Claims for Patent: 10,058,600

Summary for Patent: 10,058,600

Title:	Detoxified Escherichia coli immunogens
Abstract:	Detoxified variants of the pathogenic E. coli `AcfD precursor` (orf3526) have been identified that raise a substantially similar immune response in a subject as the native AcfD (orB526) protein. The detoxified variants may be further modified to have increased solubility as compared to the native AcfD (orf3526) protein.
Inventor(s):	Serino; Laura (Siena, IT), Fontana; Maria Rita (Siena, IT), Gomes Moriel; Danilo (Siena, IT)
Assignee:	GLAXOSMITHKLINE BIOLOGICALS SA (Rixensart, BE)
Application Number:	14/525,033
Patent Claims:	1. An immunogenic polypeptide comprising a fragment or mutant of an E. coli AcfD (orf3526) protein, wherein the immunogenic polypeptide does not comprise at least the last 300 C-terminal amino acids of the E. coli AcfD (orf3526) protein, wherein the E. coli AcfD (orf3526) protein has an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-19, wherein the immunogenic polypeptide raises at least 70% of the immune response in a subject as the E. coli AcfD (orf3526) protein and wherein the immunogenic polypeptide has a decreased protease activity as compared to the E. coli AcfD protein. 2. An immunogenic polypeptide comprising a fragment of an E. coli AcfD (orf3526) protein, wherein the immunogenic polypeptide does not comprise at least the last 400 C-terminal amino acids of the E. coli AcfD (orf3526) protein, wherein the E. coli AcfD (orf3526) protein has an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-19, wherein the immunogenic polypeptide raises at least 70% of the immune response in a subject as the E. coli AcfD (orf3526) protein and wherein the immunogenic polypeptide has a decreased protease activity as compared to the E. coli AcfD protein. 3. The immunogenic polypeptide of claim 1, wherein the immunogenic polypeptide fragment is purified. 4. An immunogenic composition comprising the immunogenic polypeptide of claim 1 and an adjuvant. 5. A vaccine comprising the immunogenic polypeptide of claim 3 and an adjuvant. 6. A vaccine comprising the immunogenic polypeptide of claim 1 and an adjuvant. 7. The vaccine of claim 5, further comprising an additional vaccine component selected from: a Neisseria meningitidis antigen, a Streptococcus pneumoniae antigen, a Streptococcus pyogenes antigen, a Moraxella catarrhalis antigen, a Bordetella pertussis antigen, a Staphylococcus aureus antigen, a Staphylococcus epidermis antigen, a Clostridium tetani antigen, a Cornynebacterium diphtheriae antigen, a Haemophilus influenzae type B (Hib) antigen, a Pseudomonas aeruginosa antigen, a Legionella pneumophila antigen, a Streptococcus agalactiae antigen, a Neiserria gonorrhoeae antigen, a Chlamydia trachomatis antigen, a Treponema pallidum antigen, a Haemophilus ducreyi antigen, a Enterococcus faecalis antigen, a Enterococcus faecium antigen, a Helicobacter pylori antigen, a Staphylococcus saprophyticus antigen, a Yersinia enterocolitica antigen, an additional E. coli antigen, a Bacillus anthracis antigen, a Yersinia pestis antigen, a Mycobacterium tuberculosis antigen, a Rickettsia antigen, a Listeria monocytogenes antigen, a Chlamydia pneumoniae antigen, a Vibrio cholerae antigen, a Salmonella typhi antigen, a Borrelia burgdorferi antigen, a Porphyromonas gingivalis antigen, and a Klebsiella antigen. 8. The vaccine of claim 6, further comprising an additional vaccine component selected from: a Neisseria meningitidis antigen, a Streptococcus pneumoniae antigen, a Streptococcus pyogenes antigen, a Moraxella catarrhalis antigen, a Bordetella pertussis antigen, a Staphylococcus aureus antigen, a Staphylococcus epidermis antigen, a Clostridium tetani antigen, a Cornynebacterium diphtheriae antigen, a Haemophilus influenzae type B (Hib) antigen, a Pseudomonas aeruginosa antigen, a Legionella pneumophila antigen, a Streptococcus agalactiae antigen, a Neiserria gonorrhoeae antigen, a Chlamydia trachomatis antigen, a Treponema pallidum antigen, a Haemophilus ducreyi antigen, a Enterococcus faecalis antigen, a Enterococcus faecium antigen, a Helicobacter pylori antigen, a Staphylococcus saprophyticus antigen, a Yersinia enterocolitica antigen, an additional E. coli antigen, a Bacillus anthracis antigen, a Yersinia pestis antigen, a Mycobacterium tuberculosis antigen, a Rickettsia antigen, a Listeria monocytogenes antigen, a Chlamydia pneumoniae antigen, a Vibrio cholerae antigen, a Salmonella typhi antigen, a Borrelia burgdorferi antigen, a Porphyromonas gingivalis antigen, and a Klebsiella antigen.

Details for Patent 10,058,600

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821	11/12/1998		2029-07-16