“This submission is an important milestone for the ProMIS team as we advance our lead compound, PMN310, toward the clinic. We are excited to continue the development of PMN310 to potentially provide a new treatment option with a differentiated profile for patients with Alzheimer’s disease,” said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences. “We look forward to our transition to a clinical stage company, pending regulatory clearance of the IND.”

PMN310 is a novel monoclonal antibody which is designed to be highly selective for toxic oligomers of amyloid-beta (Aβ) that are believed to be a major driver of AD, as opposed to monomers or plaque. In preclinical studies, PMN310 showed strong ex vivo target engagement of toxic oligomers in brain samples from patients with AD. In a recent presentation of in vitro data at the AD/PD 2023 conference, PMN310 compared to other Aβ-directed antibodies was the least impacted by monomer competition, resulting in an overall greater toxic oligomer binding level versus all comparators. In addition, PMN310’s lack of off-target binding to Aβ plaque also suggests the possibility of a more favorable safety profile, since off-target plaque binding by Aβ-directed antibodies has been associated with Aβ-related imaging abnormalities (ARIA). These data support a potentially differentiated clinical profile when compared to other antibody therapeutics in AD, either approved or currently in development.