SK Bioscience Co. has secured additional funding for phase III clinical trial of GBP510, its COVID-19 vaccine candidate jointly developed with the Institute for Protein Design at the University of Washington.
The South Korean vaccine maker will receive up to $173.4 million from Coalition for Epidemic Preparedness Innovations (CEPI) for GBP510, according to the company on May 24.
Launched in 2017, CEPI is a global health partnership between public, private, philanthropic and civil society organizations with the aim to develop vaccines to stop future epidemics.
CEPI’s additional funding of $173.4 million brings the amount of investment on SK Bioscience’s GBP510 candidate to $210.1 million in total, the largest international funding for any vaccine development program in Korea, according to the vaccine maker.
Prior to this round of funding, SK Bioscience had received financial support from the Bill & Melinda Gates Foundation for GBP510’s non-clinical study and again from CEPI for phase I and II clinical trials.
Last year, GBP510 was selected as the first program in CEPI’s Wave 2 (Next Generation COVID-19 Vaccine) project, launched to support the development of next-generation COVID-19 vaccine candidates.
“Tackling COVID-19 and its variants is a core part of CEPI’s longer-term five-year plan to reduce and eliminate the risk of epidemic and pandemic diseases. I’m pleased to expand our partnership with SK Bioscience to further strengthen the world’s ability to control this deadly disease,” said CEPI CEO Richard Hatchett.
SK Bioscience said CEPI’s new funding will be used for phase III clinical trials, related regulatory activities, purchase of raw materials and additional R&D initiatives in response to COVID-19 variants.
Regarding the manufacturing part of the vaccine candidate, the company said it will also use the money to develop relevant commercial processes to produce hundreds of millions of doses per year.
GBP510 entered phase I and II clinical trials at the end of last year and is currently undergoing the second stage of phase II clinical study. The company will submit an investigational new drug (IND) filing for multinational phase III clinical trials to South Korea’s Ministry of Food and Drug Safety (MFDS) and other relevant authorities within the first half of 2021.
SK Bioscience added that GBP510 expects commercialization within the first half of 2022 as it will push for an expedited approval process including the emergency use license granted by the MFDS.
Once commercialized, GBP510 will be supplied globally including to the underdeveloped regions in Africa and South America, through the COVID-19 Vaccine Global Access (COVAX) Facility.
The COVAX Facility, operated by the World Health Organization together with CEPI and Global Alliance for Vaccines and Immunizations (Gavi), is a procurement mechanism that purchases vaccines from a portfolio of producers on behalf of countries that are COVAX members.
SK Bioscience said it expects the demand for its vaccine product to be high in Europe as well, highlighting its recent obtainment of EU-Good Manufacturing Practice (EU-GMP) certification from the European Medicines Agency (EMA) for its COVID-19 vaccine manufacturing facility at Andong, South Korea.
“The wholehearted support of CEPI reflects the technological level and potential value of our vaccine candidate, GBP510. We will successfully develop the COVID-19 vaccine that also has preventive effects on variants, and widen the vaccine’s access to all parts of the world by strengthening our manufacturing capabilities,” said SK Bioscience CEO Ahn Jae-yong.
Write to Min-Soo Han at
hms@hankyung.comDaniel Cho edited this article.
