Nuravax and IMM Advance Alzheimer’s Vaccine AV-1959R to Phase 2 Following Strong Phase 1 Results

Nuravax and IMM report impressive Phase 1 data for AV-1959R Alzheimer’s vaccine at CTAD 2025 and present the design of the planned Phase 2 trials

IRVINE, CA, UNITED STATES, December 30, 2025 /EINPresswire.com/ -- Nuravax Inc., in collaboration with the Institute for Molecular Medicine (IMM), reveals Phase 1 results and details plans for a Phase 2 trial of the amyloid-beta (Aβ) vaccine AV-1959R. The announcement follows two presentations of the data at the 18th Clinical Trials on Alzheimer’s Disease conference (CTAD 2025) in San Diego.

AV-1959R was originally developed at IMM and is being advanced clinically and commercially by Nuravax under an exclusive license agreement.

In the Phase 1 study involving 16 cognitively unimpaired adults aged 40–60, AV-1959R achieved its primary safety and secondary immunogenicity goals. The vaccine was safe and well-tolerated, with no vaccine-related serious adverse events. All vaccinated participants produced strong IgG antibody responses targeting pathological Aβ42 fibrils and protofibrils.

On average, endpoint antibody titers increased approximately 355-fold from baseline following two immunizations, even at the lowest dose of 100 µg. By week 8, every participant had received either the vaccine or a placebo. The 12 individuals who received a third immunization showed further rises in antibody levels compared to pre-boost levels, with these elevated levels remaining high throughout the 24-week follow-up period.

“To describe the longitudinal kinetics of vaccine-induced antibody titers, we used a mathematical model to analyze how antibody levels change over time after vaccination," said Dr. Michael Agadjanyan, professor of immunology at IMM. “This model indicates that a single yearly booster could be enough to sustain therapeutic levels of anti-Ab42 antibodies, offering a practical benefit for using AV-1959R preventively in cognitively unimpaired individuals at risk for Alzheimer’s disease."

At CTAD 2025, investigators also presented the design of the planned Phase 2 secondary-preventive therapy trials involving preclinical AD stage individuals with evidence of amyloid pathology. The efficacy of this novel, immunogenic AV-1959R vaccine will be assessed by changes in blood-based biomarkers and amyloid PET.

“Phase 2 aims to link the strong antibody responses seen in Phase 1 with biological indicators of amyloid pathology. This will be carried out in a randomized, placebo-controlled trial involving 160 preclinical, asymptomatic (cognitively unimpaired) amyloid-positive participants,” said Roman Kniazev, CEO of Nuravax.
“We will assess potential efficacy using biomarker-based endpoints, including amyloid PET scans and plasma biomarkers such as p-tau217/Aβ42,”

These data will help IMM and Nuravax evaluate target engagement and inform future Phase 2 and Phase 3 trials aimed at delaying the onset of Alzheimer’s disease.

About AV-1959R

AV-1959R is an adjuvanted, epitope-specific Aβ vaccine using the MultiTEP platform at IMM. It aims to overcome immunological tolerance, induce durable antibody responses, and minimize autoreactive T-cell responses. AV-1959R targets secondary prevention in biomarker-positive Alzheimer’s individuals and primary prevention for those at high lifetime risk due to genetic or medical factors.

About the AV-1959R Phase 1 Study

The Phase 1 trial of AV-1959R was a randomized, placebo-controlled study with 16 healthy adults aged 40–60. Participants received 100 µg or 300 µg of AV-1959R, randomly assigned in a 3:1 ratio, via intramuscular injections at baseline and Week 4. A booster was administered in Week 14, with monitoring continuing for 22 weeks. The primary goal was safety and tolerability, with immunogenicity as a secondary endpoint. Results showed AV-1959R was well tolerated, with no serious adverse events, and induced strong anti-amyloid-β IgG responses targeting aggregated amyloid-β species.

About Nuravax

Nuravax is a clinical-stage biotech developing immunotherapy vaccines for Alzheimer’s, Parkinson’s, brain injury, and chronic traumatic encephalopathy (CTE). Focused on early, biology-driven intervention, it leads clinical, regulatory, and manufacturing efforts for Duvax and other MultiTEP-based vaccines licensed from IMM.

About the Institute for Molecular Medicine (IMM)

Founded in 1996, IMM is a nonprofit research institute dedicated to developing vaccines and immunotherapies for neurodegenerative diseases, including Alzheimer’s, Parkinson’s, and CTE. The IMM team developed the MultiTEP platform and has conducted extensive preclinical and translational research to support MultiTEP-based products.

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