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Last Updated: March 28, 2024

Claims for Patent: 10,100,130


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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 10/21/1942 ⤷  Try a Trial 2027-09-26
Baxalta Us Inc. BUMINATE, FLEXBUMIN albumin (human) Injection 101452 03/03/1954 ⤷  Try a Trial 2027-09-26
Csl Behring Ag ALBURX albumin (human) Injection 102366 07/23/1976 ⤷  Try a Trial 2027-09-26
Grifols Biologicals Llc ALBUTEIN albumin (human) Injection 102478 08/15/1978 ⤷  Try a Trial 2027-09-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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