US 11,723,975 B2
Compositions comprising an anti-LAG-3 antibody or an anti-LAG-3 antibody and an anti-PD-1 or anti-PD-L1 antibody
Lori S. Burton, Robbinsville, NJ (US); William Ying, Martinsville, NJ (US); Nils Lonberg, Woodside, CA (US); Sudhir Chakravarthi, Manalapan, NJ (US); and Pedro Smith, Crane Crossing, PA (US)
Assigned to Bristol-Myers Squibb Company, Princeton, NJ (US)
Appl. No. 16/616,583
Filed by Bristol-Myers Squibb Company, Princeton, NJ (US)
PCT Filed May 30, 2018, PCT No. PCT/US2018/035142
§ 371(c)(1), (2) Date Nov. 25, 2019,
PCT Pub. No. WO2018/222722, PCT Pub. Date Dec. 6, 2018.
Claims priority of provisional application 62/513,816, filed on Jun. 1, 2017.
Claims priority of provisional application 62/512,644, filed on May 30, 2017.
Prior Publication US 2021/0283251 A1, Sep. 16, 2021
Int. Cl. A61K 39/395 (2006.01); A61K 9/00 (2006.01); A61K 45/06 (2006.01); A61K 47/02 (2006.01); A61K 47/12 (2006.01); A61K 47/18 (2017.01); A61K 47/22 (2006.01); A61K 47/26 (2006.01); A61K 47/34 (2017.01); C07K 16/28 (2006.01); A61J 1/14 (2023.01); A61K 39/00 (2006.01)
CPC A61K 39/39591 (2013.01) [A61K 9/0019 (2013.01); A61K 39/3955 (2013.01); A61K 45/06 (2013.01); A61K 47/02 (2013.01); A61K 47/12 (2013.01); A61K 47/183 (2013.01); A61K 47/22 (2013.01); A61K 47/26 (2013.01); A61K 47/34 (2013.01); C07K 16/2803 (2013.01); C07K 16/2818 (2013.01); C07K 16/2827 (2013.01); A61J 1/1412 (2013.01); A61K 2039/54 (2013.01); A61K 2039/545 (2013.01); C07K 2317/21 (2013.01); C07K 2317/24 (2013.01); C07K 2317/565 (2013.01)] 24 Claims
 
1. A pharmaceutical composition comprising:
(a) about 80 mg of an anti-LAG-3 antibody or antigen binding fragment thereof comprising CDR1, CDR2, and CDR3 domains of the heavy chain variable region having the sequence set forth in SEQ ID NO:3, and CDR1, CDR2, and CDR3 domains of the light chain variable region having the sequence set forth in SEQ ID NO:5;
(b) about 240 mg of an anti-PD-1 antibody or antigen binding fragment thereof comprising CDR1, CDR2, and CDR3 domains of the heavy chain variable region having the sequence set forth in SEQ ID NO:19, and CDR1, CDR2, and CDR3 domains of the light chain variable region having the sequence set forth in SEQ ID NO:21;
(c) about 20 mM of histidine buffer;
(d) about 250 mM of sucrose;
(e) about 20 μM of DTPA; and
(f) about 0.05% (w/v) of polysorbate 80;
wherein the pharmaceutical composition has a pH of about 5.8.