Anti-Ror2 antibodies, antibody fragments, their immunoconjugates and uses thereof
Inventors
Short, Jay M. • Chang, Hwai Wen • Frey, Gerhard
Assignees
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Publication Number
US-11254742-B2
Publication Date
2022-02-22
Expiration Date
Abstract
A polypeptide having a heavy chain variable region and/or light chain variable region that specifically binds to Ror2 protein as well as antibodies and antibody fragments containing the heavy chain variable region and/or the light chain variable region that bind to Ror2 protein. Pharmaceutical compositions and kits comprising the polypeptide or antibodies and antibody fragments containing the polypeptide are also provided.
Core Innovation
The invention relates to an antigen binding polypeptide that specifically binds to Ror2 protein. The polypeptide includes a heavy chain variable region with three complementarity determining regions H1, H2, and H3 and a light chain variable region with three complementarity determining regions L1, L2, and L3, with sequences defined by specified sequence patterns, SEQ ID NOs, and allowed substitutions.
The antigen binding polypeptide has only one single point mutation in one of the heavy and light chain complementarity determining regions H1, H2, H3, L1, L2 and L3, where the mutation is determined in comparison with a parent polypeptide. The invention also covers immunoconjugates comprising anti-Ror2 antibody or antibody fragments with heavy and light chain variable regions defined by specific SEQ ID NO amino acid sequences.
The document also describes diagnostic and detection contexts for anti-Ror2 antibodies, including radiolabels and imaging modalities, together with therapeutic uses for cancer and other disorders through pharmaceutical compositions and therapeutic methods. In addition, it describes immunoconjugate and ADC production and characterization approaches, including drug loading control, heterogeneous ADC mixtures, and analysis by dual ELISA and analytical methods.
Claims Coverage
Two independent claims are identified. The claim coverage centers on anti-Ror2 binding polypeptides defined by specific heavy- and light-chain variable-region CDR sequence structures with an explicit single-point-mutation limitation, and on immunoconjugates that use anti-Ror2 antibody or antibody fragments defined by particular heavy- and light-chain variable-region amino acid sequences.
Ror2-specific antigen binding polypeptide with substitution-limited CDR motifs
An antigen binding polypeptide specifically binding to Ror2 protein, comprising a heavy chain variable region with H1, H2, and H3 complementarity determining regions defined by specified sequence motifs and allowed substitutions, and a light chain variable region with L1, L2, and L3 complementarity determining regions defined by specified sequence motifs and allowed substitutions.
Only one single point mutation in CDRs versus a parent polypeptide
The antigen binding polypeptide has only one single point mutation in one of the heavy and light chain complementarity determining regions H1, H2, H3, L1, L2 and L3, where the one single point mutation is determined in comparison with a parent polypeptide.
Immunoconjugate with anti-Ror2 antibody fragments defined by specific SEQ ID variable-region amino acid sequences
An immunoconjugate comprising an anti-Ror2 antibody or antibody fragment with heavy and light chain variable regions having specific SEQ ID NO amino acid sequences.
Overall, the claim coverage centers on a Ror2-specific antigen binding polypeptide defined by particular heavy- and light-chain CDR sequence motifs with controlled substitutions, restricted to only one single point mutation relative to a parent polypeptide, and an immunoconjugate that incorporates anti-Ror2 antibodies or antibody fragments specified by exact SEQ ID NO variable-region amino acid sequences.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Diagnostic and detection use of anti-Ror2 antibodies with radiolabels and imaging modalities for cancers and diseases associated with Ror2 for diagnosis and monitoring.
Therapeutic use for cancer and other disorders through pharmaceutical compositions and therapeutic methods using the described antibodies or immunoconjugates.
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