TCBP Announces Successful Completion of Initial Cohort B Patient Dosing in the ACHIEVE Clinical Trial
TC BioPharm (TCBP) announced successful completion of initial Cohort B patient dosing in the ACHIEVE Phase 2B clinical trial, evaluating TCB008 for Acute Myeloid Leukemia (AML). The first Cohort B patient received all four planned doses, totaling approximately 819 million Gamma Delta T-cells, with a fifth dose expected.
The ACHIEVE trial, an open-label Phase II study, evaluates TCB008's efficacy and safety in patients with AML and myelodysplastic syndromes (MDS/AML). Cohort B specifically targets patients in remission but with detectable minimal residual disease (MRD). Recruitment began in Q4 2024, ahead of schedule, with the first patient dosed in October 2024.
Preliminary data shows no drug-related adverse events following cumulative infusions of up to a billion cells, supporting TCB008's positive safety profile. The company expects to complete Cohort B enrollment in H1 2025, with data readout anticipated later in the year.
TC BioPharm (TCBP) ha annunciato il completamento con successo della somministrazione ai pazienti del primo gruppo B nella fase 2B dello studio clinico ACHIEVE, che valuta il TCB008 per la Leucemia Mieloide Acuta (LMA). Il primo paziente del gruppo B ha ricevuto tutte e quattro le dosi previste, per un totale di circa 819 milioni di cellule T Gamma Delta, con una quinta dose prevista.
Lo studio ACHIEVE, uno studio di fase II aperto, valuta l'efficacia e la sicurezza del TCB008 in pazienti affetti da LMA e sindromi mielodisplastiche (SMD/LMA). Il gruppo B si concentra specificamente su pazienti in remissione ma con malattia minima residua (MRD) rilevabile. Il reclutamento è iniziato nel quarto trimestre del 2024, con anticipo rispetto al programma, e il primo paziente è stato trattato nell'ottobre 2024.
I dati preliminari mostrano che non ci sono eventi avversi correlati al farmaco dopo infusioni cumulative fino a un miliardo di cellule, supportando il profilo di sicurezza positivo del TCB008. L'azienda prevede di completare il reclutamento del gruppo B nel primo semestre del 2025, con la lettura dei dati prevista per la fine dell'anno.
TC BioPharm (TCBP) anunció la finalización exitosa de la administración de pacientes en la fase inicial del Cohorte B del ensayo clínico ACHIEVE de fase 2B, que evalúa el TCB008 para la Leucemia Mieloide Aguda (LMA). El primer paciente del Cohorte B recibió las cuatro dosis planificadas, sumando aproximadamente 819 millones de células T Gamma Delta, y se espera una quinta dosis.
El ensayo ACHIEVE, un estudio abierto de fase II, evalúa la eficacia y seguridad del TCB008 en pacientes con LMA y síndromes mielodisplásicos (SMD/LMA). El Cohorte B está dirigido específicamente a pacientes en remisión pero con enfermedad mínima residual (EMR) detectable. El reclutamiento comenzó en el cuarto trimestre de 2024, adelantándose al cronograma, y el primer paciente recibió la dosis en octubre de 2024.
Los datos preliminares no muestran eventos adversos relacionados con el fármaco tras infusiones acumulativas de hasta mil millones de células, lo que respalda el perfil de seguridad positivo del TCB008. La empresa espera completar la inscripción del Cohorte B en el primer semestre de 2025, con la lectura de datos anticipada para finales de año.
TC BioPharm (TCBP)는 급성 골수성 백혈병(AML) 치료를 위한 TCB008의 임상 시험 ACHIEVE 2B 단계에서 Cohort B 환자 투약을 성공적으로 완료했다고 발표했습니다. 첫 번째 Cohort B 환자는 계획된 4회 모든 투약을 받았으며, 총 약 8억 1900만 개의 감마 델타 T 세포가 주어졌고, 다섯 번째 투약이 예상됩니다.
