TCBP Advances ACHIEVE Phase 2b Clinical Trial with Final Dosing of 3 Patients
TC BioPharm (NASDAQ: TCBP) reported progress in its ACHIEVE Phase 2b clinical trial, with 3 patients completing the full-dose regimen without drug-related adverse events. The trial evaluates TCB008 in patients with AML or MDS/AML. Current enrollment status: 10 patients received first dose, 9 second dose, 4 third dose, and 3 completed all four doses. Nine patients are in Cohort A (relapsed/refractory patients), and one in Cohort B (remission with detectable residual disease). The trial aims to recruit 14 patients initially in each cohort, with potential for 10 more per cohort, totaling 48 patients. The 5mL TCB008 dose shows good tolerability with no drug-related adverse events.
TC BioPharm (NASDAQ: TCBP) ha riportato progressi nel suo studio clinico di fase 2b denominato ACHIEVE, con 3 pazienti che hanno completato il regime di dose completa senza eventi avversi correlati ai farmaci. Lo studio valuta TCB008 in pazienti con AML o MDS/AML. Stato attuale delle iscrizioni: 10 pazienti hanno ricevuto la prima dose, 9 la seconda dose, 4 la terza dose e 3 hanno completato tutte e quattro le dosi. Nove pazienti fanno parte del Coorte A (pazienti in recrudescenza/rifrazione), e uno è nel Coorte B (remissione con malattia residua rilevabile). Lo studio mira inizialmente a reclutare 14 pazienti in ciascuna coorte, con la possibilità di 10 ulteriori per coorte, per un totale di 48 pazienti. La dose di 5mL di TCB008 mostra una buona tollerabilità senza eventi avversi correlati ai farmaci.
TC BioPharm (NASDAQ: TCBP) informó sobre avances en su ensayo clínico de fase 2b denominado ACHIEVE, con 3 pacientes que completaron el régimen de dosis completa sin eventos adversos relacionados con el fármaco. El ensayo evalúa TCB008 en pacientes con AML o MDS/AML. Estado actual de inscripción: 10 pacientes recibieron la primera dosis, 9 la segunda, 4 la tercera y 3 completaron las cuatro dosis. Nueve pacientes están en el Cohorte A (pacientes en recaída/refractarios), y uno en el Cohorte B (remisión con enfermedad residual detectable). El ensayo tiene como objetivo reclutar inicialmente 14 pacientes en cada cohorte, con potencial para 10 más por cohorte, totalizando 48 pacientes. La dosis de 5 mL de TCB008 muestra buena tolerabilidad sin eventos adversos relacionados con el fármaco.
TC BioPharm (NASDAQ: TCBP)는 약물 관련 부작용 없이 전체 용량 요법을 완수한 3명의 환자를 포함하여 ACHIEVE 2b 임상 시험에서 진전을 보고했습니다. 이 시험은 AML 또는 MDS/AML 환자에서 TCB008을 평가합니다. 현재 등록 상태: 10명의 환자가 첫 번째 용량을 받았고, 9명이 두 번째 용량, 4명이 세 번째 용량, 3명이 네 가지 용량을 모두 완료했습니다. 9명의 환자가 코호트 A(재발/저항성 환자)에 있으며, 1명이 코호트 B(잔여 질병이 발견되는 완화 상태)에 있습니다. 이 시험은 각 코호트에서 처음에 14명의 환자를 모집할 계획이며, 각 코호트에 대해 추가로 10명을 모집할 가능성이 있어 총 48명의 환자가 모집될 예정입니다. 5mL TCB008 용량은 약물 관련 부작용 없이 좋은 내약성을 보입니다.
TC BioPharm (NASDAQ: TCBP) a rapporté des progrès dans son essai clinique de phase 2b dénommé ACHIEVE, avec 3 patients ayant complété le régime de dose complète sans événements indésirables liés au médicament. L'essai évalue TCB008 chez des patients atteints de LMA ou de LMA/MDS. État actuel des inscriptions : 10 patients ont reçu la première dose, 9 ont reçu la deuxième dose, 4 la troisième dose et 3 ont complété les quatre doses. Neuf patients sont dans le Cohorte A (patients en rechute/résistants), et un dans le Cohorte B (rémission avec maladie résiduelle détectable). L'essai vise à recruter initialement 14 patients dans chaque cohorte, avec un potentiel de 10 de plus par cohorte, pour un total de 48 patients. La dose de 5 mL de TCB008 montre une bonne tolérance sans événements indésirables liés au médicament.
