Drugs / PMN310
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | Alzheimer disease | 2023-04-10 | “today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for PMN310 for the treatment of AD.” promisneurosciences.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06750432 | Dec 2024 → Dec 2026 expected | early-onset autosomal dominant Alzheimer disease | ProMis Neurosciences, Inc | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06105528 | Nov 2023 → Jul 2024 | — | ProMis Neurosciences, Inc | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 26
| Date | Issuer | Release |
|---|---|---|
| 2026-07-28 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Reports Positive Blinded Six-Month Interim Safety and Biomarker Data for PMN310 in the PRECISE-AD Phase 1b Alzheimer’s Disease Trial promisneurosciences.com ↗ |
| 2026-07-14 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Reports First Human Evidence of Amyloid-Beta Oligomer Target Engagement by PMN310 at AAIC 2026 promisneurosciences.com ↗
This represents one of the first quantitative demonstrations of treatment-related oligomer reduction in humans. |
| 2025-12-10 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Announces New Peer-Reviewed Publication Highlighting Selective Targeting of Toxic Oligomers for Potential Clinical Benefit and Reduced ARIA Risk promisneurosciences.com ↗
Results support the potential of PMN310 to improve outcomes by selectively targeting oligomers and avoiding binding to monomer and plaque |
| 2025-07-21 | ProMis Neurosciences, Inc | Regulatory ProMIS Neurosciences Granted Fast Track Designation by U.S. FDA for PMN310 in the Treatment of Alzheimer’s Disease promisneurosciences.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PMN310, the Company’s lead therapeutic candidate in development for the treatment of Alzheimer’s disease (AD). |
| 2024-10-30 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Presents Positive Data from PMN310 Phase1a Clinical Trial at the 17th Clinical Trials on Alzheimer’s Disease Conference promisneurosciences.com ↗
Results indicated PMN310 was generally well-tolerated and monthly dosing can provide CSF levels adequate for target engagement |
| 2024-07-30 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Showcases Novel Vaccine Approach for Maximal Targeting of Toxic Amyloid-Beta Oligomers at the 2024 Alzheimer’s Association International Conference promisneurosciences.com ↗
Importantly, immunization with epitope 301, the target of PMN310, alone was sufficient to produce maximal reactivity against brain AßO. |
| 2024-07-26 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Reports Positive Top-Line Data from its Phase 1a Alzheimer's Trial promisneurosciences.com ↗
Topline results demonstrated a favorable safety profile and tolerability across four ascending dose levels in healthy volunteers and showed dose dependent levels of PMN310 antibody in Cerebrospinal fluid (CSF) suggestive of its potential for target engagement in Alzheimer’s disease patients |
| 2024-04-30 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Publishes Study Highlighting Oligomer Selectivity and Benefit of Amyloid-Beta-Directed Antibodies promisneurosciences.com ↗
The results indicate that selectivity for soluble toxic Aß oligomers may be a driver of clinical efficacy and indicated that PMN310 displayed the greatest degree of oligomer selectivity. |
| 2023-07-17 | ProMis Neurosciences, Inc | Results ProMIS Showcases Preclinical Data at the Alzheimer’s Association International Conference 2023 on Computationally-Derived Antibody and Vaccine from Alzheimer’s Pipeline promisneurosciences.com ↗
The results demonstrated that PMN310 was able to selectively bind to toxic AβO in AD brain extract and was less impacted by monomer competition than other Aβ-directed antibodies except ACU193, which was equivalent to PMN310. |
| 2023-05-08 | ProMis Neurosciences, Inc | Regulatory ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in Alzheimer’s Disease promisneurosciences.com ↗
ProMIS Neurosciences Inc. (TSX: PMN) (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PMN310 for the treatment of AD. |
| 2023-04-24 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Presents Preclinical Data Highlighting Targeting of Toxic Misfolded Proteins in Alzheimer’s Disease and ALS at American Academy of Neurology Annual Meeting promisneurosciences.com ↗
We are excited to share the data differentiating our lead therapeutic candidate for Alzheimer’s disease, PMN310, which exhibited characteristics in preclinical studies that may provide greater therapeutic potential and support a favorable tolerability profile compared to other amyloid-beta antibodies. |
| 2023-04-10 | ProMis Neurosciences, Inc | Regulatory ProMIS Neurosciences Announces Submission of Investigational New Drug (IND) Application for Lead Antibody PMN310 promisneurosciences.com ↗
today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for PMN310 for the treatment of AD. |
| 2023-03-29 | ProMis Neurosciences, Inc | Results Lead Therapeutic Candidate, PMN310, Demonstrates Enhanced Selectivity for Toxic Oligomers Compared to Other Amyloid-Beta-Directed Antibodies in Poster Presentation at AD/PD 2023 promisneurosciences.com ↗
PMN310 demonstrated greater selectivity for target toxic oligomers over monomers compared to other amyloid-beta-directed antibodies. |
| 2022-08-02 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Presents at 2022 Alzheimer’s Association International Conference promisneurosciences.com ↗
