Catalent, S.Biomedics partner on stem-cell therapy for Parkinson’s

Catalent, a global contract development and manufacturing organization (CDMO), and stem cell therapy company S.Biomedics announced a strategic partnership to support development and manufacturing of TED-A9, an allogeneic pluripotent stem-cell-derived dopaminergic precursor therapy in development for Parkinson’s disease.

TED-A9 is derived from S.Biomedics’ targeted embryonic stem cell differentiation platform and is being advanced toward a U.S. clinical study designed as a pivotal trial. Under the agreement, Catalent will leverage its global cell therapy network, analytical services, and GMP manufacturing capabilities — including experience with induced pluripotent stem cells and embryonic stem cells — to help establish a scalable manufacturing foundation to support clinical development and potential commercialization.

The partnership follows a period of transition within Catalent’s cell and gene therapy operations. Last month, the company announced plans to close its Gosselies, Belgium, cell therapy and plasmid DNA site amid a reported decline in production, while evaluating transitions of certain programs to other facilities in its network. 

Despite the move, Catalent executives have said the fundamentals of the biologics business remain strong and that the company continues to invest in cell and gene therapy capabilities under its ownership by Novo Holdings.

Also in January, Catalent entered a nonexclusive license agreement with SmartCella to use its proprietary GMP-compliant iPSC platform to support development of regenerative therapies targeting cardiac disease and Parkinson’s disease. 

The company has continued to advance its SMARTag antibody-drug conjugate platform, recently introducing enhanced dual- and triple-payload ADC technologies and presenting preclinical data for a MUC1-targeting ADC candidate, as it expands capabilities across advanced biologics modalities.