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Publication Number
US-12195544-B2
Publication Date
2025-01-14
Expiration Date
Abstract
Provided herein are EGFR binding proteins and EGFR targeting trispecific proteins comprising a domain binding to CD3, a half-life extension domain, and a domain binding to EGFR. Also provided are pharmaceutical compositions thereof, as well as nucleic acids, recombinant expression vectors and host cells for making such EGFR binding proteins, EGFR targeting trispecific proteins. Also disclosed are methods of using the disclosed EGFR binding proteins, EGFR targeting trispecific proteins in the prevention, and/or treatment diseases, conditions and disorders.
Core Innovation
The disclosure relates to an EGFR binding protein comprising complementarity determining region 1 (CDR1), complementarity determining region 2 (CDR2), and complementarity determining region 3 (CDR3), wherein each CDR comprises amino acid sequences selected from specified SEQ ID No. combinations. The protein is presented as a binder architecture based on defined CDR sequence content.
The document further describes EGFR-targeting TriTAC™ trispecific proteins that include an EGFR-binding domain, a CD3-binding domain, and a half-life extension domain. The embodiments describe linked domain formats and variable domain orders, including additional anti-human albumin domain language in the trispecific format.
Additional embodiments describe pharmaceutical compositions, nucleic acids, recombinant expression vectors, host cells, and therapeutic uses directed to prevention and treatment of EGFR-associated proliferative or tumorous diseases, including multiple solid tumors. The document also reports functional evaluation of EGFR TriTAC™ proteins in TDCC assay outcomes and binding affinity measurements.
Claims Coverage
The provided claim coverage centers on one explicit independent claim defining an EGFR binding protein by specified CDR1, CDR2, and CDR3 amino acid sequences using SEQ ID No. references. The broader claim family extends to related embodiments in nucleic acids, vectors, production-related contexts, and a trispecific format including a CD3-binding domain and a half-life extension domain.
Egfr binding protein defined by specific cdr1/cdr2/cdr3 sequences
An EGFR binding protein comprises CDR1, CDR2, and CDR3 wherein each CDR comprises amino acid sequences selected from the enumerated SEQ ID No. sets.
Trispecific EGFR-binding format
A trispecific protein includes an EGFR-binding domain using the defined EGFR binding protein together with a CD3-binding domain and a half-life extension domain.
Claim coverage centers on an EGFR binding protein defined by specific CDR amino acid sequences selected from the enumerated SEQ ID No. sets, with dependent embodiments extending to polynucleotides, vectors, production-related contexts, and a trispecific EGFR binding protein format that includes a first domain binding human CD3, a second half-life extension domain, and a third EGFR-binding domain using the defined EGFR binding protein.
Stated Advantages
Small size.
Extended elimination half-time.
Improved tissue penetration.
Selective T-cell-mediated killing of EGFR-expressing tumor cells.
Documented Applications
TDCC activity testing of EGFR TriTAC™ proteins, including comparisons and a GFP negative control.
TDCC activity assessment on Caov3 engineered tumor cells across donor T cells.
In vivo xenograft tumor model study setup for efficacy using NOD/scid mice.
Phase I/II clinical trial protocol outline.
Pharmaceutical compositions.
Nucleic acids.
Recombinant expression vectors.
Host cells.
Prevention and treatment of EGFR-associated proliferative or tumorous diseases, including multiple solid tumors.
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