Trial Design Finalized in Consultation and Alignment with U.S. Food and Drug Administration Study Designed to Establish a New Standard for Adult Pneumococcal Conjugate Vaccines Through Head-to-Head Safety, Tolerability and Immunogenicity Comparisons of VAX-31 with Capvaxive (PCV21) and Prevnar 20 (PCV20), the Current Standards of Care Company Expects to Report Topline Safety, Tolerability and Immunogenicity Data for OPUS Phase 3, Noninferiority Trial in the Fourth Quarter of 2026 and Initiate Additional P ...

Core Insights - Vaxcyte, Inc. announced positive final data from the VAX-24 infant Phase 2 dose-finding study, confirming previously reported interim results and supporting the evaluation of higher doses in the ongoing VAX-31 infant Phase 2 study [1][4][10] - The company plans to initiate the VAX-31 adult pivotal, non-inferiority study in December 2025, with topline data expected in 2026 [1][2] - Vaxcyte is establishing fill-finish manufacturing in North Carolina, representing a long-term commitment of up to $1 billion, aligning with U.S. biomanufacturing initiatives [1][12] - The company appointed Mike Mullette as Chief Commercial Officer to lead commercialization efforts for VAX-31 as it advances to Phase 3 [1][14] - Vaxcyte reported a cash position of approximately $2.7 billion as of September 30, 2025, expected to fund operations into mid-2028 [1][2] PCV Program Updates - The final data from the VAX-24 study showed robust, dose-dependent immune responses with minimal carrier suppression, validating the rationale for higher doses in the VAX-31 study [2][4][6] - The VAX-31 infant Phase 2 study has progressed to its third and final stage, aiming to expand coverage against invasive pneumococcal disease (IPD) in children under five years of age [10][12] - VAX-31 is designed to increase protection against IPD from approximately 69% to 92% by adding 11 incremental serotypes compared to the current standard, PCV20 [10] Financial Highlights - For Q3 2025, Vaxcyte reported a net loss of $212.8 million, compared to a net loss of $103.1 million in Q3 2024 [23] - Research and development expenses for Q3 2025 were $209.9 million, up from $116.9 million in the same period in 2024, primarily due to increased development activities [17][23] - General and administrative expenses rose to $32.4 million in Q3 2025 from $23.0 million in Q3 2024, reflecting higher personnel costs [17][23] Manufacturing and Leadership - The company is expanding its fill-finish manufacturing capacity in North Carolina through a partnership with Thermo Fisher Scientific, enhancing its supply chain and commercial readiness [12] - Mike Mullette's appointment as Chief Commercial Officer is aimed at strengthening the company's commercialization strategy for its pneumococcal conjugate vaccine programs [14] Upcoming Milestones - Vaxcyte anticipates initiating the VAX-31 Phase 3 pivotal study in December 2025 and plans to announce topline safety and immunogenicity data in 2026 [15][18]

Core Insights - Vaxcyte, Inc. is advancing its VAX-31 infant Phase 2 randomized, dose-finding study to the final stage, focusing on a 31-valent pneumococcal conjugate vaccine designed to prevent invasive pneumococcal disease (IPD) in infants [1][2][3] - The VAX-31 Optimized Dose aims to elicit stronger immune responses in infants, with the majority of serotypes dosed at 4.4mcg and the balance at 3.3mcg, potentially covering approximately 92% of IPD and 93% of acute otitis media in U.S. children under five [1][3][6] - The company plans to release topline data from the primary immunization series and booster dose by the end of the first half of 2027 [1][2] Company Overview - Vaxcyte is a clinical-stage vaccine innovation company focused on developing high-fidelity vaccines to combat bacterial diseases [1][8] - The company is also developing VAX-24, a 24-valent PCV candidate, which aims to cover more serotypes than any existing infant PCV on the market [8][9] - Vaxcyte utilizes the XpressCF platform for cell-free protein synthesis, enhancing its ability to produce complex vaccines [9] Study Details - The VAX-31 infant Phase 2 study is a randomized, double-blind, active-controlled trial evaluating safety, tolerability, and immunogenicity compared to Prevnar 20 (PCV20) [4][10] - The study will enroll approximately 900 participants, including those previously in the Low Dose arm, and will assess immune responses through serotype-specific immunoglobulin G (IgG) seroconversion rates [2][10] - The study consists of three stages, with the first stage completed and the second stage modified to include the new Optimized Dose arm [4][10] Disease Context - Pneumococcal disease, caused by Streptococcus pneumoniae, is a leading cause of vaccine-preventable deaths among children under five, with significant morbidity and mortality [5][6] - The disease can lead to severe conditions such as meningitis and bacteremia, highlighting the urgent need for a broader-spectrum vaccine [5][6] Regulatory Status - The FDA has expanded the Breakthrough Therapy designation for VAX-31 to include the prevention of pneumonia caused by Streptococcus pneumoniae, indicating potential substantial improvement over existing therapies [7]

VAX-31 Phase 1/2 Study Results Overview - VAX-31 demonstrated a safety profile similar to Prevnar 20® (PCV20) at all doses studied[14] - VAX-31 induced robust OPA immune responses for all 31 serotypes (STs) at all doses studied, with all three doses advanceable to Phase 3[14] - The VAX-31 data validate the potential of Vaxcyte's carrier-sparing platform to deliver the broadest-spectrum PCVs[15] Immunogenicity Data - High and Middle doses of VAX-31 met or exceeded OPA regulatory immunogenicity criteria for all 31 STs, while the Low dose met the criteria for 29 of 31 STs[17] - For the 20 STs common with PCV20, the High dose had 18 with GMR greater than 10, the Middle dose had 13 with GMR greater than 10, and the Low dose had 8 with GMR greater than 10[17] - For the 11 additional STs unique to VAX-31, all 11 met the superiority criteria at all doses[17] Clinical Development Plan - Vaxcyte plans to initiate a Phase 3 pivotal, non-inferiority study for VAX-31 in adults by mid-2025, with topline results expected in 2026[18] - Vaxcyte plans to initiate a VAX-31 infant Phase 2 study in 1Q:2025 following IND submission and clearance[18] Market Opportunity - The pneumococcal vaccine market is expected to reach approximately $13 billion by 2027[105] - VAX-31 is designed to increase coverage to more than 95% of IPD circulating in U S adults[104]