PMN310 has been granted Fast Track Designation by the U.S. FDA for the treatment of Alzheimer’s disease.
A Potential Best-in-Class Therapy for Alzheimer’s Disease
ProMIS’ lead therapeutic product candidate, PMN310, is a monoclonal therapeutic antibody designed for the treatment of Alzheimer’s disease (AD). By selectively targeting the toxic oligomers of amyloid-beta (Aβ), PMN310 may possess the qualities necessary to potentially be “best-in-class”, if approved, with a possibly more favorable clinical safety and efficacy profile over other amyloid-directed antibody therapeutics currently in clinical development.
PMN310 was granted Fast Track Designation by U.S. FDA for treatment of Alzheimer’s disease.
Three Forms of Amyloid Protein
- Monomers - Simple strings of amino acids that play a role in normal brain health.
- Oligomers - Small clumps of molecules that consist of several monomer units.
- Plaque - Insoluble, solid deposits of amyloid (similar to plaque in arteries) that can build up over time. Usually present, but does not appear to play a significant role in disease progression.
The Right Target
Only misfolded oligomers are toxic, which can lead to neuronal death and synaptic loss that causes AD-related cognitive decline. Studies indicate that safe and effective antibody therapies for AD will be those that selectively target and bind only to misfolded oligomers while avoiding any binding to monomers and/or plaque forms of amyloid.
Misfolded Protein Targets for Alzheimer’s
| Misfolded Protein Target | Lead Indication | Other Indications | Status |
|---|---|---|---|
| Toxic Amyloid-Beta Oligomers | Alzheimer’s disease | Ph1b Trial Ongoing |
PMN310 Key Features
Our PMN310 program is a next-generation, potential best-in-class anti-amyloid therapy in development.
- Highly selective for only misfolded, toxic oligomers
- Does not bind monomer
- Does not bind plaque or vascular deposits
- Potentially lower risk of amyloid-related imaging abnormality-edema (ARIA-E) (brain swelling) side effect
- Doses may not to be limited by off-target binding or side effects
- All dosed PMN310 will be focused on neutralizing toxic oligomers
- Potentially more favorable clinical efficacy profile
Screening and Validation for PMN310
Identifying Toxic Oligomers of Amyloid
PMN310 was designed using our proprietary technology platform to target only the toxic form of amyloid-beta (Aβ). Six different conformational epitopes were identified that were predicted to be exposed only on the surface of toxic oligomers of amyloid. Our scientists then created six peptide antigens that mirrored those epitopes and immunized mice with the newly developed antigens.
The immune systems of these mice created multiple antibody candidates that were screened for selectivity, preclinical efficacy, and binding to biological samples from patients (cadaveric brain material from patients who died from AD). From this extensive screening process, PMN310 emerged as the lead antibody candidate.
Targeting Only the Most Neuropathogenic Aβ Species
PMN310’s selectivity for the toxic oligomer form of amyloid indicates that it may possess the features necessary to be considered a potentially “best-in-class” treatment for AD, if approved, possibly with a more favorable clinical safety and efficacy profile over other antibody therapeutic candidates currently in development. PMN310’s lack of off-target binding to Aβ plaque, which has been associated with a high incidence of ARIA-E, also suggests a more favorable safety profile.
Scientific Posters & Publications
Our scientific expertise is backed by decades of research on protein misfolding diseases such as AD, MSA, ALS, and PD. We encourage you to visit our scientific library to learn more about our programs.
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