Vaxcyte, Inc.

-- Advancement to Stage 2 of Infant Study Supported by Review of Stage 1 Safety and Tolerability Data -- -- Company Expects to Announce VAX-31 Infant Study Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series in Mid-2026, Followed by Topline Data from the Booster Dose Approximately Nine Months Later -- -- VAX-31 is Designed to Cover Approximately 94% of Invasive Pneumococcal Disease and Approximately 93% of Acute Otitis Media in U.S. Children Under Five -- -- Company Remains on Track to Announce VAX-24 Phase 2 Infant Study Topline Data from Primary Immunization Series by End of First Quarter of 2025 -- -- VAX-31 and VAX-24 Offer Potential to Protect Vulnerable Population by Providing Greater Coverage Against Both Currently Circulating and Historically Prevalent Strains Relative to Standard-Of-Care Pneumococcal Conjugate Vaccines -- Feb. 05, 2025 -- 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 first study participants have been dosed in the second and final stage of the ongoing Phase 2 study of VAX-31 in healthy infants. Advancement to Stage 2 follows a blinded assessment of the Stage 1 safety and tolerability data per the study protocol. This study is evaluating the safety, tolerability and immunogenicity of VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), in healthy infants. The Company expects to share topline data from the primary three-dose immunization series of the study in mid-2026, followed by topline data from the booster dose approximately nine months later. “Advancing to Stage 2 of the VAX-31 infant Phase 2 study represents a significant step forward in evaluating the broadest vaccine candidate in the clinic today for this vulnerable population,” said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte. “PCVs have been a bedrock of the vaccination schedule for decades, providing critical protection against invasive pneumococcal disease for our communities. With our PCV franchise, VAX-24 and VAX-31, we are working to set a new standard that expands protection against currently and historically circulating strains while maintaining strong immune responses. We look forward to sharing topline data for safety, tolerability and immunogenicity from the VAX-31 infant study primary immunization series in mid-2026, and from the booster dose approximately nine months later.” “PCVs have demonstrated the ability to deliver herd immunity to protect against devastating diseases caused by Streptococcus pneumoniae bacteria, and our technology has the potential to deliver best-in-class PCVs with broader coverage for both infants and adults,” said Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte. “Based on the body of positive evidence from the VAX-31 and VAX-24 adult Phase 1/2 programs, we believe our carrier-sparing platform has the potential to set a new standard in disease coverage.” The VAX-31 infant Phase 2 study is a randomized, double-blind, active controlled, dose-finding, two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-31 compared to Prevnar 20 (PCV20) in healthy infants. Stage 1 of the study evaluated the safety and tolerability of VAX-31 after the first vaccination at each of three ascending dose levels (low, middle and high) in 48 infants who received VAX-31 or PCV20 in one of three dose-escalating cohorts. In the low, middle and high doses, all serotypes were dosed at 1.1mcg, 2.2mcg and 3.3mcg, respectively, except serotypes 1, 5 and 22F, which were dosed at 1.65mcg, 3.3mcg, and 4.4mcg, respectively. Participants who received VAX-31 in Stage 1 will continue the standard dosing regimen as part of Stage 2 and will be included in the safety, tolerability and immunogenicity analysis of the study. Stage 2 of the study is evaluating the safety, tolerability and immunogenicity of VAX-31 at the same three dose levels and compared to PCV20 in approximately 750 infants. In line with recommendations from the Advisory Committee on Immunization Practices (ACIP), the study design includes a primary immunization series consisting of three doses given at two months, four months and six months of age, followed by a subsequent booster dose at 12-15 months of age. The key prespecified immunogenicity study endpoints include an assessment of immune responses for each of the VAX-31 dose levels in comparison with PCV20 for the 20 common and 11 unique serotypes in VAX-31. Post-primary series (post-dose 3 or PD3) immune responses will be assessed based on serotype-specific immunoglobulin G (IgG) seroconversion rates (proportion of participants achieving the accepted IgG threshold value of ≥0.35mcg/mL) at 30 days PD3. IgG geometric mean titers will be assessed at 30 days PD3 and post-dose 4 (PD4), along with other key immunogenicity endpoints. Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae bacteria. It can result in invasive pneumococcal disease (IPD), including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. In the United States, pneumococcal pneumonia is estimated to result in approximately 150,000 hospitalizations each year. Streptococcus pneumoniae is among the World Health Organization’s top antibiotic-resistant pathogens to be urgently addressed, and the U.S. CDC lists drug-resistant Streptococcus pneumoniae as a “serious threat.” In children under five, Streptococcus pneumoniae is the leading cause of vaccine-preventable deaths globally. 