Claims for Patent: 10,058,610

Summary for Patent: 10,058,610

Title:	Methods for treating cancer by administering humanized pan-HER antibody compositions
Abstract:	The invention relates to humanized recombinant antibodies targeting the EGFR family receptors EGFR, HER2 and HER3, compositions comprising at least one humanized anti-EGFR antibody, at least one humanized anti-HER2 antibody and at least one humanized anti-HER3 antibody, and use of the antibody compositions for treatment of cancer. The invention also relates to the use of antibodies targeting multiple EGFR-family receptors to treat cancer (e.g., pancreatic cancer) and cancer that has acquired resistance to previous therapies.
Inventor(s):	Lantto; Johan (Lund, SE), Andersen; Kim Vilbour (Bronshoj, DK), Andersen; Peter Sejer (Vanlose, DK), Strandh; Magnus (Malmo, SE), Koefoed; Klaus (Kobenhavn S, DK), Nielsen; Lars Sogaard (Niva, DK), Pedersen; Mikkel Wandahl (Alleroed, DK), Jacobsen; Helle (Virum, DK), Kragh; Michael (Copenhagen, DK), Kjaer; Ida (Copenhagen, DK), Poulsen; Thomas Tuxen (Dyssegaard, DK)
Assignee:	Symphogen A/S (Ballerup, DK)
Application Number:	15/350,801
Patent Claims:	1. A method for treating cancer in a human patient, the method comprising administering to said patient an effective amount of an antibody composition comprising: a) an anti-epidermal growth factor receptor (EGFR) antibody comprising a heavy chain and a light chain that comprise the amino acid sequences of: SEQ ID NOs: 42 and 43, respectively, SEQ ID NOs: 38 and 39, respectively, SEQ ID NOs: 40 and 41, respectively, SEQ ID NOs: 44 and 45, respectively, or SEQ ID NOs: 46 and 47, respectively; b) an anti-human epidermal growth factor receptor 2 (HER2) antibody comprising a heavy chain and a light chain that comprise the amino acid sequences of: SEQ ID NOs: 50 and 51, respectively, SEQ ID NOs: 48 and 49, respectively, or SEQ ID NOs: 52 and 53, respectively; and c) an anti-human epidermal growth factor receptor 3 (HER3) antibody comprising a heavy chain and a light chain that comprise the amino acid sequences of: SEQ ID NOs: 54 and 55, respectively, SEQ ID NOs: 56 and 57, respectively, SEQ ID NOs: 58 and 59, respectively, or SEQ ID NOs: 60 and 61, respectively. 2. The method of claim 1, wherein said antibody composition comprises: a) an anti-epidermal growth factor receptor (EGFR) antibody comprising a heavy chain and a light chain that comprise the amino acid sequences of: SEQ ID NOs: 38 and 39, respectively, SEQ ID NOs: 40 and 41, respectively, or SEQ ID NOs: 42 and 43, respectively; b) an anti-EGFR antibody comprising a heavy chain and a light chain that comprise the amino acid sequences of: SEQ ID NOs: 44 and 45, respectively, or SEQ ID NOs: 46 and 47, respectively; c) an anti-human epidermal growth factor receptor 2 (HER2) antibody comprising a heavy chain and a light chain that comprise the amino acid sequences of: SEQ ID NOs: 48 and 49, respectively, or SEQ ID NOs: 50 and 51, respectively; d) an anti-HER2 antibody comprising a heavy chain that comprises the amino acid sequence of SEQ ID NO: 52 and a light chain that comprises the amino acid sequence of SEQ ID NO: 53; e) an anti-human epidermal growth factor receptor 3 (HER3) antibody comprising a heavy chain and a light chain that comprise the amino acid sequences of: SEQ ID NOs: 54 and 55, respectively, or SEQ ID NOs: 56 and 57, respectively; and f) an anti-HER3 antibody comprising a heavy chain and a light chain that comprise the amino acid sequences of: SEQ ID NOs: 58 and 59, respectively, or SEQ ID NOs: 60 and 61, respectively. 3. The method of claim 1, wherein said antibody composition has at least one of the following properties: a) inhibits cancer growth in the patient; b) reduces EGFR, HER2, or HER3 expression in cancer cells in the patient; and c) prevents EGFR, HER2, or HER3 up-regulation in cancer cells in the patient. 4. The method of claim 1, wherein the patient has pancreatic cancer, lung cancer, head and neck cancer, breast cancer, gastric cancer, colorectal cancer, esophageal cancer, or ovarian cancer. 5. The method of claim 1, wherein the patient has pancreatic cancer and a KRAS mutation. 6. The method of claim 1, wherein at least one of the antibodies is conjugated to an anti-cancer agent. 7. The method of claim 1, wherein the patient has been treated for cancer previously. 8. The method of claim 1, wherein said patient has acquired resistance to treatment with an antibody and/or a tyrosine kinase inhibitor. 9. The method of claim 8, wherein the antibody is cetuximab, trastuzumab, or pertuzumab. 