AC Immune | MedPath

Promising Alzheimer's Vaccine Targeting Tau Protein Advances Toward Human Trials

a month ago

• University of New Mexico researchers have developed a vaccine that generates antibodies against pathological tau protein (pT181), showing efficacy in both mice and non-human primates with strong immune responses. • The vaccine uses virus-like particles (VLPs) as a delivery platform, requiring only one primary shot and two boosters without adjuvants, demonstrating safety and durability in preclinical studies. • Researchers are now seeking funding to advance to Phase 1 human clinical trials, potentially offering a more effective approach than current amyloid beta-targeting treatments that show only modest effects on Alzheimer's progression.

AC Immune's Parkinson's Immunotherapy Shows Promising Results in Phase 2 Trial

2 months ago

• ACI-7104.056 active immunotherapy demonstrated strong immunogenicity in early Parkinson's disease patients, producing anti-alpha-synuclein antibody levels 20-fold higher than placebo after four immunizations. • The Phase 2 VacSYn trial showed repeated immunizations successfully amplified antibody response, with no serious adverse events reported and only mild injection site reactions and headaches as common side effects. • AC Immune may expand the trial to include 150 additional patients later in 2025, with plans to evaluate disease progression markers and establish proof-of-concept for this potential first-in-class treatment approach.

European Regulators Reject Eli Lilly's Alzheimer's Drug Kisunla Over Safety Concerns

2 months ago

• The European Medicines Agency's advisory committee has recommended against approving Eli Lilly's Alzheimer's treatment Kisunla, citing safety concerns related to brain swelling. • European regulators determined that the risks of amyloid-related imaging abnormalities (ARIA) outweigh the potential benefits of the drug, creating a notable divergence from US regulatory decisions. • This rejection marks another instance where European and American regulators have reached different conclusions on new Alzheimer's treatments, highlighting regional differences in benefit-risk assessment.

ANKTIVA Receives Permanent J-Code from CMS, Streamlining Reimbursement for Bladder Cancer Treatment

5 months ago

• The Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code (J9028) for ANKTIVA, effective January 1, 2025, to streamline billing. • ANKTIVA, in combination with BCG, is FDA-approved for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). • Clinical trial data shows ANKTIVA achieved a 71% complete response rate in patients with BCG-unresponsive NMIBC CIS, with durable responses up to 54 months.

FDA Gears Up for Critical Decisions on Alzheimer's, Breast Cancer, and Neurological Therapies in Early 2025

5 months ago

• The FDA is set to decide on Biogen and Eisai's Leqembi for monthly intravenous maintenance in early Alzheimer's disease, potentially improving patient convenience. • AstraZeneca and Daiichi Sankyo await a decision on Dato-DXd for metastatic HR-positive, HER2-negative breast cancer, offering a new antibody-drug conjugate approach. • Vertex's suzetrigine, a non-opioid analgesic for moderate-to-severe acute pain, anticipates FDA verdict, representing a novel drug class for pain management. • SpringWorks' mirdametinib is under priority review for neurofibromatosis type 1-associated plexiform neurofibromas, addressing a significant unmet need.

Alzheimer's Disease Pipeline Shows Promise with 120+ Therapies in Development

5 months ago

• Over 120 Alzheimer's Disease treatment therapies are under development by 110+ companies globally, ranging from preclinical to marketed phases. • Emerging therapies like NRDN-201, ST-501, and KarXT are in various clinical trial phases, showing potential for significant market impact. • MapLight Therapeutics initiated a Phase 1 trial for ML-007/PAC, targeting schizophrenia and Alzheimer's disease psychosis, with Phase 2 trials planned. • The FDA granted conventional approval to Leqembi (lecanemab-irmb), marking the first amyloid beta-directed antibody to transition from accelerated approval.

AC Immune Reports Positive Q3 2024 Driven by Alzheimer's and Parkinson's Programs

6 months ago

• AC Immune's Q3 2024 was marked by advancements in its ACI-7104.056 VacSYn Phase 2 trial for Parkinson's disease and a CHF 24.6 million milestone payment in an Alzheimer's Phase 2b trial. • The FDA granted Fast Track designation to JNJ-2056, supporting AC Immune's Alzheimer's program, indicating an expedited review process for this potential therapy. • A strong cash position of CHF 157.9 million, boosted by milestone payments, provides AC Immune with operational runway into 2027, ensuring continued research and development. • AC Immune reported a net income of CHF 5.5 million, a significant improvement from the previous year's net loss, demonstrating financial resilience and strategic growth.

Links Between Common Cardio Drugs and Dementia Risk, Plus Updates on MS, Parkinson's, Alzheimer's, and Migraine

6 months ago

• Long-term use of some cardiovascular drugs is associated with a reduced risk of dementia, while anti-platelet use shows a higher dementia risk, according to Swedish data. • Fampridine (Fampyra) demonstrates potential in enhancing working memory performance among adults with lower cognitive function, suggesting benefits beyond its use in multiple sclerosis. • Interim phase II data indicates that ACI-7104.056, an investigational drug, effectively induces high levels of anti-alpha-synuclein antibodies in patients with early Parkinson's disease. • The FDA has expanded the age indication for the Nerivio migraine treatment device, enabling its use for preventive treatment in pediatric patients.

ACI-7104 Parkinson's Vaccine Shows Promise in Phase 2 Trial

6 months ago

• AC Immune's ACI-7104 vaccine demonstrates safety and tolerability in an early-stage Parkinson's disease Phase 2 trial. • The vaccine effectively stimulates the production of anti-alpha-synuclein antibodies, a key target for Parkinson's treatment. • Interim results support potential advancement to the trial's second part, involving a larger patient group for expanded testing. • Further updates, including progression into the second phase, are expected in the first half of 2025.

