TCBP Partners with CareDx to Support ACHIEVE Clinical Trial Using AlloCell for Pharmacokinetic Monitoring of Allogeneic Cell Therapy
TC BioPharm (NASDAQ: TCBP), a clinical-stage biotechnology company developing allogeneic gamma-delta T cell therapies, announced a partnership with CareDx (NASDAQ: CDNA) to support the ACHIEVE clinical trial. This phase II, open-label study aims to evaluate the efficacy of TCB008, an allogeneic gamma delta T cell therapy for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS).
CareDx will use its AlloCell solution for pharmacokinetic analysis to monitor the expansion and persistence of TCB008 in patients. The data collected will help understand the duration and effect of TCB008 in reconstituting the immune system of AML patients. Alison Bracchi, EVP of Clinical Operations at TC BioPharm, highlighted the partnership as a significant milestone in developing TCB008. Marica Grskovic, PhD, CareDx Chief Strategy Officer, emphasized the collaboration's role in advancing allogeneic cell therapy for AML patients.
TC BioPharm (NASDAQ: TCBP), un'azienda biofarmaceutica in fase clinica che sviluppa terapie con cellule T gamma-delta allogeniche, ha annunciato una collaborazione con CareDx (NASDAQ: CDNA) per supportare lo studio clinico ACHIEVE. Questo studio di fase II, a etichetta aperta, mira a valutare l'efficacia di TCB008, una terapia con cellule T gamma-delta allogeniche per la Leucemia Mieloide Acuta (LMA) e la Sindrome Mielodisplastica (SMD).
CareDx utilizzerà la sua soluzione AlloCell per l'analisi farmacocinetica per monitorare l'espansione e la persistenza di TCB008 nei pazienti. I dati raccolti aiuteranno a comprendere la durata e l'effetto di TCB008 nella ricostruzione del sistema immunitario dei pazienti affetti da LMA. Alison Bracchi, EVP delle Operazioni Cliniche presso TC BioPharm, ha sottolineato la partnership come un traguardo significativo nello sviluppo di TCB008. Marica Grskovic, PhD, Chief Strategy Officer di CareDx, ha enfatizzato il ruolo della collaborazione nell'avanzare la terapia cellulare allogenica per i pazienti con LMA.
TC BioPharm (NASDAQ: TCBP), una empresa biofarmacéutica en fase clínica que desarrolla terapias con células T gamma-delta alogénicas, anunció una asociación con CareDx (NASDAQ: CDNA) para apoyar el ensayo clínico ACHIEVE. Este estudio de fase II, de etiqueta abierta, tiene como objetivo evaluar la eficacia de TCB008, una terapia con células T gamma-delta alogénicas para la Leucemia Mieloide Aguda (LMA) y el Síndrome Mielodisplásico (SMD).
CareDx utilizará su solución AlloCell para el análisis farmacocinético para monitorear la expansión y persistencia de TCB008 en los pacientes. Los datos recopilados ayudarán a comprender la duración y el efecto de TCB008 en la reconstitución del sistema inmunitario de los pacientes con LMA. Alison Bracchi, EVP de Operaciones Clínicas en TC BioPharm, destacó la asociación como un hito significativo en el desarrollo de TCB008. Marica Grskovic, PhD, directora de estrategia de CareDx, enfatizó el papel de la colaboración en el avance de la terapia celular alogénica para los pacientes con LMA.
TC BioPharm (NASDAQ: TCBP)는 자가 이식 감마 델타 T세포 치료제를 개발하는 임상 단계의 생명공학 회사로, ACHIEVE 임상 시험을 지원하기 위해 CareDx (NASDAQ: CDNA)와 파트너십을 체결했습니다. 이 개방형 이중 연구는 급성 골수성 백혈병(AML) 및 골수형성이상 증후군(MDS)을 위한 자가 이식 감마 델타 T세포 치료제인 TCB008의 효능을 평가하는 것을 목표로 합니다.
CareDx는 환자에서 TCB008의 확장 및 지속성을 모니터링하기 위해 약물 동태 분석을 위해 AlloCell 솔루션을 사용할 것입니다. 수집된 데이터는 AML 환자의 면역 체계를 재구성하는 데 있어 TCB008의 지속 시간 및 효과를 이해하는 데 도움이 될 것입니다. TC BioPharm의 임상 운영 부사장인 Alison Bracchi는 TCB008 개발의 중요한 이정표로서 이 파트너십을 강조했습니다. CareDx의 전략 총괄이사 Marica Grskovic 박사는 AML 환자를 위한 이식 세포 치료의 발전에 있어 협력의 역할을 강조했습니다.
TC BioPharm (NASDAQ: TCBP), une entreprise de biotechnologie en phase clinique développant des thérapies par cellules T gamma-delta allogéniques, a annoncé un partenariat avec CareDx (NASDAQ: CDNA) pour soutenir l'essai clinique ACHIEVE. Cette étude de phase II, à étiquetage ouvert, vise à évaluer l'efficacité de TCB008, une thérapie par cellules T gamma-delta allogéniques pour la leucémie myéloïde aiguë (LMA) et le syndrome myélodysplasique (SMD).
