[Biz Leader] Sangkyun Lee, CEO of CreoSG, "Advancing as a Bio-specialized Company... Accelerating FDA Phase 2 Clinical Trials"

Development of AIDS Vaccine Using Entire HIV Virus
Expansion of Immuno-Oncology Drugs with Core Technology SUV-MAP

Sangkyun Lee, CEO of Creo ESG. Photo by Hyowon Jang

"We are developing the world's first AIDS vaccine using the entire human immunodeficiency virus (HIV). The U.S. FDA has shown great interest, and there is also the possibility of fast-track designation to conduct clinical phases 2 and 3 simultaneously."

Lee Sang-gyun, CEO of Creo ESG, said this about the company during a meeting with Asia Economy at the International Vaccine Institute (IVI) located within Seoul National University. Creo ESG is the only bio company housed in IVI, the first UN-affiliated international organization in Korea.

Creo ESG was established in 2004 as an IT service specialist. In 2005, aiming to expand into the bio sector, it incorporated ImmunoVaxBio (formerly Smagen) as a subsidiary and has steadily supported AIDS vaccine development. Starting this year, to transform into a bio-specialized company, Dr. Lee Sang-gyun, who was managing the subsidiary, was appointed CEO, and the subsidiary was merged.

CEO Lee Sang-gyun completed his bachelor's and master's degrees at Seoul National University and earned a Ph.D. in toxicology from Iowa State University in the U.S. He served as head of the Safety Center at LG Life Sciences' Technology Research Institute, leading various new drug development projects. Leveraging his network with entrepreneurs from LG Life Sciences, he has been providing business-related consulting to Alteogen from its early days and was a founding member of Ligagem Bio, where he helped establish new drug development processes.

CEO Lee explained, "We are developing the world's first vaccine in the AIDS vaccine field that uses the entire HIV virus," adding, "We have patented HIV inactivation process technology and HIV virus-producing cell lines and culture methods, enabling us to manufacture vaccines that respond to the continuously evolving HIV."

One of Creo ESG's main pipelines is the whole inactivated AIDS vaccine 'SAV001.' It successfully completed phase 1 clinical trials with the U.S. Food and Drug Administration (FDA) and is preparing for phase 2. Creo ESG's AIDS vaccine uses the entire HIV virus as an antigen. Since the vaccine includes all structures of the virus, it is said to enhance efficacy.

CEO Lee stated, "Once production and analysis of clinical samples meeting U.S. FDA certification standards are completed soon, we plan to proceed immediately with phase 2 clinical trials," adding, "We coordinated opinions on the design and plan of phase 2 clinical trials through an FDA Type C meeting, and the possibility of applying the fast-track system to conduct phases 2 and 3 simultaneously is also encouraging."

Creo ESG's core technology is the attenuated recombinant vesicular stomatitis virus-based viral vector platform 'SUV-MAP.' This technology enables effective vaccine development against viruses and provides a system for rapid vaccine development in response to emerging new viruses. It is said to have demonstrated excellent vaccine efficacy in various vaccine developments, including COVID-19 vaccines.

CEO Lee said, "According to IVI's research results, vaccines developed using the SUV-MAP platform have excellent efficacy and high productivity," adding, "Also, because it is designed to be temperature-sensitive, replication is limited after administration in the human body, making it safe."

Based on this, vaccines for COVID-19, MERS, and Zika are also under development. The COVID-19 vaccine is the first vaccine developed using the SUV-MAP platform and showed superior efficacy compared to other vaccines in animal efficacy tests. The MERS vaccine demonstrated protective effects not only against the original MERS virus isolated in Saudi Arabia but also against the MERS virus isolated in Korea in 2015. A vaccine against the mosquito-borne Zika virus is also being developed, and the company is currently in contact with international organizations or global corporate partners.

Creo ESG collaborates with various international organizations and global companies during the vaccine development process. It focuses on recombinant vesicular stomatitis virus (rVSV)-based vaccine development research with IVI. It cooperates with the Vaccine Commercialization Center of the Gyeongbuk Bio Industry Research Institute on COVID-19 vaccine development. For the AIDS vaccine, materials from the Microbial Immunology Laboratory at the University of Western Ontario (UWO) in Canada were transferred to the company for development, and currently, clinical phase 2 samples are being produced by Naobiotech in France.

Creo ESG is expanding research not only in vaccines but also in the immuno-oncology field. This is because the patented SUV-MAP platform technology used in existing vaccine development can also be applied to anticancer drugs.

CEO Lee explained, "Since we have already developed therapeutic and preventive vaccines for viral infectious diseases, cancer therapeutic vaccines are not unfamiliar territory," adding, "Because the delivery vehicle for new drug candidates used in both anticancer drugs and vaccines is the SUV-MAP rVSV platform, there is an advantage in reusing existing research achievements during research, development, and approval processes."

He continued, "We plan to first explore therapeutic genes that activate anticancer immunity by loading cytokines or antibody genes with immune activation effects," adding, "The initial research strategy is to compare their efficacy in large-scale animal experiments, and we plan to pursue technology transfer for candidates that have completed non-clinical trials."