Cartherics Pty Ltd and Catalent have signed an amended commercial license agreement enabling the use of a Catalent cGMP‑compliant induced pluripotent stem cells (iPSC) line for the manufacture and commercialization of Cartherics’ iPSC-derived Chimeric Antigen Receptor Natural Killer (CAR-NK) cell therapies. The agreement supports Cartherics’ mission to develop immune cell therapy products for the treatment of cancer and endometriosis.
Dr. Ian Nisbet, CEO of Cartherics, commented, “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. We are confident that our collaboration with Catalent will underpin cost-effective manufacturing of our products.”
“We are thrilled to broaden our partnership with Cartherics and support the important work the company is doing to develop Natural Killer cells for the treatment of cancer,” said David McErlane, Biologics Group President for Catalent. “Our teams are highly engaged in achieving positive outcomes across all stages of development, and we look forward to advancing Cartherics’ program toward commercialization.”
Under the terms of the agreement, Cartherics is granted rights to develop and commercialize multiple product candidates derived from a Catalent off-the-shelf cGMP iPSC line, including its lead CAR‑NK cell product, CTH‑401. The licensed iPSC line is part of a broader portfolio of fully characterized, donor‑consented, clinical‑grade iPSC lines generated under GMP conditions, supported by validated workflows for reprogramming, expansion, gene editing, differentiation and quality control.
With Catalent’s support, Cartherics has already obtained approval from the U.S. Food and Drug Administration (FDA) for use of the licensed iPSC line as the starting cell for generation of Cartherics’ CTH‑401. The two companies have also demonstrated full compatibility between CTH-401 and Catalent’s iPSC-NK manufacturing platform.
The agreement enhances Cartherics’ manufacturing capabilities by providing a robust framework for collaboration and incentives for utilizing Catalent as its contract manufacturing organization for late-stage clinical trials and commercial supply. Importantly, Cartherics retains the ability to manufacture clinical trial material and retains the right to participate in downstream manufacturing as the partnership evolves.