Claims for Patent: 10,100,130

Summary for Patent: 10,100,130

Title:	Dual specificity antibody fusions
Abstract:	The present invention provides dual specificity antibody fusion proteins comprising an antibody Fab or Fab\' fragment with specificity for an antigen of interest, said fragment being fused to at least one single domain antibody which has specificity for a second antigen of interest.
Inventor(s):	Humphreys; David Paul (Slough, GB), Dave; Emma (Slough, GB), Griffin; Laura (Slough, GB), Heywood; Sam Philip (Slough, GB)
Assignee:	UCB BIOPHARMA SPRL (Brussels, BE)
Application Number:	15/792,373
Patent Claims:	1. A nucleic acid molecule encoding a dual specificity antibody fusion protein comprising an antibody Fab fragment or an antibody Fab' fragment with specificity for an antigen of interest, the fragment being fused to two single domain antibodies that have specificity for serum albumin; wherein one single domain antibody is fused to the C-terminus of the light chain of the Fab fragment or the Fab' fragment and the other single domain antibody is fused to a C-terminus of a heavy chain of the Fab fragment or the Fab' fragment; and wherein one single domain antibody is a VH domain comprising the sequence given in SEQ ID NO:56 for CDR-H1, the sequence given in SEQ ID NO:57 for CDR-H2 and the sequence given in SEQ ID NO:58 for CDR-H3, and the other single domain antibody is a VL domain comprising the sequence given in SEQ ID NO:59 for CDR-L1, the sequence given in SEQ ID NO:60 for CDR-L2 and the sequence given in SEQ ID NO:61 for CDR-L3, wherein the VH domain is fused to the C-terminus of the heavy chain of the Fab fragment or the Fab' fragment and the VL domain is fused to the C-terminus of the light chain of the Fab fragment or the Fab' fragment. 2. The nucleic acid molecule of claim 1, wherein the nucleic acid molecule is cDNA. 3. An expression vector comprising the nucleic acid molecule of claim 1. 4. A recombinant host cell comprising the expression vector of claim 3. 5. The nucleic acid molecule of claim 1, wherein each single domain antibody is humanised. 6. The nucleic acid molecule of claim 1, wherein the Fab or Fab' of the dual specificity antibody fusion protein is fully human or humanised. 7. The nucleic acid molecule of claim 1, wherein each single domain antibody fused to the antibody Fab or Fab' fragment is fused via a linker of the amino acid sequence set forth in any one of SEQ ID NOs:1, 2, 3, or 45. 8. The nucleic acid molecule of claim 1, wherein the VH domain is linked to the C-terminus of the heavy chain of the Fab or Fab' fragment via a linker having the amino acid sequence set forth in SEQ ID NOs:2 or 45 and the VL domain is linked to the C-terminus of the light chain of the Fab or Fab' fragment via a linker having the amino acid sequence set forth in SEQ ID NOs:1 or 45. 9. The nucleic acid molecule of claim 1, wherein the serum albumin is human serum albumin. 10. A pharmaceutical composition comprising the dual specificity antibody fusion protein encoded by the nucleic acid of claim 1. 11. The pharmaceutical composition of claim 10, wherein the composition is for the treatment of a disease or disorder; wherein the disease or disorder is an inflammatory disease or disorder, an immune disease or disorder, a fibrotic disorder and/or a cancer; wherein the inflammatory disease or disorder and/or the immune disease or disorder comprise rheumatoid arthritis, psoriatic arthritis, still's disease, Muckle Wells disease, psoriasis, Crohn's disease, ulcerative colitis, SLE (Systemic Lupus Erythematosus), asthma, allergic rhinitis, atopic dermatitis, multiple sclerosis, vasculitis, Type I diabetes mellitus, transplantation and graft-versus-host disease; wherein the fibrotic disorder comprises idiopathic pulmonary fibrosis (IPF), systemic sclerosis (or scleroderma), kidney fibrosis, diabetic nephropathy, IgA nephropathy, hypertension, end-stage renal disease, peritoneal fibrosis (continuous ambulatory peritoneal dialysis), liver cirrhosis, age-related macular degeneration (ARMD), retinopathy, cardiac reactive fibrosis, scarring, keloids, burns, skin ulcers, angioplasty, coronary bypass surgery, arthroplasty and cataract surgery; and wherein the cancer comprises (i) a malignant new growth that arises from epithelium, found in skin or the lining of breast, ovary, prostate, lung, kidney, pancreas, stomach, bladder or bowel and/or (ii) bone, liver, lung or brain cancer.

Details for Patent 10,100,130

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	October 21, 1942	10,100,130	2027-09-26
Takeda Pharmaceuticals U.s.a., Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	March 03, 1954	10,100,130	2027-09-26
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	July 23, 1976	10,100,130	2027-09-26
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	August 15, 1978	10,100,130	2027-09-26
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	November 29, 2022	10,100,130	2027-09-26
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	February 17, 1995	10,100,130	2027-09-26
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	June 11, 2003	10,100,130	2027-09-26