- TED-A9 is an allogeneic cell therapy in development for Parkinson’s disease
- Program builds on S.Biomedics’ growing pipeline of stem-cell-based therapies
TAMPA, Fla. & SEOUL, South Korea–(BUSINESS WIRE)–Catalent and S.Biomedics today announced a strategic partnership to support the development and manufacturing of TED‑A9, S.Biomedics’ allogeneic pluripotent stem-cell-derived ventral midbrain–specific dopaminergic precursor cell therapy being developed for the treatment of Parkinson’s disease.
TED‑A9 represents S.Biomedics’ ambition to deliver a new class of regenerative medicine for patients with Parkinson’s disease. The program reflects years of development using S.Biomedics’ proprietary targeted embryonic stem cell differentiation (TED) platform and builds on the company’s growing clinical pipeline of stem‑cell–based therapies.
“Initiating our first U.S. clinical study, which is designed as a pivotal trial, represents a critical step toward delivering new treatment options to patients,” said Tony Kang, chief executive officer of S.Biomedics. “We are pleased to partner with Catalent, a global leader in cell therapy CDMO services, as we establish a scalable, GMP‑ready manufacturing foundation to support pivotal development and enable a potential path toward future commercialization, with the ultimate goal of bringing hope to patients and families affected by Parkinson’s disease worldwide.”
“Catalent’s advanced cell therapy development and manufacturing capabilities are designed to help innovators like S.Biomedics move confidently through pivotal studies toward commercial readiness,” said David McErlane, Group President, Biologics at Catalent. “We are proud to work together to build a robust, scalable foundation that can accelerate access to this promising therapy for patients and families worldwide.”
Catalent will leverage its global network and deep expertise in cell therapy development, analytical services, and GMP manufacturing to support TED-A9. Catalent’s integrated platforms and iPSC/ESC experience position the company to accelerate programs like TED-A9 from early development through clinical and commercial launch.
About S.Biomedics
S.Biomedics Co., Ltd. is a leading stem cell therapy innovator specializing in regenerative medicine. Leveraging two core proprietary platforms—including its TED technology—the company is advancing a pipeline of seven cell therapy programs targeting intractable diseases, with several candidates currently in clinical development. More information on the TED-A9 (A9-DPC) Phase 1/2a clinical trial for Parkinson’s disease is available at ClinicalTrials.gov (NCT05887466). For more information, visit www.sbiomedics.com/eng/.
About Catalent
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers’ needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.
Contacts
Media Contact:
Catalent
Laura Hortas, Vice President, Corporate Communications
[email protected]
S.Biomedics
Kyu Yeon Han, Manager, Development
[email protected]
