US 12,291,566 B2
Anti-TNF antibodies, compositions, and methods for the treatment of active Ankylosing Spondylitis
Diane D. Harrison, Philadelphia, PA (US); Elizabeth C. Hsia, Kenneth Square, PA (US); Lee-Lian Kim, North Wales, PA (US); and Kim Hung Lo, Exton, PA (US)
Assigned to Janssen Biotech, Inc., Horsham, PA (US)
Filed by Janssen Biotech, Inc., Horsham, PA (US)
Filed on Apr. 22, 2021, as Appl. No. 17/237,650.
Application 17/237,650 is a continuation of application No. 16/517,592, filed on Jul. 20, 2019, granted, now 11,014,982.
Application 16/517,592 is a continuation of application No. 15/818,015, filed on Nov. 20, 2017, abandoned.
Claims priority of provisional application 62/455,651, filed on Feb. 7, 2017.
Prior Publication US 2021/0238271 A1, Aug. 5, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. C07K 16/24 (2006.01); A61K 9/00 (2006.01); A61K 31/4402 (2006.01); A61K 31/4706 (2006.01); A61K 31/519 (2006.01); A61K 39/395 (2006.01); A61P 19/02 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/241 (2013.01) [A61K 9/0019 (2013.01); A61K 31/4402 (2013.01); A61K 31/4706 (2013.01); A61K 31/519 (2013.01); A61K 39/3955 (2013.01); A61P 19/02 (2018.01); A61K 2039/505 (2013.01); A61K 2039/545 (2013.01); C07K 2317/21 (2013.01); C07K 2317/76 (2013.01); C07K 2317/92 (2013.01)] 7 Claims
 
1. A method for treating a TNF related condition, wherein the TNF related condition is active ankylosing spondylitis, the method comprising: administering a composition comprising a safe and effective amount of at least one isolated mammalian anti-TNF antibody comprising:
a. a heavy chain (HC) complementary determining region (CDR) 1 comprising an amino acid sequence of SEQ ID NO: 1;
b. a HC CDR2 comprising an amino acid sequence of SEQ ID NO: 2; wherein position 1 of SEQ ID NO: 2 is phenylalanine, position 2 of SEQ ID NO: 2 is methionine, position 3 of SEQ ID NO: 2 is serine, position 4 of SEQ ID NO: 2 is tyrosine, position 10 of SEQ ID NO: 2 is lysine, position 11 of SEQ ID NO: 2 is tyrosine, and position 17 of SEQ ID NO: 2 is glycine;
c. a HC CDR3 comprising an amino acid sequence of SEQ ID NO: 3; wherein position 4 of SEQ ID NO: 3 is isoleucine, position 5 of SEQ ID NO: 3 is alanine, and position 9 of SEQ ID NO: 3 is asparagine;
d. a light chain (LC) CDR1 comprising an amino acid sequence of SEQ ID NO: 4; wherein position 7 of SEQ ID NO: 4 is tyrosine;
e. a LC CDR2 comprising an amino acid sequence of SEQ ID NO: 5; and
f. a LC CDR3 comprising an amino acid sequence of SEQ ID NO: 6, and at least one pharmaceutically acceptable carrier or diluent, wherein said composition is administered via IV infusion at a dose of 2 mg/kg, administered over 30±10 minutes, at Weeks 0 and 4, and then every 8 weeks (q8w) thereafter, and wherein a patient treated with the composition achieves an Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (<1.3) at 4 weeks of treatment or at 2 weeks of treatment.