TC Biopharm (Holdings) Plc is a clinical-stage biopharmaceutical company, which engages in the development of novel immunotherapy products based on its proprietary allogeneic gamma delta T cell platform. The company was founded by Michael Leek and Angela Scott in 2013 and is headquartered in Motherwell, the United Kingdom.
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- Multiple pharmaceutical companies including Bavarian Nordic, BioNTech, and Moderna are advancing innovative monkeypox vaccines and treatments through clinical trials and regulatory approvals. - Bavarian Nordic's JYNNEOS vaccine provided broad coverage during the 2022-2023 outbreak, while the company seeks regulatory extension for adolescent use of IMVANEX. - mRNA-based vaccine candidates from Moderna (mRNA-1769) and BioNTech (BNT166a) are progressing through clinical trials to enhance immune responses against monkeypox. - Recent developments include TC BioPharm initiating preclinical studies for TCB 008 and preliminary results from NIH trials on SIGA's tecovirimat treatment.
- DelveInsight's analysis reveals a robust acute myeloid leukemia pipeline with over 100 companies actively developing 150+ therapeutic candidates across various clinical stages. - Recent regulatory milestones include FDA approval of KOMZIFTI (ziftomenib) for relapsed/refractory NPM1-mutated AML and priority review acceptance for revumenib, both representing first-in-class menin inhibitors. - The pipeline features diverse therapeutic approaches including targeted therapies like isocitrate dehydrogenase inhibitors, immunotherapies, and novel mechanisms of action addressing unmet medical needs in this aggressive blood cancer.
- TC Biopharm's OmnImmune is advancing through a pivotal Phase 2/3 trial for acute myeloid leukemia, representing one of the most advanced gamma delta T cell therapies globally. - The company's TCB008 candidate achieved complete molecular remission in a relapsed patient with detectable minimal residual disease after just two doses in the Phase 2 ACHIEVE trial. - More than 25 gamma delta T cell therapies are currently in clinical development worldwide, with the highest phase reaching Phase 2/3, though no therapies have achieved commercial availability as of June 2025. - The field remains predominantly focused on hematologic malignancies, with fewer programs targeting solid tumors due to complex tumor microenvironments and immune evasion mechanisms.
- Allogeneic "off-the-shelf" cell therapies are being developed to overcome the complex manufacturing and supply chain limitations of current autologous CAR-T treatments, which require 9-14 days to produce individualized therapies. - TC Biopharm's allogeneic gamma-delta T-cell platform has demonstrated lower-cost and efficacy data in acute lymphoblastic leukemia, with the ability to treat broader patient populations using healthy donor cells rather than compromised patient cells. - The cell and gene therapy pipeline includes 147 late-stage trials with multiple allogeneic approaches nearing commercialization, while the overall field shows 36% annual growth projected through 2030 with 10-20 new approvals expected yearly.
- TC BioPharm has signed a non-binding letter of intent to acquire a commercial-stage ophthalmic pharmaceutical company with an FDA-approved once-daily eye drop for glaucoma and ocular hypertension. - The all-stock acquisition will diversify TC BioPharm's portfolio beyond its gamma-delta T cell therapies for cancer, entering the glaucoma market projected to reach USD 12.69 billion by 2032. - The acquired company's product is currently being distributed to 300 physicians for sampling, with commercial launch and revenue generation expected in 2025.
- CareDx partners with TC BioPharm to perform pharmacokinetic analysis in the ACHIEVE clinical trial using its AlloCell solution. - The ACHIEVE trial is a Phase II study evaluating TCB008, an allogeneic gamma-delta T-cell therapy, for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS). - AlloCell will assess the expansion and persistence of TCB008, providing insights into its duration and effect on immune system reconstitution in AML patients. - The collaboration aims to advance allogeneic cell therapy and optimize TCB008 as a treatment for AML and other blood cancers.
- TC BioPharm's ACHIEVE Phase 2b trial evaluates TCB008 for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS/AML). - The trial's Cohort A, focusing on relapsed/refractory AML patients, has completed dosing with a favorable safety profile and some achieving stable disease. - Cohort B, involving patients in remission with minimal residual disease, has seen its first patient complete dosing, with recruitment ongoing. - Preliminary data from the ACHIEVE trial supports the positive safety profile of TCB008, with no drug-related adverse events reported.
- TC BioPharm has opened a new clinical trial site at Guys and St. Thomas Hospital in London to accelerate enrollment in the ACHIEVE study. - The ACHIEVE trial is a Phase II study evaluating TCB008, an allogeneic gamma-delta T cell therapy, for acute myeloid leukemia (AML) and MDS/AML patients. - Dr. Hugues de Lavallade, a hematologist with expertise in myeloid disorders, will serve as the Principal Investigator at the new site. - TC BioPharm anticipates data from the ACHIEVE clinical trial in the first half of 2025, with strong enrollment progress reported.
- TC BioPharm announced the first patient completed the full dosing regimen of TCB008 in the ACHIEVE Phase 2b trial without drug-related adverse events. - The ACHIEVE trial is evaluating TCB008's efficacy in patients with refractory or relapsed AML or MDS/AML. - Preliminary data suggests TCB008 is well-tolerated at the 5mL dose, supporting the trial's safety objectives. - The company anticipates releasing a full data set, including primary and secondary endpoints, in the first half of 2025.
- TC BioPharm is initiating preclinical studies for TCB008, an unmodified cell therapy, to treat Mpox, leveraging the role of gamma delta T-cells in viral infections. - TCB008, which contains activated and expanded gamma delta T cells, aims to prevent death, reduce viral infection duration, and potentially slow the spread of Mpox. - The company is also progressing with its ACHIEVE Phase 2b trial, evaluating TCB008 in AML or MDS/AML patients, and has secured a European patent for modified gamma delta cells. - TC BioPharm believes TCB008 could be a game-changing monotherapy for blood cancers, as reflected by strong enrollment and patient retention rates in the ACHIEVE Phase 2b trial.
