Cellares and Cabaletta Bio Successfully Complete Manufacturing Technology Adoption Program for Rese-cel Using the Cell Shuttle™ Platform

Technology Adoption Program (TAP) program success demonstrates the ability of Cellares' IDMO Smart Factory to automate, lower costs and scale out manufacturing for Cabaletta Bio's clinical-stage CAR T program to treat patients with autoimmune diseases.

Cellares, the first Integrated Development and Manufacturing Organization (IDMO), has concluded the Technology Adoption Program (TAP) on its automated cell therapy manufacturing Cell Shuttle™ for resecabtagene autoleucel, (rese-cel, previously known as CABA-201). Rese-cel is the lead clinical candidate in development by Cabaletta Bio, a biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. This successful collaboration facilitates the opportunity to engage in a clinical and commercial manufacturing relationship.

Cellares' TAP assessed the feasibility of using Cellares' innovative Cell Shuttle platform to automate the manufacturing of Cabaletta's rese-cel drug product, a CD19-targeting CAR T cell therapy designed to treat patients with a broad range of autoimmune diseases. The TAP successfully delivered automated, concurrent manufacture of multiple rese-cel batches on a single Cell Shuttle. Cabaletta Bio and Cellares are now working towards the goal of manufacturing cGMP cell therapy batches to be delivered to patients. The Cellares network of global IDMO Smart Factories planned for the US, Europe, and Japan has the potential to provide Cabaletta Bio with the ability to automate, lower costs, and scale out manufacturing. Additionally, this partnership may facilitate global expansion of rese-cel via rapid technology transfer to additional IDMO Smart Factories. This has the potential to allow Cabaletta Bio to achieve the global scale required to meet the total patient demand across multiple autoimmune diseases, including 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.), in a fraction of the time and initial investment it would typically take to develop and deliver global supply for these large patient populations.

Cellares' Cell Shuttle performed all unit operations in an automated manner, including cell isolation, enrichment, gene editing, activation, and expansion. Each unit operation met predefined in-process requirements. The automated process delivered drug products that met pre-defined quality ranges.

"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. I believe that the potential increase in capacity, meaningful reduction in costs, and rapid global technology transfer offers a potential solution for the global scale out of rese-cel for patients with autoimmune disease," said Gwendolyn Binder, President, Science and Technology at Cabaletta Bio. "We look forward to continuing our work together to complete activities required to enable use of the Cell Shuttle in clinical trials to support the delivery of these potentially curative autologous therapies to more patients with autoimmune diseases."

"The success of this Technology Adoption Program (TAP) 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 next-generation automation," said Fabian Gerlinghaus, CEO of Cellares. "We are excited to contribute to the advancement of rese-cel and the delivery of life-changing therapies to patients worldwide."

Cellares IDMO Smart Factories allow clients to effectively realize economies of scale even at the low batch numbers required by clients in early clinical development. As clinical development proceeds and the number of batches required grows, the technology allows for the seamless expansion of manufacturing capacity up to commercial volumes of cell therapy batches. These capabilities have the potential to enable Cabaletta Bio to meet the large total global demand from patients with autoimmune disease.

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.

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