CareDx Partners with TC BioPharm to Support ACHIEVE Clinical Trial Using AlloCell for Pharmacokinetic Monitoring of Allogeneic Cell Therapy
CareDx (CDNA) announces a partnership with TC BioPharm to provide pharmacokinetic analysis using its AlloCell™ solution in the ACHIEVE clinical trial. The phase II trial evaluates TCB008, an allogeneic gamma-delta T-cell therapy for patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). AlloCell, which has been used in ten previous cell therapy trials, will monitor the expansion and persistence of TCB008 in trial patients. This partnership aligns with CareDx's strategic expansion into hematology oncology, specifically focusing on pharmacokinetic and monitoring assays for cell therapy patients.
CareDx (CDNA) annuncia una partnership con TC BioPharm per fornire analisi farmacocinetiche utilizzando la sua soluzione AlloCell™ nel trial clinico ACHIEVE. Il trial di fase II valuta TCB008, una terapia cellulare allogenica con cellule T gamma-delta per pazienti con leucemia mieloide acuta (AML) o sindrome mielodisplastica (MDS). AlloCell, già utilizzato in dieci precedenti trial di terapia cellulare, monitorerà l'espansione e la persistenza di TCB008 nei pazienti del trial. Questa partnership si allinea con l'espansione strategica di CareDx nell'oncologia ematologica, concentrandosi specificamente su analisi farmacocinetiche e di monitoraggio per i pazienti in terapia cellulare.
CareDx (CDNA) anuncia una asociación con TC BioPharm para proporcionar análisis farmacocinéticos utilizando su solución AlloCell™ en el ensayo clínico ACHIEVE. El ensayo de fase II evalúa TCB008, una terapia con células T gamma-delta alogénicas para pacientes con leucemia mieloide aguda (AML) o síndrome mielodisplásico (MDS). AlloCell, que ha sido utilizado en diez ensayos de terapia celular anteriores, monitoreará la expansión y persistencia de TCB008 en los pacientes del ensayo. Esta asociación está en línea con la expansión estratégica de CareDx en oncología hematológica, centrándose específicamente en ensayos farmacocinéticos y de monitoreo para pacientes en terapia celular.
CareDx (CDNA)는 ACHIEVE 임상 시험에서 AlloCell™ 솔루션을 사용하여 약리학적 분석을 제공하기 위해 TC BioPharm과 파트너십을 발표했습니다. 2단계 시험은 급성 골수성 Leukemia(AML) 또는 골수형성이상 증후군(MDS) 환자에 대한 알로겐 gamma-delta T세포 요법인 TCB008을 평가합니다. AlloCell은 이전의 10개 세포 요법 시험에서 사용되었으며, 시험 환자에서 TCB008의 확장 및 지속성을 모니터링합니다. 이 파트너십은 CareDx가 혈액종양학 분야로의 전략적 확장을 추진하며, 세포 요법 환자에 대한 약리학적 및 모니터링 분석에 집중하고 있음을 나타냅니다.
CareDx (CDNA) annonce un partenariat avec TC BioPharm pour fournir une analyse pharmacocinétique en utilisant sa solution AlloCell™ dans l'essai clinique ACHIEVE. L'essai de phase II évalue TCB008, une thérapie par cellules T gamma-delta allogéniques pour les patients atteints de leucémie myéloïde aiguë (LMA) ou de syndrome myélodysplasique (SMD). AlloCell, qui a été utilisé dans dix essais précédents de thérapie cellulaire, surveillera l'expansion et la persistance de TCB008 chez les patients de l'essai. Ce partenariat s'inscrit dans l'extension stratégique de CareDx vers l'oncologie hématologique, se concentrant spécifiquement sur les analyses pharmacocinétiques et de surveillance pour les patients en thérapie cellulaire.
CareDx (CDNA) kündigt eine Partnerschaft mit TC BioPharm an, um pharmakokinetische Analysen unter Verwendung seiner AlloCell™ Lösung im ACHIEVE klinischen Versuch bereitzustellen. Die Phase-II-Studie bewertet TCB008, eine allogene gamma-delta T-Zelltherapie für Patienten mit akuter myeloischer Leukämie (AML) oder myelodysplastischem Syndrom (MDS). AlloCell, das in zehn vorherigen Zelltherapiestudien verwendet wurde, wird die Expansion und Persistenz von TCB008 bei den Studienteilnehmern überwachen. Diese Partnerschaft passt zu CareDxs strategischer Expansion in die Hämatologie-Onkologie, mit einem speziellen Fokus auf pharmakokinetische und Überwachungsassays für Zelltherapie-Patienten.
- Expansion into hematology oncology market through strategic partnership
- AlloCell solution already proven with usage in 10 previous clinical trials
- Currently active in 4 ongoing clinical trials
- None.
Insights
The partnership between CareDx and TC BioPharm marks a significant advancement in cell therapy monitoring capabilities. AlloCell's implementation in the ACHIEVE trial for AML and MDS patients represents a important step in understanding treatment efficacy. The ability to track pharmacokinetics of allogeneic gamma-delta T-cells (TCB008) with precision is vital for optimizing dosing strategies and predicting treatment outcomes. With AlloCell's proven track record in ten previous clinical trials and current active use in four ongoing trials, this collaboration strengthens CareDx's position in the hematology-oncology space. The technology's ability to monitor cell expansion and persistence will provide valuable insights into immune system reconstitution, potentially improving treatment protocols for blood cancer patients.
This strategic partnership enhances CareDx's market position in the growing cell therapy monitoring segment. The expansion into hematology-oncology represents a significant revenue diversification opportunity beyond their core transplant business. With a market cap of
CareDx Continues Strategic Expansion into Hematology Oncology with Pharmacokinetic and Monitoring Assays for Cell Therapy Patients
AlloCell has been used in ten prior cell therapy clinical trials and with the addition of the ACHIEVE trial is being actively used in four clinical trials.
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).
“This partnership builds upon our growth strategy to expand into hematology oncology with pharmacokinetic and monitoring assays for patients undergoing cell therapy,” said Marica Grskovic, PhD, CareDx Chief Strategy Officer. “We are thrilled to continue to progress the science of allogeneic cell therapy for patients battling acute myeloid leukemia.”
“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.”
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 the 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.
About CareDx – The Transplant Company
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Forward Looking Statements
This press release includes forward-looking statements related to CareDx, Inc. and its strategic partnership with TC BioPharm, including statements regarding the partnership’s ability to drive innovation, the ACHIEVE clinical trial, and the potential benefits and results that may be achieved with AlloCell. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, all of which are difficult to predict and many of which are beyond CareDx’s control, that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of the strategic partnership of the ACHIEVE clinical trial, or of AlloCell itself. These statements are also subject to general economic and market factors; and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by CareDx with the SEC on February 28, 2024, the Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed by CareDx with the SEC on May 9, 2024 and the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024 filed by CareDx with the SEC on July 31, 2024, the Quarterly Report on Form10-Q for the quarter ended September 30, 2024 filed by CareDx with the SEC on November 4, 2024, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
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FAQ
What is the purpose of CareDx's partnership with TC BioPharm for the ACHIEVE trial?
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What type of therapy is being evaluated in the ACHIEVE trial that CDNA is monitoring?
How does the TC BioPharm partnership align with CDNA's growth strategy?
