Tillkännagivande • Mar 23

Vaxcyte Inc Completes Enrollment Of OPUS-1 And OPUS-2 Phase 3 Trials Evaluating VAX-31 For The Prevention Of Invasive Pneumococcal Disease And Pneumonia In Adults

Vaxcyte, Inc. announced the completion of enrollment in the VAX-31 OPUS-1 Phase 3 pivotal, noninferiority trial with approximately 4,000 participants and the OPUS-2 Phase 3 trial evaluating VAX-31 concomitantly administered with a seasonal influenza vaccine in approximately 1,300 participants. The Phase 3 program evaluating VAX-31, the Company’s next-generation 31-valent pneumococcal conjugate vaccine (PCV) candidate, for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults was finalized in consultation and alignment with the U.S. Food and Drug Administration (FDA) and is intended to generate a broad and robust dataset to support a planned Biologics License Application (BLA) submission. Topline safety, tolerability and immunogenicity data from OPUS-1 Phase 3 study are expected in Fourth Quarter of 2026. Results from the OPUS-2 and OPUS-3 trials are expected in the first half of 2027. The pivotal Phase 3 study of VAX-31 is now fully enrolled with approximately 4,000 adults. The randomized, double-blind, active-controlled trial is evaluating the safety, tolerability and immunogenicity of the VAX-31 High Dose, the adult formulation being evaluated in the OPUS Phase 3 program, in healthy, pneumococcal-naïve U.S. adults aged 50 years and older, with a separate cohort of adults aged 18-49 years. In this formulation, all serotypes are dosed at 3.3 mcg, except serotypes 1, 5 and 22F, which are dosed at 4.4 mcg. The study is being conducted at approximately 50 sites across the United States. Adults aged =50 years: Participants in this age group were randomized 1:1:1 to receive a single dose of VAX-31, Capvaxive (PCV21) or Prevnar 20 (PCV20) on Day 1. Adults aged 18-49 years: Participants in this age group were randomized 3:1 to receive a single dose of VAX-31 or PCV20 on Day 1, with PCV20 serving as the safety comparator. For all participants, safety and tolerability will be assessed for six months following initial vaccination of VAX-31, PCV21 or PCV20. Primary immunogenicity objectives: Noninferiority of VAX-31 compared with PCV21 and/or PCV20 for the 28 serotypes shared with either or both comparator vaccines in adults aged 50 years and older (criterion: lower bound (LB) of the two-sided 95% confidence interval (CI) of the OPA GMR is >0.667). Superiority of VAX-31 compared with PCV21 or PCV20 for the three serotypes unique to VAX-31 (2, 7C and 20C) and for serotype 20B in adults aged 50 years and older (criterion: LB of the two-sided 95% CI of the OPA GMR is >2.0). Noninferiority of VAX-31 immune responses in adults aged 18-49 years compared with those in adults aged 50-64 years (criterion: LB of the two-sided 95% CI of the OPA GMR is >0.667). Key secondary immunogenicity objectives: Noninferiority of VAX-31 compared with both PCV21 and PCV20 for the 11 serotypes common to all three vaccines in adults aged 50 years and older (criterion: LB of the two-sided 95% CI of the OPA GMR is >0.5). Statistically greater immune responses elicited by VAX-31 compared with those elicited by PCV21 or PCV20 for the 28 shared serotypes in adults aged 50 years and older (criterion: