Sanofi is handing SK bioscience 50 million euros ($52 million) as the longtime partners take their next-gen pneumococcal conjugate vaccine program into phase 3.
The move follows a phase 2 win last year for the candidate, a 21-valent pneumococcal conjugate vaccine previously called GBP410 and now renamed PCV21, which demonstrated comparable immunogenicity to a control vaccine.
By including 21 serotypes, the partners aim to offer broader coverage than the current approved pneumococcal conjugate vaccines for children. Sanofi announced Monday morning that it has now launched the shot into a phase 3 study, making it the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter a late-stage study in infants and toddlers.
Sanofi and SK will co-fund the research and development costs, with Sanofi also paying SK the 50 million euro upfront fee. An undisclosed amount of development and commercial milestone payments could follow. Should PCV21 make it to market, Sanofi will commercialize the vaccine worldwide, except for in SK’s home turf of South Korea.
“Given the vast unmet public health needs in [invasive pneumococcal disease], we’re delighted to expand this collaboration and continue our pursuit of innovative work in PCV,” Thomas Triomphe, Sanofi's head of vaccines, said in the Dec. 23 release.
“Our collaboration leverages SK bioscience’s capabilities and Sanofi’s expertise in developing and bringing innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease,” Triomphe added.
The partnership between Sanofi and SK dates back to 2014, when the French pharma paid $23 million upfront to get the ball rolling on vaccine development.
There are currently two FDA-approved pneumococcal vaccines for children—Merck & Co.’s 15-valent Vaxneuvance and Pfizer’s 20-valent Prevnar 20.
Sanofi isn’t the only Big Pharma hoping to expand the range of serotypes available in pneumococcal vaccines. GSK had been working on a 24-valent candidate acquired via its $2.1 billion acquisition of Affinivax but revealed in October that it had axed the asset. In June, Merck’s 21-valent Capvaxive became the first pneumococcal vaccine specifically designed for adults to receive FDA approval.
Then, in September, Vaxcyte unveiled what analysts called “stunning” phase 1/2 data in adults for its 31-valent candidate that, if replicated in a large pivotal study, could pose a serious threat to Prevnar 20. A separate phase 2 trial of Vaxcyte’s shot in infants has recently launched.