ScaleReady announces a G-Rex® Grant has been awarded to renowned cancer immunologist Dr. Christopher A. Klebanoff
ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne (NASDAQ: TECH), and CellReady, has awarded a $300,000 G-Rex® Grant to Dr. Christopher A. Klebanoff, a renowned cancer immunologist at Memorial Sloan Kettering Cancer Center (MSK). The grant will support the development of a novel CD8α/β-armored TCR-T cell therapy targeting an HLA-A*11:01-restricted RAS (G12D) public neoantigen for a Phase 1 clinical trial.
The grant will provide enabling reagents for process development, IND-enabling studies, and clinical manufacturing. Dr. Klebanoff's team plans to incorporate Wilson Wolf's fully closed-system G-Rex bioreactors and the GatheRex for cell processing. The project aims to develop a robust manufacturing framework for generating infusion products for cancer patients, potentially benefiting those with treatment options.
As part of the grant, MSK will receive early access to Bio-Techne's new line of closed system GMP reagents, including the G-Rex ProPak™ CAR-TCR Cytokine Kits, designed for use with G-Rex bioreactors.
ScaleReady, in collaborazione con Wilson Wolf Manufacturing, Bio-Techne (NASDAQ: TECH) e CellReady, ha assegnato una sovvenzione G-Rex® di $300.000 al Dr. Christopher A. Klebanoff, un rinomato immunologo oncologico presso il Memorial Sloan Kettering Cancer Center (MSK). La sovvenzione supporterà lo sviluppo di una nuova terapia cellulare TCR-T armata CD8α/β mirata a un neoantigene pubblico RAS (G12D) limitato da HLA-A*11:01 per uno studio clinico di Fase 1.
La sovvenzione fornirà reagenti abilitanti per lo sviluppo del processo, studi abilitanti IND e produzione clinica. Il team del Dr. Klebanoff prevede di incorporare i bioreattori G-Rex completamente chiusi di Wilson Wolf e il GatheRex per il processamento cellulare. Il progetto mira a sviluppare un robusto framework di produzione per generare prodotti di infusione per pazienti oncologici, potenzialmente a beneficio di coloro con opzioni di trattamento.
Come parte della sovvenzione, il MSK riceverà accesso anticipato alla nuova linea di reagenti GMP a sistema chiuso di Bio-Techne, inclusi i kit di citochine G-Rex ProPak™ CAR-TCR, progettati per l'uso con i bioreattori G-Rex.
ScaleReady, en colaboración con Wilson Wolf Manufacturing, Bio-Techne (NASDAQ: TECH) y CellReady, ha otorgado una subvención G-Rex® de $300,000 al Dr. Christopher A. Klebanoff, un renombrado inmunólogo del cáncer en el Memorial Sloan Kettering Cancer Center (MSK). La subvención apoyará el desarrollo de una nueva terapia celular TCR-T armada CD8α/β que se dirige a un neoantígeno público RAS (G12D) restringido por HLA-A*11:01 para un ensayo clínico de Fase 1.
La subvención proporcionará reactivos habilitadores para el desarrollo de procesos, estudios habilitantes IND y fabricación clínica. El equipo del Dr. Klebanoff planea incorporar los biorreactores G-Rex de sistema completamente cerrado de Wilson Wolf y el GatheRex para el procesamiento celular. El proyecto tiene como objetivo desarrollar un marco de fabricación robusto para generar productos de infusión para pacientes con cáncer, beneficiando potencialmente a aquellos con opciones de tratamiento.
Como parte de la subvención, MSK recibirá acceso anticipado a la nueva línea de reactivos GMP de sistema cerrado de Bio-Techne, incluidos los kits de citoquinas G-Rex ProPak™ CAR-TCR, diseñados para su uso con biorreactores G-Rex.
ScaleReady는 Wilson Wolf Manufacturing, Bio-Techne (NASDAQ: TECH) 및 CellReady와 협력하여 Memorial Sloan Kettering Cancer Center (MSK)의 유명한 암 면역학자인 Dr. Christopher A. Klebanoff에게 $300,000 G-Rex® 보조금을 수여했습니다. 이 보조금은 HLA-A*11:01에 제한된 RAS (G12D) 공용 네오항원을 목표로 하는 새로운 CD8α/β 장착 TCR-T 세포 치료법 개발을 지원할 것입니다. 이는 1상 임상 시험을 위한 것입니다.
