Pipeline

Our Therapeutic Approach

Targeting PNAG offers the potential of creating the first broad-spectrum, anti-infective immune therapeutics. We have developed two approaches targeting PNAG, both of which have completed phase 1 clinical trials - a fully human monoclonal antibody – F598 – and chemically synthesized vaccine - AV0328. The initial target indications being pursued will permit the development of anti-PNAG therapeutics in a focused fashion and, if successful, will establish Alopexx’s therapeutic platform to prevent and treat a wide range of disorders.

In Vivo Efficacy Studies Targeting Deacetylated PNAG (dPNAG)

A summary of the protective immunity observed in targeting dPNAG in animal models is shown in the table “Efficacy in In Vivo Animal Models.” Over 14 different pathogens in more than 20 infection models have demonstrated the relevance of targeting PNAG. These data suggest that a dPNAG vaccine or monoclonal antibody could be used to protect against a broad range of pathogens that produce surface PNAG.

Targeting PNAG

Efficacy in In Vivo Animal Models

14+ Pathogens studied in > 20 infection models
Pathogen Animal Infection Model
S. aureus Mouse
  • Lethal peritonitis
  • Bacteremia
  • Skin infection
  • Corneal keratitis
  • Lethal systemic infection
E. coli
  • Lethal peritonitis
  • Oral infection with shiga-toxin producing strains
Burkholderia complex
  • Lethal peritonitis
A. baumannii
  • Neonatal infections
N. meningitidis serogroup B
  • Neonatal infections
N. gonorrhoeae
  • Conjunctivitis
S. pyogenes
  • Lethal infections
L. monocytogenes
  • Lethal infections
S. pneumoniae
  • Pneumonia
  • Corneal infections
K. pneumoniae
  • Pneumonia
C. albicans
  • Keratitis
P. berghei
  • Malaria
R. equi Horses
  • Pneumonia
S. aureus Goats
  • Mastitis
  • Lethal infections
A. pleuropneumoniae Pigs
  • Pneumonia

Strategic Approach

The broad distribution of PNAG allows for an expansive range of microbial targets and disease indications that can be targeted by Alopexx’s immunotherapeutics. These can be divided into two broad categories – specific microbial infections as well as diseases where PNAG-containing factors have been implicated in driving disease progression.

The key elements of our strategic approach are the following:

  • Focus on areas with high potential for approval
  • Advance clinical development of our monoclonal antibody F598
  • Develop mAB F598 as the standard of care for patients in the ICU
  • Advance clinical development of our lead vaccine AV0328
  • Develop vaccine AV0328 as a complement to currently approved Streptococcus pneumoniae vaccines
  • Pursue the development of F598 and AV0328 for other indications
  • Leverage the growing scientific knowledge that several chronic diseases involve alterations in the microbes normally found in and on our body surfaces to develop new indications for F598 and AV0328

Pipeline Summary

The 2 immune therapeutics developed by Alopexx have both completed phase 1 clinical trials. They provide distinct approaches to the prevention of infectious diseases. As with Covid, a vaccine and an antibody have different roles to play. The antibody provides immediate but time limited protection. Vaccines take longer to become effective but provide prolonged protection. Both of Alopexx’s immune therapeutics have been shown to be effective against AMR organisms.

These differences in Alopexx’s antibody and vaccine mean that they can be developed for different non-competing applications. That is shown in the pipeline figure where the initial therapeutic focus of the antibody and vaccine are highlighted:

  • Prevention of Hospital acquired infections for the antibody
  • Expanding coverage of licensed vaccines to protect against strains not included in these vaccines
Compound Indication Discovery Pre-Clinical Phase 1 Phase 2 Phase 3

F598

Prevention of hospital acquired infections
Discovery Phase complete
Pre-Clinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started

AV0328

Expanded coverage when added to existing vaccines
Discovery Phase complete
Pre-Clinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
Non-Overlapping Utility of Antibody and Vaccine F598 AV0328
Immediate Protection check
Long Term Protection check
Skin Infection check
Corneal Keratitis check
Lethal Systemic Infection check check

A Broad and Expanding Number of Potential Indications

Due to the broad-spectrum potential of these therapeutics there are multiple other indications that can be pursued. 

Overall Potential of Targeting PNAG