Drug intelligence / Profile preview

ACI-35

Development stage
Phase 2
Lead developer
OMJ Pharmaceuticals
Modality
Peptides, Vaccines & Immunotherapeutics
Administration
Subcutaneous
01

Overview

ACI-35 is a first-generation, liposome-based active immunotherapy (vaccine) developed by AC Immune SA, in collaboration with Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine), for the treatment of Alzheimer's disease. It consists of a tetra-palmitoylated phospho-tau (pTau) T3 peptide spanning residues 393-408 of the longest human Tau isoform, phosphorylated at pathological residues S396 and S404, embedded in a lipid bilayer along with the adjuvant monophosphoryl lipid A (MPLA). The vaccine contains 16 copies of this synthetic tau fragment. Its biological target is pathological phosphorylated tau (pTau) protein in the brain, and its mechanism is to elicit a specific antibody-mediated immune response against pathological conformers of pTau without triggering autoimmune responses against physiological tau. ACI-35 was evaluated in a Phase 1b clinical trial in patients with mild-to-moderate Alzheimer's disease, where it demonstrated a favorable safety and tolerability profile and an early target-specific antibody response against pTau, but failed to generate sustained antibody responses upon subsequent booster injections. It served as the basis for the second-generation vaccine ACI-35.030 (JNJ-64042056).

Other names
ACI-35ACI35ACI 35VAC20121VAC-20121VAC 20121
02

Targets

p-tau396/404 (Microtubule-associated protein tau (phosphorylated at Ser396/Ser404))

Beyond the preview

Go deeper on ACI-35.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Full profile access

Follow clinical development from study design and recruitment through results.

  • Trial phase
  • Status
  • Readouts

Indications & development

Full profile access

Explore development by indication, patient population, and geography.

  • Indications
  • Development status
  • Countries

Licensing & deals

Full profile access

Trace asset ownership, licensing agreements, and commercial partnerships.

  • Partners
  • Deal terms
  • Milestones

Patents & exclusivity

Full profile access

Explore the patent landscape and regulatory exclusivity around an asset.

  • Patents
  • Expiration dates
  • Exclusivity

Competitive landscape

Full profile access

Compare development programs by target, modality, and indication.

  • Competing assets
  • Targets
  • Development stage

Research & analysis

Full profile access

Connect source evidence and development news to your research questions.

  • Publications
  • News
  • Analysis

Bring the full picture into focus.

See how Gosset can support your research on ACI-35.

Explore the full profile

Gosset Free

Get started with Gosset.

Enter your work email and we’ll be in touch with next steps.

Work email preferred.

Book a call