High-Fidelity Vaccines Engineered to Go the Distance
We believe our clinical-stage company is uniquely positioned to create vaccines that can overcome bacteria’s formidable defense mechanisms and be produced on a significant scale. We are leveraging our XpressCF™ cell-free protein synthesis platform to create high-fidelity vaccines featuring distinct protein carriers and antigens – the critical building blocks of vaccines – for invasive pneumococcal disease, Group A Strep, periodontitis and Shigella.
Lead Candidate 24-Valent PCV
- Phase 2 Adults 18-64
- Adults 18-64
- Phase 2 Adults 65+
- Adults 65+
- Phase 2 Infants
Hold meetings with the FDA regarding the Company’s CMC strategy to finalize the Company’s adult Phase 3 program and BLA requirements through 1Q:24Learn More
- Hold meetings with the FDA regarding the Company’s CMC strategy to finalize the Company’s adult Phase 3 program and BLA requirements through 1Q:24
- Announce topline safety, tolerability and immunogenicity data from Phase 3 pivotal, non-inferiority study in adults in 2025
- Announce topline safety, tolerability and immunogenicity data from Phase 2 infant study primary three-dose immunization series by 2025
- Announce topline data from Phase 2 infant study booster dose approximately nine months following primary series data
Next-Generation 31-Valent PCV
- Phase 2 Adults 50+
- Adults 50+
- Pre-clinical Infants
Announce topline safety, tolerability and immunogenicity data from the Phase 1/2 study in adults in second half of 2024
Novel Group A Strep Vaccine
- Pre-clinical Adults and Infants
- Adults and Infants
Novel Therapeutic Periodontitis Vaccine
- Pre-clinical Adults
Novel Shigella Vaccine Program
- Pre-clinical Adults and Infants
- Adults and Infants
The Rising Consequences of Bacterial Infections
Numerous forces are contributing to the prevalence of life-threatening bacterial infections, including antibiotic resistance; fast-growing populations of aging, high-risk adults with reduced functional immune capacity and increased susceptibility; and new pathogenic strains not covered by existing vaccines.
We are initially focusing our efforts on developing broadly protective vaccines for the following:
Pneumococcal disease is an infection caused by Streptococcus pneumoniae bacteria. It can result in invasive pneumococcal disease, including meningitis and bacteremia, and non-invasive pneumococcal disease, including pneumonia, otitis media and sinusitis. In the United States, approximately 320,000 people get pneumococcal pneumonia each year, resulting in approximately 150,000 hospitalizations and 5,000 deaths. Given these serious consequences, the public health community continues to affirm the need for broader-spectrum vaccines to prevent pneumococcal disease.
Group A Strep is a pervasive disease with no available preventive treatment that causes 700 million global cases of illness annually, including pharyngitis, or strep throat, and certain severe invasive infections such as sepsis, necrotizing fasciitis and toxic shock syndrome. The CDC has upgraded this disease as a threat because widespread use of some antibiotics has driven antimicrobial resistance, which has nearly tripled in the past decade.
Periodontitis is a widely prevalent disease without adequate therapies that affects an estimated 65 million US adults and causes measurable oral bone loss, tooth loss and chronic inflammation in more than half of Americans over the age of 40.
Shigella is a bacteria that causes dysentery and shigellosis, which has no available preventative treatment. Shigella affects an estimated 188 million people worldwide each year and results in approximately 164,000 deaths annually, mostly among children under five years of age in low- and middle-income areas. With the aim of reducing morbidity and mortality due to the disease, the World Health Organization lists Shigella vaccine development as a priority goal.
Vaccine Candidates Engineered to Overtake Convention
VAX-24, our lead vaccine candidate, is a clinical-stage 24-valent pneumococcal conjugate vaccine (PCV) designed to improve upon existing vaccines by covering the serotypes responsible for most of the remaining pneumococcal disease currently in circulation, while maintaining an immunogenicity profile comparable to PCVs available today. In October 2022, we announced positive topline results from the VAX-24 Phase 1/2 proof-of-concept study in adults aged 18 to 64. The findings indicate a potential best-in-class profile for VAX-24 and validate our carrier-sparing approach to enable the development of broader-spectrum PCVs. VAX-24 has been granted FDA Breakthrough Therapy designation for the prevention of invasive pneumococcal disease in adults.
VAX-31, our second PCV candidate, builds on what’s been established with VAX-24. This 31-valent PCV candidate is intended to address over 90% of pneumococcal disease currently circulating in the US.
VAX-A1 is a novel preclinical conjugate vaccine candidate being developed to prevent Group A Strep, for which there is currently no vaccine. The global need for a vaccine to prevent Group A Strep is compelling in both children and adults and, as a result, this development program is supported by an award from CARB-X, a global non-profit partnership dedicated to supporting early development antibacterial R&D to address the rising global threat of drug-resistant bacteria.
VAX-PG is our novel therapeutic vaccine candidate designed to treat periodontal disease. It leverages a key application of our cell-free protein synthesis platform, which is the ability to make “tough-to-make” protein antigens that have high-fidelity with native pathogens. A highly prevalent condition, Periodontal disease afflicts 65 million US adults, resulting in an estimated loss of $330.6 billion in the US and Europe in 2018, with direct costs exceeding $6 billion.
VAX-GI is a novel preclinical vaccine candidate being developed as a preventative treatment for dysentery and shigellosis, which is caused by Shigella bacteria. The central antigen in VAX-GI is IpaB and while this is a well-appreciated antigen, others have been unable to produce it in an amount sufficient to enable a commercial product. With our cell-free technology, we believe we can produce this antigen at substantially improved yields, allowing for commercial-scale production. Our VAX-GI work is funded in part by two National Institutes of Health research grants.
Expanded Access Policy
Vaxcyte does not currently offer an expanded access program and is not accepting expanded access requests for its vaccine candidates, including VAX-24. Our current priority is to complete the development program for VAX-24 in order to obtain the required safety, tolerability and immunogenicity data needed for regulatory approval.
Individuals interested in receiving our vaccine candidates may be able to receive them by participating in a clinical trial. If you or someone you know would like to learn more about Vaxcyte’s clinical trials, we encourage you to view our trials at www.clinicaltrials.gov.
If you have additional questions about Vaxcyte’s expanded access policy, please email us at [email protected]. As we continue to advance our vaccine pipeline, we may review and update our expanded access policy.