PCV20

Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults

Retrieved on: 
Monday, April 29, 2024
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The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine.

Key Points: 
  • The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine.
  • V116 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
  • The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024.
  • V116 is specifically designed to help protect adults from invasive pneumococcal disease; the serotypes in V116 account for approximately 83% of adult invasive pneumococcal disease in individuals 65 and older, according to U.S. Centers for Disease Control and Prevention data from 2018-2021.

Merck Announces Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrated Immune Responses in Adults

Retrieved on: 
Tuesday, March 19, 2024
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Emory University, Antigen, Streptococcus, International Society, HIV, Risk, Global health, Patient, Cohort, Hospital, Merck & Co., Aes, OPA, Epidemiology, Training school (United States), PCV20, Immunoglobulin G, Attenuated vaccine, MRK, Pediatrics, CDC, Vaccination, PPSV23, Community-acquired pneumonia, Food, FDA, PDUFA, Medicine, Vaccine

V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.

Key Points: 
  • V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.
  • If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.
  • Participants were enrolled based on previous pneumococcal vaccination with PPSV23, PCV15, PCV13 (pneumococcal 13-valent conjugate vaccine), PPSV23+PCV13, PCV13+PPSV23 or PCV15+PPSV23, and received either V116, PCV15 or PPSV23.
  • V116 elicited comparable immune responses to the comparator, PCV15+PPSV23, for all 13 shared serotypes and higher immune responses for the eight serotypes covered only by V116.

Vaxcyte Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, February 27, 2024
Licensure, Investment, Growth, Exercise, Tolerability, Immunization, Host, Trial of the century, Ageing, PCV20, PCV, P-value, Safety, BLA, Success, Phase 10, Genetically modified bacteria, Net, G&A, CMC, SAN, Research and development, ID, OPA, Conference, The Lancet, Biologics license application, Breakthrough therapy, Advisory Committee, PCV15, POC, FDA, End, Food, Breakthrough, Element, Fireside chats, Administration, IPD

-- Significant Progress in Establishing Global Commercial Manufacturing Capacity for Vaxcyte's PCV Candidates, Including Expanded Collaboration with Lonza --

Key Points: 
  • ET / 1:30 p.m. PT --
    SAN CARLOS, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • Additionally, as part of ongoing Chemistry, Manufacturing and Controls (CMC)-focused discussions, Vaxcyte received encouraging input from the FDA regarding the VAX-24 adult licensure requirements.
  • The six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.
  • Vaxcyte will host a conference call and webcast to discuss this announcement today, February 27, 2024, at 4:30 p.m.

Vaxcyte Provides Clinical and Regulatory Progress Update on Potential Best-in-Class Pneumococcal Conjugate Vaccine (PCV) Franchise

Retrieved on: 
Thursday, January 4, 2024
Licensure, Food, PCV, End, Breakthrough therapy, FDA, CMC, Ageing, Phase 10, SAN, Pivotal, Biologics license application, Advisory Committee, PCV20, Breakthrough, Data monitoring committee, Immunization, Initiation, IPD, PCV15, Infant, Safety, Tolerability, Genetically modified bacteria, BLA, Vaccine

-- Enrollment in Ongoing VAX-24 Infant Phase 2 Study Continues to Progress; Topline Data from Primary Immunization Series Expected by End of First Quarter of 2025, Followed by Topline Data from Booster Dose by End of 2025 --

Key Points: 
  • Vaxcyte’s carrier-sparing PCV franchise candidates, including VAX-24, a 24-valent PCV proceeding to Phase 3, and VAX-31, the Company’s next-generation 31-valent PCV, are being studied for the prevention of invasive pneumococcal disease (IPD).
  • The VAX-24 Phase 2 infant study continues to enroll participants in the second and final stage of the study.
  • This is a randomized, observer-blind, dose-finding two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-24 in healthy infants.
  • Topline safety, tolerability and immunogenicity data from the ongoing adult Phase 1/2 study in the third quarter of 2024.

