TCBP Announces Successful Completion of Cohort A in the ACHIEVE Clinical Trial
TC BioPharm (TCBP) has announced the completion of Cohort A dosing in its ACHIEVE Phase 2B UK clinical trial, evaluating TCB008 for acute myeloid leukemia (AML) and myelodysplastic syndromes. The preliminary results show promising outcomes with no drug-related adverse events and evidence of stable disease in several patients following multiple TCB008 infusions.
Cohort A, which was re-initiated in July 2024, targeted patients ineligible for or who had exhausted all available therapies. The trial utilized higher doses of TCB008, containing up to a billion Gamma Delta T-Cells. While Cohort A enrollment has concluded, recruitment for Cohort B continues. The company reports expedited data delivery, occurring just six months after study re-initiation.
TC BioPharm (TCBP) ha annunciato il completamento della somministrazione del dosaggio del Coorte A nel suo trial clinico di Fase 2B nel Regno Unito, che valuta TCB008 per la leucemia mieloide acuta (AML) e le sindromi mielodisplastiche. I risultati preliminari mostrano esiti promettenti con nessun evento avverso correlato al farmaco e evidenza di malattia stabile in diversi pazienti dopo più infusioni di TCB008.
Il Coorte A, che è stato riavviato nel luglio 2024, ha mirato a pazienti non idonei o che avevano esaurito tutte le terapie disponibili. Lo studio ha utilizzato dosi più elevate di TCB008, contenente fino a un miliardo di cellule T Gamma Delta. Anche se l'arruolamento del Coorte A si è concluso, il reclutamento per il Coorte B continua. L'azienda riporta una consegna dei dati accelerata, avvenuta solo sei mesi dopo il riavvio dello studio.
TC BioPharm (TCBP) ha anunciado la finalización de la dosificación del Cohorte A en su ensayo clínico de Fase 2B en el Reino Unido, que evalúa TCB008 para la leucemia mieloide aguda (LMA) y los síndromes mielodisplásicos. Los resultados preliminares muestran resultados prometedores con ningún evento adverso relacionado con el fármaco y evidencia de enfermedad estable en varios pacientes tras múltiples infusiones de TCB008.
El Cohorte A, que se reinició en julio de 2024, se dirigió a pacientes no elegibles o que habían agotado todas las terapias disponibles. El ensayo utilizó dosis más altas de TCB008, que contenía hasta mil millones de células T Gamma Delta. Aunque el reclutamiento para el Cohorte A ha concluido, la captación para el Cohorte B continúa. La compañía informa sobre una entrega de datos acelerada, que ocurrió solo seis meses después del reinicio del estudio.
TC BioPharm (TCBP)는 급성 골수성 백혈병(AML)과 골수형성이상증후군에 대한 TCB008을 평가하는 영국의 ACHIEVE 2B 임상 시험에서 코호트 A의 투약 완료를 발표했습니다. 초기 결과는 약물 관련 부작용 없음과 여러 환자에서 TCB008의 여러 차례 주입 후 안정적인 질병의 증거를 보여주는 유망한 결과를 나타냅니다.
2024년 7월에 재개된 코호트 A는 치료 자격이 없거나 모든 사용 가능한 치료를 소진한 환자를 대상으로 했습니다. 이 시험에서는 최대 10억 개의 감마 델타 T 세포를 포함한 TCB008의 고용량이 사용되었습니다. 코호트 A의 등록은 종료되었지만, 코호트 B에 대한 모집은 계속되고 있습니다. 회사는 연구 재개 후 단 6개월 만에 신속한 데이터 전달이 이루어졌다고 보고했습니다.
TC BioPharm (TCBP) a annoncé l'achèvement de l'administration de la Cohorte A dans son essai clinique ACHIEVE de Phase 2B au Royaume-Uni, évaluant TCB008 pour la leucémie myéloïde aiguë (LMA) et les syndromes myélodysplasiques. Les résultats préliminaires montrent des résultats prometteurs avec aucun effet indésirable lié au médicament et des preuves de maladie stable chez plusieurs patients après plusieurs perfusions de TCB008.
La Cohorte A, qui a été réinitiée en juillet 2024, ciblait des patients inéligibles ou qui avaient épuisé toutes les thérapies disponibles. L'essai a utilisé des doses plus élevées de TCB008, contenant jusqu'à un milliard de cellules T Gamma Delta. Bien que le recrutement pour la Cohorte A soit terminé, le recrutement pour la Cohorte B se poursuit. L'entreprise rapporte une livraison de données accélérée, survenant seulement six mois après le redémarrage de l'étude.