이 지원금은 공정 개발, IND 지원 연구 및 임상 제조를 위한 지원 용역을 제공합니다. Klebanoff 박사의 팀은 Wilson Wolf의 완전 폐쇄 시스템 G-Rex 생물 반응기와 세포 처리를 위한 GatheRex를 통합할 계획입니다. 이 프로젝트는 암 환자를 위한 주입 제품을 생성하기 위한 강력한 제조 프레임워크를 개발하는 것을 목표로 하며, 치료 옵션이 있는 환자에게 혜택을 줄 수 있습니다.
보조금의 일환으로 MSK는 Bio-Techne의 새로운 폐쇄형 GMP 시약 라인에 조기 접근하게 되며, 여기에는 G-Rex 생물 반응기와 함께 사용하기 위해 설계된 G-Rex ProPak™ CAR-TCR 사이토카인 키트가 포함됩니다.
ScaleReady, en collaboration avec Wilson Wolf Manufacturing, Bio-Techne (NASDAQ: TECH) et CellReady, a attribué une subvention G-Rex® de 300 000 $ au Dr Christopher A. Klebanoff, un immunologiste reconnu dans le domaine du cancer au Memorial Sloan Kettering Cancer Center (MSK). Cette subvention soutiendra le développement d'une thérapie cellulaire TCR-T armée CD8α/β visant un néoantigène public RAS (G12D) restreint par HLA-A*11:01 pour un essai clinique de phase 1.
La subvention fournira des réactifs facilitants pour le développement de processus, des études de soutien IND et la fabrication clinique. L'équipe du Dr Klebanoff prévoit d'incorporer les bioréacteurs G-Rex à système entièrement fermé de Wilson Wolf et le GatheRex pour le traitement cellulaire. Le projet vise à développer un cadre de fabrication robuste pour la création de produits d'infusion pour les patients atteints de cancer, pouvant potentiellement bénéficier à ceux ayant des options de traitement.
Dans le cadre de la subvention, le MSK aura un accès anticipé à la nouvelle gamme de réactifs GMP à système fermé de Bio-Techne, y compris les kits de cytokines G-Rex ProPak™ CAR-TCR, conçus pour être utilisés avec les bioréacteurs G-Rex.
ScaleReady hat in Zusammenarbeit mit Wilson Wolf Manufacturing, Bio-Techne (NASDAQ: TECH) und CellReady einen G-Rex®-Zuschuss in Höhe von 300.000 USD an Dr. Christopher A. Klebanoff, einen renommierten Krebsimmunologen am Memorial Sloan Kettering Cancer Center (MSK), vergeben. Der Zuschuss unterstützt die Entwicklung einer neuartigen CD8α/β-gerichteten TCR-T-Zelltherapie, die auf ein HLA-A*11:01-restriktiertes RAS (G12D) öffentliches Neoantigen für eine Phase-1-Studie abzielt.
Der Zuschuss wird hilfsstoffliche Reagenzien für die Prozessentwicklung, IND-unterstützende Studien und die klinische Herstellung bereitstellen. Das Team von Dr. Klebanoff plant, die vollständig geschlossenen G-Rex-Bioreaktoren von Wilson Wolf sowie den GatheRex für die Zellverarbeitung zu integrieren. Das Projekt zielt darauf ab, ein robustes Herstellungsframework zur Erzeugung von Infusionsprodukten für Krebspatienten zu entwickeln, was potenziell Patienten mit Behandlungsoptionen zugutekommen könnte.
Im Rahmen des Zuschusses erhält MSK frühzeitigen Zugang zur neuen Linie geschlossener GMP-Reagenzien von Bio-Techne, einschließlich der G-Rex ProPak™ CAR-TCR-Zytokinkits, die für den Einsatz mit G-Rex-Bioreaktoren konzipiert sind.
- Awarded $300,000 G-Rex® Grant to support novel cancer immunotherapy development
- Collaboration with renowned cancer immunologist Dr. Christopher A. Klebanoff at MSK
- Potential to accelerate clinical trials for a new TCR-T cell therapy
- Early access to new line of closed system GMP reagents from Bio-Techne
- None.
"Dr. Klebanoff is a leader in the field with over 20 years of experience, and we are fortunate to be able to support his novel approach to cancer treatment. We are confident that this G-Rex Grant will significantly accelerate the path to clinical results and simultaneously set the stage for highly efficient closed system scale out. We are also hopeful that patients will receive significant benefit from treatment with armored TCR-T drug products," said John Wilson, CEO of Wilson Wolf and co-inventor of G-Rex.
