This section highlights FDA-related milestones and regulatory updates for drugs developed by TC Biopharm (TCBP).
Over the past two years, TC Biopharm has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TCB, TCB008, and TCB-008. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TCB 008 - FDA Regulatory Timeline and Events
TCB 008 is a drug developed by TC Biopharm for the following indication: For Treatment of Monkey Pox.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TCB 008
- Announced Date:
- September 9, 2024
- Indication:
- For Treatment of Monkey Pox
Announcement
TC BioPharm announced that it intends to begin Proof of Concept preclinical studies for its lead therapeutic TCB 008, for treatment in monkey pox.
AI Summary
TC BioPharm announced plans to begin Proof of Concept preclinical studies for its lead therapeutic, TCB008, aimed at treating monkeypox. This new approach uses activated and expanded gamma delta T cells, which are a key part of the body’s immune response to viral infections. The company is looking to partner with renowned infectious disease centers or universities to speed up these studies and quickly advance the development process.
The research is part of a rapid-response effort to find effective treatments against aggressive viral infections such as monkeypox. By using a frozen/thawed product that can be delivered quickly, TC BioPharm hopes to prevent severe illness, reduce extended viral infection, and help contain outbreaks. This initiative could mark an important step forward in combating a global health emergency and open up significant new treatment opportunities.
Read Announcement
TCB008 - FDA Regulatory Timeline and Events
TCB008 is a drug developed by TC Biopharm for the following indication: In patients with AML or MDS/AML, with either refractory or relapsed disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TCB008
- Announced Date:
- June 11, 2025
- Indication:
- In patients with AML or MDS/AML, with either refractory or relapsed disease.
Announcement
TC BioPharm 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.
Read Announcement- Drug:
- TCB008
- Announced Date:
- February 13, 2025
- Indication:
- In patients with AML or MDS/AML, with either refractory or relapsed disease.
Announcement
TC BioPharm announced that it has concluded dosing of Cohort A patients in the ACHIEVE Phase 2B UK clinical trial.
AI Summary
TC BioPharm announced that it has completed dosing of Cohort A patients in the ACHIEVE Phase 2B UK clinical trial. This cohort included patients with relapsed or refractory acute myeloid leukemia who had limited treatment options. The early results show a strong safety profile with no drug-related adverse events, and several patients experienced stable disease after receiving multiple infusions of TCB008.
The positive initial findings have boosted the company’s confidence in the potential of TCB008. The results will help guide further clinical studies aimed at enhancing and prolonging the therapeutic effects. Enrollment for Cohort A has ended due to robust patient and investigator participation, while recruitment for Cohort B is still active, paving the way for additional research opportunities in the treatment strategy.
Read Announcement- Drug:
- TCB008
- Announced Date:
- February 10, 2025
- Indication:
- In patients with AML or MDS/AML, with either refractory or relapsed disease.
Announcement
TC BioPharm (Holdings) announced the first Cohort B patient in the ACHIEVE Phase 2B UK trial of TCB008 in Acute Myeloid Leukemia has completed the full dosing regimen.
AI Summary
TC BioPharm (Holdings) announced an important milestone in the ACHIEVE Phase 2B UK trial, where the first patient in Cohort B has completed the full dosing regimen of TCB008 for Acute Myeloid Leukemia. In this open-label trial, TCB008 is being tested for its safety and effectiveness in patients with AML and related conditions. Cohort B focuses on patients who have reached remission after previous treatment but still show a minimal residual disease. The patient received all four planned doses starting in October 2024 and is expected to receive an additional fifth dose. Early findings from the trial have shown no drug-related adverse events, including severe side effects like cytokine release syndrome and neurotoxicity. Recruitment for Cohort B, which began ahead of schedule in the fourth quarter of 2024, is progressing well with a second patient now enrolled.
Read Announcement- Drug:
- TCB008
- Announced Date:
- December 20, 2024
- Indication:
- In patients with AML or MDS/AML, with either refractory or relapsed disease.
Announcement
TC BioPharm announced 3 patients have now completed the full-dose regimen in the ACHIEVE Phase 2b trial in the UK with no drug-related Adverse Events seen in any of the restart patients.
AI Summary
TC BioPharm recently announced positive safety results from its ACHIEVE Phase 2b trial in the UK. The company reported that three patients have now completed the full-dose regimen, and importantly, none of these restart patients experienced any drug-related adverse events. This trial, which is focused on patients with acute myeloid leukemia or myelodysplastic syndrome/acute myeloid leukemia, is assessing the safety and potential effectiveness of TCB008. Initial findings show that the 5 mL dose of TCB008 is well tolerated, making the completion of the dosing regimen without safety issues an encouraging milestone for the study.
