US 11,932,693 B2
Monoclonal antibodies directed against programmed death-1 protein and their use in medicine
Ugur Sahin, Mainz (DE); Sina Fellermeier-Kopf, Mainz (DE); Friederike Gieseke, Mainz (DE); Karsten Beckmann, Mainz (DE); Claudia Paulmann, Mainz (DE); Alexander Muik, Mainz (DE); Ivan Kuzmanov, Mainz (DE); Esther Cornelia Wilhelmina Breij, Utrecht (NL); Patricia Garrido Castro, Utrecht (NL); Jordan Blum, Utrecht (NL); Lars Guelen, Utrecht (NL); Joost Neijssen, Utrecht (NL); Bart-Jan De Kreuk, Utrecht (NL); Richard Hibbert, Utrecht (NL); Janine Schuurman, Utrecht (NL); and Aran Frank Labrijn, Utrecht (NL)
Assigned to BioNTech SE, Mainz (DE); and Genmab A/S, Copenhagen (DK)
Filed by BioNTech SE, Mainz (DE); and Genmab A/S, Copenhagen V (DK)
Filed on May 11, 2023, as Appl. No. 18/315,686.
Claims priority of provisional application 63/364,595, filed on May 12, 2022.
Prior Publication US 2023/0365693 A1, Nov. 16, 2023
Int. Cl. C07K 16/28 (2006.01)
CPC C07K 16/2818 (2013.01) [C07K 2317/24 (2013.01); C07K 2317/92 (2013.01)] 30 Claims
 
1. An antibody or antigen-binding fragment thereof having the ability to bind to PD-1, wherein the antibody or the antigen-binding fragment thereof comprises a heavy chain having a heavy chain constant region (CH) and a heavy chain variable region (VH) and a light chain having a light chain constant region (CL) and a light chain variable region (VL),
wherein the heavy chain constant region is a human IgG1 constant region that comprises phenylalanine at the position corresponding to position 234 in a human IgG1 heavy chain according to EU numbering, glutamate at the position corresponding to position 235 in a human IgG1 heavy chain according to EU numbering, and arginine at the position corresponding to position 236 in a human IgG1 heavy chain according to EU numbering, and
wherein (i) the heavy chain variable region (VH) comprises a HCDR1, HCDR2, and HCDR3 sequence, wherein the HCDR1, HCDR2 and HCDR3 sequences according to Kabat numbering comprise or have the sequence as set forth in SEQ ID NO: 12, SEQ ID NO: 11, and SEQ ID NO: 8, respectively, and
the light chain variable region (VL) comprises a LCDR1, LCDR2, and LCDR3 sequence, wherein the LCDR1, LCDR2 and LCDR3 sequences according to Kabat numbering comprise or have the sequence as set forth in SEQ ID NO: 17, SEQ ID NO: 15, and SEQ ID NO: 14, respectively; or
(ii) the heavy chain variable region (VH) comprises a HCDR1, HCDR2, and HCDR3 sequence, wherein the HCDR1, HCDR2 and HCDR3 sequences according to IMGT numbering comprise or have the sequence as set forth in SEQ ID NO: 13, SEQ ID NO: 10, and SEQ ID NO: 9, respectively, and
the light chain variable region (VL) comprises a LCDR1, LCDR2, and LCDR3 sequence, wherein the LCDR1, LCDR2 and LCDR3 sequences according to IMGT numbering comprise or have the sequence as set forth in SEQ ID NO: 16, QAS, and SEQ ID NO: 14, respectively.