- Cartherics and Catalent have expanded their partnership through a commercial license agreement for iPSC-based CAR-NK cell therapy manufacturing.
- The agreement supports development and commercialization of multiple cell therapy candidates, including lead program CTH-401.
Cartherics Pty Ltd has expanded its partnership with Catalent through an amended commercial license agreement to support the development and manufacturing of its cell therapy pipeline. The agreement enables Cartherics to use Catalent’s cGMP-compliant induced pluripotent stem cell (iPSC) line for the manufacture and commercialization of CAR-NK therapies.
The collaboration focuses on advancing off-the-shelf immune cell therapies targeting conditions such as ovarian cancer and endometriosis. Under the agreement, Cartherics gains rights to develop and commercialize multiple product candidates derived from Catalent’s iPSC platform, including its lead program, CTH-401.
Catalent’s iPSC line is part of a portfolio of clinical-grade, donor-consented cell lines developed under GMP conditions. The platform supports key processes including gene editing, expansion, differentiation, and quality control. The companies also confirmed that the iPSC line has received U.S. Food and Drug Administration approval as a starting material for CTH-401, and compatibility has been demonstrated with Catalent’s iPSC-NK manufacturing platform.
The agreement is structured to support Cartherics’ manufacturing strategy, including incentives to utilize Catalent as its contract development and manufacturing organization (CDMO) for late-stage clinical trials and commercial supply. At the same time, Cartherics retains the ability to manufacture clinical trial materials and participate in downstream manufacturing activities.
“We are delighted to have established a collaborative relationship with Catalent, a leading cell and gene therapy CDMO, to expedite the development of our CAR-NK cell products.”
Dr. Ian Nisbet, CEO of Cartherics
