Cabaletta eyes commercialization through WuXi ATU expansion

The expanded agreement sees CDMO WuXi manufacture CAR-T therapy CABA-201, in preparation for commercialization and planned clinical trials.

Calabetta Bio and contract development manufacturing organization (CDMO) WuXi Advanced Therapies (WuXi ATU) initially partnered two years ago for the GMP manufacturing of cell therapies. Under the extended agreement, WuXi ATU will provide GMP manufacturing of CABA-201, a fully human CD19- chimeric antigen receptor (CAR) T-cell investigational therapy.

The investigational therapy aims to treat individuals with systemic lupus erythematosus and idiopathic inflammatory myopathies, or myositis. Additionally, the CDMO will support all  of Cabaletta’s upcoming clinical trials and will serve as the firm’s cell processing production partner for the MusCAARTes Phase I clinical trial of MuSK-CAART.

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“We have had a successful collaboration with WuXi ATU over the past two years for the GMP compliant production of novel cell therapies. Based on this initial collaboration, we chose to expand our partnership to include WuXi ATU as a manufacturer for our CABA-201 clinical programs,” said Gwendolyn Binder, president of Science and Technology at Cabaletta.

“WuXi ATU’s dedicated production capacity for CABA-201 supports our planned global expansion and commercial preparedness efforts and will enable us to dose patients in multiple clinical trials with separate parallel cohorts, while maintaining a capital-efficient manufacturing strategy.”

The CDMO, a subsidiary of WuXi AppTec – established in 2017 –  has been upping its cell and gene therapy (CGT) capabilities over recent years to meet client and market demands. In October 2022, WuXi ATU said it had its expanded its CGT testing capabilities in preparation for as many as 200 products reaching the market in the next seven years. Furthermore, in December 2021 the firm opened a testing facility in Philadelphia, US to cater for growing demand in the CGT space.

“We are delighted to expand our partnership with Cabaletta to advance the development of CABA-201 for patients with autoimmune diseases,” said David Chang, chief technology officer of WuXi ATU.

“We look forward to applying our expertise in cell and gene therapy manufacturing to better support our customers to bring potentially life-saving treatments faster to patients in need.”