{"doi":"10.1002/alz.13028","title":"Preclinical characterization and IND‐enabling safety studies for PNT001, an antibody that recognizes <i>cis</i>‐pT231 tau","abstract":"BACKGROUND: The cis-conformer of tau phosphorylated at threonine-231 (cis-pT231 tau) is hypothesized to contribute to tauopathies. PNT001 is a humanized, monoclonal antibody that recognizes cis-pT231 tau. PNT001 was characterized to assess clinical development readiness. METHODS: Affinity and selectivity were assessed by surface plasmon resonance and enzyme-linked immunosorbent assay. Immunohistochemistry (IHC) was performed with brain sections from human tauopathy patients and controls. Real-time quaking-induced conversion (RT-QuIC) was used to assess whether PNT001 reduced tau seeds from Tg4510 transgenic mouse brain. Murine PNT001 was evaluated in vivo in the Tg4510 mouse. RESULTS: The affinity of PNT001 for a cis-pT231 peptide was 0.3 to 3 nM. IHC revealed neurofibrillary tangle-like structures in tauopathy patients with no detectable staining in controls. Incubation of Tg4510 brain homogenates with PNT001 lowered seeding in RT-QuIC. Multiple endpoints were improved in the Tg4510 mouse. No adverse findings attributable to PNT001 were detected in Good Laboratory Practice safety studies. DISCUSSION: The data support clinical development of PNT001 in human tauopathies.","journal":"Alzheimer s & Dementia","year":2023,"id":342482,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":14,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9562,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":482667,"name":"Matteo Manca","orcid":"0000-0001-5178-0957","position":1,"is_corresponding":false},{"id":1078990,"name":"Kim F. McClure","orcid":"0000-0002-3232-8719","position":2,"is_corresponding":false},{"id":1079423,"name":"Pyry Koivula","orcid":null,"position":3,"is_corresponding":false},{"id":27606,"name":"John Q. Trojanowski","orcid":"0000-0002-9239-8794","position":4,"is_corresponding":false},{"id":1039243,"name":"Daniel Havas","orcid":"0000-0002-5220-852X","position":5,"is_corresponding":false},{"id":1078991,"name":"Sarah E. Chancellor","orcid":"0000-0002-0916-9721","position":6,"is_corresponding":false},{"id":297230,"name":"Lee E. Goldstein","orcid":"0000-0001-8419-9800","position":7,"is_corresponding":false},{"id":357077,"name":"Kurt R. Brunden","orcid":"0000-0002-9732-134X","position":8,"is_corresponding":false},{"id":268828,"name":"Allison Kraus","orcid":"0000-0001-8477-0894","position":9,"is_corresponding":false},{"id":1079424,"name":"Michael K. Ahlijanian","orcid":null,"position":10,"is_corresponding":false},{"id":1078989,"name":"Kelly Foster","orcid":"0000-0002-3328-2177","position":0,"is_corresponding":true}],"reference_count":67,"raw_metadata":null,"created_at":"2026-07-19T01:11:12.506815Z","pmid":"37002928","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}