Pipeline

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 pneumococcal disease, Group A Strep and periodontitis.
Phase
  • Precli.
  • Ph1
  • Ph2
  • Ph3
Anticipated Key Milestones (1)

Lead Candidate 24-Valent PCV

VAX-24
  • Phase 2 Adults 18-64
  • Adults 18-64
  • Phase 2 Adults 65+
  • Adults 65+
  • Pre-clinical Infants
  • Infants

Topline safety, tolerability and immunogenicity data from Phase 2 study in adults 65 and older anticipated in 1H:23

Learn More5

Topline safety, tolerability and immunogenicity data from Phase 2 study in adults 65 and older anticipated in 1H:23

Learn More5
  • Topline safety, tolerability and immunogenicity data from Phase 2 study in adults 65 and older anticipated in 1H:23
  • Final results with 6-month safety data for both Phase 2 adult studies anticipated in 1H:23
  • Following receipt of final safety reports, regulatory interactions to inform adult Phase 3 program anticipated in 2H:23
  • Topline data from Phase 3 non-inferiority study in adults expected in 2025
  • Infant IND submission and Phase 2 study initiation anticipated in 1H:23
  • Topline safety, tolerability and immunogenicity data from the infant Phase 2 study following the primary 3-dose immunization series expected by 2025

Next-Generation >31-Valent PCV

VAX-XP
  • Pre-clinical Adults and Infants
  • Adults and Infants

Anticipate adult IND application submission to FDA in 2H:23

Learn More5

Anticipate adult IND application submission to FDA in 2H:23

Learn More5
  • Anticipate adult IND application submission to FDA in 2H:23
  • Topline safety, tolerability and immunogenicity data from Phase 1/2 study in adults expected in 2024

Novel Group A Strep Vaccine

VAX-A1
  • Pre-clinical Adults and Infants
  • Adults and Infants

Anticipate providing guidance for an adult IND application submission to the FDA in 2H:22

Anticipate providing guidance for an adult IND application submission to the FDA in 2H:22

Novel Therapeutic Periodontitis Vaccine

VAX-PG
  • Pre-clinical Adults
  • Adults

Anticipate selecting final vaccine candidate by end of 2022

Anticipate selecting final vaccine candidate by end of 2022

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 effective vaccines for:

Pneumococcal disease accounts for more than 4 million illnesses worldwide each year and is one of the leading causes of death globally for children under five. In the US, approximately 900,000 people get pneumococcal pneumonia each year, resulting in 150,000 hospitalizations. Given these serious consequences, the public health community continues to affirm the need for broader-spectrum vaccines to prevent pneumococcal disease.

Group A Strep, a pervasive disease with no available preventive treatment that causes 700 million global annual cases of strep throat and increases the risk of 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, 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.

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. It is currently being investigated in a Phase 1/2 clinical proof-of-concept study in adults [NCT05266456].

VAX-XP, our second PCV candidate, builds on what’s been established with VAX-24. This PCV candidate includes an expanded breadth of coverage of greater than 30 strains 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 accelerating antibacterial products to address 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. Globally, severe periodontal disease afflicts 10% to 15% of the adult population, resulting in productivity losses estimated at nearly $54 billion in 2010.

Posters & Publications