ScaleReady Announces a G-Rex® Grant has been awarded to BrainChild Bio
ScaleReady has awarded a $300,000 G-Rex® Grant to BrainChild Bio to support the development of BCB-276, an autologous CAR-T therapy for treating diffuse intrinsic pontine glioma (DIPG), an incurable pediatric brain tumor. The grant is part of ScaleReady's $20M initiative to advance cell and gene-modified cell therapy development.
BrainChild Bio plans to advance BCB-276 into a multi-center Phase 2 pivotal clinical trial in 2025. The grant will help optimize their G-Rex based CAR-T cell manufacturing process, offering process simplicity, consistency, and flexibility. Additionally, BrainChild Bio will have the option to evaluate CellReady's standardized 7-day CAR-T cell process, which uses closed system G-Rex bioreactors and Bio-Techne's ProPak GMP cytokines.
ScaleReady ha assegnato un finanziamento G-Rex® da 300.000 dollari a BrainChild Bio per supportare lo sviluppo di BCB-276, una terapia CAR-T autologa per il trattamento del glioma pontino intrinseco diffuso (DIPG), un tumore cerebrale pediatrico incurabile. Il finanziamento fa parte dell'iniziativa da 20 milioni di dollari di ScaleReady per promuovere lo sviluppo di terapie cellulari e geniche modificate.
BrainChild Bio prevede di portare BCB-276 in una sperimentazione clinica pilota di Fase 2 multicentrica nel 2025. Il finanziamento contribuirà a ottimizzare il processo di produzione delle cellule CAR-T basato su G-Rex, offrendo semplicità, coerenza e flessibilità nel processo. Inoltre, BrainChild Bio avrà la possibilità di valutare il processo standardizzato di 7 giorni per le cellule CAR-T di CellReady, che utilizza bioreattori G-Rex a sistema chiuso e citochine GMP ProPak di Bio-Techne.
ScaleReady ha otorgado una subvención G-Rex® de 300,000 dólares a BrainChild Bio para apoyar el desarrollo de BCB-276, una terapia CAR-T autóloga para el tratamiento del glioma pontino intrínseco difuso (DIPG), un tumor cerebral pediátrico incurable. La subvención forma parte de la iniciativa de 20 millones de dólares de ScaleReady para avanzar en el desarrollo de terapias celulares y modificadas por genes.
BrainChild Bio planea avanzar BCB-276 a un ensayo clínico pivotal de Fase 2 multicéntrico en 2025. La subvención ayudará a optimizar su proceso de fabricación de células CAR-T basado en G-Rex, ofreciendo simplicidad, consistencia y flexibilidad en el proceso. Además, BrainChild Bio tendrá la opción de evaluar el proceso estandarizado de 7 días de células CAR-T de CellReady, que utiliza bioreactores G-Rex de sistema cerrado y citoquinas GMP ProPak de Bio-Techne.
ScaleReady는 BrainChild Bio에 300,000 달러의 G-Rex® 보조금을 수여하여 확산성 본체 뇌종양(DIPG)의 치료를 위한 자가 CAR-T 요법인 BCB-276의 개발을 지원합니다. 이 보조금은 세포 및 유전자 변형 세포 치료 개발을 촉진하기 위한 ScaleReady의 2천만 달러 이니셔티브의 일환입니다.
BrainChild Bio는 2025년에 BCB-276을 다기관 2상 주요 임상 시험으로 진행할 계획입니다. 이 보조금은 G-Rex 기반 CAR-T 세포 제조 과정을 최적화하는 데 도움을 주어, 과정의 단순성, 일관성 및 유연성을 제공합니다. 또한 BrainChild Bio는 폐쇄형 G-Rex 생물 반응기와 Bio-Techne의 ProPak GMP 사이토카인을 사용하는 CellReady의 표준화된 7일 CAR-T 세포 프로세스를 평가할 옵션을 갖게 됩니다.
ScaleReady a octroyé une subvention G-Rex® de 300 000 $ à BrainChild Bio pour soutenir le développement de BCB-276, une thérapie CAR-T autologue pour traiter le gliome pontin intrinsèque diffus (DIPG), une tumeur cérébrale pédiatrique incurable. La subvention fait partie de l'initiative de 20 millions de dollars de ScaleReady pour faire progresser le développement de thérapies cellulaires et de thérapies modifiées par des gènes.
BrainChild Bio prévoit de faire avancer BCB-276 vers un essai clinique pivot de phase 2 multicentrique en 2025. La subvention les aidera à optimiser leur processus de fabrication de cellules CAR-T basé sur G-Rex, offrant simplicité, cohérence et flexibilité dans le processus. De plus, BrainChild Bio aura la possibilité d'évaluer le processus standardisé de 7 jours pour les cellules CAR-T de CellReady, qui utilise des bioréacteurs G-Rex à système fermé et des cytokines GMP ProPak de Bio-Techne.
ScaleReady hat der BrainChild Bio eine G-Rex®-Zuwendung in Höhe von 300.000 Dollar gewährt, um die Entwicklung von BCB-276, einer autologen CAR-T-Therapie zur Behandlung des diffusen intrinsischen Ponsglioms (DIPG), einem unheilbaren pädiatrischen Hirntumor, zu unterstützen. Die Zuwendung ist Teil der 20 Millionen Dollar schweren Initiative von ScaleReady zur Förderung der Entwicklung von Zell- und genmodifizierten Zelltherapien.
