ACI-24.060 anti-Abeta Vaccine Active Immunotherapy Clinical Trials, Dosage, Efficacy. Indication, Side Effects
AC Immune SA ACI-24.060 anti-amyloid-beta (Abeta) vaccine active Immunotherapy candidate is designed to generate antibodies targeting misfolded Abeta to prevent accumulation and enhance clearance of amyloid plaques. The ACI-24 anti-Abeta vaccine candidates are expected to produce a broad immune response binding key pathological species such as Abeta oligomers and the highly neurotoxic pyroglutamate Abeta (N3pE-Abeta). This investigational candidate has the potential to inhibit plaque formation, increase plaque clearance efficiency, and reduce disease progression.
ACI-24.060 is derived from AC Immune's SupraAntigen® platform. In preclinical studies, it has been shown to induce a strong polyclonal antibody response that matures and is maintained against both oligomeric and pyroglutamate-Abeta species. These essential pathological forms of Abeta are believed to drive Abeta plaque formation and disease progression. ACI-24.060 is designed to enhance the formation of broad-spectrum protective antibodies with the same safety and tolerability previously demonstrated in the ACI-24 program in Phase 1 and 2 trials.
Targeting Abeta using antibodies has recently been validated with U.S. Food and Drug Administration (FDA) approvals of new monoclonal antibody (mAbs) treatments for patients with AD. By eliciting polyclonal anti-Abeta antibodies, the ACI-24.060 anti-Abeta vaccine development program aims to ultimately deliver significant benefits to patients, their caregivers, and healthcare systems regarding potential safety and tolerability, low-frequency dosing, low overall costs, and durable responses.
Early results from the first cohort of AD patients in the phase 1/2 ABATE clinical study showed that low dose ACI-24.060 could elicit an anti-Abeta antibody response as soon as week 6 (2 weeks after the second injection). The data show that ACI-24.060 vaccination has been safe and well tolerated. As a result, dosing in ABATE's second, higher-dose AD cohort began, and the trial was cleared to start screening individuals with DS for part 2 of the study. Further safety and immunogenicity findings from ABATE cohorts are expected in H2 2023. The initial data on amyloid plaque reduction measured via PET imaging is anticipated in 2024. On June 27, 2023, the company confirmed the FDA awarded Fast Track Designation. This follows FDA clearance of the Investigational New Drug (IND) application, enabling the expansion of the ongoing ABATE study in patients with AD and individuals with Down syndrome (DS).
On March 14, 2024, Dr. Andrea Pfeifer, CEO of AC Immune SA, commented in a press release, "In the second quarter and second half of 2024, we will be reporting Phase 2 ACI-24.060 data on amyloid plaque reduction after 6—and 12-month treatment, respectively. Amyloid plaque is a clinically validated biomarker of efficacy, making these data announcements potentially de-risking and providing an opportunity to accelerate ACI-24.060 into a registrational program." On May 13, 2024, Takeda and AC Immune SA announced an exclusive, worldwide option and license agreement for AC Immune's active immunotherapies targeting toxic forms of Abeta, including ACI-24.060 for treating Alzheimer's disease.
AC Immune SA is a clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, and NeuroOrphan indications driven by misfolded proteins.
ACI-24060 anti-Abeta Vaccine Indication
ACI-24 anti-Abeta vaccine candidates are indicated to slow Alzheimer's disease and dementia progression.
ACI-24.060 anti-Abeta Vaccine News
May 13, 2024 - "As pioneers in active immunotherapy, we are developing an innovative approach that could change the treatment paradigm for Alzheimer's disease and address the multifaceted burden that patients and the broader community face. We believe the maximum impact of ACI-24.060 can best be realized by partnering with Takeda at this critical juncture in its development, which will help us move rapidly into Phase 3," said Dr. Andrea Pfeifer, CEO of AC Immune. "This agreement allows us to leverage the developmental expertise, strategic vision, and financial capacity of an accomplished organization that has demonstrated its ability to execute the type of comprehensive global program required for Phase 3 trials in Alzheimer's disease while allowing us to focus on completing Phase 1b/2 development and accelerating our efforts to replicate this success with enhanced funding for our early-stage pipeline."
June 27, 2023 - Dr. Johannes Streffer, CMO of AC Immune SA, commented: "ABATE's expansion into the USA will allow us to accelerate the trial's advancement and build upon the strong momentum we've generated in Europe. With today's announcement, we remain firmly on track to report additional interim safety and immunogenicity data later this year and for the crucial interim readout of Abeta-PET imaging data in AD in the first half of next year. By benchmarking the amount of Abeta plaque reduction achieved with ACI-24.060 against those achieved with FDA-approved monoclonal antibodies, we believe we can generate early evidence of our vaccine's therapeutic potential to support its expeditious advancement towards pivotal programs in AD and DS-related AD."
January 26, 2023 - AC Immune SA announced the first interim safety, tolerability, and immunogenicity findings from the Phase 1b/2 ABATE trial of its Abeta vaccine ACI-24.060 in patients with prodromal AD. ABATE will now be expanded, as planned, to include individuals with Down syndrome and to evaluate higher doses in Alzheimer's patients. Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "We are delighted with the encouraging initial safety and immunogenicity findings for ACI-24.060 in ABATE reported today. We believe ACI-24.060's successful development could provide patients with a novel therapeutic option offering numerous potential advantages in treatment, maintenance, and prevention settings. These early findings from ABATE represent an important step towards this goal, and we look forward to reporting more detailed data at a future conference."
February 4, 2022 - AC Immune announced their wholly-owned ACI-24, an amyloid-beta vaccine program. Preclinical data show the optimized ACI-24 formulation induced a broad polyclonal anti-Abeta response, including high titers of antibodies targeting pyroGlu-Abeta variants, and was well tolerated in non-human primates and mice.
ACI-24.060 anti-Abeta Vaccine Clinical Trials
AC Immune is advancing one of the broadest product portfolios focused on pioneering precision medicine for neurodegenerative diseases. The original formulation of ACI-24 has been evaluated in Phase 1b/2 (2009) and Phase 2 trials in AD patients and a Phase 1b trial in individuals with DS. ACI-24.060 targets the same toxic species as disease-modifying anti-Abeta monoclonal antibodies that slowed AD progression in Phase 3 clinical trials.
