NPM1 transcripts. This suggests the therapy rapidly eliminated residual cancer cells that chemotherapy couldn't address.

The therapy's mechanism - using gamma delta T cells that can recognize and target cancer cells - appears to work exceptionally well in this MRD setting. This aligns with current understanding that targeting minimal disease burden often yields better results than treating advanced disease.

This data point, while from a single patient, provides proof-of-concept for TCB008 in MRD, potentially positioning it as a maintenance therapy to prevent relapse in blood cancers - a massive market given that over 1 million patients are diagnosed with blood cancers globally each year. If consistently effective, this approach could reduce reliance on more intensive treatments like bone marrow transplantation, significantly improving patient quality of life.

• First patient in Cohort B achieved CR after 2^nd dose of TCB008

EDINBURGH, Scotland, June 11, 2025 /PRNewswire/ -- TC BioPharm (Holdings) PLC (NASDAQ: TCBP), a clinical-stage biotechnology company pioneering gamma delta T cell therapies for the treatment of cancer, today announced the first patient treated in Cohort B, presenting with detectable Minimal Residual Disease (MRD), is now in complete molecular remission following treatment with the lead drug candidate TCB008.

The response was achieved after the patient's second dose of 250,000,000 gamma delta t-cells, two weeks after treatment began, in total the patient received approximately 500,000,000 gamma delta t-cells over two weeks. The patient received 2 of a possible 4 infusions of TCB008 and continues to be monitored under the care of Dr. Hugues de Lavallade at Guy's and St. Thomas' NHS Foundation Trust and remains in remission state two months after treatment.

This data readout represents a major milestone in TC BioPharm's mission to develop innovative cell therapies that target and eradicate malignant cells with precision and durability. Over 1 million patients are diagnosed with blood cancers globally each year. Patients who initially achieve remission can retain a molecular burden of disease that results in relapse. Multiple factors, including previous treatments, limit treatment options for relapsed patients.

'This patient experienced molecular relapse while continuing low-intensity chemotherapy," said Dr. Hugues de Lavallade, consultant hematologist at Guy's and St. Thomas' NHS Foundation Trust.  "NPM1 transcript levels detected the rising MRD on repeated samples, and chemotherapy was stopped. After two doses of the IMP, given post-lymphodepletion, the patient has now achieved a complete molecular response with no detectable NPM1 transcripts."

"This is an encouraging patient response, and our team is invigorated by this important step forward. We believe TCB008 has the potential to become a foundational component of post-remission therapy for patients with blood cancers, helping to extend survival and improve long-term outcomes, as well as newly diagnosed patients where TCB008 can potentially be impactful as a monotherapy to avoid an arduous bone marrow transplant process" said Bryan Kobel, CEO of TC BioPharm. "Treating MRD effectively halts disease progression before it has the chance to return, and TCB008's targeted immune activity continues to show great promise in this setting. This response to TCB008 heightens our focus on this patient population, where we believe the ability of the gamma deltas to rapidly overwhelm the cancer cells and bring about a high-grade patient response is value-enhancing and commercially impactful."

About TC BioPharm (Holdings) PLC
TC BioPharm is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing gamma-delta T-cell therapies for cancer treatment 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 the treatment of acute myeloid leukemia using the Company's proprietary allogeneic CryoTC technology to provide frozen product to clinics worldwide.

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.

 

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SOURCE TC BioPharm

FAQ

What results did TCBP announce for their TCB008 drug candidate?

TCBP announced that the first patient in Cohort B with Minimal Residual Disease achieved complete molecular remission after receiving two doses of TCB008, with remission maintained for two months post-treatment.

How many doses of TCB008 did the patient receive to achieve complete response?

The patient received 2 doses of 250 million gamma delta t-cells each, totaling 500 million cells over two weeks, out of a possible 4 infusions.

What is the potential market impact of TCB008 for TC BioPharm?

TCB008 could become a foundational component of post-remission therapy for blood cancer patients and potentially serve as a monotherapy alternative to bone marrow transplants.

How does TCB008 treatment work for blood cancer patients?

TCB008 uses gamma delta T cell therapy to target and eradicate malignant cells, particularly effective in treating Minimal Residual Disease (MRD) to prevent cancer recurrence.

What is the significance of treating MRD in blood cancer patients?

Treating MRD is crucial as it helps halt disease progression before cancer has a chance to return, potentially extending survival and improving long-term outcomes for patients.