ScaleReady Awards G-Rex Grants to Advance Novel CAR-T Cell Therapy Manufacturing
核心洞察
ScaleReady (搜索) has awarded a $200,000 G-Rex (搜索) Grant to March Biosciences (搜索) to advance manufacturing of MB-105, a novel CAR-T (搜索) therapy targeting CD5 (搜索) for T-cell lymphomas that received FDA orphan drug designation in January 2025.
A2 Biotherapeutics (搜索) received a $300,000 G-Rex (搜索) Grant to evaluate the G-CART process, a standardized workflow designed for high-throughput CAR-T (搜索) manufacturing that can be adapted for commercial scale production.
The G-Rex (搜索) platform, currently used by over 800 organizations in approximately 50% of CGT clinical trials, aims to reduce complexity, time, and costs in cell therapy manufacturing through a modular and flexible approach.
ScaleReady (搜索) has awarded significant grants to two biotechnology companies to advance manufacturing processes for novel CAR-T (搜索) cell therapies, addressing key challenges in cell therapy production scalability and efficiency.
March Biosciences (搜索) received a $200,000 G-Rex (搜索) Grant to further develop manufacturing capabilities for MB-105, their lead investigational autologous CAR-T (搜索) cell therapy targeting CD5 (搜索) for patients with T-cell lymphomas. Simultaneously, A2 Biotherapeutics (搜索) secured a $300,000 grant to evaluate G-Rex for their proprietary Tmod (搜索) platform-based CAR-T therapies targeting solid tumors.
Advancing Manufacturing for T-Cell Lymphoma Therapy
March Biosciences (搜索) will utilize the grant to enhance the manufacturing process for MB-105, which received U.S. FDA orphan drug designation in January 2025 for relapsed/refractory CD5 (搜索)-positive T-cell lymphoma (搜索). The therapy employs a proprietary CAR design that selectively targets malignant cells while preserving normal T-cell function.
"As we ramp up clinical manufacturing and advance towards commercialization of MB-105, scalability continues to be an important focal point," said Dr. Maksim Mamonkin, Chief Scientific Officer at March Biosciences (搜索). "This grant will enable continued development of a robust cGMP process with the G-Rex (搜索) bioreactor to further reduce complexity, time, and costs incurred with manufacturing autologous CAR-T (搜索) products."
MB-105 is currently in Phase 2 clinical trials (NCT06534060) for patients with relapsed/refractory T-cell lymphoma (搜索). The therapy is also in development for other CD5 (搜索)-positive hematologic malignancies, including T-cell acute lymphoblastic leukemia (搜索) (T-ALL), chronic lymphocytic leukemia (搜索) (CLL), mantle cell lymphoma (搜索) (MCL), and other CD5+ B-cell non-Hodgkin's Lymphoma (搜索) indications.
Expanding CAR-T Manufacturing Capabilities for Solid Tumors
A2 Biotherapeutics (搜索) will use their $300,000 grant to expedite process development and qualification of a G-Rex (搜索)-based production system for their CAR-T (搜索) cell pipeline, which targets various solid tumor indications including colorectal, lung, pancreatic, and ovarian cancers.
"We are very impressed by the simplicity and scalability of the G-Rex (搜索) platform and look forward to exploring its applications in our clinical development programs," said Dr. Agi Hamburger, Chief Operating Officer at A2 Biotherapeutics (搜索). "As an early-stage company, the G-Rex Grant provides valuable resources to support the process development and comparability studies."
A2's therapies are based on their proprietary Tmod (搜索) platform, a dual-signal integrator system that distinguishes normal cells from tumor cells by utilizing tumor loss of heterozygosity. The system consists of an activating receptor and an inhibitory receptor (blocker module) that can differentiate between normal cells containing both activator and blocker antigens from tumor cells that have lost the blocker antigen.
G-CART Process: Standardizing CAR-T Manufacturing
As part of their grant, A2 Biotherapeutics (搜索) will evaluate the G-CART process, a standardized workflow for assembling CAR-T (搜索) drug products currently in development at CellReady (搜索), the first G-Rex (搜索)-centric contract development and manufacturing organization.
John Wilson, CEO of Wilson Wolf (搜索) and co-inventor of G-Rex (搜索), emphasized the importance of flexible manufacturing approaches: "We believe a modular and flexible closed approach is necessary for cell therapy developers to set the basis for LEAN manufacturing while establishing phase appropriate production. This is the best way to generate drug product supply that is commensurate with their total patient demand."
The G-CART process is designed for high-throughput manufacturing in both centralized and point-of-care models, with the capability for full end-to-end robotic automation for commercial scale production. The process incorporates novel sub-assemblies to streamline drug substance flow, including GMP ProPak cytokines from Bio-Techne (搜索)—sterile-weldable bags containing GMP-grade, liquid-formulated cytokines specifically sized for G-Rex (搜索) devices.
Growing Impact of G-Rex Platform in Cell Therapy
The G-Rex (搜索) manufacturing platform has gained significant traction in the cell and gene therapy field, currently used by over 800 organizations and producing drug products for approximately 50% of CGT clinical trials, as well as five commercially approved CGT drugs.
ScaleReady (搜索)'s G-Rex (搜索) Grant Program has awarded nearly 200 grants to date, with over 50 new applications in queue. The program has been extended with millions of dollars in additional funding to continue advancing cell and gene-modified cell therapy development and manufacturing.
Grant recipients gain access to exclusive support from ScaleReady (搜索)'s consortium of G-Rex (搜索) Grant Partners, who provide tools, technologies, and expertise in cGMP manufacturing, quality and regulatory affairs, and CGT business operations.
Collaborative Effort to Transform Cell Therapy Manufacturing
ScaleReady (搜索) is a collaboration between Wilson Wolf (搜索) Manufacturing, Bio-Techne (搜索) Corporation, and CellReady (搜索), focused on providing practical, flexible, and scalable manufacturing solutions for cell and gene therapies.
Wilson Wolf (搜索) is dedicated to simplifying CGT research, process development, and manufacturing through its scalable G-Rex (搜索) technology. Bio-Techne (搜索) creates media and cytokines specifically tailored to G-Rex Bioreactors, while CellReady (搜索) specializes in G-Rex-based cell and gene-modified cell therapy development and manufacturing services.
Through these strategic partnerships and grant programs, ScaleReady (搜索) aims to help CGT developers save time and reduce costs on the path to commercialization, ultimately bringing innovative cell therapies to patients more efficiently.