News Column

"Methods and Compositions for the Treatment of Autoimmune and Inflammatory Diseases" in Patent Application Approval Process

September 4, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- A patent application by the inventors Laury-Kleintop, Lisa (Ambler, PA); Mandik-Nayak, Laura (Plymouth Meeting, PA); Prendergast, George C. (Penn Valley, PA); Duhadaway, James (Wilmington, DE), filed on August 9, 2012, was made available online on August 21, 2014, according to news reporting originating from Washington, D.C., by VerticalNews correspondents.

This patent application is assigned to Lankenau Institute for Medical Research.

The following quote was obtained by the news editors from the background information supplied by the inventors: "Autoimmune disease occurs when an organism fails to recognize its own constituent parts as 'self,' thereby resulting in an immune response against its own cells and tissues. In other words, the body actually attacks its own cells. The immune system mistakes some part of the body as a pathogen and attacks it. Current treatments for autoimmune diseases typically include immunosuppression and/or symptomatic treatment with non-disease modifying anti-inflammatories in order to decreases the damage of the aberrant immune response. However, there is a need in the art for methods and compositions for inhibiting and/or delaying the onset of pathology associated with autoimmune disorders."

In addition to the background information obtained for this patent application, VerticalNews journalists also obtained the inventors' summary information for this patent application: "In accordance with one aspect of the instant invention, methods for inhibiting, treating, and/or preventing the onset of an autoimmune and/or inflammatory disease and/or diseases that have an autoimmune and/or inflammatory component in their pathology in patients in need thereof are provided. The methods comprise the administration of at least one RhoB inhibitor. In a particular embodiment, the RhoB inhibitor is an antibody or antibody fragment immunologically specific for RhoB or a peptide fragment thereof. In a particular embodiment, the RhoB inhibitor is a structurally related or derived small molecule of the antibody, antibody fragment, peptide fragment or chemical or biologically mimetic of the antibodies' CDR regions and epitopes recognized by the CDRs. In a particular embodiment, the RhoB inhibitor is a RhoB peptide. In a particular embodiment, the methods comprise the administration of a composition comprising at least one RhoB peptide and/or antibody or antibody fragment immunologically specific for RhoB or a peptide fragment thereof and at least one pharmaceutically acceptable carrier. In a particular embodiment, the methods further comprise the administration of at least one anti-inflammatory agent and/or immunosuppressant concurrently and/or sequentially with the at least one RhoB inhibitor (e.g., an antibody or antibody fragment immunologically specific for RhoB or a peptide fragment thereof).

"Compositions for the inhibition, treatment, and/or prevention of inflammatory or autoimmune disease are also provided. The compositions comprise at least one RhoB inhibitor and at least one pharmaceutically acceptable carrier. In a particular embodiment, the RhoB inhibitor is antibody or antibody fragment immunologically specific for RhoB or a peptide fragment thereof. In a particular embodiment, the RhoB inhibitor is a RhoB peptide. In another embodiment, the composition further comprises at least one anti-inflammatory compound and/or at least one immunosuppressive agent.

"The instant invention also provides anti-RhoB antibodies, RhoB peptide (e.g., for the generation of antibodies), or structurally related or derived small molecules of the antibody, antibody fragment, peptide fragment or chemical or biologically mimetic of the antibodies' CDR regions and epitopes recognized by the CDRs, and compositions comprising the same.

"In accordance with one aspect of the instant invention, methods for inhibiting, treating, and/or preventing a condition or disorder associated with increased levels of immunoglobulin in the blood serum (e.g., hypergammaglobulinemia or monoclonal gammopathy of undetermined significance) in patients in need thereof are provided. The methods comprise the administration of at least one RhoB inhibitor as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

"FIG. 1 is a graph of the mean ankle thickness over time of K/BxN mice which were treated with anti-RhoB-peptide serum, anti-KLH serum, or carrier alone.