CareDx utilisera sa solution AlloCell pour des analyses pharmacocinétiques afin de surveiller l'expansion et la persistance de TCB008 chez les patients. Les données collectées aideront à comprendre la durée et l'effet de TCB008 dans la reconstitution du système immunitaire des patients atteints de LMA. Alison Bracchi, EVP des opérations cliniques chez TC BioPharm, a souligné le partenariat comme un jalon important dans le développement de TCB008. Marica Grskovic, PhD, chief strategy officer de CareDx, a mis en avant le rôle de la collaboration dans l'avancement de la thérapie cellulaire allogénique pour les patients atteints de LMA.
TC BioPharm (NASDAQ: TCBP), ein biopharmazeutisches Unternehmen in der klinischen Phase, das allogene gamma-delta T-Zelltherapien entwickelt, gab eine Partnerschaft mit CareDx (NASDAQ: CDNA) bekannt, um die klinische Studie ACHIEVE zu unterstützen. Diese Phase-II-Studie mit offener Etikette hat das Ziel, die Wirksamkeit von TCB008, einer allogenen gamma-delta T-Zelltherapie bei akuter myeloischer Leukämie (AML) und myelodysplastischem Syndrom (MDS), zu bewerten.
CareDx wird seine AlloCell-Lösung für pharmakokinetische Analysen nutzen, um die Expansion und Persistenz von TCB008 bei den Patienten zu überwachen. Die gesammelten Daten werden dabei helfen, die Dauer und Wirkung von TCB008 bei der Rekonstitution des Immunsystems bei AML-Patienten zu verstehen. Alison Bracchi, EVP der klinischen Operationen bei TC BioPharm, hob die Partnerschaft als einen bedeutenden Meilenstein in der Entwicklung von TCB008 hervor. Marica Grskovic, PhD, Chief Strategy Officer von CareDx, betonte die Rolle der Zusammenarbeit zur Förderung der allogenen Zelltherapie für AML-Patienten.
- Partnership with CareDx for pharmacokinetic analysis using AlloCell.
- ACHIEVE trial aims to evaluate TCB008 for AML and MDS patients.
- Phase II study indicates progress in clinical development.
- None.
Insights
This partnership represents a significant advancement in monitoring allogeneic cell therapy effectiveness. The integration of CareDx's AlloCell™ solution for pharmacokinetic analysis in the ACHIEVE trial will provide important data on TCB008's persistence and expansion in AML/MDS patients. This sophisticated monitoring capability could help optimize dosing strategies and better understand treatment efficacy, potentially improving patient outcomes. The ability to track gamma-delta T cells in real-time is particularly valuable for assessing immune system reconstitution in blood cancer patients.
However, while this collaboration enhances the trial's monitoring capabilities, it's primarily a technical partnership that doesn't directly impact the therapy's efficacy. The Phase II ACHIEVE trial remains the key determinant of TCB008's potential success. For a micro-cap company like TC BioPharm, such partnerships with established players can provide valuable validation and technical support.
The partnership with CareDx adds significant value to TC BioPharm's ACHIEVE trial by incorporating advanced monitoring capabilities. AlloCell's pharmacokinetic monitoring will provide essential data about TCB008's behavior and persistence in patients, which is important for optimizing cell therapy treatments. This collaboration demonstrates TC BioPharm's commitment to robust clinical development and could potentially accelerate the pathway to commercialization if the therapy proves successful.
For a company with a market cap of just
The ACHIEVE clinical trial is an adaptive, open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008, an allogeneic gamma delta T cell therapy for patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).
CareDx is a leading precision medicine company focused on discovering, developing, and commercializing healthcare solutions for transplant patients and caregivers. CareDx's AlloCell test, a sensitive solution for pharmacokinetic monitoring of allogeneic immune and stem cell therapies, will be used to evaluate the expansion and persistence of TCB008 in patients enrolled in the ACHIEVE trial.
It is expected that these expansion and persistence data will provide an understanding of the duration and effect of TCB008 Gamma Delta T-Cells in reconstituting the immune system of acute myeloid leukemia patients enrolled in the ACHIEVE trial.
"Our partnership with CareDx is a significant milestone," said Alison Bracchi, Executive Vice President of Clinical Operations at TC BioPharm. "The collaboration is pivotal to the development and optimization of TCB008 as a therapy for acute myeloid leukemia and other blood cancers."
"We are thrilled to continue to progress the science of allogeneic cell therapy for patients battling acute myeloid leukemia," said Marica Grskovic, PhD, CareDx Chief Strategy Officer. "This partnership builds upon our growth strategy to expand into hematology oncology with pharmacokinetic and monitoring assays for patients undergoing cell therapy."
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.
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
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