Stable formulations of programmed death receptor 1 (pd-1) antibodies and hyaluronidase variants and fragments thereof and methods of use thereof

A formulation comprising:

• a) about 20 mg/mL to about 200 mg/mL of an anti-human PD-1 antibody, or antigen binding fragment thereof;
• b) about 0.0009-0.050 mg/ml of a PH20 variant or fragment thereof;
• c) about 5 mM to about 20 mM buffer;
• d) about 3% to about 10% weight/volume (w/v) of a non-reducing dissacharide selected from the group consisting of sucrose and trehalose;
• e) about 0.005% to about 0.10% (w/v) non-ionic surfactant;
• and, optionally
• f) about 1 mM to about 30 mM anti-oxidant;
• wherein the anti-human PD-1 antibody or antigen binding fragment thereof comprises a light chain variable region comprising three light chain CDRs comprising CDRL1 or SEQ ID NO:1, CDRL2 of SEQ ID NO:2 and CDRL3 of SEQ ID NO:3 and a heavy chain variable region comprising three heavy chain CDRs comprising CDRL1 of SEQ ID NO:6, CDRH2 of SEQ ID NO:7 and CDRH3 of SEQ ID NO:8;
• wherein the PH20 variant has amino acid residue substitutions comprising M345T, S347T, M348K, K349E, L352Q, L353A, L354I, D355K, N356E, E359D, and I361T in SEQ ID NO:
• 21, and the fragment thereof has either an N-terminus deletion of amino acid residues 1-36, 1-37, 1-38, 1-39, 1-40, 1-41, or 1-42 of SEQ ID NO:
• 21 and/or a C-terminus deletion of amino acid residues 455-509, 456-509, 457-509, 458-509, 459-509, 460-509, 461-509, 462-509, 463-509, 464-509, 465-509, 466-509, 467-509, 468-509, 469-509, 480-509, 481-509, 482-509, 483-509, 484-509, 485-509, 486-509, 487-509, 488-509, 489, 509, 490-509, 491-509, 492-509, 493-509, 494-509, 495-509, 496-509, 497-509, 498-509, 499-509, 500-509, 501-509, 502-509, 503-509, 504-509, 505-509, 506-509, 507-509, 508-509, or 509, wherein the numbering is by reference to SEQ ID NO:
• 21.