BioTech IP Review

Assignee: Immunocore Limited
Patent Number: 12,195,534 B2
Filed: January 5, 2024
Issued: January 14, 2025
Title: Binding Molecules Comprising T Cell Receptor (TCR) Variable Domains

What This Patent Covers

This patent protects engineered binding molecules that include T‑cell receptor (TCR) variable domains capable of specifically binding cancer‑associated peptide‑HLA complexes — structures formed when peptides from inside a cancer cell are presented on its surface by human leukocyte antigen (HLA) proteins.

Specifically, the invention covers:

• Soluble binding molecules where one part is a TCR variable domain engineered to recognize a defined peptide‑HLA target (e.g., derived from tumor antigens like PRAME) with high affinity.
• Compositions and sequences for such TCR‑based binding molecules that can be formulated for therapeutic use against malignant disease.
• Pharmaceutical applications of these molecules as immunotherapeutic reagents capable of recruiting and activating T cells to attack cancer cells presenting the target peptide‑HLA complex.

These engineered TCR binding molecules are often used as the targeting domains in bispecific TCR‑anti‑CD3 fusion proteins (ImmTAC®) that simultaneously bind tumor peptide‑HLA complexes on cancer cells and the CD3 complex on T cells, driving targeted immune responses against tumors.

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Why This Patent Is Important

• Underpins core therapeutic platform: Immunocore’s ImmTAC bispecific TCR therapies — including its approved product KIMMTRAK® (tebentafusp) and next‑generation candidates like IMC‑P115C (half‑life extended ImmTAC) — rely on engineered TCR binding domains to recognize disease antigens.
• Broad commercial relevance: Patents on TCR binding molecule technology apply to multiple oncology assets as well as emerging programs in infectious and autoimmune diseases, boosting Immunocore’s pipeline value.
• Supports lifecycle expansion: With ongoing Phase 1/2 and Phase 3 trials of ImmTAC candidates (e.g., PRAME, PIWIL1 targets), this patent strengthens exclusivity over key targeting domains for bispecific biologics.
• Long‑term protection: Filed in 2024 and issued in early 2025, it adds fresh protection to the company’s intellectual property estate with potential expiration into the mid‑2040s (20‑year term), subject to adjustments and extensions.

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US 12,195,534 B2 (Binding Molecules Comprising T Cell Receptor (TCR) Variable Domains) — issued January 14, 2025, from a January 2024 filing — is one of Immunocore’s most commercially important patents active. It protects engineered TCR binding molecules that form the core targeting modules of Immunocore’s bispecific immunotherapies, enabling targeted recruitment of T cells against cancer cells and directly supporting multiple therapeutic candidates in clinical development and commercialization.