BrainChild Bio plant, BCB-276 im Jahr 2025 in eine multizentrische Phase-2-Studie zu bringen. Die Zuwendung wird helfen, ihren G-Rex-basierten CAR-T-Zellherstellungsprozess zu optimieren, der Prozesssimpelheit, Konsistenz und Flexibilität bietet. Darüber hinaus hat BrainChild Bio die Möglichkeit, den standardisierten 7-tägigen CAR-T-Zellprozess von CellReady zu bewerten, der geschlossene G-Rex-Bioreaktoren und Bio-Techne's ProPak-GMP-Zytokine verwendet.
- Secured $300,000 grant funding for process development
- Advancing to Phase 2 pivotal clinical trial in 2025
- Access to standardized 7-day manufacturing process
- Part of larger $20M industry development initiative
- None.
Insights
The
The collaboration leverages G-Rex's established track record in CAR-T manufacturing since 2012 at Seattle Children's, combined with CellReady's standardized 7-day manufacturing process. The integration of closed system bioreactors and Bio-Techne's ProPak GMP cytokines suggests a streamlined, scalable manufacturing approach that could significantly reduce production time and costs while maintaining product quality.
Think of this as upgrading from a manual car assembly line to a sophisticated automated factory - it's about achieving consistent quality at scale. For investors, this development signals potential manufacturing efficiency gains that could improve margins and accelerate time-to-market for BCB-276.
The focus on DIPG treatment represents a important unmet medical need in pediatric oncology. DIPG affects approximately 300-400 children annually in the U.S., with a median survival of only 9 months post-diagnosis. BCB-276's advancement to Phase 2 trials could mark a pivotal moment in treating this devastating condition.
The involvement of Dr. Michael Jensen, a renowned figure in CAR-T development, adds substantial credibility to this project. His team's 15-year track record in pioneering CAR-T therapies suggests a strong foundation for BCB-276's development. The optimization of the manufacturing process through this grant could address one of the key challenges in CAR-T therapy - producing consistent, high-quality cell products efficiently.
In simple terms, imagine trying to create a perfect recipe that can be replicated in multiple kitchens simultaneously - that's what this manufacturing optimization aims to achieve in the context of life-saving cellular therapies.
"G-Rex has been an essential element of our clinical CAR-T manufacturing program at Seattle Children's dating back to 2012. We greatly appreciate the support of ScaleReady's G-Rex Grant Program as well as the technical expertise offered to us by ScaleReady related to new advancements," said Dr. Michael Jensen, Chief Scientific Officer at BrainChild Bio.
"We have a tremendous amount of respect for pioneering CAR-T therapies that Dr. Jensen and his team have advanced over the last 15 years. Their relentless pursuit of cancer cures is inspiring. It's an honor for our team to be able to help accelerate BrainChild's novel BCB-276 treatment for brain tumors to those in need and this program is perfectly aligned with our goal of bringing hope to cancer patients," said John Wilson, CEO of Wilson Wolf Manufacturing Corporation and co-inventor of G-Rex.
As part of the G-Rex Grant, BrainChild Bio will perform process development and optimization of their G-Rex based CAR-T cell manufacturing process in anticipation of a pivotal clinical trial. Through this G-Rex Grant, ScaleReady will help BrainChild quickly establish optimal process simplicity, consistency, and flexibility in their manufacturing approach for BCB-276. Additionally, BrainChild Bio will have the option to evaluate CellReady's standardized CAR-T cell process, a highly efficient 7-day manufacturing process. The CellReady CAR-T process is a fully closed end-to-end process that incorporates the use of closed system G-Rex bioreactors and Bio-Techne's new closed system ProPak GMP cytokines in a manufacturing workflow capable of delivering high-throughput products to patients.
ScaleReady's G-Rex Grant Program is a
For more information about the G-Rex® Grant Program, please contact info@scaleready.com.
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.
About BrainChild Bio
BrainChild Bio, Inc., is a kids-first, clinical-stage biotechnology company harnessing the power of CAR T-cell technology to treat tumors in the central nervous system, prioritizing pediatric indications with plans to expand into adult CNS tumors, specifically Glioblastoma and Brain Metastasis. BrainChild Bio is advancing a next-generation CAR T-cell therapy platform for tumors of the CNS that weaves together synthetic technologies, including multiplex targeting and enhanced potency controls, to enable multiple targets in a single CAR T-cell therapy, novel transgenes to increase potency, delivery technology for durable efficacy, and streamlined CAR T-cell design and manufacturing. BrainChild Bio's lead drug candidate is BCB-276, an autologous CAR T-cell therapy that targets the immune checkpoint B7-H3, that is advancing in clinical trials for the treatment of diffuse intrinsic pontine glioma (DIPG), a pediatric cancer that forms in the brainstem which currently has no approved treatments. More information is available at www.brainchildbio.com
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SOURCE Bio-Techne Corporation
FAQ
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