Immunoglobulin single variable domain antibody against RSV prefusion F protein
Inventors
Saelens, Xavier • Schepens, Bert • ROSSEY, Iebe • Graham, Barney • McLellan, Jason • GILMAN, Morgan
Assignees
Unnversiteit Gent • Universiteit Gent • Vlaams Instituut voor Biotechnologie VIB • Dartmouth College • US Department of Health and Human Services
Publication Number
US-11248039-B2
Publication Date
2022-02-15
Expiration Date
2036-06-20
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Abstract
The present invention relates to immunoglobulin single variable domains (ISVDs) that are directed against respiratory syncytial virus (RSV). More specifically, it relates to ISVDs that bind to the prefusion form of the fusion (F) protein of RSV. The invention relates further to the use of these ISVDs for prevention and/or treatment of RSV infections, and to pharmaceutical compositions comprising these ISVDs.
Core Innovation
The present invention relates to immunoglobulin single variable domains (ISVDs) that specifically bind to the prefusion form of the fusion (F) protein of respiratory syncytial virus (RSV). These ISVDs exhibit strong neutralization activity against both RSV serotypes A and B in their monovalent format. This contradicts prior beliefs that multivalent constructs are required for potent inhibition of RSV serotypes.
The invention addresses the unmet need for a potent anti-RSV drug useful for effective treatment and/or prevention of RSV infections. Current prophylactic options, such as palivizumab, are expensive and limited to prophylactic use, while effective RSV-specific therapeutics and vaccines have not been clinically developed. The present ISVDs bind to epitopes unique to the prefusion conformation of RSV F protein, offering highly potent inhibition in a small, stable antibody fragment format.
Claims Coverage
The patent claims cover three main inventive features directed to using specific immunoglobulin single variable domains (ISVDs) targeting the RSV prefusion F protein for treatment of RSV infection, encompassing various sequence specifications and methods of administration.
Method for treating RSV infection using ISVDs with defined CDR sequences
A method of treating RSV infection by administering an ISVD that binds specifically to the prefusion form of RSV F protein, wherein the ISVD comprises a CDR1 sequence of SEQ ID NO:1, a CDR2 sequence of SEQ ID NO:3 or SEQ ID NO:4, and a CDR3 sequence of SEQ ID NO:5 or SEQ ID NO:6.
Method for treating RSV infection with ISVD comprising amino acids 1-125 of SEQ ID NO:8
Administration of an ISVD comprising amino acids 1-125 of SEQ ID NO:8 that binds specifically to the prefusion form of RSV F protein to treat RSV infection.
Method for treating RSV infection with ISVD comprising amino acids 1-125 of SEQ ID NO:10
Administration of an ISVD comprising amino acids 1-125 of SEQ ID NO:10 that binds specifically to the prefusion form of RSV F protein to treat RSV infection.
The claims focus on methods of treating RSV infection utilizing ISVDs that specifically bind the prefusion RSV F protein, defined by particular complementarity determining region (CDR) sequences or full ISVD sequences, with various formulations and administration routes.
Stated Advantages
The ISVDs exhibit potent neutralization activity against both RSV serotypes A and B in monovalent format, overcoming prior limitations requiring multivalent constructs for potency.
ISVDs provide a smaller, more stable alternative to conventional antibodies, which are cumbersome to produce and have limited stability.
Due to their small size, these ISVDs can recognize epitopes that may be hindered for larger conventional antibodies, enhancing efficacy in complex environments.
Documented Applications
Use of ISVDs for therapeutic treatment of RSV infection in subjects in need thereof.
Use of ISVDs for prevention (prophylactic treatment) of RSV infections.
Pharmaceutical compositions comprising ISVDs for administration by systemic, oral, or intranasal routes, including nasal inhalation.
Administration of ISVDs as proteins, nucleic acid molecules, or vectors encoding ISVDs, potentially via gene therapy approaches.
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