SK’s COVID-19 vaccine ‘GBP510’ secures up to $173.4 million of additional funding to phase 3 clinical trial and manufacturing.
Potentially most extensive funding event for vaccine development program in Korea. SK aims to submit IND for phase 3 clinical trial within next month.
SK bioscience (“SK”) has secured additional funding for the COVID-19 vaccine.
On 24th May, SK bioscience announced that it will receive up to $173.4 million (200 billion KRW) additional support from the international organization, Coalition for Epidemic Preparedness Innovations (“CEPI”), to be used for development including phase 3 clinical trial of the COVID-19 vaccine candidate ‘GBP510’, which is jointly developed with the Institute for Protein Design (“IPD”) at the University of Washington (“UW”).
Prior to this funding, SK received support from the Bill & Melinda Gates Foundation (“BMGF”) for development of the candidate including non-clinical study, and from CEPI for phase 1/2 clinical trials, and process development, and variants research respectively. This brings total investment in SK bioscience to $210.1 million in total, marking it as the most extensive international funding ever for vaccine development program in Korea.
The large-scale support for GBP510 from international organizations such as CEPI follows promising safety and immunogenicity data from phase 1/2 trials.
SK bioscience will utilize the additionally secured fund on GBP510 to proceed with i) phase 3 clinical trials and regulatory activities ii) development of commercial processes with manufacturing scale of hundreds of millions of doses per year and purchasing raw materials, and iii) additional R&D in response to variants.
GBP510 entered into phase 1/2 clinical trial end of last year and is currently undergoing stage 2 as phase 2 clinical study. SK Bioscience plans to submit an IND for multi-national phase 3 clinical trials to the Ministry of Food and Drug Safety and other relevant regulatory authorities the first half of current year, and aims for commercialization within the first half of next year though expedited approval process such as emergency use license.
GBP510 was selected as the first program of the Wave 2 (Next Generation COVID-19 Vaccine) project, which CEPI launched last year to support the differentiated COVID-19 vaccine candidates, and once commercialized, it will be supplied globally through the COVAX Facility.
As SK has proven its excellence in vaccine manufacturing including recent EU-GMP certification of the COVID-19 Vaccine manufacturing facility at Andong, it is also expected high demands even in developed markets such as Europe.
GBP510 is highly evaluated for its differentiated technology and stable development platform through a structure that can maximize immunization effectiveness.
SK's genetic engineering technology and the IPD's self-assembling nanoparticle design technology were applied to GBP510’s receptor binding domain (RBD), which is one of the keys to the development of COVID-19 vaccine that induces neutralizing antibody expression to negate the COVID-19 virus.
Last year, through a non-clinical test of GBP510, SK has confirmed that stable structured RBD nanoparticles gathered from several antigens induce high level of neutralizing antibodies and block proliferation of viruses.
The sub-unit vaccine platform technology applied to GBP510 has demonstrated various advantages through conventional vaccines, which is expected to have strengths in storage, shelf life, productivity, etc. compared to other platforms.
Richard Hatchett, CEO of CEPI, said: “The whole world is at risk of the emergence of novel SARS-CoV-2 variants. As we have seen with the B.1.1.7 and B.1.617 variants—first identified in the UK and India respectively—they can arise without notice, spread rapidly, and cause tremendous disruption. Many of the variants of concern that we know about are rendering our vaccines less effective, so it is critical that we do not let our guards down.
We must protect the precious progress we have made over the past year by continuing to invest in crucial R&D so that we can adapt our vaccines, ideally within 100 days, in response to the threat posed by these variants. Tackling COVID-19, and its variants, is a core part of CEPI’s longer-term plans to substantially reduce, and eventually eliminate, the risk of epidemic and pandemic diseases. I’m pleased to expand CEPI’s partnership with SK bioscience to further strengthen the world’s ability to control this deadly disease.”
Jae-Yong Ahn, CEO of SK bioscience, said, “It is great pleasure to expand collaboration with CEPI advancing the GBP510 development including variants. The wholehearted support of CEPI and Gates Foundation reflects the technological level and potential value of our vaccine candidate” and “We are also pursuing the development cooperating closely with relevant international regulatory agencies, as well as Korean pan-government support group and MFDS. To achieve the goal against the pandemic, we will continue our highest efforts for the successful development and enlarged access to the COVID-19 vaccine that can also be preventive to variants utilizing our expanded manufacturing capabilities”.
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