TC BioPharm (Holdings) Stock Price, News & Analysis

TC BioPharm (Holdings) PLC (symbol: TCBP) is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of gamma-delta T cell therapies for the treatment of cancer and other indications. According to the company’s disclosures, its research and development work has generated human efficacy data in acute myeloid leukemia (AML), positioning gamma-delta T cells as a potential therapeutic option in blood cancers where patients often face limited treatment choices.

Gamma-delta T cells are described by TC BioPharm as naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue. This dual nature underpins the company’s approach to targeting malignant cells while aiming to preserve healthy tissue. TC BioPharm characterizes itself as a leader in developing gamma-delta T cell therapies and notes that it is the first company to conduct phase II/pivotal clinical studies in oncology using this cell type.

Core therapeutic focus and lead candidate TCB008

The company’s lead therapeutic candidate is TCB008, an allogeneic, unmodified cell therapy made up of activated and expanded gamma-delta T cells. TC BioPharm reports that TCB008 is being evaluated in patients with AML and myelodysplastic syndromes with AML features (MDS/AML), including those with refractory or relapsed disease and those with minimal residual disease (MRD) after prior therapy. The company highlights human efficacy data in AML, including patients attaining stable disease and a reported complete molecular remission in at least one MRD patient following dosing with TCB008.

TCB008 is being studied as a monotherapy in blood cancers, with TC BioPharm indicating its potential role in post-remission therapy and as a possible bridge to transplant or in combination approaches. The company also notes its intention to explore TCB008 in infectious disease indications, including planned proof-of-concept preclinical studies in H5N1 (avian “bird flu”), reflecting a broader view of gamma-delta T cell applications beyond oncology.

ACHIEVE clinical program and gamma-delta platform

TC BioPharm is conducting the ACHIEVE Phase II UK clinical trial, described as an open-label study designed to evaluate the efficacy and safety of TCB008 in AML and MDS/AML. The trial includes multiple cohorts:

• Cohort A: Patients with relapse or refractory AML who were ineligible for, or had exhausted, available therapies, unable to achieve remission or who relapsed after remission.
• Cohort B: Patients who have achieved remission following previous treatment but continue to have detectable minimal residual disease (MRD).

TC BioPharm reports that Cohort A dosing at higher cumulative doses of gamma-delta T cells has been completed, with no drug-related adverse events observed and preliminary evidence of stable disease in several patients after multiple infusions of TCB008. For Cohort B, the company has disclosed that the first patient completed the full planned dosing regimen and that another MRD patient achieved complete molecular remission after two doses of TCB008, remaining in remission at subsequent follow-up.

The ACHIEVE study’s safety objectives include grading adverse events and monitoring for cytokine release syndrome and neurotoxicity. Preliminary data described by the company indicate no drug-related adverse events following cumulative infusions containing up to approximately one billion gamma-delta T cells, supporting what the company characterizes as a favorable safety profile for TCB008 in this setting.

Allogeneic CryoTC technology and clinical trial framework

Beyond the ACHIEVE study, TC BioPharm states that it is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line. These include a Phase 2b/3 pivotal trial in the treatment of acute myeloid leukemia using the company’s proprietary allogeneic CryoTC technology, which is intended to provide frozen gamma-delta T cell product to clinics worldwide. This approach is designed to support off-the-shelf administration of allogeneic gamma-delta T cells, enabling centralized manufacture and distribution to multiple clinical sites.

The company describes its gamma-delta T cell platform as a foundation for a range of indications, noting applications in oncology and expressing intent to expand into infectious disease indications. By emphasizing allogeneic, unmodified gamma-delta T cells, TC BioPharm’s stated strategy is to harness the intrinsic disease-recognition properties of these cells without genetic modification, while using manufacturing and cryopreservation technologies to scale clinical use.

Strategic developments and operational model

TC BioPharm has disclosed several strategic and operational steps related to its clinical and corporate development. The company announced initiatives to move toward a contract development and manufacturing organization (CDMO) model for production, with the goal of accommodating larger production demand for future clinical trials. As part of this shift, the company is reviewing alternatives for new manufacturing facilities that incorporate automated and other cell therapy production technologies, and it is evaluating alternative approaches for testing and clinical needs aligned with a more decentralized drug development model.