VAX-24 Phase 1/2 Adult Proof-of-Concept Data Published in The Lancet Infectious Diseases Highlight Best-in-Class Potential of Vaxcyte’s 24-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate

Retrieved on: 
Monday, December 4, 2023
The Lancet, PCV, Death, Vaccine, Disease, Attenuated vaccine, SAN, PCV20, Public, IPD, Safety, Bacteria, Genetically modified bacteria

SAN CARLOS, Calif., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced the publication of the results from the VAX-24 Phase 1/2 clinical proof-of-concept study in the journal The Lancet Infectious Diseases. This study evaluated the safety, tolerability and immunogenicity of Vaxcyte’s investigational 24-valent, carrier-sparing pneumococcal conjugate vaccine (PCV) compared to the current standard-of-care, Prevnar 20® (PCV20), for the prevention of invasive pneumococcal disease (IPD) in healthy adults 18-64 years of age. The study results showed VAX-24 demonstrated a safety and tolerability profile that was comparable to PCV20 at all doses studied, and an immunogenicity profile that met or exceeded established regulatory immunogenicity standards for all 24 serotypes at the conventional 2.2 mcg dose. The Company plans to advance the VAX-24 2.2 mcg dose into a Phase 3 program.

Key Points: 
  • This study evaluated the safety, tolerability and immunogenicity of Vaxcyte’s investigational 24-valent, carrier-sparing pneumococcal conjugate vaccine (PCV) compared to the current standard-of-care, Prevnar 20® (PCV20), for the prevention of invasive pneumococcal disease (IPD) in healthy adults 18-64 years of age.
  • The Company plans to advance the VAX-24 2.2 mcg dose into a Phase 3 program.
  • “Despite the availability of pneumococcal vaccines, the bacteria associated with IPD continues to be a major driver of deaths as a result of antimicrobial resistance.
  • “We look forward to initiating our Phase 3 pivotal, non-inferiority study, which is designed to further establish the clinical potential of VAX-24, and announcing topline data, which we expect in 2025.”

Merck’s V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults, Demonstrated Superior Immunogenicity for 10 of 11 Unique Serotypes Compared to PCV20 in Adults 50 Years of Age and Older

Retrieved on: 
Tuesday, November 28, 2023
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, MSD, OPA, Safety, NYSE, Cohort, Merck & Co., Aes, Risk, Immunodeficiency, Patient, Molina Healthcare, GMT (TV programme), Vaccine, 9N, Fungal infection, Leucauge, Streptococcus, 20A, 10A, CDC, Attenuated vaccine, EST, Public, MRK, Pharmaceutical industry, PCV20, V116, Merck

The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine.

Key Points: 
  • The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine.
  • In adults 18 to 49 years of age (Cohort 2), V116 elicited non-inferior immune responses (immunobridged) compared to adults 50 to 64 years of age, as assessed by serotype-specific OPA GMTs 30 days post-vaccination.
  • If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.
  • Participants administered V116 and PCV20 who reported at least 1 adverse event (AE) were 61.7% and 67.2%, respectively.

Vaxcyte Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, August 8, 2023
Vaccine, Exercise, Advisory Committee on Immunization Practices, Immunization, OPA, Research and development, Streptococcus, University, Life, Investment, IPD, Safety, Public, Advisory Committee, Licensure, G&A, Research, National Institutes of Health, Payment Card Industry Security Standards Council, Bangladesh Technical Education Board, Stage 2, History of the University of Maryland, College Park, Data monitoring committee, Breakthrough therapy, Genetically modified bacteria, Death, PCV20, Administration, SAN, Breakthrough, Rocket launcher, Infant, Ageing, Growth, PCV, R, FDA, General Administration of Sport of China, Regulation of tobacco by the U.S. Food and Drug Administration, IND, Family, Announcement, Food, Pharmaceutical industry, Cryptocurrency, Shigella

SAN CARLOS, Calif., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the second quarter ended June 30, 2023 and provided a business update.

Key Points: 
  • “Our strong balance sheet provides a solid foundation as we advance our PCV franchise and pipeline programs.
  • The six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.
  • Clearance of the adult IND application by the FDA in the fourth quarter of 2023 following submission.
  • The June 30, 2023 amount includes the $545.3 million in net proceeds from the follow-on offering completed in April 2023.

