EyeGene expected to utilize TriLink’s CleanCap® technology and modified UTP manufactured by TriLink in the production of its EG-COVID mRNA COVID-19 vaccine for clinical trials
SAN DIEGO, October 4, 2021 — TriLink BioTechnologies (“TriLink”), a Maravai LifeSciences company (Nasdaq: MRVI) and a leader in the production of nucleic acids for research, diagnostics and therapeutics applications, announced today that it expects to supply its proprietary CleanCap® mRNA capping technology and the modified nucleoside, uridine triphosphate, to EyeGene, Inc. (“EyeGene”) for production of EyeGene’s mRNA COVID-19 vaccine, EG-COVID, which recently received approval to begin clinical trials from the South Korean Ministry of Food and Drug Safety (MFDS). This collaboration with EyeGene is expected to represent the first clinical-stage program to use GMP-grade modified uridine triphosphate, with an intended use for further processing, manufactured by TriLink.
“COVID-19 is one of the greatest challenges our industry has faced. We have been inspired by the ingenuity and tenacity with which the world has tackled the pandemic and are proud to be supporting important efforts to develop new vaccine approaches and expand access to COVID-19 vaccines globally,” said Brian Neel, Chief Operating Officer of TriLink BioTechnologies. “As part of these efforts, TriLink is excited to be expanding its collaboration with EyeGene in South Korea. We look forward to continuing to support them through their clinical trials, manufacturing scale up efforts and commercialization.”
Dr. H. Christian Hong, EyeGene’s Chief Business Officer added, "The pandemic is still raging around the world, and we are eager to begin clinical trials with EG-COVID. Our scientists have used a cationic liposome-based delivery system for the vaccine, and we are very confident in its safety and effectiveness. TriLink’s CleanCap technology and modified uridine triphosphate, in combination with the mRNA manufacturing platform, has enabled EyeGene to reach the clinic quickly."
TriLink and EyeGene met on September 21, 2021, at the KORUS Global Vaccine Business Roundtable held in New York, to discuss their continued collaboration as EyeGene advances development of its vaccine into phase 1 clinical testing and beyond.
Mr. Neel commented further, “In addition to providing a forum to meet with EyeGene, the KORUS vaccine roundtable gave us an opportunity to engage with other leaders within the global supply chain for vaccine manufacturing, particularly those suppliers with active efforts in the Asia Pacific region. As an example, TriLink partnered with leading global enzyme supplier New England Biolabs® to supply reagents for mRNA manufacturing in support of Eye Gene’s phase 1 studies. We look forward to continuing to partner with vaccine developers and manufacturers in the region and to bringing forward potential new mRNA vaccines that may help expand access and provide new tools in the fight against the COVID-19 pandemic and for other indications.”
CleanCap® is TriLink’s market-leading co-transcriptional mRNA capping technology which we believe offers a number of key features and benefits compared to enzymatic capping products. We believe CleanCap enables higher yield, more bioavailable end product and enables customers to produce vaccines faster and at a lower cost.
EG-COVID will undergo a Phase 1/2a clinical trial to test the safety, tolerability, and immunogenicity of the vaccine. The vaccine uses a cationic liposome-based vaccine delivery system and is produced in a freeze-drying formula. It is refrigerated at 2–8 ℃ for preservation and is thus competitive for export to foreign markets with insufficient low-temperature refrigeration facilities.
TriLink BioTechnologies, part of Maravai LifeSciences, is a CDMO helping life science leaders and innovators overcome challenges in the synthesis and scale-up of nucleic acids, NTPs and mRNA capping analogs with scale-up expertise and unique mRNA production capabilities, including its proprietary CleanCap® mRNA capping technology. TriLink continues to expand its cGMP and general manufacturing capacity at its new global headquarters to support mRNA, oligonucleotide & plasmid therapeutic, vaccine and diagnostic customers. For more information about TriLink, visit www.trilinkbiotech.com
Maravai is a leading life sciences company providing critical products to enable the development of drug therapies, diagnostics, novel vaccines, and support research on human diseases. Maravai's companies are leaders in providing products and services in the fields of nucleic acid synthesis, bioprocess impurity detection and analysis, and protein labeling and detection to many of the world's leading biopharmaceutical, vaccine, diagnostics, and cell and gene therapy companies. For more information about Maravai LifeSciences, visit www.maravai.com.
EyeGene took its first step in the development of innovative biopharmaceutical drugs when it was first established in June 2000. Since then, EyeGene's R&D Scientists have continued to research and develop innovative drugs for the treatment and prevention of age-related diseases. For more information about EyeGene, visit eyegene.co.kr/kor/.
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release which are not strictly historical statements constitute forward-looking statements, including, without limitation, statements regarding EyeGene’s continued use of CleanCap and modified UTP manufactured by TriLink, our ability to develop new partnerships, and the benefits of CleanCap compared with enzymatic capping methods, constitute forward-looking statements and are identified by words like “aim,” “believe,” “expect,” “may,” “will,” “should,” “seek,” “anticipate,” “look forward,” or “could” and similar expressions. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation and uncertainties related to the level of demand for our products and services, continued validation of the safety and effectiveness of our technology, new scientific developments and competition from other products. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, as well as other documents on file with the Securities and Exchange Commission. Actual results may differ materially from those contemplated by these forward-looking statements, and therefore you should not rely upon them. These forward-looking statements reflect our current views and we do not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date hereof except as required by law.
Media Contact: Sara Michelmore
Investor Contact: Deb Hart
+ 1 858-988-5917
EyeGene Contact: H Christian Hong