ENCell rides high on emergence of CAR-T therapies like Kymriah and Carvykti
ENCell, a contract manufacturer of semi-finished products of CAR-T therapies Kymriah (tisagenlecleucel) and Carvykti (ciltacabtagene autoleucel) for global pharmaceutical companies, is showing tangible results in line with the expansion of the CAR-T drug market.
The company said Tuesday that it has been awarded an additional contract to supply semi-finished products for CAR-T therapeutics from a global pharmaceutical company it has been working with.
ENCell explained that it had completed the supply of semi-finished products for two clinical trials of CAR-T therapeutics to the global pharmaceutical company since 2021, and based on the trust built through this, it won a third project last Thursday. However, the company did not disclose the specific products or details under the contract terms.
“The additional order was possible because global pharmaceutical companies have recognized our GMP production and management level through long-term cooperation,” an ENCEL official said. “We are also receiving inquiries from new global pharmaceutical companies conducting CAR-T trials in Korea.”
A semi-finished product of CAR-T (chimeric antigen receptor T-cell) therapy is a drug that has reached a certain stage in the complex manufacturing process before it is offered as a final finished product. CAR-T therapies are made by extracting a patient's T-cells, genetically modifying them, and growing them in vitro. A semi-finished product has reached a particular stage before quality control and further processing to become a finished product.
These semi-finished products are mainly produced by contract development and manufacturing organizations (CDMOs) and supplied to pharmaceutical companies, which ultimately customize and provide them to patients.
In 2021, ENCell became the first company in Korea to produce semi-finished CAR-T therapeutics for clinical trials with Samsung Medical Center. Currently, it has been designated as a central cell processing center (CCPC) for CAR-T therapeutics by global pharmaceutical companies, such as Novartis and Janssen, and is contract manufacturing semi-finished products for commercial and phase 3 B-cell lymphoma therapies.
In January 2021, ENCell was designated CAR-T CCPC for both companies. In April 2022, the company opened Novartis' Kymriah Korea CCPC at its GMP Plant 2.
GMP Plant 1 (580 square meters) at Samsung Medical Center in Gangnam-gu, Seoul, has aseptic processing rooms and pretreatment rooms to produce clinical-grade stem cells, immune cells, and exosome therapies. GMP Plants 2 and 3 (totaling 4,604㎡) in Hanam, Gyeonggi Province, have negative and positive pressure facilities. The second plant produces clinical-grade CAR-T and CAR-NK anticancer therapies, and the third produces clinical-grade gene therapy viral vectors.
By the end of November, ENCell will have produced 195 semi-finished CAR-T therapeutic products for clinical trials and commercialization and will reach 200 by December.
Securities analysts are also positive. In a report in October, SK Securities analyst Heo Sun-jae said, “ENCell is the No. 1 (60 percent market share) CMO specializing in CGT in Korea, having won 33 projects from 17 companies, including the domestic production of semi-finished products for Novartis and Janssen's CAR-T drugs Kymriah and Carvykti.”
“Future growth is expected to be driven by new orders and the progression of existing orders to the clinical stage,” Heo said. “Most of the projects are currently in phase I of IND approval and will advance to phase 2 next year, and revenue is expected to increase as clinical scale expands.”
The analyst added that when the fourth plant expansion is completed, ENCell’s annual production value will double from 50 billion won ($35.6 million) to 100 billion won.