ACHIEVE 시험은 AML 및 골수형성이상 증후군(MDS/AML) 환자를 대상으로 TCB008의 효능과 안전성을 평가하는 개방형 2상 연구입니다. Cohort B는 특히 완화 상태에 있지만 최소 잔여 질병(MRD)이 검출되는 환자를 타겟으로 합니다. 모집은 2024년 4분기에 예정보다 빨리 시작되었으며, 첫 번째 환자는 2024년 10월에 투약되었습니다.
초기 데이터에 따르면 최대 10억 세포의 누적 주입 후 약물 관련 부작용이 없으며, 이것은 TCB008의 긍정적인 안전성 프로파일을 지지합니다. 이 회사는 2025년 상반기 내에 Cohort B 등록을 완료할 것으로 예상하며, 데이터 출시는 연말에 계획되고 있습니다.
TC BioPharm (TCBP) a annoncé l'achèvement réussi de l'administration des premiers patients du Cohorte B dans l'essai clinique ACHIEVE Phase 2B, évaluant le TCB008 pour la Leucémie Myéloïde Aiguë (LMA). Le premier patient du Cohorte B a reçu les quatre doses prévues, totalisant environ 819 millions de cellules T Gamma Delta, avec une cinquième dose attendue.
L'essai ACHIEVE, une étude de phase II en ouvert, évalue l'efficacité et la sécurité du TCB008 chez des patients atteints de LMA et de syndromes myélodysplasiques (SMD/LMA). Le Cohorte B cible spécifiquement les patients en rémission mais avec une maladie résiduelle minimale (MRD) détectable. Le recrutement a commencé au quatrième trimestre 2024, en avance sur le calendrier, avec le premier patient traité en octobre 2024.
Les données préliminaires montrent qu'aucun événement indésirable lié au médicament n'est survenu après des infusions cumulées allant jusqu'à un milliard de cellules, soutenant le profil de sécurité positif du TCB008. L'entreprise prévoit de compléter l'inscription du Cohorte B au premier semestre 2025, avec une lecture des données anticipée plus tard dans l'année.
TC BioPharm (TCBP) hat den erfolgreichen Abschluss der Patienten-Dosierung in der ersten Kohorte B der ACHIEVE Phase 2B-Studie angekündigt, die TCB008 zur Behandlung der akuten myeloischen Leukämie (AML) evaluiert. Der erste Patient der Kohorte B erhielt alle vier geplanten Dosen, insgesamt etwa 819 Millionen Gamma-Delta-T-Zellen, wobei eine fünfte Dosis erwartet wird.
Die ACHIEVE-Studie, eine offene Phase-II-Studie, bewertet die Wirksamkeit und Sicherheit von TCB008 bei Patienten mit AML und myelodysplastischen Syndromen (MDS/AML). Kohorte B richtet sich speziell an Patienten in Remission, bei denen jedoch eine nachweisbare minimale Restkrankheit (MRD) besteht. Die Rekrutierung begann im vierten Quartal 2024, vor dem Zeitplan, und der erste Patient wurde im Oktober 2024 dosiert.
Vorläufige Daten zeigen, dass es nach kumulativen Infusionen von bis zu einer Milliarde Zellen keine behandlungsbedingten unerwünschten Ereignisse gab, was das positive Sicherheitsprofil von TCB008 unterstützt. Das Unternehmen rechnet damit, die Rekrutierung der Kohorte B im ersten Halbjahr 2025 abzuschließen, wobei die Datenauswertung für später im Jahr erwartet wird.
- No drug-related adverse events reported in preliminary data
- Trial progressing ahead of schedule
- Successful completion of full dosing regiment for first Cohort B patient
- Second Cohort B patient enrollment initiated
- Promising efficacy signals showing cellular recovery and inflammation reduction
- None.
