— VAX-31, a 31-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate, is the Broadest-Spectrum PCV to Enter the Clinic —
— Topline Safety, Tolerability and Immunogenicity Data Expected in Second Half of 2024 —
— VAX-31 is Designed to Provide Coverage for Approximately 95% of Invasive Pneumococcal Disease Circulating in the U.S. Adult Population —
SAN CARLOS, CA, USA I November 09, 2023 I Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced that the first participants were dosed in a Phase 1/2 clinical study for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), in adults. The study, which will evaluate the safety, tolerability and immunogenicity of VAX-31, is expected to enroll approximately 1,000 adults aged 50 and older. The Company expects to announce topline data from the Phase 1/2 study in the second half of 2024.
“We are pleased to initiate the first adult clinical study of VAX-31, which is the broadest-spectrum PCV to enter the clinic, with the potential to protect against approximately 95 percent of IPD circulating in the U.S. adult population,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “Leveraging the foundation established by our lead PCV candidate, VAX-24, we believe we have an opportunity to deliver a best-in-class PCV franchise that provides the broadest-spectrum of coverage and improved immune responses compared to the standard-of-care in adults today. We look forward to sharing the anticipated topline study results from the VAX-31 study in adults aged 50 and older in the second half of 2024.”
About the VAX-31 Phase 1/2 Study
The VAX-31 Phase 1/2 clinical study is a randomized, observer-blind, active-controlled, dose-finding clinical study designed to evaluate the safety, tolerability and immunogenicity of VAX-31 compared to Prevnar 20® (PCV20) in approximately 1,000 healthy adults aged 50 and older. The Phase 1 portion of the study will evaluate the safety and tolerability of a single injection of VAX-31 at three dose levels (low, middle and high) and compared to PCV20 in approximately 64 healthy adults 50 to 64 years of age. An independent Data Monitoring Committee will conduct an assessment of the Phase 1 safety and tolerability results prior to the study proceeding to Phase 2. Phase 1 participants will also be evaluated for immunogenicity, and the Phase 1 safety, tolerability and immunogenicity data will be pooled with the participants in the Phase 2 portion of the study. Phase 2 will evaluate the safety, tolerability and immunogenicity of a single injection of VAX-31 at the same three dose levels and compared to PCV20 in approximately 936 healthy adults 50 years of age and older. In both portions of the study, participants will be randomized equally in four separate arms and 30 days after participants are dosed, serology samples will be collected to assess immunogenicity. The immunogenicity objectives of the study include an assessment of the induction of antibody responses, using opsonophagocytic activity (OPA) and immunoglobulin G (IgG), at each of the three VAX-31 doses and compared to PCV20 for the 20 serotypes in common, as well as for the additional 11 serotypes contained in VAX-31, but not in PCV20. Participants in the study will be evaluated for safety through six months after vaccination. The study will be conducted in approximately 25 sites in the United States.
About Pneumococcal Disease
Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae (pneumococcus) bacteria. It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. In the United States, approximately 320,000 people get pneumococcal pneumonia each year, which is estimated to result in approximately 150,000 hospitalizations and 5,000 deaths. Pneumococci also cause over 50% of all cases of bacterial meningitis in the United States. Antibiotics are used to treat PD, but some strains of the bacteria have developed resistance to treatments. The morbidity and mortality due to PD are significant, particularly for young children and older adults, underscoring the need for a more broad-spectrum vaccine.
About VAX-31
VAX-31, an investigational 31-valent PCV candidate, is designed to prevent IPD, which is especially serious in infants, young children, older adults, and those with immune deficiencies or certain chronic health conditions. The public health community continues to affirm the need for vaccines that offer broader protection to prevent IPD. Both VAX-31 and VAX-24, Vaxcyte’s 24-valent PCV candidate entering Phase 3, are designed to improve upon the standard-of-care PCVs for both children and adults by covering the serotypes that are responsible for a significant portion of IPD in circulation and are associated with high case-fatality rates, antibiotic resistance and meningitis. VAX-31 was designed to provide coverage for approximately 95 percent of the IPD circulating in the U.S. adult population. Vaxcyte aims to efficiently create and deliver high-fidelity, broad-spectrum vaccines by using modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform. With VAX-31 and VAX-24, Vaxcyte is deploying this approach with the intent of adding more pneumococcal strains without compromising the overall immune response.
About Vaxcyte
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum, carrier-sparing PCV being developed for the prevention of IPD and is poised to move into Phase 3. VAX-31, the broadest-spectrum PCV candidate in the clinic today, is a follow-on candidate to VAX-24 and part of the Company’s PCV franchise.
Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com.
