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TCBP Announces Site Opening of Guys and St. Thomas Hospital

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TC BioPharm (NASDAQ: TCBP) has announced the opening of a new site for its ACHIEVE UK Trial at Guys and St. Thomas Hospital in London. This leading hospital, known for its extensive experience in cell therapy and oncology trials, will contribute to increasing enrollment velocity for the study. Dr. Hugues de Lavallade, a consultant hematologist with over 10 years of experience in myeloid disorders, will serve as the Principal Investigator.

The ACHIEVE clinical trial, which is evaluating TCB008 in patients with AML or MDS/AML, has been progressing positively since a dose increase earlier this year. The company reports strong enrollment and remains on schedule for data release in the first half of 2025. TC BioPharm's Executive VP of Clinical, Alison Bracchi, expressed enthusiasm about the positive feedback from clinicians and the AML community as they continue to activate new sites for this phase II, open-label study.

TC BioPharm (NASDAQ: TCBP) ha annunciato l'apertura di un nuovo sito per il suo Trial ACHIEVE UK presso il Guys e St. Thomas Hospital di Londra. Questo ospedale di punta, noto per la sua vasta esperienza in terapia cellulare e trial oncologici, contribuirà ad aumentare la velocità di reclutamento per lo studio. Il Dr. Hugues de Lavallade, ematologo consulente con oltre 10 anni di esperienza nei disturbi mieloidi, servirà come Investigatore Principale.

Il trial clinico ACHIEVE, che sta valutando il TCB008 in pazienti con AML o MDS/AML, sta progredendo positivamente da un aumento della dose avvenuto all'inizio di quest'anno. L'azienda riporta un forte reclutamento e rimane in linea con il calendario per il rilascio dei dati nella prima metà del 2025. Alison Bracchi, Vicepresidente Esecutivo per le attività Cliniche di TC BioPharm, ha espresso entusiasmo riguardo ai riscontri positivi da parte dei clinici e della comunità AML mentre continuano ad attivare nuovi siti per questo studio di fase II, a etichetta aperta.

TC BioPharm (NASDAQ: TCBP) ha anunciado la apertura de un nuevo sitio para su Ensayo ACHIEVE UK en el Hospital Guys y St. Thomas en Londres. Este hospital líder, conocido por su amplia experiencia en terapia celular y ensayos oncológicos, contribuirá a aumentar la velocidad de reclutamiento para el estudio. El Dr. Hugues de Lavallade, hematólogo consultor con más de 10 años de experiencia en trastornos mieloides, será el Investigador Principal.

El ensayo clínico ACHIEVE, que está evaluando el TCB008 en pacientes con AML o MDS/AML, ha estado progresando positivamente desde un aumento de dosis a principios de este año. La compañía informa de un fuerte reclutamiento y se mantiene en la programación para la liberación de datos en la primera mitad de 2025. Alison Bracchi, Vicepresidenta Ejecutiva de Asuntos Clínicos de TC BioPharm, expresó entusiasmo por los comentarios positivos de los clínicos y la comunidad de AML mientras continúan activando nuevos sitios para este estudio de fase II, de etiqueta abierta.

TC BioPharm (NASDAQ: TCBP)는 런던에 있는 Guys 및 St. Thomas 병원에서 ACHIEVE UK 시험을 위한 새로운 사이트 개설을 발표했습니다. 세포 치료 및 종양학 시험에 대한 광범위한 경험으로 알려진 이 선도 병원은 연구의 등록 속도를 높이는 데 기여할 것입니다. 10년 이상의 골수 질환 관련 경험을 가진 컨설턴트 혈액학자인 Hugues de Lavallade 박사가 주요 연구자로 임명되었습니다.

TCB008을 AML 또는 MDS/AML 환자에서 평가하는 ACHIEVE 임상 시험은 올해 초 용량 증가 이후 긍정적으로 진행되고 있습니다. 회사는 강력한 등록을 보고하며 2025년 상반기 데이터 공개 일정에 맞추고 있습니다. TC BioPharm의 임상 부사장인 Alison Bracchi는 새로운 사이트를 활성화하는 과정에서 의료진과 AML 커뮤니티로부터 긍정적인 피드백을 받고 있어 열광적이라고 표현했습니다. 이 연구는 2단계 개방형 시험입니다.

TC BioPharm (NASDAQ: TCBP) a annoncé l'ouverture d'un nouveau site pour son Essai ACHIEVE UK au Guys et au St. Thomas Hospital à Londres. Cet hôpital de premier plan, connu pour sa vaste expérience en thérapie cellulaire et en essais oncologiques, contribuera à augmenter la vitesse d'inscription pour l'étude. Le Dr Hugues de Lavallade, hématologue consultant avec plus de 10 ans d'expérience dans les maladies myéloïdes, sera l'investigateur principal.

