[Asia Economy Reporter Lee Chun-hee] ST Pharm is set to take the lead in developing a COVID-19 messenger ribonucleic acid (mRNA) vaccine applying the LNP method for the first time in Korea.
On the 1st, ST Pharm announced that it will accelerate the development of an mRNA vaccine capable of responding to COVID-19 variants by applying Genevant's LNP technology, used by Moderna and Pfizer who have already succeeded in developing COVID-19 mRNA vaccines, along with its patented 5-prime capping (5’-capping) mRNA platform technology.
ST Pharm’s vaccine under development not only includes the spike protein antigen, which is the viral spike that binds to host cells, but also reinforces a second antigen and adds peptide fragments called 'T-cell epitopes' that can enhance the response of immune cells known as T cells. ST Pharm expects that using this development approach will enable the creation of vaccines that are more effective than existing mRNA vaccines developed with the spike protein as a sole antigen and maintain high preventive efficacy against variant viruses for a longer duration.
Currently, ST Pharm has identified a total of 22 candidate substances and selected three candidates with excellent efficacy: STP2104, STP2108, and STP2120. The company plans to finalize the candidate by the end of this year and initiate Phase 1 clinical trials. Since mRNA vaccines can be developed rapidly, they aim to complete emergency use authorization by the first half of next year.
ST Pharm explained that during the candidate selection process, applying the company’s proprietary 5-prime capping technology called 'SmartCap' demonstrated efficacy equal to or greater than TriLink’s 'CleanCap.' Additionally, ST Pharm noted that its in-house mass production capability allows for prices more than 30% lower. The company expects that since CleanCap is currently monopolized worldwide for mRNA drug development but faces supply delays, ST Pharm’s SmartCap could substantially replace it in the future.
Furthermore, ST Pharm stated that it can produce key lipids used in LNPs, such as ionizable lipids and polyethylene glycol-conjugated lipids (PEG-lipids), on an annual scale of tons. This production capacity corresponds to over one billion doses annually based on COVID-19 mRNA vaccines.
An ST Pharm official said, “ST Pharm is the only company worldwide capable of independently developing and producing the capping technology, LNP drug delivery technology, and the necessary raw materials for mRNA drug development,” adding, “We are fully prepared to develop a COVID mRNA vaccine.” He further explained, “We are targeting cross-neutralizing responses against variants from the UK, South Africa, Brazil, and India, expecting to maintain continuous preventive effects against COVID-19.”
At the end of last month, ST Pharm completed a mid-scale GMP facility dedicated to mRNA and is currently conducting pilot production for mRNA vaccine manufacturing. The company is also considering expanding large-scale production facilities to produce over 100 million doses annually, based on Pfizer/BioNTech’s COVID-19 vaccine standards.
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