ENCell announced on the 18th that it has entered into a contract development and manufacturing organization (CDMO) agreement for clinical trial pharmaceuticals with CellInCells, a domestic organoid (mini organ) therapeutic developer.
Organoids are mini organs created using stem-cell and tissue-derived cells in a three-dimensional structure, allowing for the partial simulation of the structure and function of actual organs and enabling the reproduction of a physiological environment similar to human organs in the laboratory. In April, the U.S. Food and Drug Administration (FDA) announced it would reduce animal testing in the preclinical stage and promote alternative technologies like organoids.
CellInCells, with which ENCell has signed a contract, is an organoid regenerative therapeutic developer founded in 2014 by professor Jae-Jin Jo of Seoul National University’s School of Dentistry. The skin regeneration treatment ‘TRTP-101’ currently under development has confirmed its safety and efficacy as the first domestic organoid to be directly involved in therapeutic development in clinical phase 1. The company is developing a range of other organoid regenerative therapy products in addition to TRTP-101.
This contract also includes an additional stability test agreement separate from the client’s clinical pharmaceutical CDMO contract, and the main details including the contract amount are not disclosed in accordance with a confidentiality agreement between the two companies.
ENCell is the number one corporation in the domestic cell and gene therapy (CGT) CDMO sector by revenue and market share. In particular, it is the only corporation capable of simultaneously producing cells and viruses through globally standard Good Manufacturing Practice (GMP) facilities, allowing for differentiated production and quality management along with one-stop service.
Jang Jong-Wook, CEO of ENCell, noted, “Following last month’s CDMO order worth about 2 billion won, we are currently discussing with several corporations to expand the CDMO order scale in the second half of the year through our contract with CellInCells.” He added, “We are making efforts not only to secure orders but also to prioritize customer satisfaction and to obtain AAV CDMO orders, which we have identified as a next-generation opportunity.”
Jae-Jin Jo, CEO of CellInCells, said, “If TRTP-101 secures stable data on efficacy in clinical phase 2, it will present a new possibility as a fundamental treatment for scar therapy and could grow into a global corporation in the field of therapeutic organoids.”