SOURCE: Vaxcyte
Post Views: 303
— VAX-31, a 31-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate, is the Broadest-Spectrum PCV to Enter the Clinic —
— Topline Safety, Tolerability and Immunogenicity Data Expected in Second Half of 2024 —
— VAX-31 is Designed to Provide Coverage for Approximately 95% of Invasive Pneumococcal Disease Circulating in the U.S. Adult Population —
SAN CARLOS, CA, USA I November 09, 2023 I Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced that the first participants were dosed in a Phase 1/2 clinical study for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), in adults. The study, which will evaluate the safety, tolerability and immunogenicity of VAX-31, is expected to enroll approximately 1,000 adults aged 50 and older. The Company expects to announce topline data from the Phase 1/2 study in the second half of 2024.
“We are pleased to initiate the first adult clinical study of VAX-31, which is the broadest-spectrum PCV to enter the clinic, with the potential to protect against approximately 95 percent of IPD circulating in the U.S. adult population,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “Leveraging the foundation established by our lead PCV candidate, VAX-24, we believe we have an opportunity to deliver a best-in-class PCV franchise that provides the broadest-spectrum of coverage and improved immune responses compared to the standard-of-care in adults today. We look forward to sharing the anticipated topline study results from the VAX-31 study in adults aged 50 and older in the second half of 2024.”
About the VAX-31 Phase 1/2 Study
The VAX-31 Phase 1/2 clinical study is a randomized, observer-blind, active-controlled, dose-finding clinical study designed to evaluate the safety, tolerability and immunogenicity of VAX-31 compared to Prevnar 20® (PCV20) in approximately 1,000 healthy adults aged 50 and older. The Phase 1 portion of the study will evaluate the safety and tolerability of a single injection of VAX-31 at three dose levels (low, middle and high) and compared to PCV20 in approximately 64 healthy adults 50 to 64 years of age. An independent Data Monitoring Committee will conduct an assessment of the Phase 1 safety and tolerability results prior to the study proceeding to Phase 2. Phase 1 participants will also be evaluated for immunogenicity, and the Phase 1 safety, tolerability and immunogenicity data will be pooled with the participants in the Phase 2 portion of the study. Phase 2 will evaluate the safety, tolerability and immunogenicity of a single injection of VAX-31 at the same three dose levels and compared to PCV20 in approximately 936 healthy adults 50 years of age and older. In both portions of the study, participants will be randomized equally in four separate arms and 30 days after participants are dosed, serology samples will be collected to assess immunogenicity. The immunogenicity objectives of the study include an assessment of the induction of antibody responses, using opsonophagocytic activity (OPA) and immunoglobulin G (IgG), at each of the three VAX-31 doses and compared to PCV20 for the 20 serotypes in common, as well as for the additional 11 serotypes contained in VAX-31, but not in PCV20. Participants in the study will be evaluated for safety through six months after vaccination. The study will be conducted in approximately 25 sites in the United States.
About Pneumococcal Disease
Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae (pneumococcus) bacteria. It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. In the United States, approximately 320,000 people get pneumococcal pneumonia each year, which is estimated to result in approximately 150,000 hospitalizations and 5,000 deaths. Pneumococci also cause over 50% of all cases of bacterial meningitis in the United States. Antibiotics are used to treat PD, but some strains of the bacteria have developed resistance to treatments. The morbidity and mortality due to PD are significant, particularly for young children and older adults, underscoring the need for a more broad-spectrum vaccine.
About VAX-31
VAX-31, an investigational 31-valent PCV candidate, is designed to prevent IPD, which is especially serious in infants, young children, older adults, and those with immune deficiencies or certain chronic health conditions. The public health community continues to affirm the need for vaccines that offer broader protection to prevent IPD. Both VAX-31 and VAX-24, Vaxcyte’s 24-valent PCV candidate entering Phase 3, are designed to improve upon the standard-of-care PCVs for both children and adults by covering the serotypes that are responsible for a significant portion of IPD in circulation and are associated with high case-fatality rates, antibiotic resistance and meningitis. VAX-31 was designed to provide coverage for approximately 95 percent of the IPD circulating in the U.S. adult population. Vaxcyte aims to efficiently create and deliver high-fidelity, broad-spectrum vaccines by using modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform. With VAX-31 and VAX-24, Vaxcyte is deploying this approach with the intent of adding more pneumococcal strains without compromising the overall immune response.
About Vaxcyte
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum, carrier-sparing PCV being developed for the prevention of IPD and is poised to move into Phase 3. VAX-31, the broadest-spectrum PCV candidate in the clinic today, is a follow-on candidate to VAX-24 and part of the Company’s PCV franchise.
Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com.
SOURCE: Vaxcyte
Post Views: 303
