-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.

“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.”

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.