TC BioPharm (TCBP) hat den Abschluss der Dosierung der Kohorte A in seiner ACHIEVE Phase 2B klinischen Studie im Vereinigten Königreich bekannt gegeben, die TCB008 zur Behandlung von akuter myeloischer Leukämie (AML) und myelodysplastischen Syndromen evaluiert. Die vorläufigen Ergebnisse zeigen vielversprechende Resultate mit keinen medikamentenbezogenen unerwünschten Ereignissen und Anzeichen einer stabilen Erkrankung bei mehreren Patienten nach mehreren Infusionen von TCB008.
Kohorte A, die im Juli 2024 neu gestartet wurde, richtete sich an Patienten, die für keine der verfügbaren Therapien geeignet waren oder diese erschöpft hatten. Die Studie verwendete höhere Dosen von TCB008, die bis zu einer Milliarde Gamma Delta T-Zellen enthielten. Während die Rekrutierung für Kohorte A abgeschlossen ist, läuft die Rekrutierung für Kohorte B weiterhin. Das Unternehmen berichtet von einer beschleunigten Datenlieferung, die nur sechs Monate nach dem Neustart der Studie stattfand.
- No drug-related adverse events reported in Cohort A patients
- Multiple patients achieved stable disease following TCB008 treatment
- Successful completion of Cohort A enrollment ahead of schedule
- Positive preliminary safety and efficacy profile demonstrated
- Stable disease achieved rather than disease regression or remission
- Additional data review needed before determining next steps
Insights
The completion of Cohort A in TC BioPharm's ACHIEVE trial represents a significant milestone in the development of TCB008, with several noteworthy implications for both clinical and investment perspectives. The absence of drug-related adverse events is particularly meaningful in relapsed/refractory AML patients, who typically experience significant toxicities with conventional treatments. This clean safety profile could position TCB008 as a valuable option in a challenging therapeutic landscape.
The observation of stable disease in multiple patients receiving the higher-dose regimen (up to 1 billion gamma-delta T-cells) is encouraging, though requires careful interpretation. In r/r AML, where disease progression is typically aggressive and rapid, achieving disease stabilization represents a meaningful clinical benefit. The rapid completion of enrollment, accomplished in just six months, suggests strong investigator interest and potentially reflects the significant unmet need in this patient population.
Several key aspects warrant attention from investors:
- The company's strategic positioning of TCB008 as a potential bridge to transplant or combination therapy partner could expand its market opportunity
- The successful implementation of higher doses without safety issues demonstrates manufacturing capability and dose-dependent biological activity
- The expedited recruitment timeline suggests potential for accelerated development in future trials
However, critical questions remain about durability of response and the pathway to market. Investors should monitor:
- Complete data from Cohort A, including duration of stable disease and biomarker analyses
- Progress in Cohort B enrollment and whether similar safety/efficacy profiles are observed
- The company's strategy for potential combination studies or bridge-to-transplant investigations
- No adverse events related to TCB008 have occurred
- Evidence of stable disease following TCB008 infusion
The available data show a favorable safety and efficacy response in Cohort A patients, patients with relapse or refractory AML. No patients have experienced any drug-related adverse event, and preliminary efficacy data demonstrate a number of patients attaining stable disease following multiple infusions of TCB008.
"We're thrilled to be sharing these preliminary results," stated Alison Bracchi, EVP of Clinical Operations. "These early data points pave the way for future clinical studies, as we consider how the therapeutic effect of TCB008 can be prolonged or enhanced to reverse the disease state in these incredibly sick patient populations. We have additional data review to complete, which will further define our next steps with TCB008, including as a potential bridge to transplant or other combination efforts."
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 in patients suffering from acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS/AML). Cohort A targeted patients who were ineligible for, or had exhausted all, available therapies, as they were unable to achieve remission or had subsequently relapsed following remission.
Cohort A recruitment was re-initiated in July 2024 using higher doses of TCB008 that contained a cumulative dose of up to a billion Gamma Delta T-Cells. Investigator and patient interest in the ACHIEVE trial has allowed the Company to expedite recruitment; as such, enrolment into Cohort A has concluded. Recruitment into Cohort B continues.
"This early safety and efficacy data, obtained in patients with significant unmet clinical need, reiterates our confidence in our lead candidate, TCB008," said Bryan Kobel, CEO of TC BioPharm. "We're seeing the expedited delivery of data, six months after study re-initiation, signalling a positive safety and efficacy profile for TCB008. This data will shape our approach to clinical development as we continue to investigate how stable disease can be sustained, both to prevent relapse and to progress patients to additional treatment options in conjunction wth TCB008."
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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