• Agreement to strategic partnership and collaboration for clinical development of pan-coronavirus mRNA vaccines; promotion of Global Training Hub for Biomanufacturing (GTH-B) for LMICs

November 24, 2022, SEOUL, Republic of Korea – The International Vaccine Institute (IVI) and ST Pharm announced November 24 that they exchanged a memorandum of understanding to establish a strategic partnership and facilitate collaboration for clinical development of a pan-coronavirus mRNA vaccine.

ST Pharm is a manufacturer for RNA-based drugs including mRNA vaccines in the Republic of Korea. The company has advanced GMP production facilities, which enables it to provide robust CDMO services to worldwide clients including IVI’s partners.

Under the MOU, IVI and ST Pharm have agreed to collaborate in clinical development of an mRNA COVID-19 vaccine as well as in efforts to promote Korea’s WHO Global Training Hub for Biomanufacturing (GTH-B) strategy.

Specifically, IVI and ST Pharm will work together in defining a Clinical Development Plan (CDP) and regulatory strategy for ST Pharm’s pan-coronavirus vaccine candidate. IVI will act as a collaborative partner for Phase 1/2a clinical trials of the vaccine candidate to be conducted in Korea and a country in Africa. ST Pharm won a grant from KmVAC (Korea mRNA Vaccine Initiative) launched and funded by the Ministry of Health and Welfare and the Disease Control and Prevention Agency.

The two sides will seek opportunities for multinational clinical trials of mRNA vaccine candidates by utilizing their experiences in clinical trials and development and IVI’s international network.

The two organizations have also agreed to cooperate in training of biomanufacturing workforce in low- and middle-income countries. Currently, LMICs are introducing and installing mRNA vaccine manufacturing facilities with support from global funds as part of the World Health Organization’s initiative, and these facilities have required extensive training of relevant workforce. Equipped with world-class production facilities, professional staff, technique and know-how, ST Pharm is considered a strong potential partner for biomanufacturing training through IVI’s GTH-B project, which is supported by the Government of Korea.

ST Pharm CEO Kyungjin Peter Kim said, “ST Pharm is thrilled to form a cooperative partnership with IVI, which has robust capabilities and track record in global vaccine clinical trials. With key essential platform technologies SmartCap^® and SmartLNP^® necessary for mRNA vaccines development, ST Pharm has capabilities in ODM production of quality vaccines. Banking on these capabilities of the two organizations, we are committed to synergizing with IVI to contribute to the development of mRNA vaccines, and training of biomanufacturing staff from LMICs through the GTH-B project.”

IVI has been supporting a number of companies from Korea and overseas to accelerate preclinical and clinical development (including clinical sample analysis) of various vaccine candidates in different stages including mRNA vaccines. “Our recent experience with variants highlights the importance of a vaccines capable of handling present and future variants. This collaboration hopes to be able to demonstrate this concept using ST Pharm’s mRNA vaccine platform,” said Dr. Jerome Kim, Director General of IVI. “This partnership will help strengthen our two organizations’ endeavors in global clinical trials to accelerate new generation mRNA vaccines.”

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About ST Pharm

ST Pharm is an API CDMO specializing in antiviral treatments and has supplied intermediates and APIs for Zidovudine, the world’s first AIDS treatment since the 1980s, and since 2010 participated as a CDMO supplying API from the clinical stage of development to commercialization for Sofosbuvir, the world’s first HCV treatment. Participating in new drug development by global pharmaceutical companies from the clinical stage, ST Pharm provides development of optimized process technology and analytical methods, GMP validation, preparation of CMC documents for new drug approval, and production of raw materials for commercialization from clinical samples to large-scale commercialization, and maintains global-level GMP capabilities and production systems with cGMP certifications from the USA (FDA), EU, Japan, Australia, and WHO. In 2001, ST Pharm entered the new drug CDMO business arena through development of oligonucleotide synthesis and purification technology, and maintains a competitive edge in the global market as one of the top 3 players. Through the acquisition of AnaPath, a CRO company based in Europe, at the end of 2019, ST Pharm became a one-stop service covering the entire process of new drug development. Additionally, expanding on ST Pharm’s mRNA platform technology that has been prepared since 2018, the company has secured unique patent technologies for SmartCap^® and SmartLNP^®, and with global biotech company contracts, such as a 25B KRW contract scale for lipids in LNP formulation, ST Pharm continues to expand its mRNA CDMO business.

About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a non-profit international organization established in 1997 at the initiative of the United Nations Development Programme with a mission to discover, develop, and deliver safe, effective, and affordable vaccines for global health.

IVI’s current portfolio includes vaccines at all stages of pre-clinical and clinical development for infectious diseases that disproportionately affect low- and middle-income countries, such as cholera, typhoid, chikungunya, shigella, salmonella, schistosomiasis, hepatitis E, HPV, COVID-19, and more. IVI developed the world’s first low-cost oral cholera vaccine, pre-qualified by the World Health Organization (WHO), and developed a new-generation typhoid conjugate vaccine that is currently under assessment for WHO PQ.

IVI is headquartered in Seoul, Republic of Korea with a Europe Regional Office in Sweden and Collaborating Centers in Ghana, Ethiopia, and Madagascar. 39 countries and the WHO are members of IVI, and the governments of the Republic of Korea, Sweden, India, and Finland provide state funding. For more information, please visit https://www.ivi.int.

CONTACT

Aerie Em, Global Communications & Media Specialist
+82 2 881 1386 | aerie.em@www.ivi.int