• Collaboration with intent to validate Cellares’ Cell Shuttle platform for manufacturing of CABA-201, Cabaletta Bio’s fully human CD19-CAR T product candidate, which is being evaluated in parallel phase 1/2 trials across multiple autoimmune diseases

SOUTH SAN FRANCISCO, Calif. / Nov 06, 2023 / Business Wire / Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, and Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced Cabaletta will evaluate Cellares’ automated manufacturing platform, the Cell Shuttle™, through Cellares’ Technology Adoption Partnership (TAP) program. As part of the collaboration, the companies have agreed on a proof-of-concept technology transfer process for the manufacture of CABA-201, Cabaletta’s clinical-stage fully human CD19-CAR T cell product candidate, using the Cell Shuttle.

Chimeric antigen receptor (CAR) T cell therapy is a personalized immunotherapy that involves collecting and genetically engineering a patient’s own T cells to bind and eliminate disease-causing cells. CABA-201 is a 4-1BB-containing fully human CD19-CAR T cell investigational therapy with the potential to transiently, but completely, eliminate B cells throughout the body, potentially enabling an immune system reset in patients with autoimmune disease. CABA-201 is currently under evaluation in Phase 1/2 clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis, and generalized myasthenia gravis.

“As we continue to pursue our goal of developing and launching the first targeted curative cellular therapies for patients with autoimmune diseases, we are actively evaluating and pursuing means to efficiently scale manufacturing in order to meet the potential demand from patients,” said Gwendolyn Binder, Ph.D., President of Science and Technology at Cabaletta. “Cellares has made impressive progress with their automated cell therapy manufacturing capabilities. Their dedication to deploying these technologies at scale aligns well with our goal of bringing potentially transformative therapies to patients with autoimmune diseases.”

“This partnership enables us to leverage the unique capabilities of our Cell Shuttle platform to accelerate the production of CABA-201, Cabaletta Bio's innovative CD19-CAR T product candidate,” said Fabian Gerlinghaus, CEO of Cellares. “Through our Technology Adoption Partnership program, we aim to fully automate all cell therapy manufacturing processes, thereby bringing us a step closer to potentially delivering CAR T cell therapies for patients with a broad range of autoimmune diseases. Together, we're not just enhancing manufacturing efficiency, but also fostering an environment that can facilitate the rapid advancement of life-altering therapies.”

Cellares’ TAP program offers cell therapy developers a swift and low-risk path to embrace the company’s automated manufacturing technology for their pipeline products. Cabaletta is utilizing this program to assess the automated manufacturing process and generate data that validates the Cell Shuttle’s viability as a manufacturing option for CABA-201. Cellares partners with leading developers through its TAP program to integrate the Cell Shuttle as a GMP manufacturing solution for pre-clinical, clinical and commercial-stage cell therapies at their IDMO Smart Factories.

Cellares’ innovative manufacturing technology transforms autologous and allogeneic cell therapy processes, covering nearly 90% of cell therapy modalities. Through its TAP program, Cellares can facilitate the automation and tech transfer of manual processes onto the Cell Shuttle manufacturing platform in just six months. This program allows cell therapy developers to seamlessly integrate their processes onto a Cell Shuttle at any stage of development – from pre-clinical to post-regulatory approval. With automation, standardization, and software-defined manufacturing (SDM), subsequent tech transfers become instant to any other Cell Shuttle in any IDMO Smart Factory worldwide.

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 both 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. Cell Shuttles will be deployed in Cellares’ Smart Factories worldwide to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.

The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.

For more information about Cellares, please visit cellares.com.

About Cabaletta Bio

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis; and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: Cabaletta’s ability to advance its autoimmune-focused pipeline; Cabaletta’s expectations around the potential success and therapeutic benefits of CABA-201; the Company’s Phase 1/2 clinical trials of CABA-201 in subjects with systemic lupus erythematosus, myositis, systemic sclerosis, and generalized myasthenia gravis; the planned collaboration between Cellares and Cabaletta and technology transfer process for the manufacture of Cabaletta’s CD19-CAR T cell investigational therapy; the anticipated benefits and timing of Cellares' automated manufacturing platform; and other statements that are not historical fact. These statements are based on Lyell's current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to:

Any forward-looking statements in this press release are based on the Company’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to regulatory filings and potential clearance; the risk that signs of biologic activity or persistence may not inform long-term results; Cabaletta’s ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its preclinical studies and clinical trials; risks related to clinical trial site activation or enrollment rates that are lower than expected; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to volatile market and economic conditions and public health crises; Cabaletta’s ability to retain and recognize the intended incentives conferred by Orphan Drug Designation and Fast Track Designation for its product candidates, as applicable; risks related to Cabaletta’s ability to protect and maintain its intellectual property position; risks related to fostering and maintaining successful relationships with Cabaletta’s collaboration and manufacturing partners; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; the risk that any one or more of Cabaletta’s product candidates will not be successfully developed and/or commercialized; and the risk that the initial or interim results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Cabaletta’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta’s other and subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.