GC Cell Corporation and Taiwan-based Lukas Biomedical has formally signed an international strategic cooperation agreement. GC Cell is a fully integrated pioneer in cell and gene therapy and a subsidiary of Korean-listed pharmaceutical group GC Biopharma Corp.

This collaboration aims to increase awareness of autologous T cell therapy as well as to expand the patient access market through leveraging each other's strengths in innovative cell treatment areas. By sharing cutting-edge research projects, clinical trial data, regulatory knowledge across multiple countries, and exploring clinical research, market development, and various activities for cancers and other challenging diseases, both parties strive to accelerate drug development and establish a platform for precision medicine solutions. This partnership seeks to bring the benefits of innovative cell therapy to a wider range of patients.

Having successfully completed clinical trials in Japanand Korea, GC Cell's Immuncell-LC autologous T cell therapy obtained approval from the Ministry of Food and Drug Safety (MFDS) in 2007 following favorable Phase IV trials. With a track record of over 10,000 treatment cases, GC Cell has been obtaining successful clinical and commercial records in Korea. Lukas's LuLym-T memory T cell cultivation technology originated from Japanese National Cancer Center and GC LTEC, formerly Lymphotec, a subsidiary of Green Cross Group. Based on the licensing agreement with originator of the technology and the tech transfer from the company, Lukas has brought this technology to Taiwan for market expansion and further enhancement.

Taiwan's government has demonstrated significant commitment to the advancement of the regenerative medicine sector. Following the implementation of the Special Regulations on Regenerative Medicine, the Regenerative Medicine Act was enacted on June 4 this year. Lukas's LuLym-T cell therapy technology, supported by international clinical trials and evidence-based data generated by GC Cell, aligns closely with Taiwan governmental policies and regulations. It appears poised to secure a five-year conditional approval under the new regulations, thus establishing Lukas as a prominent player in Taiwan's cell therapy landscape, with a focus on domestic growth and global market expansion.

Presently, Lukas has entered agreements with 13 medical institutions, including National Taiwan University Hospital, Chang Gung Memorial Hospital, and Taipei Veterans General Hospital, to conduct Phase II clinical trials focused on preventing liver cancer recurrence and exploring combined immunotherapy with chemotherapy/radiotherapy for head and neck cancer at Taipei Veterans General Hospital.