Antibody cocktail against SARS-CoV-2 spike protein
Inventors
Robinson, Matthew K. • Nikitin, Pavel • MORIN, Michael John • DIMUZIO, Jillian • HOWANSKI, Ray • DOWLING, John P.
Assignees
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Publication Number
US-11834493-B2
Publication Date
2023-12-05
Expiration Date
Abstract
Provided herein are antibodies that are useful for treating SARS-CoV-2 infections in a subject. Also provided herein are compositions comprising one or more antibodies, methods of treatment comprising administering one or more antibodies, and kits comprising one or more antibodies.
Core Innovation
The invention relates to antibodies or antigen binding fragments that bind a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Spike protein. The antibodies are defined by specified HCVR and LCVR amino acid sequence sets, or by specified VH and VL complementarity-determining region (CDR) amino acid sequence sets.
The disclosed antibodies are described with binding outcomes including inhibition of SARS-CoV-2 binding to the host ACE2 receptor, complement fixation to the SARS-CoV-2 virus, and induction of phagocytosis of the SARS-CoV-2 virus, alone or in combination. The invention also specifies antibody format features such as Fc immunoglobulin isotypes and allotypes.
The invention further addresses SARS-CoV-2 Spike targeting across named variants including Alpha, Beta, Gamma, Delta, Epsilon, Lambda, Omicron, U.K. (B.1.1.7), South African (B.1.351), multiple California lineages, Brazilian (P.1) and (P.2), New York (B.1.526) and (B.1.526.1), and UK/Nigeria (B.1.525). It is also described in the context of multi-antibody Spike-binding compositions, pharmaceutical compositions, kits, and combination regimens with additional therapeutic agents.
Claims Coverage
The provided independent claims cover sequence-defined antibodies binding SARS-CoV-2 Spike, alternative sequence-defined VH/VL CDR-defined antibodies, and treatment or prevention of SARS-CoV-2 infection by administering the sequence-defined Spike-binding antibody or fragment. Across these independent claims, the main inventive features comprise specified HCVR/LCVR or specified VH/VL HCDR/LCDR sequences, and the method context tied to administering the specified Spike-binding antibody or fragment.
Sequence-defined HCVR and LCVR binding SARS-CoV-2 Spike
An antibody or antigen binding fragment that binds a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Spike protein, wherein the antibody or antigen binding fragment thereof comprises a HCVR and a LCVR comprising specified SEQ ID NO alternatives.
Sequence-defined VH and VL CDR binding SARS-CoV-2 Spike
An antibody or antigen binding fragment that binds to a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Spike protein, wherein the antibody or antigen binding fragment thereof comprises a VH with HCDR1, HCDR2, and HCDR3 amino acid sequences defined by specified SEQ ID NO alternatives and a VL with LCDR1, LCDR2, and LCDR3 amino acid sequences defined by specified SEQ ID NO alternatives.
Administering a sequence-defined Spike-binding antibody for treatment or prevention
A method of treating or preventing a SARS-CoV-2 infection in a subject, comprising administering an antibody or fragment thereof that binds to a SARS-CoV-2 Spike protein, wherein the antibody comprises VH and VL with HCDR1/HCDR2/HCDR3 and LCDR1/LCDR2/LCDR3 amino acid sequences defined by specified SEQ ID NO alternatives.
Across the independent claims, coverage centers on antibodies or antigen binding fragments that bind SARS-CoV-2 Spike protein and are defined by specified HCVR/LCVR sequences or by specified VH/VL CDR sequences. One independent claim applies these sequence-defined Spike-binding antibodies in a method for treating or preventing SARS-CoV-2 infection by administering the antibody or fragment to a subject.
Stated Advantages
Provides Spike-binding antibodies and fragments with defined HCVR/LCVR or VH/VL HCDR/LCDR sequence sets for neutralization across multiple SARS-CoV-2 variants.
Supports ACE2-dependent and ACE2-independent/ACE2-noncompeting neutralization by including antibodies that bind non-overlapping Spike epitopes, including some within the ACE2 receptor-binding site and others outside it.
Enables combination effects described as combinatorial/synergistic effects for neutralization across variants.
Documented Applications
Treating or preventing a SARS-CoV-2 infection in a subject by administering an antibody or fragment that binds a SARS-CoV-2 Spike protein.
Neutralization and binding activity described across named SARS-CoV-2 variants including Alpha, Beta, Gamma, Delta, Epsilon, Lambda, Omicron, U.K. (B.1.1.7), South African (B.1.351), multiple California lineages, Brazilian (P.1) and (P.2), New York (B.1.526) and (B.1.526.1), and UK/Nigeria (B.1.525).
Pharmaceutical compositions comprising one or more of the defined antibodies, including optional mixtures of 1-4 antibodies.
Kits containing anti-Spike antibodies in combinations and combination regimens with additional therapeutic agents.
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