10. A method for treating cancer in a human patient, the method comprising administering to said patient an effective amount of an antibody composition comprising: a) an anti-epidermal growth factor receptor (EGFR) antibody comprising the heavy chain variable region (VH) amino acid sequence of SEQ ID NO: 42 and the light chain variable region (VL) amino acid sequence of SEQ ID NO: 43; b) an anti-EGFR antibody comprising the VH amino acid sequence of SEQ ID NO: 46 and the VL amino acid sequence of SEQ ID NO: 47; c) an anti-human epidermal growth factor receptor 2 (HER2) antibody comprising the VH amino acid sequence of SEQ ID NO: 50 and the VL amino acid sequence of SEQ ID NO: 51; d) an anti-HER2 antibody comprising the VH amino acid sequence of SEQ ID NO: 52 and the VL amino acid sequence of SEQ ID NO: 53; e) an anti-human epidermal growth factor receptor 3 (HER3) antibody comprising the VH amino acid sequence of SEQ ID NO: 54 and the VL amino acid sequence of SEQ ID NO: 55; and f) an anti-HER3 antibody comprising the VH amino acid sequence of SEQ ID NO: 60 and the VL amino acid sequence of SEQ ID NO: 61. 11. The method of claim 10, wherein said antibody composition has at least one of the following properties: a) inhibits cancer growth in the patient; b) reduces EGFR, HER2, or HER3 expression in cancer cells in the patient; and c) prevents EGFR, HER2, or HER3 up-regulation in cancer cells in the patient. 12. The method of claim 10, wherein the patient has pancreatic cancer, lung cancer, head and neck cancer, breast cancer, gastric cancer, colorectal cancer, esophageal cancer, or ovarian cancer. 13. The method of claim 10, wherein the patient has pancreatic cancer and a KRAS mutation. 14. The method of claim 10, wherein at least one of the antibodies is conjugated to an anti-cancer agent. 15. The method of claim 10, wherein the patient has been treated for cancer previously. 16. The method of claim 10, wherein said patient has acquired resistance to treatment with an antibody and/or a tyrosine kinase inhibitor. 17. The method of claim 16, wherein the antibody is cetuximab, trastuzumab, or pertuzumab. 18. A method for treating a human patient with a disorder characterized by overexpression of EGFR, HER2, and/or HER3, the method comprising administering to said patient an effective amount of an antibody composition comprising: a) an anti-epidermal growth factor receptor (EGFR) antibody comprising a heavy chain and a light chain that comprise the amino acid sequences of: SEQ ID NOs: 42 and 43, respectively, SEQ ID NOs: 38 and 39, respectively, SEQ ID NOs: 40 and 41, respectively, SEQ ID NOs: 44 and 45, respectively, or SEQ ID NOs: 46 and 47, respectively; b) an anti-human epidermal growth factor receptor 2 (HER2) antibody comprising a heavy chain and a light chain that comprise the amino acid sequences of: SEQ ID NOs: 50 and 51, respectively, SEQ ID NOs: 48 and 49, respectively, or SEQ ID NOs: 52 and 53, respectively; and c) an anti-human epidermal growth factor receptor 3 (HER3) antibody comprising a heavy chain and a light chain that comprise the amino acid sequences of: SEQ ID NOs: 54 and 55, respectively, SEQ ID NOs: 56 and 57, respectively, SEQ ID NOs: 58 and 59, respectively, or SEQ ID NOs: 60 and 61, respectively. 19. The method of claim 18, wherein said antibody composition comprises: a) an anti-epidermal growth factor receptor (EGFR) antibody comprising the heavy chain variable region (VH) amino acid sequence of SEQ ID NO: 42 and the light chain variable region (VL) amino acid sequence of SEQ ID NO: 43; b) an anti-EGFR antibody comprising the VH amino acid sequence of SEQ ID NO: 46 and the VL amino acid sequence of SEQ ID NO: 47; c) an anti-human epidermal growth factor receptor 2 (HER2) antibody comprising the VH amino acid sequence of SEQ ID NO: 50 and the VL amino acid sequence of SEQ ID NO: 51; d) an anti-HER2 antibody comprising the VH amino acid sequence of SEQ ID NO: 52 and the VL amino acid sequence of SEQ ID NO: 53; e) an anti-human epidermal growth factor receptor 3 (HER3) antibody comprising the VH amino acid sequence of SEQ ID NO: 54 and the VL amino acid sequence of SEQ ID NO: 55; and f) an anti-HER3 antibody comprising the VH amino acid sequence of SEQ ID NO: 60 and the VL amino acid sequence of SEQ ID NO: 61. 20. The method of claim 18, wherein said antibody composition has at least one of the following properties: a) reduces EGFR, HER2, or HER3 expression in cancer cells in the patient; and b) prevents EGFR, HER2, or HER3 up-regulation in cancer cells in the patient.

Details for Patent 10,058,610

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2032-05-02
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2032-05-02
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2032-05-02