High-Fidelity Vaccines Engineered to Go the Distance
We believe we are uniquely positioned to create vaccines that can overcome bacteria’s formidable defense mechanisms and be produced at a significant scale. We are leveraging our cell-free protein synthesis platform to create high-fidelity vaccines featuring distinct protein carriers and antigens for invasive pneumococcal disease, Group A Strep, periodontitis and Shigella.
The Rising Consequences of Bacterial Infections
Numerous forces are contributing to the prevalence of life-threatening bacterial infections, including antibiotic resistance; rapidly growing populations of aging, high-risk adults with reduced functional immune capacity and increased susceptibility; and new pathogenic strains. Streptococcus pneumoniae, Group A Strep and Shigella – for which we are advancing vaccine candidates – are among the World Health Organization’s top antibiotic-resistant pathogens requiring urgent solutions.
At Vaxcyte, we are focusing our efforts on developing broadly protective vaccines to address the following:
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. The U.S. CDC lists drug-resistant Streptococcus pneumoniae as a “serious threat.” Globally, Streptococcus pneumoniae is the leading cause of vaccine-preventable deaths in children under five, causing approximately 300,000 deaths each year. 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. Given these consequences, the public health community continues to affirm the need for broader-spectrum vaccines to prevent PD.
Group A Strep is a pervasive disease with no available preventive treatment that causes an estimated 800 million global cases of illness annually, including pharyngitis, or strep throat, and certain severe invasive infections and sequelae. The CDC lists drug-resistant Group A Strep as a “concerning threat” because widespread use of some antibiotics has driven antimicrobial resistance, which has nearly tripled in the past decade.
Periodontitis is a highly prevalent, chronic oral inflammatory disease without adequate therapies that affects an estimated 65 million U.S. adults, causing measurable oral bone and tooth loss. Periodontitis is also associated with an increased risk of heart attack, stroke, cardiovascular disease and Alzheimer’s Disease.
Shigella is a bacterial illness that causes dysentery and shigellosis and has no available preventative treatment. Shigella affects an estimated 80-165 million people worldwide each year and results in approximately 600,000 deaths annually, mostly among children.
Vaccine Candidates Engineered to Overtake Convention
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. 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. The FDA granted Breakthrough Therapy designation for VAX-31 for the prevention of IPD in adults. In infants, VAX-31 is 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.
VAX-24, a 24-valent PCV candidate being evaluated in a Phase 2 infant study, is designed to prevent IPD. VAX-24 has the potential to cover more serotypes than any infant PCV on-market today, including serotypes associated with high case-fatality rates, antibiotic resistance and meningitis. VAX-24 is designed to provide protection against both currently circulating and historically prevalent serotypes.
Based on the body of positive evidence from the VAX-31 and VAX-24 adult Phase 1/2 programs, Vaxcyte believes its carrier-sparing platform has the potential to set a new standard in disease coverage.
VAX-A1 is a novel preclinical conjugate vaccine candidate being developed to prevent disease caused by Group A Strep, for which there is currently no vaccine. It is designed to provide robust, boostable and durable protection against a broad spectrum of subtypes of Group A Strep infections.
VAX-PG is a novel therapeutic vaccine candidate targeting the keystone pathogen responsible for periodontitis. It leverages a key application of our cell-free protein synthesis platform, which is the ability to develop “tough-to-make” protein antigens that have high-fidelity with native pathogens. A highly prevalent condition, Periodontal disease afflicts an estimated 65 million U.S. adults, resulting in an estimated loss of approximately $330 billion in the U.S. 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 and has no available preventative treatment. Antimicrobial-resistant Shigella infections have been rising since 2016, underscoring the urgent need for effective treatment options. With the aim of reducing morbidity and mortality due to the disease, the World Health Organization lists Shigella vaccine development as a priority goal. 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 we are not accepting expanded access requests for our vaccine candidates, including VAX-31 or VAX-24. Our current priority is to complete the development programs for VAX-31 and 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.