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 broader-spectrum vaccine. VAX-31, a 31-valent PCV candidate advancing to a Phase 3 adult clinical program and currently being evaluated in a Phase 2 infant clinical program, 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. IPD is associated with high case-fatality rates, antibiotic resistance and meningitis. VAX-31 is the broadest-spectrum PCV in the clinic and has the potential to provide protection against both currently circulating and historically prevalent serotypes. VAX-31 was designed to increase coverage, in a single vaccine, to more than 95% of IPD circulating in adults in the United States aged 50 and older, with the potential to provide an incremental 12-40% of coverage over current standard-of-care adult PCVs. In infants, it was designed to cover approximately 94% of IPD and approximately 93% of acute otitis media due to Streptococcus pneumoniae in children under five years of age in the United States. In November 2024, Vaxcyte announced that the FDA granted Breakthrough Therapy designation to VAX-31 for the prevention of IPD in adults. The Breakthrough Therapy designation process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. 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. VAX-31 is a 31-valent, carrier-sparing PCV being developed for the prevention of IPD in adults and infants and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, the Company’s 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is currently being evaluated in a Phase 2 infant study. Both VAX-31 and VAX-24 are designed to improve upon the standard-of-care PCVs by covering the serotypes in circulation that are responsible for a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice. 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 candidate 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. The content above comes from the network. if any infringement, please contact us to modify.

SAN DIEGO --(BUSINESS WIRE)--Feb. 4, 2025-- Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced the appointment of Moncef Slaoui , Ph.D., as Chair Designate. Dr. Slaoui has been serving on the Company’s Board of Directors since June 2024 . “Dr. Moncef Slaoui has a long-proven track record in the pharmaceutical and biotechnology industry, and we are delighted to have him as our Chair Designate,” said Joseph Payne , President & Chief Executive Officer of Arcturus. “We look forward to working with him as we enter a transformative year of advancing our pipeline of therapeutics and vaccines.” “Arcturus has deep expertise in mRNA delivery for therapeutics and a validated commercial stage vaccines platform,” said Dr. Moncef Slaoui . “I am excited to work with the company during this potentially transformational time with multiple key data readouts across its pipeline.” About Dr. Moncef Slaoui Dr. Moncef Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed. Under his leadership the operation enabled the fastest ever development, manufacturing, and approval of multiple COVID-19 vaccines in less than 11 months after the virus genetic sequence was described. Dr. Slaoui has sat on several biotechnology company boards, including Moderna, Inc. and Lonza Group AG , and he chaired the boards of Galvani, and Vaxcyte, a vaccine development platform company. Dr. Slaoui spent nearly 30 years at GlaxoSmithKline (GSK) holding leadership positions including as member of the Board of Directors of GSK PLC; Chairman of Pharmaceutical R&D; Chairman Global R&D, Vaccines & Oncology; and Chairman, Global Vaccines. As Chairman of Pharmaceutical R&D, Dr. Slaoui led a redesign of GSK’s R&D structure and culture to improve focus on innovation and productivity. As Chairman of Global Vaccines, Dr. Slaoui was directly involved in GSK's vaccine pipeline, leading to the creation of 14 new vaccines, including Shingrix®, to prevent shingles; Cervarix®, to prevent cervical cancer; Mosquirix, to prevent malaria; Rotarix®, to prevent rotavirus gastroenteritis; and Synflorix, to prevent pneumococcal disease. In 2016, Dr. Slaoui was recognized as one of Fortune's 50 Greatest World Leaders for his work in under-researched diseases common in the developing world. He served on the Advisory Committee to the Director of the NIH from 2011 to 2016 and has advised the U.S. President's Council of Advisors on Science and Technology . Dr. Slaoui holds a Ph.D. in Molecular Biology and Immunology from the Université Libre de Bruxelles , completed postdoctoral studies at Harvard Medical School and Tufts University School of Medicine , and was a Professor of Immunology at the University of Mons , Belgium . He received an accelerated Master of Business Administration from IMD, Switzerland in 1998. About Arcturus Founded in 2013 and based in San Diego, California , Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan , ARCALIS , focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 400 patents and patent applications in the U.S. , Europe , Japan , China , and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/home/20250204663825/en/ Arcturus Therapeutics Public Relations & Investor Relations Neda Safarzadeh VP, Head of IR/PR/Marketing (858) 900-2682 IR@ArcturusRx.com Source: Arcturus Therapeutics Holdings Inc.

