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

MWN-AI** Summary

TC BioPharm (Holdings) PLC, a biotech innovator specializing in gamma delta T cell therapies for cancer treatment, has reported encouraging results from its clinical trial. On June 11, 2025, the company announced that the first patient in Cohort B of its study, who was diagnosed with detectable Minimal Residual Disease (MRD), achieved complete molecular remission after receiving its lead drug candidate, TCB008. This significant milestone was reached following the patient’s second infusion of approximately 250 million gamma delta T cells, totaling 500 million administered over two weeks.

The patient, under the care of Dr. Hugues de Lavallade at Guy's and St. Thomas' NHS Foundation Trust, continues to be monitored and remains in remission two months post-treatment. This development is particularly critical as over 1 million individuals are diagnosed with blood cancers annually, often facing challenges with treatment options due to relapses after initial remission. Dr. Lavallade noted the importance of TCB008 in this context, especially for a patient who exhibited molecular relapse while on low-intensity chemotherapy.

Bryan Kobel, CEO of TC BioPharm, expressed optimism regarding TCB008’s potential role in improving long-term outcomes for blood cancer patients. He underscored the drug's capability to effectively address MRD, aiming to halt disease progression before recurrence. The company is pioneering the development of gamma delta T cell therapies, having launched pivotal clinical trials for acute myeloid leukemia treatment.

TC BioPharm’s advancements not only enhance hopes for improved survival but also aim to simplify treatment pathways for patients facing arduous procedures such as bone marrow transplants. The promising data from this trial reinforces the company’s commitment to targeting and eradicating cancer cells with precision.

MWN-AI** Analysis

TC BioPharm (NASDAQ: TCBP) recently announced a landmark achievement in its ongoing development of gamma delta T cell therapies, particularly with the lead candidate TCB008, which has shown promising results in a patient with Minimal Residual Disease (MRD). This milestone highlights the potential of TCB008 as an effective treatment avenue for patients with blood cancers who are often left with few viable options after initial therapies.

The achievement of complete molecular remission in the first patient from Cohort B is not just a clinical victory; it underscores the therapeutic promise of gamma delta T cells in addressing MRD—a prevalent issue that can lead to relapse post-remission. As the patient received just two doses of TCB008 and has maintained remission status for two months, this success could herald a new phase in cancer treatment, enhancing the company’s value proposition in a market characterized by significant unmet need.

Investors should carefully monitor TCBP's upcoming trials and patient data, particularly as it continues to explore the efficacy of TCB008 in various settings. The company's competitive edge lies in its innovative CryoTC technology, which allows for more accessible and widespread delivery of these therapies. Given that over one million blood cancer diagnoses occur annually, TC BioPharm may capture a crucial share of this market, especially if TCB008 can prove both effective and safer than existing therapies.

However, potential investors should also remain cognizant of inherent risks. As with any clinical-stage biotech, TCBP faces uncertainties related to trial outcomes, regulatory approvals, and broader market dynamics. Conducting thorough due diligence, considering both the promising developments and potential risks, will be essential for making informed investment decisions in this dynamic sector.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: PR Newswire

PR Newswire

  • 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.

SOURCE TC BioPharm

FAQ**

How does the complete response observed in the MRD patient treated with TCB008 enhance TC BioPharm (Holdings) plc TCBP's position in the competitive landscape of cancer treatments, particularly for blood cancers?

The complete response in the MRD patient treated with TCB008 enhances TC BioPharm's position by demonstrating the potential of their innovative therapies to effectively target challenging blood cancers, thereby differentiating them in a competitive market and attracting potential investors.

What are the next steps for TC BioPharm (Holdings) plc TCBP after achieving a complete molecular remission in this patient, and how will this impact the ongoing clinical trials for TCB008?

Following the complete molecular remission in the patient, TC BioPharm plans to advance its clinical trials for TCB008, potentially enhancing trial recruitment, validating treatment efficacy, and increasing investor confidence in its therapeutic potential.

Can you elaborate on how the mechanism of action of TCB008 contributes to its effectiveness in treating patients with Minimal Residual Disease (MRD) within TC BioPharm (Holdings) plc TCBP's clinical development strategy?

TCB008's mechanism of action targets specific cancer cells while sparing healthy tissues, enhancing immune response and effectively reducing Minimal Residual Disease (MRD), thereby aligning with TC BioPharm (Holdings) plc's clinical strategy to improve patient outcomes in oncology.

What potential implications does this complete response have for TC BioPharm (Holdings) plc TCBP's future collaborations with healthcare providers and researchers in oncology treatments for blood cancer patients?

The complete response may enhance TC BioPharm's credibility and attractiveness to healthcare providers and researchers, fostering collaborative opportunities that could advance oncology treatments for blood cancer patients and ultimately lead to innovative therapies.

**MWN-AI FAQ is based on asking OpenAI questions about TC BioPharm (Holdings) plc (NASDAQ: TCBP).

TC BioPharm (Holdings) plc

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