First two GMP doses of rese-cel manufactured on the Cell Shuttle™ met all release specifications, were delivered on time, and have been infused into patients within Cabaletta Bio's RESET™ clinical trial program.

Cellares, the first Integrated Development and Manufacturing Organization (IDMO), today announced that Cabaletta Bio Inc.'s ("Cabaletta Bio" or "Cabaletta") (NASDAQ:CABA) investigational CAR T cell therapy rese-cel (resecabtagene autoleucel) has been infused into the first two patients using drug product manufactured on Cellares' Cell Shuttle™ automated manufacturing platform. The administration of an autologous cell therapy, which met all release criteria and was manufactured on an automated manufacturing platform, represents an important step on the journey to realizing a future where scalable manufacturing of autologous products to supply thousands of patients per year can be achieved with minimal capital investment and a low cost of goods.

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First Patients Dosed with Cabaletta Bio's Rese-cel Manufactured on Cellares' Automated Cell Shuttle™ Platform

While the transformative clinical benefits of autologous CAR T cell therapy are well established in oncology, the high manufacturing costs, lack of scalability, process inconsistency, and operational inflexibility associated with the current highly manual way of manufacturing have created meaningful barriers to patient access, reducing patient accessibility to these therapies. As autologous CAR T products continue to demonstrate compelling clinical impact on patients with autoimmune diseases, the challenges associated with achieving unprecedented scale have been magnified. The Cell Shuttle and Cell Q systems offer the potential of highly scalable production capacity that can be secured by biotech and pharmaceutical companies alike with minimal capital investment and a low cost of goods to address large market opportunities.

In 2023, Cabaletta recognized the potential of Cellares' fully automated, industrialized approach to fundamentally address the cost and scale challenges associated with autologous CAR T manufacturing. Over the past three years, the two companies collaborated closely to adapt the rese-cel manufacturing process to the Cell Shuttle and to generate comparability data across multiple process development and engineering runs, benchmarking the automated manufacturing process against Cabaletta's established process. The resulting dataset supported the submission and subsequent FDA clearance of an Investigational New Drug amendment to use the Cell Shuttle platform for clinical manufacturing of rese-cel.

"This is an important milestone that reflects focused collaboration between the teams at Cabaletta and Cellares since 2023," said Steven Nichtberger, M.D., Co-founder, Chairman, and Chief Executive Officer of Cabaletta Bio. "The dosing of these first two patients is an important demonstration of Cellares' GMP manufacturing and supply chain capabilities with their automated manufacturing platform and thus represents a significant achievement towards our goal of securing high-capacity flexible supply with minimal capital investment and a low cost of goods."

"This milestone is a transformative moment for the field of autologous cell therapy," said Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. "For years, the promise of autologous CAR T has been constrained by manufacturing models that were never designed to scale. The successful dosing of patients with rese-cel manufactured on the Cell Shuttle demonstrates that automation can deliver GMP drug products on time and within specification. This system can deliver autologous cell therapies at a scale and cost structure that makes these therapies accessible for much larger patient populations."

The Cell Shuttle's automated, end-to-end manufacturing workflow reduces manual touchpoints, minimizes variability, and enables standardized execution across runs, equipment, and facilities. When combined with the Cell Q™ high-throughput quality control and release testing platform, the integrated Cellares solution is designed to meet the demands of scalable commercial production while maintaining the rigorous quality standards required for clinical and commercial-scale use.

About Rese-cel

Rese-cel (formerly referred to as CABA-201) is an investigational, autologous CAR T cell therapy engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain, designed specifically for the treatment of autoimmune diseases. Administered as a single, weight-based infusion, rese-cel is intended to transiently and deeply deplete CD19-positive cells, with the goal of resetting the immune system and achieving durable clinical responses without the need for chronic therapy. Cabaletta is evaluating rese-cel in the RESET™ (REstoring SElf-Tolerance) clinical development program, which includes multiple ongoing company-sponsored trials across a diverse and growing range of autoimmune diseases in rheumatology, neurology and dermatology.

About Cabaletta Bio

Cabaletta Bio (NASDAQ:CABA) is a late-stage clinical 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 in 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 Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO), providing global cell therapy development and manufacturing services through an Industry 4.0 approach to the mass manufacture of the living drugs of the 21st century. The company enables biopharmaceutical partners to develop, scale, and commercialize cell therapies with the capacity, reliability, and economics required to meet total patient demand.

Cellares' fully automated platforms - Cell Shuttle™ for end-to-end cell therapy manufacturing and Cell Q™ for automated in-process and release quality control - are deployed across its network of IDMO Smart Factories worldwide. These technologies deliver industry-leading manufacturing economics, higher process success rates, and the ability to produce up to 10× more cell therapy batches than conventional CDMOs with comparable footprint and headcount, resulting in the lowest cost of manufacturing in the industry.

Headquartered in South San Francisco, California, Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities under construction in Europe and Japan. Through its global manufacturing network, Cellares is purpose-built to support both clinical and commercial programs and to expand access to life-saving cell therapies worldwide. For more information, visit www.cellares.com and follow Cellares on LinkedIn.

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