"Our armored TCR-T therapy is designed to recognize antigen targets that are specific to every cancer cell. We are diligently working to bring this public neoantigen cellular immunotherapy into the clinic to assess its safety and potential efficacy against common solid cancers with significant unmet medical need. The G-Rex Grant will expedite development and accelerate our entrance into human clinical trials," said Dr. Klebanoff, who serves as an Attending Physician, Laboratory Head, Human Oncology & Pathogenesis Program, and Member Investigator, Center for Cell Engineering at MSK. Dr. Klebanoff is also a Scientific Co-Founder of Affini-T Therapeutics, and a member of the Parker Institute for Cancer Immunotherapy (PICI).
As part of the G-Rex Grant, Dr. Klebanoff and Dr. Chandran at MSK plan to complete their pre-clinical process development which will include the incorporation of Wilson Wolf's fully closed-system G-Rex bioreactors and the GatheRex for semi-automated volume reduction, cell concentration, and harvest. Additionally, Dr. Klebanoff expects to perform a technology transfer to MSK's cGMP facility, which will perform engineering runs in support of an Investigational New Drug (IND) application to be filed with the FDA with the hope of initiating a Phase 1 clinical trial.
"Our goal is to thoughtfully develop and expeditiously transfer a robust manufacturing framework that will reliably and reproducibly enable the generation of infusion products for cancer patients by our cGMP facility. Our hope is that this public-neoantigen specific TCR-T therapy will benefit a patient population that currently does not have many treatment options available. We also recognize this as an invaluable opportunity to holistically learn from this bench-to-bedside experience as we continue to discover and innovate in the lab.", said Smita S. Chandran, PhD, a Scientific Research Lead in the Klebanoff Lab at MSK, who led the discovery and development of the HLA-A*11/RAS(G12D) TCR-T therapeutic.
The G-Rex Grant will also support clinical manufacturing runs of their autologous TCR-T cell therapy. Expedited patient enrollment is expected to occur because of MSK's unique IMPACT Program, that prescreens (via next generation sequencing) all incoming patients for commonly mutated genes.
MSK will also get early access to a new line of closed system GMP reagents from Bio-Techne that are tailor-made for use with fully-closed system G-Rex bioreactors. The G-Rex ProPak™ CAR-TCR Cytokine Kits, estimated to be commercially available later this year, are weldable bags of liquid cytokines and are designed to streamline reagent preparation and administration in a GMP manufacturing setting without the use of a biosafety cabinet (BSC).
ScaleReady's G-Rex Grant Program is a
About ScaleReady
ScaleReady provides the field of cell and gene-modified cell therapy (CGT) with a G-Rex centric manufacturing platform that enables the world's most practical, flexible, scalable, and affordable CGT drug product development and manufacturing.
The G-Rex manufacturing platform is currently used by a rapidly growing list of over 800 organizations and is producing drug products for approximately
CGT entities relying on the breadth and scope of ScaleReady's expertise can expect to save years of time and millions of dollars on the path to CGT commercialization.
For more information about the ScaleReady G-Rex® Grant Program, please contact info@scaleready.com.
About Wilson Wolf Manufacturing
Wilson Wolf (www.wilsonwolf.com) is dedicated to simplifying cell and gene-modified cell (CGT) therapy research, process development, and manufacturing. This is being accomplished through its scalable G-Rex® technology, which is used throughout the world in CGT applications ranging from basic research to commercial drug production.
Wilson Wolf's mission is to create hope for cancer patients, one G-Rex device at a time.
About Bio-Techne Corporation
Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne, in partnership with Wilson Wolf, is creating products such as media and cytokines that are specifically tailored to G-Rex Bioreactors, including right-sized reagent quantities in containers that are tailored to high throughput closed-system manufacturing. For more information on Bio-Techne and its brands, please visit https://www.bio-techne.com or follow the Company on social media at: Facebook, LinkedIn, Twitter or YouTube.
Contact: David Clair, Vice President, Investor Relations & Corporate Development
david.clair@bio-techne.com
612-656-4416
About CellReady LLC
CellReady is the world's first and only G-Rex centric contract development and manufacturing organization (CDMO) specializing in G-Rex based cell and gene-modified cell therapy development and manufacturing. The company offers a wide range of services to support the development and commercialization of these therapies.
CellReady's mission is to create hope for cancer patients, one G-Rex process at a time.
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SOURCE Bio-Techne Corporation
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