Sanofi and Jointly Developed 'SkyPack'
The Most Numerous 21-Valent Protein-Conjugate Vaccine
Aiming to Be the 'Best in Class' Vaccine
Phase 3 Entry in 2024 and Approval Planned for 2027
SK Bioscience has successfully completed Phase 2 clinical trials for its 21-valent pneumococcal vaccine "SkyPack (GBP410)," which is being developed with the goal of becoming the "Best-in-Class" within its category. SK Bioscience plans to begin the approval process in 2027 in collaboration with its co-developer, global big pharma Sanofi.
On the 29th (local time), at the Vaccines Investor Event hosted by Sanofi in London, UK, Jaeyong Ahn, President of SK Bioscience (left), and Thomas Triomphe, Senior Vice President of Sanofi's Vaccine Division, posed for a commemorative photo. At the event, the two companies disclosed the Phase 2 clinical trial results of the 21-valent protein-conjugate vaccine "SkyPack," which they are jointly developing. [Photo by SK Bioscience]
On the 30th, SK Bioscience announced that it confirmed excellent immunogenicity and safety in the Phase 2 clinical trial of the 21-valent pneumococcal protein-conjugate vaccine SkyPack (Sanofi project name SP0202) targeting infants and young children. The company also set a goal to enter Phase 3 clinical trials in the first half of next year and secure the final clinical results by 2027.
SkyPack is a core next-generation vaccine under SK Bioscience's new growth strategy "SKBS 3.0." It is a protein-conjugate vaccine made by conjugating a specific protein to pneumococcal capsular polysaccharides that cause pneumonia and invasive diseases. Through this, it is being developed as a 21-valent vaccine capable of preventing a total of 21 serotypes. Among the pneumococcal protein-conjugate vaccines released so far, Pfizer's 20-valent vaccine "Prevnar 20" has the highest valency, so if SK Bioscience's SkyPack development is successfully completed, it is expected to become the best vaccine in its category. MSD (U.S. Merck)'s "Pneumovax 23" is a 23-valent vaccine, but it is a polysaccharide vaccine developed in 1983. In addition to these advantages, SkyPack is expected to rapidly increase market share through synergy with Sanofi's strong marketing capabilities in the pediatric vaccine market.
According to the World Health Organization (WHO), pneumonia accounted for 14% of deaths among children under five worldwide in 2019, making it the leading cause of death overall, highlighting pneumonia prevention through vaccination as a global challenge. In South Korea as well, pneumonia ranked third among causes of death in 2020, following cancer and heart disease.
The market size is also substantial. Excluding COVID-19, it boasts the largest market size among single vaccines. According to Mordor Intelligence, the global pneumococcal vaccine market size is expected to grow from $7.82 billion (approximately 10 trillion KRW) in 2021 to $10.18 billion (approximately 13 trillion KRW) by 2027, with an average annual growth rate of about 4.4%. Among individual vaccines, Pfizer's other pneumococcal vaccine "Prevnar 13" recorded sales of $5.27 billion (approximately 7 trillion KRW) in 2021, making it the second highest-selling vaccine after the human papillomavirus (HPV) vaccine Gardasil ($5.67 billion), excluding COVID-19 vaccines.
SK Bioscience and Sanofi conducted this Phase 2 clinical trial from May 2020, targeting 140 children aged 12 to 15 months and 712 infants aged 42 to 89 days in the United States, Canada, and Honduras. After administering GBP410 and a control vaccine as primary vaccinations (at 2, 4, and 6 months of age) and booster vaccinations (at 12 to 15 months of age), immunogenicity equivalent to the control vaccine was confirmed.
In terms of safety, no serious adverse events related to the vaccine were reported in the vaccinated group. When co-administered with recommended vaccines for infants and children such as tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type B vaccines, immunogenicity and safety levels equivalent to the control vaccine were also confirmed.
As the commercialization potential of SkyPack increases, SK Bioscience plans to make large-scale facility investments with Sanofi to enter the U.S. and European markets. Through significant investment in the L House in Andong City, Gyeongbuk Province, they plan to establish production facilities compliant with the U.S. Food and Drug Administration (FDA) current Good Manufacturing Practice (cGMP) standards to introduce various proprietary vaccines, including SkyPack, into global markets including advanced countries such as the U.S. and Europe.
Jean-Francois Toussant, Global Head of Vaccine Research & Development (R&D) at Sanofi, said, "We are very pleased to have constructive cooperation with SK Bioscience to prevent pneumococcal diseases. Since the 21-valent pneumococcal vaccine is designed to provide broader protection against pneumococcal diseases through an innovative delivery system, we are confident that based on the success of this Phase 2 trial, the transition to Phase 3 and approval will proceed smoothly."
SK Bioscience President Ahn Jae-yong also stated, "Successfully developing a pneumococcal protein-conjugate vaccine up to Phase 2, which many leading foreign vaccine companies have repeatedly failed to achieve, means that SK has the technological capability to develop top-level vaccine candidates. We feel proud to have been able to collaborate with an excellent partner like Sanofi, and we will continue to create Korean vaccines that will lead the world through partnerships with various big pharma companies in the future."
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