— Company Expects to Announce VAX-31 Infant Study Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series in Mid-2026, Followed by Topline Data from the Booster Dose Approximately Nine Months Later — — VAX-31 is Designed to Cover Approximately 94% of Invasive Pneumococcal Disease and Approximately 93% of Acute Otitis Media in U.S. Children Under Five — — VAX-31 Offers Potential to Protect Vulnerable Population by Providing Greater Coverage Against Both Currently Circulating and Historically Prevalent Strains Relative to Standard-Of-Care Pneumococcal Conjugate Vaccines — — Company Remains on Track to Announce VAX-24 Phase 2 Infant Study Topline Data from Primary Immunization Series by End of First Quarter of 2025 — SAN CARLOS, CA, USA I December 03, 2024 I 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 the initiation of the Phase 2 study of VAX-31 in healthy infants and that the first study participants have been dosed. This study is evaluating the safety, tolerability and immunogenicity of VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD). The Company expects to share topline data from the primary three-dose immunization series of the study in mid-2026, followed by topline data from the booster dose approximately nine months later. “The initiation of the VAX-31 Phase 2 infant study marks a significant milestone as we continue advancing our PCV clinical programs, which also include the fully enrolled, ongoing VAX-24 Phase 2 infant study,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “PCVs are vital to combating Streptococcus pneumoniae , a serious public health threat exacerbated by increasing antimicrobial resistance. As the broadest-spectrum PCV candidate in the clinic today, VAX-31 has the potential to expand coverage and provide protection against both currently circulating and historically prevalent serotypes. We look forward to sharing topline data for safety, tolerability and immunogenicity from the VAX-31 Phase 2 infant study’s primary immunization series in mid-2026, and from the booster dose approximately nine months later.” “Despite the effectiveness of current vaccines, Streptococcus pneumoniae is the leading cause of vaccine-preventable deaths globally in children under five and IPD, including meningitis and bacteremia, remains persistent in the first years of life,” said Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte. “It has been clearly signaled by the public health community that a pneumococcal vaccine with a broader spectrum of coverage is needed to provide greater protection against this disease. VAX-31 is designed to cover approximately 94% of IPD and approximately 93% of acute otitis media in U.S. children under five, with the potential to offer much greater coverage relative to the standard-of-care PCVs.” About the VAX-31 Phase 2 Infant Study The VAX-31 Phase 2 infant study is a randomized, double-blind, active controlled, dose-finding, two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-31 compared to Prevnar 20 (PCV20) in healthy infants. About Pneumococcal Disease Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae bacteria. It can result in invasive pneumococcal disease (IPD), including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. In the United States, pneumococcal pneumonia is estimated to result in approximately 150,000 hospitalizations each year. Streptococcus pneumoniae is among the World Health Organization’s top antibiotic-resistant pathogens to be urgently addressed, and the U.S. CDC lists drug-resistant Streptococcus pneumoniae as a “serious threat.” In children under five, Streptococcus pneumoniae is the leading cause of vaccine-preventable deaths globally. 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 broader-spectrum vaccine. About VAX-31 VAX-31, a 31-valent PCV candidate advancing to a Phase 3 adult clinical program and currently being evaluated in a Phase 2 infant clinical program, 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. IPD is associated with high case-fatality rates, antibiotic resistance and meningitis. VAX-31 is the broadest-spectrum PCV in the clinic and has the potential to provide protection against both currently circulating and historically prevalent serotypes. VAX-31 was designed to increase coverage, in a single vaccine, to more than 95% of IPD circulating in adults in the United States aged 50 and older, with the potential to provide an incremental 12-40% of coverage over current standard-of-care adult PCVs. In infants, it was designed to cover approximately 94% of IPD and approximately 93% of acute otitis media due to Streptococcus pneumoniae in children under five years of age in the United States. In November 2024, Vaxcyte announced that the FDA granted Breakthrough Therapy designation to VAX-31 for the prevention of IPD in adults. The Breakthrough Therapy designation process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. 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. VAX-31 is a 31-valent, carrier-sparing PCV being developed for the prevention of IPD in adults and infants and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, the Company’s 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is currently being evaluated in a Phase 2 infant study. Both VAX-31 and VAX-24 are designed to improve upon the standard-of-care PCVs by covering the serotypes in circulation that are responsible for a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice. 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 candidate 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