Cellares and Cabaletta Bio Sign 10-Year Commercial Supply Agreement to Scale Rese-cel

• Agreement positions Cellares as a long-term commercial manufacturing partner for rese-cel, enabling thousands of batches per year at a cost per batch that is among the lowest in the industry
• Cellares’ Cell Shuttle™ and Cell Q™ platforms can support future commercial production of rese-cel for thousands of patients per year, pending FDA approval, across a global network of IDMO Smart Factories

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cellares, the first Integrated Development and Manufacturing Organization (IDMO), today announced it has entered into a 10-year commercial supply agreement with Cabaletta Bio Inc. (Nasdaq: CABA) for the automated manufacture of rese-cel (resecabtagene autoleucel), Cabaletta’s investigational CAR T cell therapy for autoimmune diseases. The agreement secures the long-term manufacturing capacity and supply predictability required to address the global patient demand for rese-cel and follows the companies’ landmark first patient dosing milestone, in which patients were dosed for the first time with an autologous CAR T therapy manufactured on an automated platform.

Autologous CAR T cell therapies have demonstrated transformative potential in both oncology and, increasingly, in autoimmune diseases, a therapeutic area where eligible patient populations can be orders of magnitude larger than those in blood cancers. Achieving commercial scale in these larger indications demands a manufacturing infrastructure capable of producing thousands of batches annually with consistent quality, fast turnaround, and a cost structure that enables broad patient access. The Cell Shuttle’s fully automated capability, closed-system manufacturing workflow, combined with Cell Q’s automated quality control and release testing capability, is designed to deliver up to 10× higher throughput than conventional CDMO approaches with comparable footprint and headcount.

“The first two doses of rese-cel manufactured on the Cell Shuttle met all release specifications and were delivered and infused on time to patients in the RESET clinical program, validating the automated manufacturing model and supply chain logistics we committed to in 2023. For a company developing potentially curative therapies for autoimmune diseases, where the addressable patient population can far exceed that in oncology, scalability, reliability, and cost efficiency are important considerations. This 10-year commercial agreement with Cellares provides the cost-efficient foundation we need to expand access to rese-cel while building a profitable business,” said Steven Nichtberger, M.D., Chief Executive Officer, Cabaletta Bio.

“Cell therapy has proven it has the potential to transform patients’ lives. For years, autologous cell therapies were constrained by manual processes that had difficulty scaling to meet commercial demand. This 10-year agreement represents a fundamental shift toward automated manufacturing that is demonstrably ready. That is exactly what we built Cellares for,” said Fabian Gerlinghaus, Co-founder and Chief Executive Officer, Cellares.

The agreement builds on more than three years of collaboration in which the companies adapted the rese-cel manufacturing process to the Cell Shuttle, secured FDA clearance of an IND amendment for clinical manufacturing using the Cell Shuttle, and dosed the first patients with GMP drug product that met all release specifications. This commercial supply agreement is the next step in a partnership built on rigorous scientific collaboration and demonstrated manufacturing performance.

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 has demonstrated the ability to transiently, reliably 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 broad 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 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 drug sponsors 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. The Cell Shuttle™ is the first cell therapy manufacturing platform to receive the FDA's Advanced Manufacturing Technology (AMT) designation, and has demonstrated a 100% automation success rate across more than a dozen automated processes.

Cellares has achieved key clinical validation milestones, including FDA clearance of IND Amendments enabling active clinical manufacturing on the Cell Shuttle™ platform, and the successful dosing of first patients in partner clinical trials — marking the platform's transition from development-stage technology to clinically validated manufacturing infrastructure. These milestones span multiple therapeutic areas and cell therapy modalities, including both oncology and autoimmune indications.

Headquartered in South San Francisco, California, Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities in Leiden, the Netherlands, and Kashiwa City, 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.