These safety results support further recruitment and ongoing data analysis for the ACHIEVE trial. TC BioPharm remains optimistic about TCB008’s potential to positively impact the treatment of serious blood disorders.
Read Announcement - Drug:
- TCB008
- Announced Date:
- December 4, 2024
- Indication:
- In patients with AML or MDS/AML, with either refractory or relapsed disease.
Announcement
TC BioPharm (Holdings) PLC announced an update on the progression of the ACHIEVE UK Trial.
AI Summary
TC BioPharm provided an update on the progression of the ACHIEVE UK Trial, reporting encouraging safety data for the TCB008 therapy. Over half of the Cohort A patients, who have advanced acute myeloid leukemia and unmet treatment needs, have received the experimental TCB008. Encouragingly, no serious adverse events have been linked to the current 5mL dose. Based on these positive safety signals, the company aims to explore higher doses, increasing from 230 million to up to 819 million Gamma Delta T-Cells, to establish the optimal biologically effective dose for these patients.
Meanwhile, recruitment of Cohort B patients continues at the current dose across four active clinical sites. TC BioPharm also plans to add at least two new UK sites in the first half of 2025, while simultaneously scaling up manufacturing to support improved delivery and increased production efficiency.
Read Announcement- Drug:
- TCB008
- Announced Date:
- September 12, 2024
- Indication:
- In patients with AML or MDS/AML, with either refractory or relapsed disease.
Announcement
TC BioPharm announces the first patient has completed the full dose regimen in the ACHIEVE Phase 2b trial ongoing in the UK with no drug related Adverse Events seen in any of the re start patients.
AI Summary
TC BioPharm announced that the first patient in the UK's ACHIEVE Phase 2b trial has successfully completed the full dosing regimen. The patient received all four intended doses, including an increased TCB008 dose of approximately one billion cells, with no drug-related adverse events observed in any of the re-start patients.
This positive safety outcome supports the company's belief in TCB008’s tolerability. The preliminary data shows that the 5mL dose of TCB008 is well-tolerated under the ACHIEVE protocol, which allows patients to receive up to four doses. Enrollment for the trial continues actively, with expectations that three additional patients will complete their full dose regimen by the end of September. Full data on efficacy and other endpoints will be released once the cohort is complete and the data is fully cleaned as per regulatory requirements.
Read Announcement- Drug:
- TCB008
- Announced Date:
- September 3, 2024
- Indication:
- In patients with AML or MDS/AML, with either refractory or relapsed disease.
Announcement
TC BioPharm announces dosing of 5 new patients in the ACHIEVE Phase 2b trial ongoing in the UK.
AI Summary
TC BioPharm announced that five new patients have been dosed in its ACHIEVE Phase 2b trial in the United Kingdom, now raising the number of patients treated at the higher dose level to six. Each patient receives a 5mL dose containing up to 230 million gamma-delta T cells, with a planned cumulative treatment of about one billion cells over four doses. The trial has already seen five patients receive their second dose and two receive their third, demonstrating progress in the study’s dosing cycle. This achievement builds on process improvements and protocol modifications made in late 2023 and early 2024, which the company believes have positively influenced patient re-dosing and retention. The ACHIEVE trial, which is an open-label Phase II study, is focused on evaluating TCB008 as a novel monotherapy in patients with blood cancers. Continuous patient enrollment and screening are part of the trial’s ongoing efforts.
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TCB-008 - FDA Regulatory Timeline and Events
TCB-008 is a drug developed by TC Biopharm for the following indication: Unmodified expanded gamma delta T cell Lymphocytes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TCB-008
- Announced Date:
- July 22, 2024
- Indication:
- Unmodified expanded gamma delta T cell Lymphocytes
Announcement
TC BioPharm nnounced that on July 16, the sixth patient in ACHIEVE (UK) was treated. This is the first patient treated with a higher dose of TCB-008 post the amendment approved by the MHRA on Feb 22, 2024.
AI Summary
TC BioPharm announced a significant update in its ACHIEVE (UK) clinical trial. On July 16, the sixth patient was treated, marking the first time a higher dose of TCB-008 has been used following the MHRA amendment approved on February 22, 2024. This milestone highlights the trial’s shift to a new dosing strategy to further assess the treatment’s safety and effectiveness.
The ACHIEVE trial is an open-label Phase II study targeting patients with acute myeloid leukemia (AML) or myelodysplastic syndrome/AML who have relapsed or are refractory to current treatments. Previously, five patients in the safety cohort were treated with a lower dose, with no drug-related serious adverse events reported. With the move to a higher dose, TC BioPharm plans to enroll more patients as it progresses toward subsequent Phase III studies.
Read Announcement
