TCBP Provides Quarterly Update on the ACHIEVE (UK) Clinical Trial
TC BioPharm (NASDAQ: TCBP) provided an update on its ACHIEVE UK Trial for TCB008, a gamma-delta T cell therapy. Over half of Cohort A patients in Stage One have received treatment, showing positive safety signals at the 5mL dose (230 million Gamma Delta T-Cells) with no serious adverse events reported.
The company plans to increase dosage up to 819 million cells to identify optimal levels. Currently, 4 UK clinical sites are recruiting patients, with 2 more sites expected in H1 2025. The trial includes two patient groups: Cohort A (failed standard treatments) and Cohort B (residual disease after initial remission). The company plans to implement increased TCB008 doses alongside a scaled-up manufacturing process in 2025.
TC BioPharm (NASDAQ: TCBP) ha fornito un aggiornamento sul suo trial ACHIEVE UK per TCB008, una terapia con cellule T gamma-delta. Oltre la metà dei pazienti del Coorte A nella Fase Uno ha ricevuto trattamento, mostrando segnali di sicurezza positivi alla dose di 5mL (230 milioni di cellule T gamma-delta) senza eventi avversi gravi riportati.
L'azienda prevede di aumentare il dosaggio fino a 819 milioni di cellule per identificare i livelli ottimali. Attualmente, 4 siti clinici nel Regno Unito stanno reclutando pazienti, con ulteriori 2 siti previsti nel primo semestre del 2025. Lo studio include due gruppi di pazienti: Coorte A (trattamenti standard falliti) e Coorte B (malattia residua dopo la remissione iniziale). L'azienda intende implementare dosi aumentate di TCB008 insieme a un processo di produzione ampliato nel 2025.
TC BioPharm (NASDAQ: TCBP) proporcionó una actualización sobre su ensayo ACHIEVE UK para TCB008, una terapia con células T gamma-delta. Más de la mitad de los pacientes del Cohorte A en la Etapa Uno han recibido tratamiento, mostrando señales de seguridad positivas con la dosis de 5mL (230 millones de células T gamma-delta) sin eventos adversos graves reportados.
La compañía planea aumentar la dosis hasta 819 millones de células para identificar niveles óptimos. Actualmente, 4 sitios clínicos en el Reino Unido están reclutando pacientes, con 2 sitios más previstos para la primera mitad de 2025. El ensayo incluye dos grupos de pacientes: Cohorte A (tratamientos estándar fallidos) y Cohorte B (enfermedad residual después de la remisión inicial). La compañía planea implementar dosis aumentadas de TCB008 junto con un proceso de fabricación ampliado en 2025.
TC BioPharm (NASDAQ: TCBP)는 TCB008, 감마 델타 T 세포 치료에 대한 ACHIEVE UK 시험에 대한 업데이트를 제공했습니다. 1단계에서 A군 환자의 절반 이상이 치료를 받았으며, 5mL 용량(2억 3000만 감마 델타 T 세포)에서 긍정적인 안전 신호를 보여주었고 심각한 부작용은 보고되지 않았습니다.
회사는 최적 용량을 식별하기 위해 8억 1900만 세포까지 용량을 증가할 계획입니다. 현재 4개 영국 임상 사이트에서 환자를 모집하고 있으며, 2025년 상반기에는 2개 사이트가 추가로 예상됩니다. 이 시험은 두 개의 환자 그룹을 포함합니다: A군(표준 치료 실패)과 B군(초기 관해 이후 잔여 질환). 회사는 2025년부터 TCB008의 증가된 용량과 함께 확대된 제조 공정을 구현할 계획입니다.
TC BioPharm (NASDAQ: TCBP) a fourni une mise à jour sur son essai ACHIEVE UK pour TCB008, une thérapie par cellules T gamma-delta. Plus de la moitié des patients du Cohorte A à l'Étape Un ont reçu un traitement, montrant des signaux de sécurité positifs à la dose de 5 mL (230 millions de cellules T gamma-delta) sans événements indésirables graves signalés.
La société prévoit d'augmenter la dose jusqu'à 819 millions de cellules pour identifier des niveaux optimaux. Actuellement, 4 sites cliniques au Royaume-Uni recrutent des patients, avec 2 sites supplémentaires prévus pour le premier semestre 2025. L'essai comprend deux groupes de patients : Cohorte A (traitements standard échoués) et Cohorte B (maladie résiduelle après une rémission initiale). La société prévoit de mettre en œuvre des doses augmentées de TCB008 parallèlement à un processus de fabrication à grande échelle en 2025.
