SK Bioscience, aiming to be 'world's best,' submits IND for 21-valent pneumonia vaccine Phase 3 in the US

Entering clinical trials next year, aiming for completion in 2027
Global minimum target of 3,550 participants

Targeting 'world's largest' 21 serotypes
Existing vaccines cover up to 20 serotypes

SK Bioscience has announced the start of Phase 3 clinical trials for the next-generation pneumococcal vaccine 'SkyPack (GBP410, Sanofi development name SP0202)', which is being developed in collaboration with global big pharma Sanofi. The goal is to enter actual clinical trials next year and complete them by 2027.

At the Vaccines Investor Event hosted by Sanofi in London, UK, last June, 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 11th, SK Bioscience and Sanofi announced that they submitted the Investigational New Drug (IND) application for the Phase 3 clinical trial of SkyPack to the U.S. Food and Drug Administration (FDA) on the 8th (local time). The related procedures are expected to be completed after additional submission processes in the future.

This clinical trial will be conducted by combining a total of three studies. First, in Study 1, the immunogenicity and safety of SkyPack will be evaluated in infants, children, and adolescents aged 6 weeks to 17 years. For 1,630 participants with no prior pneumococcal vaccine history, a licensed pneumococcal vaccine will be used as a control group, and a primary vaccination series of three doses plus one booster dose will be administered. Additionally, Study 2 will evaluate the safety of SkyPack in 1,920 participants using the same method. Furthermore, a third study, with details to be disclosed in 2025, is also planned, making a total of three clinical trials currently scheduled.

An SK Bioscience official explained, "We have currently submitted the IND for Studies 1 and 2, and will submit the IND for Study 3 later. The number of clinical trial participants may increase beyond the current 3,550 through Study 3." Geographically, starting with this FDA IND, IND applications will also be submitted in multiple countries including the United States, Europe, and Korea, proceeding as a global clinical trial.

In August, the two companies announced that SkyPack confirmed immunogenicity and safety through Phase 2 clinical trials. In a comparative clinical trial with Pfizer's pneumococcal vaccine 'Prevnar 13', involving 140 children aged 12 to 15 months and 712 infants aged 42 to 89 days, SkyPack demonstrated immunogenicity equivalent to the control vaccine. Regarding safety, no serious adverse events related to the GBP410 vaccine were reported, and when co-administered with recommended infant and pediatric vaccines such as tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type B vaccines, SkyPack showed immunogenicity and safety levels comparable to the control vaccine.

From 13-, 15-, and 20-valent to 21-valent target... Will it become the 'largest valency pneumococcal vaccine'?

Once launched on the market, SkyPack is expected to be the vaccine that prevents the widest variety of pneumococcal serotypes worldwide. SkyPack is being developed to prevent a total of 21 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F). Currently, the vaccine with the most serotypes approved globally is Pfizer's 20-valent vaccine 'Prevnar 20'. SkyPack adds the 9N serotype to Prevnar 20.

Prevnar 20 received FDA approval in 2021 and quickly dominated the market, boasting an overwhelming market share of over 90% in the United States. It has also been submitted for approval to the Korean Ministry of Food and Drug Safety. Recently, MSD (Merck & Co., USA)'s 15-valent vaccine 'Vaxneuvance' was approved domestically as the highest valency pneumococcal vaccine in Korea.

MSD (Merck, USA) PCV15 'Box New Vance' (left) and Pfizer's PCV20 'Prevnar 20' [Photo provided by each company]

Although there have been 23-valent vaccines among existing vaccines, SkyPack, a 21-valent vaccine, aims to be the highest valency vaccine because it is a different type of vaccine. Existing 23-valent vaccines are 'polysaccharide vaccines (PPSV)', while SkyPack, Prevnar, and Vaxneuvance are all 'protein-conjugate vaccines (PCV)'. PPSV is made using polysaccharides from the capsule outer wall of pneumococcus, whereas PCV conjugates polysaccharides with a protein carrier to induce T-cell dependent immune responses. PPSV covers more serotypes, providing broader protection against various strains, while PCV has fewer serotypes but is known to have higher preventive efficacy. SK Bioscience previously succeeded in developing Korea's first pneumococcal PCV13 vaccine 'SkyNemo', but it is currently unable to sell it due to patent infringement issues with Pfizer.

Jae-yong Ahn, CEO of SK Bioscience, said, "Only a few of the world's top vaccine companies have succeeded in developing pneumococcal protein-conjugate vaccines, and we are taking steps toward successful development." He added, "Since approximately 740,000 infants, children, and adolescents worldwide die annually from pneumonia, we aim to contribute to global public health through the development of SkyPack and grow into a market-leading company."

This content was produced with the assistance of AI translation services.