Claims for Patent: 10,167,342

Summary for Patent: 10,167,342

Title:	Production of hersintuzumab: a new humanized antibody against HER2 for cancer treatment
Abstract:	A monoclonal anti-HER2 antibody is mutated on complementarity determining regions (CDRs) and framework regions. The VH domain of the antibody includes a portion of the amino acid sequence as SEQ ID NO: 1. The VL domain of the antibody includes a portion of the amino acid sequence as SEQ ID NO: 5.
Inventor(s):	Shokri; Fazel (Tehran, IR), Jeddi-Tehrani; Mahmood (Tehran, IR), Mehdi Amiri; Mohammad (Tehran, IR)
Assignee:
Application Number:	15/249,910
Patent Claims:	1. A humanized monoclonal anti-HER2 antibody for treating cancer, comprising: CDR-H1 comprising amino acid residues of 31-35 of SEQ ID NO: 1; CDR-H2 comprising amino acid residues of 50-65 of SEQ ID NO: 1; CDR-H3 comprising amino acid residues of 98-105 of SEQ ID NO: 1; CDR-L1 comprising amino acid residues of 24-34 of SEQ ID NO: 5; CDR-L2 comprising amino acid residues of 50-56 of SEQ ID NO: 5; and CDR-L3 comprising amino acid residues of 89-97 of SEQ ID NO: 5. 2. The humanized monoclonal anti-HER2 antibody of claim 1, further comprising: (a) a heavy chain variable domain having at least 90% identity to the amino acid sequence of SEQ ID NO: 1; (b) a light chain variable domain having at least 90% identity to the amino acid sequence of SEQ ID NO: 5; or (c) a heavy chain variable domain according to (a) and a light chain variable domain according to (b). 3. The humanized monoclonal anti-HER2 antibody of claim 1, wherein the heavy chain variable domain is identical to SEQ ID NO: 1. 4. The humanized monoclonal anti-HER2 antibody of claim 1, wherein the light chain variable domain is identical to SEQ ID NO: 5. 5. The humanized monoclonal anti-HER2 antibody of claim 1, wherein the humanized monoclonal anti-HER2 antibody is a Fab fragment, a F(ab)'2 fragment, or a single chain variable fragment (scFv). 6. The humanized monoclonal anti-HER2 antibody of claim 1, wherein the humanized monoclonal anti-HER2 antibody is to treat breast cancer. 7. An antibody-drug conjugate for treating cancer comprising: a humanized monoclonal anti-HER2 antibody conjugated to a drug, wherein the humanized monoclonal anti-HER2 antibody comprises: CDR-H1 comprising amino acid residues of 31-35 of SEQ ID No: 1; CDR-H2 comprising amino acid residues of 50-65 of SEQ ID No: 1; CDR-H3 comprising amino acid residues of 98-105 of SEQ ID No: 1; CDR-L1 comprising amino acid residues of 24-34 of SEQ ID No: 5; CDR-L2 comprising amino acid residues of 50-56 of SEQ ID No: 5; and CDR-L3 comprising amino acid residues of 89-97 of SEQ ID No: 5. 8. The antibody-drug conjugate of claim 7, wherein the drug includes a cytotoxic agent. 9. The antibody-drug conjugate of claim 8, wherein the humanized monoclonal anti-HER2 antibody specifically delivers the cytotoxic agent to cancer cells. 10. The antibody-drug conjugate of claim 8, wherein the humanized monoclonal anti-HER2 antibody is configured to specifically bind to a tumor antigen expressed on a cancer cell surface. 11. The antibody-drug conjugate of claim 7, wherein the drug includes an anti-microtubule agent. 12. The antibody-drug conjugate of claim 7, wherein the drug includes an interstrand cross-linking agent. 13. The antibody-drug conjugate of claim 7, wherein the antibody-drug conjugate is to treat breast cancer. 14. The humanized monoclonal anti-HER2 antibody of claim 1, wherein the humanized monoclonal anti-HER2 antibody in hetero-conjugation with trastuzumab is to treat breast cancer.

Details for Patent 10,167,342

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2039-02-26
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2039-02-26
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2039-02-26