TC BioPharm (NASDAQ: TCBP) hat ein Update zu seiner ACHIEVE UK-Studie für TCB008, eine Gamma-Delta-T-Zelltherapie, bereitgestellt. Über die Hälfte der Patienten der Kohorte A in Phase Eins hat eine Behandlung erhalten und zeigte positive Sicherheitszeichen bei der Dosis von 5 mL (230 Millionen Gamma-Delta-T-Zellen), ohne ernsthafte Nebenwirkungen zu berichten.
Das Unternehmen plant, die Dosis auf bis zu 819 Millionen Zellen zu erhöhen, um optimale Werte zu identifizieren. Derzeit rekrutieren 4 klinische Standorte im Vereinigten Königreich Patienten, mit 2 weiteren Standorten, die im ersten Halbjahr 2025 erwartet werden. Die Studie umfasst zwei Patientengruppen: Kohorte A (fehlgeschlagene Standardbehandlungen) und Kohorte B (restliche Erkrankung nach anfänglicher Remission). Das Unternehmen plant, erhöhte Dosen von TCB008 neben einem hochskalierten Herstellungsprozess im Jahr 2025 umzusetzen.
- Positive safety data with no serious adverse events reported
- Trial expansion planned with 2 additional clinical sites in H1 2025
- Manufacturing process improvements planned for 2025 to increase yields and economic efficiency
- Current trial to relatively low dose (230 million cells) requiring dose escalation studies
Insights
The ACHIEVE trial update for TCB008 in acute myeloid leukemia shows promising early safety data, with no serious adverse events reported at the current 5mL dose (230 million Gamma Delta T-Cells). The trial's progression to higher doses up to 819 million cells represents a significant development in finding the optimal therapeutic dose.
The trial's structure targeting two distinct patient groups is noteworthy: Cohort A includes patients who failed standard treatments, while Cohort B targets those with residual disease after initial remission. The expansion to 6 UK sites by H1 2025 should accelerate patient recruitment.
The planned manufacturing scale-up in 2025 is important for supporting higher doses and improving commercial viability. However, investors should note that efficacy data is still pending and the focus on safety rather than efficacy metrics suggests we're still in early stages of clinical validation.
The planned manufacturing process improvements are strategically significant. The ability to scale up production to support higher doses (819 million cells) while maintaining product quality is a critical milestone for commercial viability. The focus on "economic efficiencies" suggests potential cost reductions in the manufacturing process, which is essential for commercial success in cell therapy.
The cross-functional collaboration mentioned indicates a coordinated approach to process optimization. This could lead to faster cleanroom-to-clinic delivery times and improved production yields, both important factors for cell therapy commercialization. However, implementation timeline in 2025 suggests a measured approach to validation and regulatory compliance.
- Positive safety data, allowing for exploration of higher TCB008 doses
- 4
UK -based clinical sites recruiting patients, with a further 2 sites expected in H1 2025
As of this week, over half of the Cohort A patients in Stage One of the ACHIEVE study have received TCB008. These patients have an unmet clinical need, as they have been unable to attain remission with the existing Standard of Care, other treatments, or tolerate further chemotherapy. Data evaluated at this milestone demonstrate positive safety signals for the 5mL dose of TCB008, as no Serious Adverse Events have been attributed to the TCB008 drug product. The Company intends to use this data to justify further increases in the TCB008 dose, from 230 million Gamma Delta T-Cells up to 819 million Gamma Delta T-Cells, to identify the optimal dose for Cohort A patients.
Cohort B patients with residual disease after initially achieving remission with existing available treatment continue to be actively recruited into the ACHIEVE study at the current TCB008 dose of 230 million Gamma Delta T-Cells. These patients will be recruited at 1 of the 4 active clinical trial sites. Each site, including Guy's and
"Medicinal products cannot be effective if they are not safe, and it's clear from these initial data that TCB008 is safe for our patients," said Alison Bracchi, Executive Vice President of Clinical Operations. "Our priority now, for Cohort A, is to find the optimal biologically effective dose for patients that have exhausted all other treatments to drive a long term response. We look forward to completing the recruitment of Cohort B patients, and are planning to evaluate these data in the first half of 2025."
The increased TCB008 dose will be implemented concurrently to the scaled-up manufacturing process, developed by Dr. Lauren Bor's team, in 2025.
"The operational teams at TC BioPharm are incredibly resourceful," said Callum Fiske, Head of Operations. "Cross-functional collaboration is ongoing to deliver improvements to the manufacturing process as soon as possible, enabling increased yields that will expedite TCB008 delivery from cleanroom to clinic, and drive economic efficiencies to the commercial cost, in 2025."
Forward-Looking Statements
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.
About TC BioPharm (Holdings) PLC
TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer 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 treatment of acute myeloid leukemia using the Company's proprietary allogeneic CryoTC technology to provide frozen product to clinics worldwide.
Contact:
Chris Camarra
EVP Communications
c.camarra@tcbiopharm.com
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SOURCE TC BioPharm
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