Insights
The latest update from TC BioPharm's ACHIEVE trial represents a significant milestone in the development of allogeneic gamma-delta T cell therapy for AML. The successful completion of dosing in the first Cohort B patient, with approximately 819 million cells administered across 4 doses and no drug-related adverse events, is particularly noteworthy for several reasons:
The focus on MRD-positive patients in Cohort B is strategically important. These patients, while in remission, face a high risk of relapse, representing a critical unmet need in AML treatment. The clean safety profile with high cell doses (approaching 1 billion cells) is particularly encouraging, as safety concerns often limit cell therapy applications. This could potentially position TCB008 as a maintenance therapy option, a setting where current treatment options are
The accelerated recruitment timeline, beating internal schedules, suggests strong investigator interest and efficient trial execution. The expansion across multiple UK sites enhances the trial's robustness and could expedite full enrollment, potentially leading to earlier data readout than the projected late 2025 timeline.
Critical efficacy signals indicating cellular recovery and reduced inflammation in AML patients, while preliminary, align with the therapeutic mechanism of gamma-delta T cells. These cells' natural ability to target stressed/malignant cells while sparing healthy tissue could offer a significant advantage over current treatments.
The market implications are substantial given that approximately 40-50% of AML patients who achieve remission eventually relapse. A well-tolerated maintenance therapy that could prevent relapse would address a significant market gap. The clean safety profile could also support potential combination approaches with existing therapies, expanding the therapeutic potential.
- First Cohort B patient received 4 doses (approx. 819 million Gamma Delta T-cells)
- Cohort B recruitment continues at multiple clinical sites across the
United Kingdom
The ACHIEVE trial is an open-label Phase II study dedicated to evaluating the efficacy and safety of TCB008. This trial is focused on assessing the treatment's effectiveness and tolerability on patients suffering from acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS/AML) with challenging cases such as refractory or relapsed conditions. Cohort B recruits patients who have achieved remission following previous treatment yet continue to have a detectable or minimal residual disease (MRD).
Recruitment into Cohort B was initiated during the fourth quarter of 2024, ahead of the Company's anticipated schedule. The first Cohort B patient received their dose in October 2024. The initial Cohort B patient has completed the dosing regiment, receiving all four planned doses of TCB008, and is expected to receive an additional fifth dose. Enrolment of a second Cohort B patient has also been initiated.
The safety objectives and endpoints of ACHIEVE evaluate patient responses to TCB008, including; grading of adverse events experienced and the incidence and severity of cytokine release syndrome and neurotoxicity. In a review of preliminary data, there are no drug-related adverse events following cumulative infusions of TCB008, containing up to a billion cells. These data continue to support the positive safety profile of TCB008 and the ACHIEVE
"The ACHIEVE study progressed at an incredible rate in 2024," stated Alison Bracchi, EVP of Clinical Operations. "Thanks to the hard work and dedication of both the TC BioPharm team and Clinical sites, we've reached a significant study milestone in under six months. We're seeing a fantastic safety profile from our initial data review and exciting efficacy signals that indicate cellular recovery and a reduction of inflammation in AML patients. The TC BioPharm team and I are inspired by the progress to date and look forward to sharing further updates on Cohort B."
"The progression of ACHIEVE, with dosing underway in the second cohort, is a key milestone in the clinical development of our gamma delta therapy candidate TCB008. We believe it has potential to serve as an efficacious treatment for AML patients, whom still have significant unmet needs," said Bryan Kobel, CEO of TC BioPharm. "The therapy has been well-tolerated with no unexpected events or toxicities observed and promising efficacy results observed in some patients, with additional data being collected and analyzed. Cohort B is an extremely compelling patient population for TCB008 for many reasons, including patients having a more intact immune system to amplify the impact of TCB008 and the lack of true treatment options for these patients who are unfortunately on a path to relapse. We expect to complete enrolment in the second cohort in the first half of 2025, with data readout anticipated later this year."
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
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