LB of the two-sided 95% CI of the OPA GMR is >1.0). Superiority of VAX-31 compared with PCV20 for the eight serotypes common to VAX-31 and PCV21 but not included in PCV20 in adults aged 50 years and older (criterion: LB of the two-sided 95% CI of the OPA GMR is >2.0). Superiority of VAX-31 compared with PCV21 for the nine serotypes common to VAX-31 and PCV20 but not included in PCV21 in adults aged 50 years and older (criterion: LB of the two-sided 95% CI of the OPA GMR is >2.0). VAX-31 serotypes (31): 1, 2, 3, 4, 5, 6A, 6B, 7C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 16F, 17F, 18C, 19A, 19F, 20C, 22F, 23A, 23B, 23F, 31, 33F, 35B. Serotypes common to VAX-31, PCV21 and PCV20 (11): 3, 6A, 7F, 8, 10A, 11A, 12F, 15B, 19A, 22F, 33F. Serotypes common to VAX-31 and PCV20 but not in PCV21 (9): 1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F. Serotypes common to VAX-31 and PCV21 but not in PCV20 (8): 9N, 15A, 16F, 17F, 23A, 23B, 31, 35B. Serotypes unique to VAX-31 (3): 2, 7C, 20C (20B is also being evaluated). OPUS-2 Phase 3 study, which is now fully enrolled with approximately 1,300 adults, is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and immunogenicity of VAX-31 when administered either concomitantly with or one month following administration of a licensed seasonal influenza vaccine in pneumococcal-naïve, healthy U.S. adults aged 50 years and older. The results of this descriptive study are intended to inform the design of a potential post-licensure outcomes study that further evaluates VAX-31 in concomitant use with an influenza vaccine and to provide supportive evidence as part of the broader Phase 3 dataset. The study is being conducted at approximately 25 sites in the United States. Participants were randomized 1:1 into one of two groups: Concomitant Administration Group: Participants received a seasonal influenza vaccine administered open-label and concomitantly with VAX-31 administered blinded on Day 1, followed by a blinded placebo injection at Month 1. Sequential Administration Group: Participants received a seasonal influenza vaccine administered open-label with a blinded placebo injection on Day 1, followed by VAX-31 administered blinded at Month 1. This sequential dosing approach allows for evaluation of immune responses to VAX-31 when administered alone, while preserving blinding and controlling for vaccination timing. For all participants, safety and tolerability will be assessed for six months following initial vaccination. Primary immunogenicity objectives: Assessing serotype-specific immune responses (opsonophagocytic activity (OPA) geometric mean titers (GMTs) and geometric mean fold rises (GMFRs)) elicited by VAX-31 across all 31 serotypes and serotype 20B in pneumococcal-naïve adults aged 50 years and older. Comparing strain-specific immune responses (hemagglutination inhibition (HAI) GMTs) elicited by a seasonal influenza vaccine when co-administered with VAX-31 to those elicited by a seasonal influenza vaccine alone. Secondary immunogenicity objective: Comparing immunoglobulin G (IgG) antibody responses (IgG geometric mean concentrations (GMCs)) elicited by VAX-31 across all 31 serotypes and serotype 20B when VAX-31 is co-administered with a seasonal influenza vaccine to those elicited by VAX-31 alone.