AC Immune's ACI-7104 Shows Promise in Phase II Parkinson's Disease Trial

6 months ago

• AC Immune's stock surged by over 20% following positive interim data from its Phase II VacSYn trial of ACI-7104.056 for Parkinson's disease. • The immunotherapy ACI-7104.056 induced a 16-fold increase in anti-alpha-synuclein antibodies compared to placebo after three immunizations. • The VacSYn trial is an adaptive, placebo-controlled study in early Parkinson’s patients, with plans to initiate Part 2 with up to 150 patients. • Interim results showed a positive safety profile with only transient injection site reactions and headaches reported as adverse events.

ACI-7104.056 Shows Positive Antibody Response in Phase 2 Parkinson's Trial

6 months ago

• AC Immune's ACI-7104.056 immunotherapy demonstrated a significant increase in anti-alpha-synuclein antibodies in Parkinson's disease patients after six weeks. • The Phase 2 VacSYn trial showed a 16-fold increase in antibody levels compared to placebo, indicating a strong immune response to the treatment. • ACI-7104.056 maintained a positive safety profile, with only transient injection site reactions and headaches reported as clinically relevant safety issues. • Based on these interim results, AC Immune may expand the study into Part 2 with up to 150 patients, with further data expected in H1 2025.

AC Immune's Pipeline Advances with Key Milestones in Alzheimer's and Parkinson's Disease

7 months ago

• AC Immune's ACI-7104.056 Phase 2 trial for Parkinson's disease is set to report interim safety and immunogenicity data by the end of 2024. • Milestone payment of CHF 24.6 million was triggered by rapid prescreening for the Phase 2b Retain trial of JNJ-2056 in preclinical Alzheimer's disease. • JNJ-2056, an active immunotherapy, received Fast Track designation from the FDA for Alzheimer's disease, highlighting its potential impact. • AC Immune's cash position, bolstered by milestone payments, extends the company's financial runway into 2027, supporting ongoing research and development.

Alzheimer's and Parkinson's Disease Drug Development Programs Face Setbacks in 2024

7 months ago

• Several pharmaceutical companies, including Roche, Johnson & Johnson, Sage Therapeutics, and Otsuka, have discontinued Alzheimer's and Parkinson's disease programs in 2024. • Roche terminated its collaboration with UCB and returned assets to AC Immune after disappointing clinical trial results for drugs like crenezumab and semorinemab. • Sage Therapeutics halted development of dalzanemdor in both Parkinson's and Alzheimer's after it failed to show efficacy in Phase II trials. • Despite these setbacks, experts suggest this isn't indicative of a major R&D shift, with Alzheimer's treatment projected to be a $15.5 billion market by 2031.

Roche Terminates Alzheimer's Partnership with UCB, Returns Rights to Bepranemab

7 months ago

• Roche has ended its collaboration with UCB, relinquishing rights to bepranemab, a Phase 2a Alzheimer's candidate, marking the second Alzheimer's partnership termination this year. • The initial agreement in July 2020 involved a $120 million upfront payment and potential milestone payments up to $2 billion for bepranemab development. • UCB will proceed with the Phase 2a trial of bepranemab, presenting the results at the Alzheimer's Clinical Trials Conference 2024 in Spain. • Roche's exit follows the failure of gantenerumab in 2022, but the company continues to focus on early Alzheimer's diagnosis and other early-stage assets like trontinemab.

Blood-Based p217tau Assay Shows Promise in Early Alzheimer's Detection

8 months ago

• A novel blood-based assay targeting p217tau shows high accuracy in detecting early Alzheimer's disease pathology, potentially years before symptom onset. • The p217tau assay demonstrates strong correlation with amyloid deposits, tau tangles, cognitive decline, and brain atrophy, outperforming other leading assays. • Integrating p217tau assays into clinical research may improve patient enrollment in clinical trials and accelerate the development of disease-modifying treatments. • Monoclonal antibody therapies targeting p217tau are being investigated as potential early interventions to slow the spread of tau pathology and disease progression.

Alzheimer's Drug Lecanemab Faces Scrutiny as Swissmedic Weighs Approval

8 months ago

• Swissmedic is expected to decide by the end of 2024 whether to approve lecanemab, the first new Alzheimer’s drug in two decades. • Lecanemab, already approved in the US, Japan, China, and South Korea, targets amyloid plaques and has shown to slow cognitive decline by 27% in trials. • The European Medicines Agency rejected lecanemab due to concerns about brain swelling and bleeding, while the UK's NICE cited high costs relative to benefits. • Experts emphasize the importance of early treatment and continued investment in Alzheimer's research despite the modest benefits and potential risks of current drugs.

September 2024: FDA Actions Span Diabetes, Neurology, and Rare Diseases

8 months ago

• The FDA approved Embecta's tubeless patch pump for insulin delivery in adults with type 1 and type 2 diabetes, offering a 300-unit reservoir based on patient feedback. • Sparsentan (Filspari) received full FDA approval to slow kidney function decline in adults with primary IgA nephropathy (IgAN), based on positive Phase 3 PROTECT study data. • Approvals for arimoclomol (Miplyffa) and levacetylleucine (Aqneursa) mark the first specific treatments for neurological symptoms of Niemann-Pick disease type C (NPC). • Dupilumab (Dupixent) gained approval for COPD, chronic rhinosinusitis with nasal polyps, and was submitted for label expansion for adult growth hormone deficiency.