US 11,987,642 B2
Bispecific HER2 and CD3 binding molecules
Nai-Kong V. Cheung, New York, NY (US); Andres Lopez-Albaitero, New York, NY (US); and Hong Xu, New York, NY (US)
Assigned to Memorial Sloan Kettering Cancer Center, New York, NY (US)
Filed by MEMORIAL SLOAN KETTERING CANCER CENTER, New York, NY (US)
Filed on Dec. 13, 2019, as Appl. No. 16/714,636.
Application 16/714,636 is a continuation of application No. 15/328,288, granted, now 10,519,248, previously published as PCT/US2015/041989, filed on Jul. 24, 2015.
Claims priority of provisional application 62/029,342, filed on Jul. 25, 2014.
Prior Publication US 2020/0199248 A1, Jun. 25, 2020
This patent is subject to a terminal disclaimer.
Int. Cl. C07K 16/28 (2006.01); A61K 39/395 (2006.01); A61K 45/06 (2006.01); C07K 16/32 (2006.01); C07K 16/46 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/32 (2013.01) [A61K 39/39558 (2013.01); A61K 45/06 (2013.01); C07K 16/2809 (2013.01); C07K 16/468 (2013.01); A61K 2039/505 (2013.01); A61K 2039/5158 (2013.01); C07K 2317/31 (2013.01); C07K 2317/41 (2013.01); C07K 2317/622 (2013.01); C07K 2317/64 (2013.01); C07K 2317/71 (2013.01); C07K 2317/73 (2013.01); C07K 2317/92 (2013.01); C07K 2319/00 (2013.01)] 10 Claims
 
1. A bispecific binding molecule comprising a heavy chain-aglycosylated monoclonal antibody that is an immunoglobulin that binds to HER2, comprising two identical heavy chains and two identical light chains, said light chains being a first light chain and a second light chain, wherein the first light chain is fused to a first single chain variable fragment (scFv), via a peptide linker, to create a first light chain fusion polypeptide, and wherein the second light chain is fused to a second scFv, via a peptide linker, to create a second light chain fusion polypeptide, wherein the first and second scFv (i) are identical, and (ii) bind to CD3, and wherein the first and second light chain fusion polypeptides are identical, and wherein
(a) each heavy chain comprises a heavy chain variable domination (HH) present in any of SEQ ID NOs: 23, 27, 62 and 63;
(b) each light chain comprises a light chain variable domain (VL) present in SEQ ID NO: 25; and
(c) each scFv has a VH domain sequence and a VL domain sequence selected from the group consisting of
SEQ ID NO: 64 and SEQ ID NO: 16,
SEQ ID NO: 15 and SEQ ID NO: 65, and
SEQ ID NO: 17 and SEQ ID NO: 65, respectively.