Vaxcyte’s is training its sights on a lucrative pneumococcal vaccine market

On October 24, an American vaccine developer Vaxcyte shared positive top line data from a phase I/II study of its multivalent pneumococcal conjugate vaccine VAX-24bringing the 24-valent pneumococcal injection one step closer to market.

The vaccine demonstrated a similar safety profile as of Pfizer marketed 20-serotype injected Prevnar 20 at all doses evaluated and showed non-inferior efficacy.

On the same day, the San Carlos, California-based vaccine developer announced the commencement of a proposed public offering of common stock and pre-funded warrants. Both updates meant the company’s shares opened more than 41% higher than the previous Friday. On October 26, Vaxcyte said that this proposal it was expected to bring in approximately $600 million in gross revenue The company now has a market capitalization of $2.47 billion.

What’s more, VAX-24 achieved a higher immune response to 16 of the 20 serotypes it shares with Prevnar 20. VAX-24 met standard superiority criteria for four additional serotypes, as stated in the Oct. 24 press release. The company says these four serotypes account for approximately 10-15% of the bacteria that cause pneumococcal disease in adults.

While the first pneumococcal polysaccharide vaccine was approved in the US in 1977, the first Prevnar conjugate injection was not approved until 2000. It originally targeted seven serotypes before Pfizer released an updated version that targeted 13 serotypes in 2010. June 2021 FDA approved Pfizer’s Prevnar 20 for use in adults, although approval for pediatric use is pending.

merck, known outside the US and Canada as MSD, is developing its portfolio of pneumococcal vaccines and secured FDA approval for pediatric use of its 15-serotype vaccine Vaxneuvance in June. This is in addition to its long-standing PPSV23 pneumococcal polysaccharide vaccine.

Pneumococcal vaccines are used to inoculate individuals against infections caused by the bacteria Streptococcus pneumoniae. According to the United Kingdom’s National Health Service (NHS), there are over 90 strains of this bacterium.

Currently, the Centers for Disease Control and Prevention (CDC) recommends use of Pfizer’s Prevnar 13 or Prevnar 15 for all infants and children under five, along with those at risk of pneumococcal disease up to age 18. The agency says Prevnar 15 or Prevnar 20 can be used in adults age 65 or older. The CDC suggests that adults between the ages of 19 and 64 should get the vaccine if they have medical conditions or risk factors.

MSD’s PPSV23 is being offered as a potential option by the CDC, including children with the disease between the ages of two and 18 and adults over 18 who have previously received Prevnar 15.

According to GlobalData, Pharmaceutical technologies The parent company, Prevnar 13 and Vaxneuvance are projected to have global sales of $7.26 billion and $812 million in 2028. VAX-24 has projected sales of $21 million that year.

Additional plans in development

After the first clinical stage of VAX-24, Vaxcyte foresees a number of developments in the next year for its pneumococcal vaccine. The first is a reliance on pivotal data from a second Phase II study in adults aged 65 and older, expected in the first half of 2023. Along with that, final data from the just-announced Phase II study should also be published in that period .

Vaxcyte also plans to initiate a Phase II study of VAX-24 in the pediatric population. The company expects to hold regulatory talks to shape its upcoming Phase III program in adult patients in the second half of 2023.

Separately, the company is seeking to develop a 31-valent pneumococcal vaccine VAX-XP for both adults and infants. There, the business plans to submit a Phase I/II IND application in the second half of 2023, with reporting in 2024.

Competition in an increasingly heated market

Vaxcyte’s recent clinical success brings additional competition to an increasingly heated sector. On the same day as the Vaxcyte results, MSD announced that Vaxneuvance received an extended indication by the European Commission for use in infants, children and adolescents aged between six weeks and under 18 years.

In August 2022, Pfizer announced positive top line data from its Phase III trial testing Prevnar 20 in infants. The trial had two joint objectives, one measuring the immunogenic response one month after the third dose and the other doing the same after the fourth.

Although the vaccine generated an immunogenic response against all 20 serotypes after the fourth dose, it did so against 14 serotypes after the third dose. In the same announcement, Pfizer said the company aims to submit a supplemental biologics license application (sBLA) to the FDA by the end of the year, depending on discussions with the agency.