BioTech IP Review

Patent Title: Anti‑TREM2 antibodies and methods of use thereof
Patent Number: 12,240,902 B2
Issue Date: March 4, 2025
Assignee: Denali Therapeutics Inc. (South San Francisco, CA, USA)
Invention Focus: Therapeutic antibodies targeting TREM2 for modulating immune responses in neurological diseases and related disorders

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What This Patent Covers

This U.S. patent protects novel antibody molecules that bind to TREM2 (Triggering Receptor Expressed on Myeloid cells‑2) along with associated therapeutic compositions and methods of use. The key elements of the invention include:

Target & Biology

• TREM2 is an immune receptor expressed on microglia and other myeloid cells in the brain. It plays a crucial role in regulating microglial activation, phagocytosis, and inflammatory signaling — processes that are implicated in Alzheimer’s disease, other neurodegenerative disorders, and potentially inflammatory neurodegeneration.

Antibody Composition

• The patent claims specific antibody sequences and structures that bind to TREM2 with high affinity and selectivity.
• These antibodies are engineered to modulate TREM2 signaling, which could either enhance beneficial microglial functions (e.g., debris clearance) or attenuate harmful inflammation depending on the therapeutic strategy.

Methods of Use

• Includes methods of treating neurological or neuroinflammatory diseases by administering these anti‑TREM2 antibodies to subjects in need. The claims likely span Alzheimer’s disease, Parkinson’s disease, dementia, and other CNS disorders where microglial dysfunction contributes to pathology.
• Also may claim combination therapies and dosing regimens in animal models and human patients.

Pharmaceutical Compositions

• Covers formulations containing these antibodies and their use in therapeutic regimens, potentially in combination with other agents that target neurodegeneration or lysosomal dysfunction.

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Why This Patent Is Important

1) Strategic Alignment with Denali’s Pipeline
Denali’s platform emphasizes tackling neurodegenerative and rare CNS diseases by crossing the blood–brain barrier with biologics and small molecules. An antibody that modulates microglial activity through TREM2 fits squarely within this strategy and can support multiple product candidates.

2) Broad Therapeutic Potential
TREM2 modulation is an attractive mechanism in Alzheimer’s disease and other dementia syndromes where microglial dysfunction is implicated in disease progression. Therapies addressing these pathways could tap into multi‑billion‑dollar markets if proven clinically effective.

3) Platform & Combination Value
TREM2 antibodies can be paired with other Denali programs (e.g., its TransportVehicle-enabled enzyme or oligonucleotide therapies) to create combination regimens that target both upstream immune dysfunction and downstream pathological processes — increasing potential commercial value.

4) Early Issuance in 2025
Issued early in the year (March 2025), this patent gives Denali a head start in exclusivity for TREM2‑targeted therapies and strengthens its overall intellectual property portfolio covering antibodies against key CNS targets.