24-Valent Pneumococcal Conjugate Vaccine Candidate Posts Positive Results

Vaxcyte, Inc. today announced positive results from the VAX-24 Phase 2 study in adults aged 65 and older, as well as data from the full six-month safety assessment and prespecified pooled immunogenicity analyses from both the Phase 2 study in adults aged 65 and older and the prior Phase 1/2 study in adults aged 18-64.

VAX-24, the Company's lead, broad-spectrum 24-valent pneumococcal conjugate vaccine (PCV) candidate, is being studied to prevent invasive pneumococcal disease (IPD).

The Company says, 'The public health community continues to affirm the need for vaccines that offer broader protection to prevent IPD.'

"Based on the overall strength of our data and the well-established regulatory pathway, we look forward to meeting with regulators and advancing VAX-24 into a pivotal Phase 3 study for which we expect topline data in 2025," said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte, in a press release on April 17, 2023.

"We developed VAX-24 to create a best-in-class PCV that provides broader coverage and better immune responses than standard-of-care vaccines."

"These data support that objective and demonstrate the potential of our PCV franchise, including VAX-31, our 31-valent PCV candidate."

In the Phase 2 study in adults aged 65 and older, VAX-24 demonstrated robust OPA immune responses for all 24 serotypes at all doses studied, confirming the prior adult study results.

The VAX-24 2.2mcg dose, which Vaxcyte plans to advance to Phase 3, showed an overall improvement in immune responses vs. PCV20 relative to the results from the prior Phase 2 study in adults aged 50-64.

And the six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.

The unedited announcement is posted at this link.

Other pneumococcal (PCV13, PCV15, PCV20, PCV24) vaccine news is posted at Precision Vaccinations.