These initiatives include a reduction in workforce, particularly within production and quality divisions, as the company transitions to an outsourced production framework. TC BioPharm characterizes this as part of a strategic developmental plan intended to create a leaner organization and to adjust its cost structure while preparing for expanded clinical activity and new indication verticals.

Planned expansion into ophthalmology through acquisition

TC BioPharm has announced the execution of a non-binding letter of intent to acquire a commercial-stage ophthalmic pharmaceutical company focused on therapies to decrease intraocular pressure in patients with glaucoma and ocular hypertension. According to the announcement, the acquisition candidate has an FDA-approved once-per-day eye drop to reduce intraocular pressure and a pipeline of development-stage ophthalmology assets. The proposed transaction is structured as an all-stock acquisition of 100% of the target company, and is described by TC BioPharm as part of its M&A strategy to expand its therapeutic platform into new indications and bring in later-stage assets.

The company states that the potential subsidiary’s lead therapeutic is a prescription eye drop used to treat glaucoma and ocular hypertension, and that the acquisition is intended to diversify and de-risk TC BioPharm’s platform by adding a commercial-stage product and additional development assets in ophthalmology. The company’s description of this plan emphasizes its interest in indications in underserved markets and in assets that may provide nearer-term value inflection points compared with early-stage oncology programs alone.

Infectious disease initiatives and H5N1 focus

In addition to oncology and the proposed ophthalmology expansion, TC BioPharm has announced its intention to initiate proof-of-concept preclinical studies for TCB008 in H5N1 (avian “bird flu”). The company notes that H5N1 is a viral infection often contracted through contact with sick birds and that it can be transmitted from person to person, with symptoms that may resemble common influenza but with potentially high mortality in humans.

TC BioPharm indicates that, due to the highly infectious nature of H5N1, its goal is to partner with a leading infectious disease center or university to advance proof-of-concept and preclinical studies that could support a future Phase I study. The company links this initiative to its broader view that TCB008, as a gamma-delta T cell therapy, may have applications across multiple diseases and infections because of its role within the immune system.

Trading status and capital markets actions

TC BioPharm’s securities have been listed on The Nasdaq Stock Market under the symbol TCBP. The company has reported that it received notice from a Nasdaq Hearings Panel of a determination to delist the company’s securities from Nasdaq due to non-compliance with Nasdaq Listing Rule 5550(a)(2), which requires a minimum bid price of $1.00 per share. The company has stated that trading of its securities on Nasdaq is scheduled to be suspended and that it expects its American Depositary Shares (ADSs) to be eligible to trade on the OTC Markets. TC BioPharm has also indicated that this transition does not change its obligation to file annual and certain other reports with the U.S. Securities and Exchange Commission under applicable federal securities laws.

Separately, TC BioPharm has announced an ADS ratio change, adjusting the ratio of its ADSs to ordinary shares from one ADS representing two hundred ordinary shares to one ADS representing four thousand ordinary shares. The company explains that this has the same effect as a 1-for-20 reverse ADS split for ADS holders, without impacting the number of underlying ordinary shares. Existing ADS holders are required to surrender and exchange every twenty ADSs for one new ADS, with fractional entitlements aggregated and sold by the depositary bank, and net cash proceeds distributed to applicable holders.

Position within gamma-delta T cell therapeutics

Throughout its public communications, TC BioPharm consistently describes itself as a leader in developing gamma-delta T cell therapies and notes that it is the first company to conduct phase II/pivotal clinical studies in oncology using gamma-delta T cells. The company’s platform centers on allogeneic, unmodified gamma-delta T cells, with a focus on AML and related hematologic malignancies, MRD settings, and potential expansion into infectious diseases.

By combining clinical-stage oncology programs, planned infectious disease studies, and a proposed acquisition in ophthalmology, TC BioPharm presents itself as building a therapeutics platform that spans multiple indications while remaining grounded in its core expertise in gamma-delta T cell biology and cell therapy development.

FAQs about TC BioPharm (TCBP)