AC Immune

Roche ends partnership with UCB in Alzheimer’s disease, returning rights to Phase IIa prospect bepranemab, marking Roche’s second Alzheimer’s partnership cut this year. UCB announced the partnership termination as it prepares to present Phase IIa study results at the 2024 Clinical Trials on Alzheimer’s Disease Meeting. Roche, lagging in Alzheimer’s treatment development, continues to explore early-stage assets like RG6289 and trontinemab.

Tau Inhibitors Clinical Trial Pipeline Analysis shows 25+ key companies expected to transform treatment, with increased funding accelerating advancements in neurodegenerative disease therapies.

Alzheimer’s disease (AD) is characterized by abnormal protein accumulation, with current diagnostic methods invasive and costly. Blood-based p217tau assays offer minimally invasive, cost-effective early detection, correlating with AD pathology and improving clinical trial efficiency. FDA approvals of AD blood tests highlight the need for non-invasive diagnostics, aiding in early intervention and therapeutic development.

Swissmedic to decide by end of 2024 on approving lecanemab, the first new Alzheimer’s drug in two decades. The decision faces challenges due to safety concerns and cost-effectiveness. Lecanemab, approved in the US, Japan, China, and South Korea, targets both symptoms and underlying causes of Alzheimer’s. The European Medicines Agency rejected it, citing risks, while the UK authorized it but denied reimbursement. Swissmedic's decision will impact Alzheimer’s patients and drugmakers' investment in new treatments.

In August 2024, the FDA made several decisions on new therapeutic agents, including approving Indapta Therapeutics’ g-NK cell therapy IDP-023 for progressive multiple sclerosis, Amneal Pharmaceuticals’ carbidopa/levodopa ER capsules IPX203 for Parkinson disease, and Medtronic’s deep brain stimulation technology for use during general anesthesia. The agency also granted fast track designation to Abata Therapeutics’ Treg therapy ABA-101 for progressive MS and [18F]PI-2620 tau-PET diagnostic for neurodegenerative diseases. Additionally, the FDA cleared Clearmind Biomedical’s Neuroblade System for minimally invasive neurosurgery and granted priority review to SpringWorks Therapeutics’ mirdametinib for neurofibromatosis type 1-associated plexiform neurofibromas.

The FDA granted Fast Track designation to [18F]PI-2620, a tau PET diagnostic, for Alzheimer's, PSP, and CBD, highlighting its potential for early diagnosis. It shows promise in detecting tau pathology with high accuracy, aiding in targeted treatment strategies for neurodegenerative diseases.

FDA fast-tracks AC Immune SA's JNJ-2056, an anti-pTau immunotherapy for Alzheimer's, now in phase 2b ReTain trial. The trial aims to delay cognitive decline in preclinical AD patients, using PACC-5 score and Tau PET imaging as endpoints. JNJ-2056 targets pTau, showing promise in early trials with specific IgG responses.

Switzerland excels in life sciences due to its strong regional hubs like Basel, Zurich, and Geneva/Lausanne, fostering innovation through bioparks and collaboration between academia and industry. This ecosystem supports start-ups and attracts global talent, maintaining Switzerland's leadership in drug discovery and biotech advancements.