REYON Pharmaceutical (representative directors Sunok Jeong and Yonghwan Yoo) announced on the 20th (today) that it has signed an MOU with Interbiome (CEO Roger Erickson) in the United States to establish and operate Interbiome-ll, a cGMP manufacturing facility specialized in the development and production of virus-based gene therapy.

 Through this MOU, Interbiome-II, a gene therapy manufacturing facility established by both companies in the US, will be in charge of ▲ process development, ▲ scaling up, and ▲ clinical raw material production for virus-based gene therapy products. It will serve as a bridge between the pDNA (nonviral vector) production plant currently under construction by REYON Pharmaceutical and the virus commercialization plant to be constructed later. Accordingly, the Chungju Plant is expected to be built into a “gene cell therapy global production hub” capable of producing pDNA-based gene therapy products and virus-based gene therapy products.

Interbiome, a bio company founded in the United States in 2016, is headed by Roger Erickson, an expert with decades of experience in the field of cytogene therapy, together with Peter Probst, who has 26 years of experience as an FDA reviewer and inspector. The company personnel have extensive experience in researching gene cell therapy products, as well as producing clinical raw materials, and designing, building, and investigating cGMP production facilities.

Interbiome has already successfully completed the establishment of a gene therapy product manufacturing facility in the United States through the IB-I (Interbiome-l) project. Currently, the facilities built through IB-l are operated as cGMP gene therapy product manufacturing facilities by a famous overseas CMO company.

REYON Pharmaceutical has been planning for a long time to build a business model that produces non-viral vectors (pDNA) and viral vectors, which are gene therapy products used as pharmaceuticals and raw materials as advanced biopharmaceuticals, and currently, a manufacturing facility for the production of non-viral vectors (pDNA) is under construction at the Chungju plant. At the same time, in order to establish a manufacturing facility for viral vector production, from the second half of last year, after several discussions including face-to-face meetings and on-site due diligence, the company finally signed an MOU for business cooperation.

Manufacturing facilities in the US to be established in the future include process development and stable clinical sample production required by partners currently cooperating with REYON Pharmaceutical through open innovation, and such facilities are expected to reduce the risks arising in the clinical process and to enable rapid clinical progress of partners. Furthermore, it is expected that the facilities will lead to the expansion of cooperative relationships with many domestic and overseas cell gene therapy development companies that desire rapid clinical progress for the purpose of entering the US market. In addition, linking these global-level manufacturing facilities and technologies with the Chungju Plant is expected to further accelerate the goal of building a global gene therapy manufacturing facility that covers everything from clinical to commercial sample production.

Yonghwan Yoo, CEO of REYON Pharmaceutical said, "Starting with the signing of this MOU with Interbiome, we look forward to being a continuous business partner in the future, and relish this opportunity to accelerate the establishment of a global gene therapy product manufacturing facility which has been a long-awaited business plan of ours." He added, “Based on REYON's technology, experience, and networking through Interbiome-ll, we will secure not only the manufacturing technology for non-viral vectors in the manufacture of gene therapy products, but also the technology for producing viral vector-based gene therapy products, which has recently been spotlighted (for example, AAV, etc.) as a next-generation gene therapy product. By doing so, the Chungju Plant will produce high quality raw materials for gene cell therapy and finished products.”

He concluded by saying, "Through the synergestic effects of Interbiome-ll in the US and the Chungju Plant in Korea, it will serve as a great opportunity to build a wide range of pipelines, including a wide range of cooperative relationships with various domestic and foreign bio companies, as well as for stable product production for REYON and partners.”

CEO of Interbiome, Roger Erickson, said, "REYON Pharmaceutical and Interbiome-II have allowed us the opportunity to grow as a global manufacturing company utilizing REYON's extensive know-how in manufacturing gene therapy products, and this partnership will provide a great opportunity for both companies to become global players in the commercialization of gene therapy products.”

[Terminology]
1. Non-viral gene therapy (pDNA): Representative companies that develop pharmaceuticals using pDNA so far include Helixmith and Genexin.
 * In addition, plasmid DNA (pDNA) is a raw material for gene therapy products utilizing viral vectors.
2. Viral vectors: Includes adeno-associated viruses (AAV), and Lenti viral vectors, etc. Representative companies in Korea and overseas that are developing or have licensed products using these include Neuracle Genetics, Spark Therapeutics, and Novartis.
3. Viral vectors are not only therapeutic drugs, but are also raw materials for CAR-T and cell therapy products, and representative companies in Korea and overseas that are currently developing or have obtained product licenses using CAR-T include Curocell, Novartis, and Gilead Sciences.