Vaxcyte Advances to Second Stage of Ongoing Phase 2 Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease in Infants

Retrieved on: 
Tuesday, July 11, 2023
ACIP, IPD, Public, Advisory Committee, Stage 2, Data monitoring committee, Genetically modified bacteria, PCV20, Advisory Committee on Immunization Practices, SAN, Peterborough, PCV15, PCV, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, News, Meningitis, Food, Safety, Disease, Vaccine, Pharmaceutical industry

SAN CARLOS, Calif., July 11, 2023 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced that the ongoing Phase 2 study of VAX-24 in healthy infants is advancing to the second and final stage of the study. The independent Data Safety Monitoring Board approved advancing to the second stage of the study following the review of the safety and tolerability results from the first stage. The Phase 2 study is evaluating the safety, tolerability and immunogenicity of VAX-24, the Company’s lead, broad-spectrum 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD). Vaxcyte expects to share topline data from the primary three-dose immunization series of the study by 2025, followed by topline data from the booster dose approximately nine months later.

Key Points: 
  • The independent Data Safety Monitoring Board approved advancing to the second stage of the study following the review of the safety and tolerability results from the first stage.
  • The Phase 2 study is evaluating the safety, tolerability and immunogenicity of VAX-24, the Company’s lead, broad-spectrum 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).
  • The Stage 2 portion is evaluating the safety, tolerability and immunogenicity of VAX-24 at the same three dose levels compared to PCV20 in approximately 750 infants.
  • “We believe the findings from our Phase 2 infant study will provide valuable insights into the potential utility of VAX-24, the broadest-spectrum PCV in U.S. clinics today.”

Vaxcyte Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, May 8, 2023
Exercise, OPA, Research and development, P-value, Solar eclipse of March 31, 2090, Investment, IPD, Safety, Pneumococcal conjugate vaccine, Ageing, G&A, Element, Breakthrough therapy, Genetically modified bacteria, PCV20, Safety data sheet, Administration, SAN, Peterborough, Growth, R, PCV, STS, FDA, General Administration of Sport of China, Immunization, IND, Vaccine, Pharmaceutical industry, Cryptocurrency, PCV15, Infant

-- $949.9 Million in Cash, Cash Equivalents and Investments as of March 31, 2023, Excluding Net Proceeds of $545.1 Million from Recent Public Offering --

Key Points: 
  • VAX-24, the Company’s lead, broad-spectrum 24-valent pneumococcal conjugate vaccine (PCV) candidate, is being studied for the prevention of IPD.
  • Submission of the adult IND application to the FDA and announcement of subsequent FDA clearance in the second half of 2023.
  • The March 31, 2023 amount excludes the $545.1 million in estimated net proceeds from the follow-on offering completed in April 2023.
  • Net Loss: For the three months ended March 31, 2023, net loss was $60.5 million, compared to $39.0 million for the same period in 2022.

Vaxcyte Reports Positive Data from Phase 2 Study of its 24-Valent Pneumococcal Conjugate Vaccine Candidate, VAX-24, in Adults Aged 65 and Older and Full Six-Month Safety Data from Adult Phase 1/2 and Phase 2 Studies

Retrieved on: 
Monday, April 17, 2023
Vaccine, OPA, Vaccination, IPD, Ageing, Risk, ID, GMR, Genetically modified bacteria, PCV20, Investigational New Drug, SAN, Host, Radio communication service, Webcast, Infant, PCV, Principal, STS, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, IND, Conference, Food, Safety, Pharmaceutical industry, Coke (fuel)

-- Prespecified Pooled Immunogenicity Analyses of Data from Both Adult Phase 2 Studies Showed the VAX-24 2.2mcg Dose Met OPA Non-Inferiority Criteria for All 20 STs Common with PCV20 and Superiority Criteria for the Four Additional VAX-24 STs --

Key Points: 
  • 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 six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.
  • “We believe the positive results from the Phase 2 study in adults aged 65 and older confirm the clinical potential of VAX-24 in the adult population.
  • The Company also reported the full six-month safety results from the VAX-24 Phase 2 study in adults aged 65 and older and the VAX-24 Phase 1/2 study in adults aged 18-64.