SK bioscience and Sanofi have reported positive data from the Phase II clinical trials of GBP410 (SP0202), a 21-valent pneumococcal conjugate vaccine candidate, in infants.

Co-developed by the companies, GBP410 merges certain proteins with the Streptococcus pneumoniae’s polysaccharide capsule.

The Phase II study analysed the safety and immunogenicity of the vaccine in 140 toddlers who were aged between 12 and 15 months, as well as 712 infants aged 42 to 89 days.

According to the data, GBP410 showed comparable immunogenicity versus the control vaccine, after the initial inoculation at two, four and six months of age, as well as the booster dose for those aged 12 to 15 months.

Commenced in May 2020, the study was carried out in the US, Honduras and Canada.

Based on the latest data, the companies intend to commence the Phase III study in the first half of next year with the final findings anticipated in 2027.

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By GlobalData

With SK bioscience planning to enter European and US markets with Sanofi, key investments will be made in production facilities to prepare for the vaccine’s marketing.

SK bioscience will set up manufacturing units at L HOUSE, its vaccine production plant in Andong, Korea.

Sanofi Vaccines R&D global head Jean-Francois Toussaint said: “With an innovative carrier that breaks the glass ceiling of serotype compositions, our 21-valent pneumococcal conjugate vaccine is designed to offer expanded protection against this devastating disease.

“We believe that the results offer us a strong path to Phase III and then to licensure.”

In May this year, the company partnered with Flatiron Health to boost the trial experience for sites, sponsors and patients in the oncology field.