Vaxcyte Advances VAX-31 Program With First Dosing In Adult Phase 3 OPUS-2 Trial; Plans Additional Phase 3 OPUS-3 Study In 2026; Completes Infant Phase 2 Enrollment
Benzinga Newsdesk 9 months ago
BiotechNewsGeneral
VAX-31 Adult Indication: Vaxcyte Doses First Participants in Phase 3 Study Evaluating Concomitant Administration of VAX-31 and Seasonal Influenza Vaccine (OPUS-2) and Expects to Initiate Phase 3 Study in Adults
VAX-31 Adult Indication: Vaxcyte Doses First Participants in Phase 3 Study Evaluating Concomitant Administration of VAX-31 and Seasonal Influenza Vaccine (OPUS-2) and Expects to Initiate Phase 3 Study in Adults Previously Vaccinated with Pneumococcal Vaccines (OPUS-3) in First Quarter of 2026
Company Expects to Report Topline Safety, Tolerability and Immunogenicity Data from Both OPUS-2 and OPUS-3 Phase 3 Studies in First Half of 2027, Supporting Planned BLA Submission
VAX-31 Adult Phase 3 Noninferiority Trial (OPUS-1) Continues to Enroll Subjects, with Topline Data Expected in Fourth Quarter of 2026
VAX-31 Adult Phase 3 Clinical Studies Designed in Consultation and Alignment with U.S. Food and Drug Administration
VAX-31 Infant Indication: Vaxcyte Completes Enrollment of Phase 2 Dose-Finding Study Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease, Expects to Announce Topline Data from Primary Immunization Series and Booster Dose Either Sequentially or Together by End of First Half of 2027
Company Expects to Initiate Buildout of Custom Fill-Finish Line in First Quarter of 2026 in Connection with Previously Announced Long-Term Commitment of up to $1 Billion in U.S. Manufacturing and Services and Has Established Dedicated North Carolina Presence
SAN CARLOS, Calif., Jan. 22, 2026 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (NASDAQ:PCVX), a clinical-stage vaccine innovation company, today provided updates on the continued advancement of VAX-31, the Company's next-generation 31-valent pneumococcal conjugate vaccine (PCV) candidate, across its adult and infant clinical programs.
For the VAX-31 adult indication, the first participants have been dosed in a Phase 3 trial evaluating VAX-31 when administered concomitantly with a licensed seasonal influenza vaccine in pneumococcal-naïve1 adults aged 50 years and older (OPUS-2 trial). Additionally, Vaxcyte plans to initiate a separate Phase 3 trial in the first quarter of 2026 evaluating VAX-31 in adults who have previously received a pneumococcal vaccine (OPUS-3 trial). For the VAX-31 infant indication, the Company has completed enrollment in its Phase 2 dose-finding study evaluating VAX-31 in healthy infants.