바이오스펙테이터

by Jongwon Jang

SCM LifeScience expanded its field of business into the field of next-generation immuno-cytological therapeutics, such as dendritic cell (DC)-based vaccines against cancers and CAR-CIK, during the past 2 years. Further, the company succeeded in preoccupation of the ‘cGMP Facilities for Cell Therapy Products’ for which a large-scale investment is currently in progress to secure core competencies in the future market of cell therapy products.

Last February, SCM LifeScience acquired major assets in Argos Therapeutics Inc. located in North Carolina, USA, with Genexine, including production facilities for cell therapeutics, researchers, and intellectual properties. Argos Therapeutics Inc., founded in 1999, currently operates its cGMP facilities, and has conducted Phase III Clinical Trials in Europe and USA.

Upon acquisition of Argos Therapeutics Inc., SCM LifeScience changed its name to CoImmune with Genexine, and successfully remobilized cGMP facilities after six months from the acquisition, and demonstrated its operational capability as a local establishment. Thereafter, CoImmune acquired the FDA (USA) approval of Phase IIb Clinical Trial protocol for the dendritic cell (DC)-based anticancer vaccine, the 'CMN-001', last February, for patients suffering from terminal stage metastatic renal cell carcinoma (mRCC).

SCM LifeScience conducted a new M&A after one year from the acquisition of CoImmune. CoImmune concluded the agreement of M&A with Formula Pharmaceuticals Inc. last January. The Formula Pharmaceuticals Inc. is an Italian company developing new drugs. It currently develops the CAR-CIK (Cytokine-Induced Killer Cell) therapeutics. To address the commercial limitations of current CAR-T therapeutics owing to high price and adverse effects, the next-generation CAR-CIK therapeutic is based on the umbilical cord blood of healthy persons other than patient’s blood, and avoids viral contamination.

The Phase I Clinical Trial of CAR-CIK for patients diagnosed with acute lymphoblastic leukemia conducted in Italy showed positive results. The trial comprised 13 subjects who underwent open-label, single group Phase I trials, and increased dosage resulted in complete response in 7 subjects (54%) and partial response in 3 subjects (23%). CoImmune finalized the M&A with Formula Pharmaceuticals Inc. recently, during which the invitation for primary investment of 6 million USD was also completed. President BG Rhee added, “… the investment of 15 million USD will be furnished from European and American investors,while the rest of 15 million USD will be furnished domestically…”.

Along with the emergence of next-generation cell therapeutic agents, the issues associated with their production were also highlighted in the global market. Reducing hundreds of million dollars in production costs associated with cell therapy products such as CAR-T is vital to securing core competencies in the market. The cGMP facilities of CoImmune, installed in an area of approximately 20,000 square feet, are currently spread over 10 rooms of ISO-7 and 4 QC laboratories. The company has a history of collaboration with more than 120 clinical institutions and experienced in the production of more than 400 batches of reagents required for Phase III Clinical Trials. Based on the history and experience, CoImmune intends to expand its field of business into that of CMO, as well as the development of spontaneous pipelines.

SCM LifeScience started as a company developing stem cell therapeutic agents. The original technology of ‘Subfractionation Culturing Method’ is exploited for the separation and culture of high-purity and highly efficacious stem cells compared with existing methods for the development of therapeutic agents. In particular, the technology, enabling the separation and culture of high purity products, is cost-effective.

SCM LifeScience also expedites clinical trials employing stem cell therapeutic agents. Currently, the Phase II Clinical Trial of chronic graft-versus-host disease (GVHD), Phase I/IIa Clinical Trials for acute pancreatitis, and Phase I/II Clinical Trials for atopic dermatitis are in progress. In particular, the clinical trial of therapeutic agents for multi-dose therapy of atopic dermatitis was approved by the Ministry of Food and Drug Safety last February, and the Phase I Clinical Trial is currently in progress.

Along with the stem cell therapeutic agents, SCM LifeScience also manages the development of therapeutic agents for acute respiratory distress syndrome (ARDS) as well as those for COVID 19 and septicemia, for which the clinical trial protocol will be submitted to the Ministry of Food and Drug Safety soon. Besides, the company intends to expand its field of business by making inroads into the market for diseases involving central nervous system in the future by finalizing the contracts introducing the technology of stem cell therapies for spinocerebellar ataxia, and carrying out the related domestic Phase II Clinical Trials.

President BG Rhee of SCM LifeScience emphasized, “…I thought there will be opportunities in the field of regenerative medicine (stem cells, cell and gene therapy products) to meet the challenges associated with the development of new drugs in Korea, and their management with corresponding investment. SCM LifeScience currently promotes research and development in the fields of stem cell and immuno-cytological therapeutics independently, which are supported by global cGMP production facilities. We are planning to become a global company developing new cytological therapeutics through the initial public offering…”