L'essai clinique ACHIEVE, qui évalue le TCB008 chez des patients atteints de AML ou MDS/AML, progresse positivement depuis une augmentation de dose au début de cette année. L'entreprise fait état d'une forte inscription et reste dans les délais pour la publication des données dans la première moitié de 2025. Alison Bracchi, vice-présidente exécutive des affaires cliniques de TC BioPharm, a exprimé son enthousiasme concernant les retours positifs des cliniciens et de la communauté AML alors qu'ils continuent d'activer de nouveaux sites pour cet essai de phase II à étiquette ouverte.

TC BioPharm (NASDAQ: TCBP) hat die Eröffnung eines neuen Standorts für seine ACHIEVE UK Studie im Guys und St. Thomas Hospital in London bekannt gegeben. Dieses führende Krankenhaus, das für seine umfangreiche Erfahrung in der Zelltherapie und in onkologischen Studien bekannt ist, wird dazu beitragen, die Einschreibegeschwindigkeit für die Studie zu erhöhen. Dr. Hugues de Lavallade, ein konsiliarischer Hämatologe mit über 10 Jahren Erfahrung in myeloischen Erkrankungen, wird als Hauptprüfer fungieren.

Die ACHIEVE-Studie, die TCB008 bei Patienten mit AML oder MDS/AML bewertet, verläuft seit einer Erhöhung der Dosierung zu Beginn dieses Jahres positiv. Das Unternehmen berichtet von starker Einschreibung und bleibt im Zeitplan für die Datenveröffentlichung in der ersten Hälfte von 2025. Alison Bracchi, die Executive VP für Klinische Angelegenheiten bei TC BioPharm, äußerte sich begeistert über das positive Feedback von Ärzten und der AML-Gemeinschaft, während sie weiterhin neue Standorte für diese Phase-II-Studie mit offenem Label aktivieren.

Positive
  • New site opening at Guys and St. Thomas Hospital expected to increase enrollment velocity
  • ACHIEVE clinical trial progressing positively with strong enrollment
  • On schedule for data release in the first half of 2025
  • Positive feedback from clinicians and AML community
Negative
  • None.
  • Additional London-based clinic to increase enrolment velocity
  • Leading hospital with extensive cell therapy and oncology trial experience

EDINBURGH, Scotland, Sept. 25, 2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced new site opening of Guys and St. Thomas Hospital in the ACHIEVE UK Trial.

Guys and St. Thomas is a London-based hospital with a leading oncology clinic and cell therapy clinical team. Dr. Hugues de Lavallade is the Principal Investigator on the trial, having over 10 years of experience as a consultant hematologist with a special interest in myeloid disorders. This new site was opened in September 2024, facilitating the expedited progression of the ACHIEVE clinical trial timelines using Dr. de Lavallade's experience working with AML patients with measurable residual disease.

"The progression of the ACHIEVE clinical trial since the dose increase earlier this year continues to be very positive with strong enrolment and remains on schedule for data in the first half of 2025," said Alison Bracchi, Executive Vice President of Clinical at TC BioPharm. "We are thrilled with the positive feedback from Clinicians and the wider AML community as we continue recruitment and activate new sites for this important trial, and we feel fortunate to be partnering with several centers of excellence to help us deliver on our goal of offering new hope and an alternative treatment of seriously ill AML patients."

The ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with AML or MDS/AML, with either refractory or relapsed disease.

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 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.

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SOURCE TC BioPharm

FAQ

What is the purpose of TC BioPharm's ACHIEVE UK Trial?

The ACHIEVE UK Trial is a phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with AML or MDS/AML who have either refractory or relapsed disease.

Who is the Principal Investigator for the ACHIEVE UK Trial at Guys and St. Thomas Hospital?

Dr. Hugues de Lavallade, a consultant hematologist with over 10 years of experience in myeloid disorders, is the Principal Investigator for the ACHIEVE UK Trial at Guys and St. Thomas Hospital.

When does TC BioPharm (TCBP) expect to release data from the ACHIEVE clinical trial?

TC BioPharm expects to release data from the ACHIEVE clinical trial in the first half of 2025.

How has the enrollment been for TC BioPharm's (TCBP) ACHIEVE clinical trial?

According to the company, enrollment for the ACHIEVE clinical trial has been strong, especially since a dose increase earlier in the year.

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