Cellares and Cabaletta Bio Partner to Evaluate Automated Manufacturing on Cellares’ Cell Shuttle Platform
8 November 2023
Collaborations, Mergers & Acquisitions
Cellares, an Integrated Development and Manufacturing Organization (IDMO) and clinical-stage biotechnology company Cabaletta Bio, Inc. announced a collaboration to validate Cellares’ Cell Shuttle platform for manufacturing CABA-201.
The companies have agreed on a proof-of-concept technology transfer process for manufacturing CABA-201, Cabaletta’s clinical-stage fully human CD19-CAR T cell product candidate, using the Cell Shuttle.
“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.
The partnership is intended to evaluate automated manufacturing for CABA-210, Cabaletta’s CD19-CAR T cell therapy on Cellares’ Cell Shuttle platform. It is to be done through Cellares’ Technology Adoption Partnership (TAP) program.
“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,” Gerlinghaus continued.
TAP program offers cell therapy developers a swift and low-risk path to embrace the company’s automated manufacturing technology for their pipeline products. By employing this program, Cabaletta aims to thoroughly assess the automated manufacturing process and gather valuable data that will confirm the Cell Shuttle’s potential as an efficient manufacturing solution for CABA-201.
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 I/II clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis, and generalized myasthenia gravis.
CABA-201 is a human T cell investigational therapy that contains 4-1BB and has the potential to transiently, but completely, eliminate B cells throughout the body, offering a possible immune system reset for patients with autoimmune diseases. This therapy is being evaluated in Phase 1/2 clinical trials for its effectiveness against systemic lupus erythematosus, myositis, systemic sclerosis, and generalized myasthenia gravis.
Gwendolyn Binder, Ph.D., President of Science and Technology at Cabaletta expressed how the company is actively evaluating and pursuing means to efficiently scale manufacturing to meet the potential demands of patients and stated:
“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.”
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.
“Together, we’re not just enhancing manufacturing efficiency, but also fostering an environment that can facilitate the rapid advancement of life-altering therapies,” said Gerlinghaus.
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