Claims for Patent: 9,995,753

Summary for Patent: 9,995,753

Title:	Anti-pembrolizumab antibodies
Abstract:	The present invention provides antibodies and antigen-binding fragments thereof that bind to the antibody pembrolizumab (pembrolizumab). These antibodies are useful, for example, for use as positive controls in assays for detecting the presence of anti-drug antibodies in a sample, e.g., the blood of a patient who has been administered pembrolizumab.
Inventor(s):	Loo; LiNa (Monroe, NJ), Shi; Shuangping (Mountain Lakes, NJ)
Assignee:	Merck Sharp & Dohme Corp. (Rahway, NJ)
Application Number:	15/274,330
Patent Claims:	1. An antibody or antigen-binding fragment thereof that binds pembrolizumab, comprising: three light chain CDRs of CDR-L1, CDR-L2 and CDR-L3 and three heavy chain CDRs of CDR-H1, CDR-H2 and CDR-H3, wherein CDR-L1 comprises the amino acid sequence: QASQSLSNLLA (SEQ ID NO: 25); CDR-L2 comprises the amino acid sequence: GASNLES (SEQ ID NO: 26); CDR-L3 comprises the amino acid sequence: QGGHYSGLT (SEQ ID NO: 27); CDR-H1 comprises the amino acid sequence: TNDMN (SEQ ID NO: 28); CDR-H2 comprises the amino acid sequence: VIYSDDTPDYATWAKG (SEQ ID NO: 29); and CDR-H3 comprises the amino acid sequence: GHYDSAVYAYALNI (SEQ ID NO: 30). 2. The antibody or antigen-binding fragment of claim 1 which comprises a light chain immunoglobulin and a heavy chain immunoglobulin, wherein: the light chain immunoglobulin comprises an amino acid sequence having at least 90% amino acid sequence identity to the amino acid sequence set forth in SEQ ID NO: 11; and the heavy chain immunoglobulin comprises an amino acid sequence having at least 90% amino acid sequence identity to the amino acid sequence set forth in SEQ ID NO: 12. 3. The antibody or antigen-binding fragment of claim 2 wherein said sequence identity is at least 95%. 4. The antibody or antigen-binding fragment of claim 1 comprising: a light chain immunoglobulin comprising the amino acid sequence set forth in SEQ ID NO: 11; and a heavy chain immunoglobulin comprising the amino acid sequence set forth in SEQ ID NO: 12. 5. The antibody of claim 1, which is a monoclonal antibody. 6. A composition comprising an anti-pembrolizumab antibody or antigen-binding fragment thereof of claim 1 complexed with pembrolizumab.

Details for Patent 9,995,753

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	KEYTRUDA	pembrolizumab	For Injection	125514	09/04/2014		2035-09-25
Merck Sharp & Dohme Corp.	KEYTRUDA	pembrolizumab	Injection	125514	01/15/2015		2035-09-25