Jeong Sang-won, CEO of Embrix, made these remarks during a recent meeting with Edaily at the company’s in-house research institute in Anyang, Gyeonggi Province. CEO Jeong noted, “Ex vivo CAR-T is also a good platform in terms of being personalized,” but added, “The process of collecting, processing, and culturing cells from each individual results in high costs and long wait times.”
Embrix is developing “MIC-001,” an in vivo CAR-T candidate that delivers CAR messenger RNA (mRNA) to T cells using the antibody-based targeted delivery platform “Navibody,” as its flagship pipeline. CEO Jeong, who began his career as a biopharmaceutical manufacturing process developer, founded the company with Professor Kwon Dae-hyuk of Sungkyunkwan University after completing an MBA program in the U.S. and working in the investment team at Woori Bank. Having gained extensive experience in both process development and investment, he is recognized for his strength in translating R&D achievements into commercial success.
Targeting T Cells In Vivo… Aiming for CMC with ‘Navibody’
Embrics aims to carry out this process within the body. MIC-001 is a candidate drug that combines an antibody that recognizes T cells with a lipid nanoparticle (LNP) and contains mRNA that instructs the T cells to produce CAR. It is designed so that, upon administration, the LNP delivers the mRNA to the T cells, which then express CAR to eliminate pathogenic B cells. The first target indication is autoimmune diseases such as systemic lupus erythematosus (SLE).
CEO Jeong explained, “Existing CAR-T therapies require a pretreatment process to deplete the patient’s immune cells prior to treatment, which places a significant burden on patients; some patients even miss their chance for treatment while waiting for the cells to be manufactured.” He added, “If in vivo CAR-T becomes a reality, it has the potential to improve treatment accessibility and convenience of administration while also reducing the financial burden.”
Embrix’s key differentiator is its target delivery platform, Navibody. Conventional LNPs tend to accumulate in the liver, making it difficult to selectively deliver genetic material to target cells such as immune cells. Embrix’s strategy involves using protein engineering to design antibodies that can stably bind to LNPs, thereby enabling targeted delivery to T cells.
Global in vivo CAR-T development is broadly divided into lentiviral vector-based and LNP-based approaches. While the lentiviral approach is progressing faster—with some companies already entering the clinical phase—challenges include manufacturing complexity and the need for long-term follow-up due to gene insertion. The LNP-based approach has the advantage of enabling transient mRNA expression, but it must demonstrate targeted cell delivery, safety for repeated administration, and scalability for mass production.
Embrix expects Navibody to demonstrate its strengths as it expands beyond research-grade preclinical materials into the commercial production phase. CEO Jeong stated, “The manufacturing and quality control (CMC) of compounds combining LNP and antibodies is a key hurdle for in vivo CAR-T,” adding, “Since we designed the product from the outset with a focus on the stable binding of antibodies and LNP, we believe we can establish a competitive edge in process development and scale-up.”
Based on these capabilities, Embricks recently secured a Series B investment totaling 8 billion won. Investors included Korea Investment Partners, Intervest, iGene, Korea Omega Investment Finance, LifeCore Partners, and Seoul National University Technology Holding. This is seen as recognition of the platform’s technological merit and potential for further development, even in a biotech venture investment market where investor sentiment has been subdued.
CEO Jeong cited securing actual preclinical data—beyond a mere technological concept—and the scalability of production processes with clinical development in mind as the key factors behind this investment. “What investors considered most important was whether in vivo CAR-T could actually be implemented and whether it could be scaled up into a clinical product,” he said. “During the investment process, technical validation through non-human primate data and the scalability of Navibody manufacturing were key evaluation points.”
The company plans to allocate these funds toward validating the efficacy of MIC-001, advancing CMC (Chemistry, Manufacturing, and Controls), and expanding its R&D and business development teams.
In particular, the company plans to conduct additional non-human primate trials with expanded dosing and dose groups based on the results of previous non-human primate trials. CEO Jeong stated, “While we confirmed the potential through previous small-scale non-human primate (NHP) trials, our key milestone this time is to more systematically verify CAR-T cell generation, B-cell depletion, and safety at various doses through an expanded trial involving 20 to 30 animals,” adding, “Through this, we will focus on reducing key preclinical uncertainties before entering clinical trials.”
The target date for submitting the Investigational New Drug (IND) application for MIC-001 is early 2028. Embrix plans to use this investment to reach key value-enhancing milestones: large-scale NHP validation and CMC optimization. Subsequently, based on the data obtained, the company intends to accelerate GLP toxicity testing and IND preparations while pursuing follow-up investments and global technology transfers in parallel. Large-scale non-human primate data and achievements in CMC and process development are expected to serve as the key basis for future investment and global business development.
Embrics is collaborating with Sungkyunkwan University on the development of MIC-001 and has established a development ecosystem with Samsung Medical Center, Seoul St. Mary’s Hospital, and contract development and manufacturing organizations (CDMOs). Last year, the company was successively selected for the Bio-Medical Technology Development Project and the “Ultra-Leap Startup 1000+” program.
Expanding into
Recombinant Toxins and Antivirals… A Pipeline United by “Protein Engineering” In addition to in vivo CAR-T, Embrix is developing recombinant botulinum toxin and antiviral therapeutics. Unlike conventional methods that use strains found in nature, the company produces recombinant toxins using E. coli as a host.
The company explains that the core capability unifying this seemingly disparate pipeline is protein engineering. CEO Jeong stated, “Embrix is a company that has expanded into mRNA delivery vehicles, recombinant toxins, and antiviral therapies based on its capabilities in designing and producing proteins,” adding, “We have enhanced the commercialization potential of our platform by strengthening not only our R&D capabilities but also our business development organization this year.”
The company is currently developing “MBT-002,” a recombinant botulinum toxin candidate designed to improve the speed of action and duration of effect through protein engineering. The rights for cosmetic indications were transferred to iGene last year, while the company continues to develop the product for therapeutic indications in-house.
CEO Jeong remarked, “Since there are already many companies in Korea producing Type A toxin, it is difficult to differentiate ourselves simply by making a product with the same properties,” adding, “Our differentiating factor is that we can leverage the advantages of the recombinant method to reduce our dependence on naturally derived strains and design the toxin’s function to suit specific purposes.”
Embrix plans to secure development funds through technology transfers in the short term and grow into a biotech company with its own new drug development capabilities in the medium to long term. While MIC-001 is being developed primarily for autoimmune diseases, the company is exploring ways to expand its subsequent in vivo CAR-T pipeline—which utilizes the Navibody platform—to include blood cancers and solid tumors. The Navibody platform has been classified as a core asset that the company will continue to retain and expand, rather than transferring it as a single pipeline.
CEO Jeong stated, “Rather than transferring the entire platform, we first want to pursue commercialization centered on individual pipelines, and subsequently grow into a company that develops drugs directly,” adding, “Our long-term goal is to become a biotech company that continuously launches new drugs based on our technology, similar to Amgen or Genentech.”
Embrix is targeting an initial public offering (IPO) in 2028–2029. Last year, the company generated its first revenue of approximately 700 million won through technology transfers to iGen and research services. The company plans to expand its business foundation through technology fees, royalties, and additional technology transfers in the future.
CEO Jeong said, “First and foremost, it is most important to generate efficacy and productivity data for MIC-001 to demonstrate the value of our platform,” adding, “We will grow into a company that develops high-quality medicines and provides tangible help to patients.”
