Cabaletta Bio and Cellares Partner to Automate Manufacturing of CABA-201 CAR-T Therapy for Autoimmune Diseases

Nov 07, 2023 11:27 CST Updated 11:27

Cellares

Integrated Developer and Manufacturer of Cell Therapy

Cabaletta Bio

Targeted Cell Therapy Developer

IASO Biotechnology

Cancer Treatment New Drug Developer

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On November 6, Cellares, an automated cell therapy manufacturing company, partnered with Cabaletta Bio, a cell therapy firm. Cabaletta will utilize Cellares’ Cell Shuttle platform to automate the production of its CAR-T therapy, CABA-201.

Click the video to watch the Cell Shuttle production process.

Cell Shuttle

Cell Shuttle is shaped like a "box," so it is also called a "box-style factory." The device consists of hardware, software, robotics, and consumables, using automation technology to collect patient cells, redesign them, and rapidly produce finished products.

Currently, the device canSimultaneously process 16 batches of cell therapies, reduce failure rates by 75%, labor by 90%, facility footprint by 90%, manufacturing costs by an average of 65%, and support 90% of cell therapies, truly achieving commercial-scale production of cell therapies..It can even shorten the time for cell therapy to go from R&D to market by up to 1-2 years.

Cellares has 2 smart factories in the United States. In August 2023, Cellares completed a $255 million Series C financing round.For the construction of the 3rd smart factoryThe factory, located in Bridgewater, New Jersey, spans 118,000 square feet and can accommodate 50 Cell Shuttles, with an annual production capacity of 40,000 batches.Productivity is 10 times higher compared to traditional CDMO facilities.。

CAR-T Therapy CABA-201

CABA-201 is a CD19 CAR-T cell therapy containing the 4-1BB co-stimulatory domain.It is reported that its CD19 binder is exclusively licensed from IASO Bio.

In April 2023, the FDA approved the Investigational New Drug (IND) application for CABA-201, initiating a Phase 1/2 clinical trial for the treatment of active lupus nephritis or active systemic lupus erythematosus without renal involvement. On November 6, the FDA approved the IND application for CABA-201 for the treatment of generalized myasthenia gravis.

CABA-201 can "reset" a patient's immune system by eliminating B cells in the body.

CXO (Contract Outsourcing Services in the pharmaceutical industry) companies mainly provide CRO, CMO, and CDMO services. A few large companies, such as WuXi AppTec, can offer both CRO and CDMO services simultaneously, referred to as CRDMO. However, services for different projects are often relatively independent, phased, and not highly integrated.DistrictUnlike traditional models, the "Integrated Development and Manufacturing Organization" (IDMO) is expected to overcome the limitations of traditional CDMOs and create production services with a higher level of integration.

About Cellares

Cellares is an automated cell therapy manufacturing service provider and the world's first IDMO, focusing on developing methods for scaling up cell therapy production. Cell Shuttle is an end-to-end automated device developed by Cellares that enables the creation of highly personalized cell therapies.

About Cabaletta Bio

Cabaletta Bio, Inc. was incorporated in April 2017 under the laws of the State of Delaware. The company is a clinical-stage biotechnology company focused on discovering and developing engineered T cell therapies for B cell-mediated autoimmune diseases.

R&D Pipeline

References:

[1]https://www.cellares.com/news/cellares-and-cabaletta-bio-partner-to-evaluate-automated-manufacturing-for-caba-201-cabalettas-cd19-car-t-cell-therapy-on-cellares-cell-shuttle-platform/

[2]https://www.cabalettabio.com/news-media/press-releases/detail/99/cabaletta-bio-receives-fda-clearance-of-caba-201-ind