The poster describes a study comparing ProMIS’ lead therapeutic candidate PMN310 to other Aß-directed antibodies for selectivity and ability to maintain interaction with toxic oligomers in the presence of competing Aß monomers. |
| 2022-07-27 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences to Present at 2022 Alzheimer’s Association International Conference promisneurosciences.com ↗
The poster describes the design and results of a study wherein ProMIS’ lead therapeutic candidate PMN310 was compared to other amyloid-beta-directed antibodies for selectivity and ability to maintain interaction with toxic oligomers in the presence of competing monomers. |
| 2022-03-02 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences’ PMN310 antibody demonstrates significant cognitive benefit in a mouse model of Alzheimer’s disease promisneurosciences.com ↗ |
| 2019-07-18 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Highlights Data for PMN310 at AAIC 2019 promisneurosciences.com ↗
In an oral presentation, Chief Development Officer Dr. Johanne Kaplan highlighted the therapeutic potential of PMN310 against the toxic oligomer form of amyloid beta (AßO), a root cause of Alzheimer's disease. |
| 2019-07-09 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences' Data for Alzheimer's Disease Clinical Candidate PMN310 Published in Scientific Reports promisneurosciences.com ↗
The results of activity assays show that PMN310 inhibits both the spread and toxicity of AßOs in vitro, and, in mouse studies, that PMN310 prevents AßO-induced loss of memory formation and reduces both synaptic loss and inflammation. |
| 2019-06-27 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences’ PMN310 Shows Greater Therapeutic Potential vs. Other Amyloid-Beta-Directed Antibodies promisneurosciences.com ↗
ProMIS’ Chief Development Officer Dr. Johanne Kaplan presented data showing that PMN310 possesses superior selectivity for amyloid beta toxic oligomers (AßOs) and improved therapeutic potential compared with other Aß-directed antibodies. |
| 2019-06-27 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences' PMN310 Shows Greater Therapeutic Potential vs. Other Amyloid-Beta-Directed Antibodies promisneurosciences.com ↗
ProMIS' Chief Development Officer Dr. Johanne Kaplan presented data showing that PMN310 possesses superior selectivity for amyloid beta toxic oligomers (AßOs) and improved therapeutic potential compared with other Aß-directed antibodies. |
| 2019-06-05 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Presents Lead Program for Alzheimer's Disease at Prestigious Keystone Symposia Scientific Conference promisneurosciences.com ↗
ProMIS' Chief Development Officer Dr. Johanne Kaplan will present the company's lead therapeutic candidate PMN310 which demonstrates high selectivity for the toxic forms of amyloid beta implicated as a root cause of Alzheimer's disease. |
| 2018-08-21 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Oligomer Selective Antibody Therapeutic for Alzheimer's Disease, PMN310, Shows Potential for Improved Safety Profile in Direct Comparison to Other Amyloid Beta-Directed Antibodies in Clinical Development promisneurosciences.com ↗
today announced that its lead antibody candidate for Alzheimer's disease (AD), PMN310, showed no binding to amyloid beta (A ß ) plaque in AD brain samples in stark contrast to BAN2401 and aducanumab which both displayed robust A ß plaque reactivity. |
| 2018-03-06 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Lead Product Candidate for Alzheimer's Disease Shows Potential for Improved Therapeutic Potency versus Other Amyloid Beta-Directed Antibodies promisneurosciences.com ↗
The results showed equivalent concentrations of huPMN310 and aducanumab in the circulation and in the brain indicating that the two antibodies possess a similar degree of CNS penetrance. |
| 2018-01-23 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Lead Product Candidate for Alzheimer's Disease Shows Potential for Improved Therapeutic Potency versus Other Amyloid Beta-Directed Antibodies promisneurosciences.com ↗
ProMIS is pleased to announce that its lead product candidate for AD, PMN310, compared to aducanumab (Biogen) showed significantly greater binding to the neurotoxic oligomer-enriched fraction of amyloid beta (Aβ) in brain extract from eight confirmed AD brains. |
| 2018-01-04 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Lead Product Candidate for Alzheimer's Disease, PMN310, Shows Potential for Improved Safety Profile in Direct Comparison to Other Amyloid Beta-Directed Antibodies promisneurosciences.com ↗
The binding profile of PMN310 in human AD brain tissue, as well as in brain samples from a mouse AD model, was directly compared to that of other Aβ-directed antibodies in a preclinical study using the technique of immunohistochemistry (IHC). |
| 2017-10-17 | ProMis Neurosciences, Inc | Results ProMIS Neurosciences Lead Product Candidate, PMN310, Shows Desired Target Binding Profile in Direct Comparison to Other Amyloid Beta-Directed Antibodies for Alzheimer's Disease promisneurosciences.com ↗ |
All press releases naming this drug 38 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PMN310 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06105528 ↗ |
| Modality | Monoclonal antibody | “A humanized immunoglobulin G1 (IgG1) monoclonal antibody” NCT06750432 ↗ |
| Route | Intravenous | “60-minute intravenous infusion” NCT06105528 ↗ |