Global pharmaceutical giant Moderna’s recent success with a personalized cancer vaccine has thrust messenger RNA (mRNA) technology into the spotlight. This breakthrough has positioned mRNA technology as a game-changer, not just for preventing infectious diseases, but also as a next-generation approach to cancer treatment and rare disease therapies.
Grand View Research, a leading market research firm, projects that the global mRNA vaccine and therapeutics market will experience explosive growth, ballooning from approximately 11.7 billion USD in 2023 to around 31.3 billion USD by 2030.
Against this backdrop, South Korean pharmaceutical company GC Biopharma has developed a groundbreaking platform that leverages artificial intelligence (AI) to design mRNA and independently manage the entire drug development process. The company’s strategy involves validating its technology through COVID-19 vaccine development before expanding into cancer drugs and treatments for rare diseases.
From AI Design to Production: Building an In-House Platform
Industry sources reported on Monday that GC Biopharma, in collaboration with the Mokam Life Science Institute, is using AI technology to optimize mRNA sequences. The company claims this approach has boosted protein translation efficiency by over 50% compared to global standard technologies.
GC Biopharma has also developed proprietary lipid nanoparticle technology for mRNA delivery into cells. The company has filed patent applications for eight types of lipid nanoparticles that enhance protein expression and four types targeting specific organs such as the spleen, liver, and lungs.
The company has established a comprehensive production infrastructure, enabling it to independently manage everything from candidate substance discovery to mRNA synthesis, lipid nanoparticle formulation, and finished product manufacturing. GC Biopharma produces pharmaceuticals at its Hwasun facility in South Jeolla Province and has developed in-house analytical methods to ensure product quality and stability.
Currently, GC Biopharma has inked material transfer agreements with more than ten biotech firms to validate its platform technology. The company plans to expand its business through technology exports, joint development initiatives, and contract development and manufacturing services.
Validating Technology With COVID-19 Vaccine: Aiming For Commercialization By 2028
GC Biopharma is currently applying its platform to the development of its COVID-19 vaccine, mCOVID.
Following successful non-clinical and Phase 1 clinical trials that confirmed safety, tolerability, and immunogenicity, GC Biopharma submitted a Phase 2 clinical trial plan to South Korea’s Ministry of Food and Drug Safety in July. The company aims to secure Phase 2 approval by year-end, initiate Phase 3 trials in 2027, and obtain product licensing by 2028.
Throughout the development process, GC Biopharma intends to independently manage every stage, from raw material production to finished product filling and quality assessment, to demonstrate its platform’s robust production capabilities.
GC Biopharma is also expanding its platform’s applications into cancer treatment. The company recently launched a joint research and development initiative with AbClon, a cancer drug development firm, to create a next-generation in vivo CAR-T therapy.
Unlike conventional CAR-T therapies, which require extracting a patient’s immune cells for genetic modification before reinfusion, in vivo CAR-T directly transforms immune cells within the body to attack cancer cells without extraction.
GC Biopharma aims to produce CAR-T cells in vivo by combining its proprietary cell-specific mRNA and lipid nanoparticle delivery technology with Appclone’s chimeric antigen receptor (CAR) technology.
Jae-wook Jung, GC Biopharma’s head of research and development, stated that mCOVID exemplifies the practical application of the AI-based mRNA and lipid nanoparticle platform, along with the end-to-end production capabilities. It will continue to broaden the platform’s applications through vaccine self-sufficiency and the development of innovative therapies like in vivo CAR-T.