"FIG. 2A is a graph of the titer of serum anti-glucose-6-phosphate isomerase (GPI) Ig from K/BxN mice treated with anti-RhoB-peptide serum, anti-KLH serum, or carrier alone. FIG. 2B is a graph of the number of anti-GPI secreting cells per 10.sup.5 cells of K/BxN mice treated with anti-RhoB-peptide serum, anti-KLH serum, or carrier alone.

"FIG. 3 provides the amino acid sequence of human RhoB (SEQ ID NO: 3). Underlined sequence is Peptide 1 (SEQ ID NO: 1).

"FIG. 4 provides a graph of the IgM secretion with or without lipopolysaccharide (LPS) stimulation in the presence or absence of a control antibody or anti-RhoB antibodies from a hybridoma or a subclone thereof.

"FIG. 5 provides a sequence alignment of RhoA (SEQ ID NO: 4) and RhoB (SEQ ID NO: 3). The underlined sequences and the boxed sequences represent antigens for RhoB antibodies.

"FIG. 6A provides a graph of rear ankle thickness .+-.SEM of K/BxN mice treated with anti-RhoB monoclonal antibody 9G5 or 7F7 or control Ig before the onset of arthritis (21 days of age). FIGS. 6B and 6C provide graphs of the anti-GPI autoantibody titers and the number of anti-GPI antibody secreting cells (ASCs) in the mice, respectively.

"FIG. 7A provides a graph of the rear ankle thickness .+-.SEM of K/BxN mice over a long time course that were treated with anti-RhoB monoclonal antibody 9G5 or control Ig after the onset of arthritis at 4 weeks of age. FIG. 7B provides a graph of the rear ankle thickness .+-.SEM of K/BxN mice over a shorter time course that were treated with anti-RhoB monoclonal antibody 9G5 or 7F7 or control Ig after the onset of arthritis at 4 weeks of age.

"FIG. 8A provides a graph of rear ankle thickness .+-.SEM in arthritic RhoB KO mice (RhoB KO KRN.g7). FIG. 8B provides a graph of rear ankle thickness .+-.SEM in naive C57BL/6 mice that received a serum transfer from KRN B6.g7 or RhoB KO KRN B6.g7 mice on day 0. FIG. 8C provides a graph of rear ankle thickness .+-.SEM in naive wild-type or RhoB KO C57BL/6 mice that received a serum transfer from arthritic K/BxN mice on day 0.

"FIG. 9A provides the nucleotide (SEQ ID NO: 9) and amino acid (SEQ ID NO: 10) sequences of the light chain of 7F7. FIG. 9B provides the nucleotide (SEQ ID NO: 11) and amino acid (SEQ ID NO: 12) sequences of the heavy chain of 7F7. Vertical lines represent borders between domains. Bold--variable region (V); underlined--joining region (J); italics--diversity region (D); FWR--framework region; CDR--complementarity determining region.

"FIG. 10A provides the nucleotide (SEQ ID NO: 13) and amino acid (SEQ ID NO: 14) sequences of the light chain of 9G5. FIG. 10B provides the nucleotide (SEQ ID NO: 15) and amino acid (SEQ ID NO: 16) sequences of the heavy chain of 9G5. Vertical lines represent borders between domains. Bold--variable region (V); underlined--joining region (J); italics--diversity region (D); FWR framework region; CDR--complementarity determining region."

URL and more information on this patent application, see: Laury-Kleintop, Lisa; Mandik-Nayak, Laura; Prendergast, George C.; Duhadaway, James. Methods and Compositions for the Treatment of Autoimmune and Inflammatory Diseases. Filed August 9, 2012 and posted August 21, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=2835&p=57&f=G&l=50&d=PG01&S1=20140814.PD.&OS=PD/20140814&RS=PD/20140814

Keywords for this news article include: Antibodies, Arthritis, Pathology, Immunology, Proteomics, Amino Acids, Blood Proteins, Joint Diseases, Immunoglobulins, Peptide Fragments, Musculoskeletal Diseases, Lankenau Institute for Medical Research.

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Source: Politics & Government Week


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