TC BioPharm (NASDAQ: TCBP) berichtete über Fortschritte in seiner ACHIEVE Phase 2b-Studie, bei der 3 Patienten das vollständige Dosierungsschema ohne arzneimittelbezogene unerwünschte Ereignisse abgeschlossen haben. Die Studie bewertet TCB008 bei Patienten mit AML oder MDS/AML. Aktueller Einschreibestatus: 10 Patienten erhielten die erste Dosis, 9 die zweite Dosis, 4 die dritte Dosis und 3 schlossen alle vier Dosen ab. Neun Patienten befinden sich in Kohorte A (rezidivierende/refraktäre Patienten), und einer in Kohorte B (Remission mit nachweisbarem Restkrankheit). Die Studie zielt darauf ab, zunächst 14 Patienten in jeder Kohorte zu rekrutieren, mit der Möglichkeit, weitere 10 pro Kohorte hinzuzufügen, insgesamt 48 Patienten. Die 5-mL-Dosis von TCB008 zeigt eine gute Verträglichkeit ohne arzneimittelbezogene unerwünschte Ereignisse.
- Successful recruitment with over 50% of initial Cohort A patients enrolled in less than 5 months
- No drug-related adverse events reported in any patients
- TCB008 showing good tolerability at 5mL dose
- Potential for expedited review in Cohort B patients
- Efficacy data not yet available due to regulatory framework
- Still in early stages of Cohort B recruitment
Insights
Key metrics show strong recruitment momentum with 10 patients receiving first doses, 9 receiving second doses, 4 receiving third doses and 3 completing all four doses. The trial's structure, targeting 48 total patients across two cohorts, demonstrates robust trial design. Cohort A's focus on relapsed/refractory patients (9 patients) and Cohort B's attention to residual disease (1 patient) covers critical unmet needs in AML treatment.
The absence of drug-related adverse events in the 5mL dose cohort is particularly noteworthy, suggesting a favorable safety profile that could streamline regulatory approval. The expedited recruitment rate - achieving these numbers in under 5 months - indicates strong investigator confidence and patient need. The potential for accelerated review in Cohort B, focusing on minimal residual disease, could significantly impact the development timeline.
This clinical progress represents significant value potential for TCBP's market position. The trial's efficient recruitment rate and clean safety profile in completed dosing patients are particularly important given TCBP's micro-cap status (
The mention of possible expedited review for Cohort B suggests potential acceleration of development timelines, which could significantly impact the company's cash runway and commercialization timeline. The strong execution in patient recruitment and dosing completion without safety issues reduces development risk, though investors should note that efficacy data remains pending. The involvement of respected institutions like King's College Hospital adds credibility to the trial execution.
The ACHIEVE
To date, 10 patients have received their first dose, 9 patients have received their second dose, 4 patients have received their third dose, and 3 patients have received their fourth and final dose. 9 out of 10 patients recruited to date are in Cohort A, representing relapsed/refractory patients who have been unable to attain remission. One patient has been enrolled into Cohort B, representing patients who have attained remission following prior treatment yet continue to have a detectable residual disease. The patient enrolled in Cohort B received their fourth and final dose in November 2024. Initially, 14 patients are planned to be recruited into Cohort A and Cohort B and, following confirmation of study endpoints, a further 10 patients will be recruited into each cohort, giving a total of 48 patients.
The preliminary safety data shows that the 5mL dose of TCB008 is well tolerated, with no drug-related Adverse Events. These data outputs remain aligned with TCB008's safety profile, in support of the ACHIEVE study safety objectives and endpoints.
"Recruitment into the ACHIEVE trial has been an overwhelming success in 2024," said Alison Bracchi, Executive Vice President of Clinical Operations. "Currently, more than half of the patients in the initial stage of Cohort A have been recruited into the ACHIEVE study. We're also thrilled to observe the progression of Cohort B. This expedited rate of recruitment has been accomplished in less than 5 months due to the hard work and dedication of both the ACHIEVE Clinical sites and the entire TCBP team. The TCBP team and I look forward to continued success with recruitment and preliminary data from the ACHIEVE study in 2025."
"As we progress with Cohort B, there is the potential for an expedited review given these patients' stage and disease expression," said Bryan Kobel, CEO of TC BioPharm. "We believe minimal residual disease represents a high opportunity for TCB008 to be extremely impactful. We could see a response indicating high responsiveness in fewer than the currently proposed cohort size. At this trial stage, we are still collating data, due to the regulatory framework, we cannot yet comment on efficacy specifically, but we are encouraged to see patients completing the dosing regimen successfully and without any safety issues. Our immediate clinical focus will be high recruitment on Cohort B in 2025 and completing the Cohort A patient set for data review. We appreciate the hard work of the King's College Hospital and our fantastic investigator group including Dr. Victoria Potter, and Dr. Emma Nicholson. The recruitment has been exceptional and we look forward to continuing our work with them in 2025."
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 for TC BioPharm
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 is the current status of TCBP's ACHIEVE Phase 2b trial patient enrollment?
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