Cellares and Cabaletta Bio Successfully Complete Technology Adoption Program for Rese-cel Using Cell Shuttle™ Platform
Cellares, the first Integrated Development and Manufacturing Organization (IDMO), has successfully concluded the Technology Adoption Program (TAP) for its innovative automated cell therapy manufacturing platform, the Cell Shuttle™. The program focused on the production of resecabtagene autoleucel (rese-cel, formerly known as CABA-201), Cabaletta Bio’s lead clinical candidate. Rese-cel is a CD19-targeting CAR T-cell therapy designed to treat autoimmune diseases. This successful partnership marks an important step in the ongoing development of curative targeted cell therapies for patients suffering from a variety of autoimmune conditions.
Streamlining Rese-cel Manufacturing with Cell Shuttle™
The Technology Adoption Program was designed to assess the feasibility of utilizing Cellares’ Cell Shuttle platform to automate the manufacturing process for Cabaletta Bio’s rese-cel drug product. As part of the TAP, Cellares demonstrated the capability of its platform to concurrently manufacture multiple batches of rese-cel on a single Cell Shuttle, a key achievement in automating the production of CAR T-cell therapies. This success opens the door for Cabaletta Bio to scale its production, reduce manufacturing costs, and rapidly expand the reach of rese-cel to treat autoimmune diseases globally.
Rese-cel, which is designed to treat patients with a range of autoimmune diseases, is one of Cabaletta Bio’s most promising therapeutic candidates. The automation of its production could help expedite clinical trials and move toward large-scale manufacturing to meet the needs of patients worldwide. The companies are now focused on achieving the goal of producing current Good Manufacturing Practice (cGMP) cell therapy batches, which will be delivered to patients as part of the ongoing clinical development process.
Expanding Manufacturing Capabilities for Global Reach
Cellares’ innovative Cell Shuttle platform offers a unique advantage by enabling a more scalable and cost-effective solution for the manufacturing of cell therapies like rese-cel. With Cellares’ network of IDMO Smart Factories planned in the U.S., Europe, and Japan, Cabaletta Bio can leverage these facilities to automate production, reduce costs, and increase manufacturing capacity. This partnership also provides an opportunity for rapid technology transfer to additional Smart Factories, which could facilitate global expansion of rese-cel.
This expansion is crucial as Cabaletta Bio seeks to address the needs of a broad patient population with autoimmune diseases. Autoimmune diseases such as myositis (~70,000 patients in the U.S.), scleroderma (~90,000 patients in the U.S.), and lupus nephritis (~100,000 patients in the U.S.) all present significant treatment challenges. By utilizing Cellares’ automated manufacturing platform, Cabaletta Bio can scale production more quickly and efficiently, reducing the time and investment typically required to deliver global supply for such large patient populations.
Automated Manufacturing Achieves Critical Milestones
Cellares’ Cell Shuttle platform is designed to automate all key steps in the cell therapy manufacturing process, including cell isolation, enrichment, gene editing, activation, and expansion. Throughout the TAP, the Cell Shuttle platform successfully met predefined in-process requirements for each of these operations, delivering drug products that met quality specifications.
Gwendolyn Binder, President of Science and Technology at Cabaletta Bio, commented on the success of the program: “Through our partnership with Cellares, our teams have successfully achieved proof of concept for the ability to automate the rese-cel cellular drug substance manufacturing process. The potential to increase capacity, reduce costs, and facilitate rapid global technology transfer offers a promising solution for scaling out rese-cel for patients with autoimmune diseases. We look forward to continuing our work with Cellares to support the delivery of these potentially curative therapies to more patients.”
A Partnership Focused on Innovation and Scalability
The success of the TAP highlights the potential for small biotech companies to collaborate with Cellares and benefit from next-generation automation technologies. Fabian Gerlinghaus, CEO of Cellares, praised the partnership and the significant progress made during the program: “The success of this Technology Adoption Program demonstrates the effectiveness of the Cell Shuttle as a scalable, automated, and cost-effective platform for the manufacturing of cell therapies. Working with Cabaletta Bio proves that small biotech companies can successfully partner with Cellares to benefit from the latest advancements in automation. We are excited to contribute to the advancement of rese-cel and the delivery of life-changing therapies to patients worldwide.”
Meeting the Global Demand for Autoimmune Disease Therapies
The integration of Cellares’ Cell Shuttle platform into the drug manufacturing process offers significant potential for meeting the global demand for autoimmune disease therapies. Cellares’ IDMO Smart Factories are designed to scale seamlessly, enabling clients to efficiently meet the needs of both early clinical trials and later-stage commercial production. As clinical development progresses and the demand for rese-cel increases, the ability to rapidly scale production to meet commercial volumes will be critical.
Cellares’ platform allows for efficient scaling, even when dealing with low batch numbers required during early clinical development stages. As the clinical pipeline advances, the technology facilitates the smooth expansion of manufacturing capacity to meet the increasing global demand for rese-cel and similar cell therapies. This capability is crucial for Cabaletta Bio as it works to address the needs of autoimmune disease patients worldwide.
Conclusion
The successful completion of the Technology Adoption Program marks a major milestone in the development of rese-cel and the future of automated cell therapy manufacturing. By partnering with Cellares, Cabaletta Bio can now scale up production, reduce costs, and accelerate the global delivery of potentially life-saving therapies for autoimmune diseases. With the ability to automate and expand manufacturing capacity across multiple regions, this collaboration represents a significant step forward in the field of cell therapies, offering the potential to meet the needs of a global patient population.
About Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle™ integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation.
While the Cell Shuttle automates cell therapy manufacturing, the Cell Q™ automates quality control both for in-process and release testing. Cell Shuttles™ and Cell Qs™ will be deployed in Cellares’ Smart Factories around the world, enabling each Smart Factory to produce 10 times as many cell therapy batches as a conventional CDMO with the same facility size and headcount. Partnering with Cellares enables early-stage cell therapy developers advantages of immediate, small-volume economies of scale as well as the ability to scale seamlessly to meet the total global patient demand for commercially approved therapies.
The company is headquartered in South San Francisco, California with its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. Cellares is building a global network of IDMO Smart Factories with additional facilities under construction in Europe and Japan. The company is backed by world-class investors and has raised over $355 million in financing.
About Cabaletta Bio
Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy.
Rese-cel is currently being evaluated with a single weight-based dosing regimen across the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.
About rese-cel
Rese-cel is a 4-1BB-containing fully human CD19-CAR T cell investigational therapy for patients with autoimmune diseases where B cells contribute to the initiation and/or maintenance of disease. Following a one-time infusion of a weight-based dose, rese-cel is designed to transiently and deeply deplete all CD19-positive cells in both the peripheral circulation and within tissues. This approach has the potential to reset the immune system and result in profound clinical responses without chronic therapy requirements in patients. Cabaletta is currently evaluating rese-cel in the RESET™ (REstoring SElf-Tolerance) clinical development program which includes multiple disease-specific, company-sponsored clinical trials across expanding portfolios of autoimmune diseases in a broad range of therapeutic areas, including rheumatology, neurology and dermatology.
For more information about Cellares, please visit cellares.com.
