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.
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 Target | Lead Indication | Other Indications | Status |
|---|---|---|---|
| Amyloid-beta | Alzheimer’s | IND Enabling Work Ongoing | |
| Tau | Alzheimer’s | PSP, Other Tauopathies | Lead Selection |
Our PMN310 program is a next-generation, potential best-in-class anti-amyloid therapy in development.
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.
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.
Recent advances in blood-based biomarkers may allow us to detect an objective treatment signal as early as Phase 1, potentially providing rapid and cost-effective proof-of-concept.
Upon completing producer cell line development for PMN310, we will complete the further preclinical work necessary (including a good manufacturing practice (GMP) compliant manufacturing dossier) to enable us to submit an Investigational New Drug (IND) application to the FDA and pursue clinical testing in the U.S.
Through the strategic use of disease-associated epitopes identified through our proprietary discovery platform, we aim to develop a safe and effective vaccine to induce a specific immune response against toxic Aβ oligomers (AβOs). An AD vaccine capable of inducing an effective antibody response against pathogenic Aβ could be administered as a preventative measure to at-risk individuals to prevent the development of symptomatic disease or given therapeutically to diagnosed patients to inhibit the progression of AD. ProMIS is collaborating with the Vaccine and Infectious Disease Organization (VIDO) of the University of Saskatchewan to conduct preclinical vaccine development.
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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