Tillkännagivande • Jan 23

Vaxcyte, Inc. Advances Adult and Infant Programs for VAX-31, a Potential Best-In-Class, Next-Generation Pneumococcal Conjugate Vaccine

Vaxcyte, Inc. 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-naïve 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. VAX-31 Adult Indication: Vaxcyte is advancing a comprehensive Phase 3 adult clinical program for VAX-31 to support a planned BLA submission. The announced Phase 3 clinical studies, which were finalized in consultation and alignment with the FDA, include the pivotal, noninferiority trial evaluating VAX-31 for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults (OPUS-1, enrolling); a trial evaluating VAX-31 when administered concomitantly with a licensed seasonal influenza vaccine in pneumococcal-naïve adults (OPUS-2, enrolling); and a trial in adults who have previously received a pneumococcal vaccine (OPUS-3, not yet enrolling). Across these three studies, approximately 6,000 adults are expected to be enrolled in total, of whom approximately 3,400 will receive VAX-31, with the intent to generate a broad and robust safety, tolerability and immunogenicity dataset. Vaxcyte is also planning for a manufacturing consistency study (e.g., a lot-to-lot study). About OPUS-2, the Adult Phase 3 Trial of VAX-31 Concomitantly Administered with a Seasonal Influenza Vaccine (n~1,300) This Phase 3 study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and immunogenicity of VAX-31 when administered either concomitantly with or one month following administration of a licensed seasonal influenza vaccine in pneumococcal-naïve, healthy U.S. adults aged 50 years and older. The study is expected to enroll approximately 1,300 participants at approximately 25 sites in the United States. The results of this descriptive study are intended to inform the design of a potential post-licensure outcomes study that further evaluates VAX-31 in concomitant use with an influenza vaccine and to provide supportive evidence as part of the broader Phase 3 dataset. Participant Overview: Participants will be randomized 1:1 into one of two groups: Concomitant Administration Group (n~650): Participants receive a seasonal influenza vaccine administered open-label and concomitantly with VAX-31 administered blinded on Day 1, followed by a blinded placebo injection at Month 1. Sequential Administration Group (n~650): Participants receive a seasonal influenza vaccine administered open-label with a blinded placebo injection on Day 1, followed by VAX-31 administered blinded at Month 1. This sequential dosing approach allows for evaluation of immune responses to VAX-31 when administered alone, while preserving blinding and controlling for vaccination timing. For all participants, safety and tolerability will be assessed for six months following initial vaccination. Immunogenicity Analyses Primary immunogenicity objectives: Month 1: Assessing serotype-specific immune responses (opsonophagocytic activity (OPA) geometric mean titers (GMTs) and geometric mean fold rises (GMFRs)) elicited by VAX-31 across all 31 serotypes and serotype 20B in pneumococcal-naïve adults aged 50 years and older. Month 2: Comparing strain-specific immune responses (hemagglutination inhibition (HAI) GMTs) elicited by a seasonal influenza vaccine when co-administered with VAX-31 to those elicited by a seasonal influenza vaccine alone. Secondary immunogenicity objective: Comparing immunoglobulin G (IgG) antibody responses (IgG geometric mean concentrations (GMCs)) elicited by VAX-31 across all 31 serotypes and serotype 20B when VAX-31 is co-administered with a seasonal influenza vaccine to those elicited by VAX-31 alone. About OPUS-3, the VAX-31 Adult Phase 3 Trial in Subjects Who Have Previously Received a Pneumococcal Vaccine (n~720): This Phase 3 study is a randomized, double-blind, active-controlled, descriptive clinical trial designed to evaluate the safety, tolerability and immunogenicity of a single dose of VAX-31 in approximately 720 healthy U.S. adults aged 50 years and older with a history of prior pneumococcal vaccination at least six months prior. The study will be conducted at approximately 30 sites in the United States.Participant Overview: Approximately 720 participants will be assigned to one of three groups (~240 each) based on prior pneumococcal vaccination history, comprising adults who have previously received 1) Pneumovax 23 (PPSV23), 2) Prevnar 20 (PCV20) or 3) other licensed pneumococcal vaccines, alone or in combination. Participants in each group will be randomized 3:1 to receive VAX-31 or PCV20, the active comparator, on Day 1. For all participants, safety and tolerability will be assessed for six months following initial vaccination.Immunogenicity Analyses. Primary immunogenicity objective: Month 1: Assessing serotype-specific immune responses (OPA GMTs and GMFRs) elicited by VAX-31 across all 31 serotypes and serotype 20B in adults who have previously received a licensed pneumococcal vaccine or a combination of licensed pneumococcal vaccines. Secondary immunogenicity objective: Describing serotype-specific IgG antibody responses (IgG GMCs and GMFRs) elicited by VAX-31 across all 31 serotypes and serotype 20B.

Total avkastning till aktieägarna	-7.9%
Framtida utdelningsavkastning	0%
Utdelningstillväxt	n/a
Nästa utbetalningsdag för utdelning	n/a
Ex utdelningsdag	n/a
Utdelning per aktie	n/a
Utdelningsandel	n/a

Segment	Utdelningsavkastning
Företag (PCVX)	n/a
Marknadens lägsta 25% (US)	1.4%
Marknad Topp 25% (US)	4.2%
Genomsnitt för branschen (Biotechs)	2.5%
Prognosanalytiker (PCVX) (upp till 3 år)	0%

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/05/11 06:09
Aktiekurs vid dagens slut	2026/05/11 00:00
Intäkter	2026/03/31
Årlig intjäning	2025/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
Jason Matthew Gerberry	BofA Global Research
Thomas Shrader	BTIG
Carter Gould	Cantor Fitzgerald & Co.

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Recent updates

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New minor risk - Shareholder dilution

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Executive VP & COO notifies of intention to sell stock

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New major risk - Shareholder dilution

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Executive VP & COO notifies of intention to sell stock

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Insufficient new directors

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New major risk - Revenue and earnings growth

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Vaxcyte, Inc., Annual General Meeting, Jun 06, 2024

President & CFO notifies of intention to sell stock

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