Claims for Patent: 10,336,823

Summary for Patent: 10,336,823

Title:	Anti-B7-H1 antibodies for treating tumors
Abstract:	Provided herein are methods of treating B7-H1-expressing tumors comprising administering an effective amount of MEDI4736 or an antigen-binding fragment thereof.
Inventor(s):	Narwal; Rajesh (Gaithersburg, MD), Fairman; David (Cambridge, GB), Robbins; Paul (Gaithersburg, MD), Liang; Meina (Gaithersburg, MD), Schneider; Amy (Gaithersburg, MD), Chavez; Carlos (Gaithersburg, MD), Herl; Carina (Gaithersburg, MD), Pak; Min (Gaithersburg, MD), Lu; Hong (Gaithersburg, MD), Rebelatto; Marlon (Gaithersburg, MD), Steele; Keith (Gaithersburg, MD), Boutrin; Anmarie (Gaithersburg, MD), Shi; Li (Gaithersburg, MD), Hong; Shengyan (Gaithersburg, MD), Higgs; Brandon (Gaithersburg, MD), Roskos; Lorin (Gaithersburg, MD)
Assignee:	MedImmune Limited (Cambridge, GB)
Application Number:	15/021,161
Patent Claims:	1. A method of treating a patient identified as having non-small cell lung carcinoma (NSCLC), the method comprising administering to the patient 10 mg/kg of an isolated antibody or an antigen-binding fragment thereof that specifically binds to PD-L1, the isolated antibody or fragment thereof comprising: a VH CDR1 having the amino acid sequence of SEQ ID NO: 3; a VH CDR2 having the amino acid sequence of SEQ ID NO: 4; a VH CDR3 having the amino acid sequence of SEQ ID NO: 5; a VL CDR1 having the amino acid sequence of SEQ ID NO: 6; a VL CDR2 having the amino acid sequence of SEQ ID NO: 7; and a VL CDR3 having the amino acid sequence of SEQ ID NO: 8, wherein at least 25% of the NSCLC tumor cells are PD-L1 positive. 2. The method of claim 1, wherein the administration is repeated every 14 to 21 days. 3. The method of claim 2, wherein the administration is repeated every 14 days. 4. The method of claim 1, wherein the tumor is refractory to at least one chemotherapeutic agent. 5. The method of claim 4, wherein the chemotherapeutic agent is Vemurafenib, Afatinib, Cetuximab, Carboplatin, Bevacizumab, Erlotinib, or Pemetrexed. 6. The method of claim 1, wherein the tumor is a non-small cell lung cancer that is a squamous cell carcinoma. 7. The method of claim 1, wherein the tumor is a non-small cell lung cancer that is a non-squamous cell carcinoma. 8. The method of claim 1, wherein PD-L1 status is detected using immunohistochemistry. 9. A method of treating a patient identified as having non-small cell lung carcinoma (NSCLC), the method comprising administering to the patient 15 mg/kg of an isolated antibody or an antigen-binding fragment thereof that specifically binds to PD-L1, the isolated antibody or fragment thereof comprising: a VH CDR1 having the amino acid sequence of SEQ ID NO: 3; a VH CDR2 having the amino acid sequence of SEQ ID NO: 4; a VH CDR3 having the amino acid sequence of SEQ ID NO: 5; a VL CDR1 having the amino acid sequence of SEQ ID NO: 6; a VL CDR2 having the amino acid sequence of SEQ ID NO: 7; and a VL CDR3 having the amino acid sequence of SEQ ID NO: 8, wherein at least 25% of the NSCLC tumor cells are PD-L1 positive. 10. A method of treating a patient identified as having non-small cell lung carcinoma (NSCLC), the method comprising administering to the patient 10 mg/kg of an isolated antibody or an antigen-binding fragment thereof that specifically binds to PD-L1, the isolated antibody or fragment thereof comprising a VL having the amino acid sequence of SEQ ID NO: 1; and a VH having the amino acid sequence of SEQ ID NO: 2, wherein at least 25% of the NSCLC tumor cells are PD-L1 positive. 11. The method of claim 10, wherein the administration is repeated every 14 to 21 days. 12. The method of claim 11, wherein the administration is repeated every 14 days. 13. The method of claim 10, wherein the tumor is refractory to at least one chemotherapeutic agent. 14. The method of claim 13, wherein the chemotherapeutic agent is Vemurafenib, Afatinib, Cetuximab, Carboplatin, Bevacizumab, Erlotinib, or Pemetrexed. 15. The method of claim 10, wherein the tumor is a non-small cell lung cancer that is a squamous cell carcinoma. 16. The method of claim 10, wherein the tumor is a non-small cell lung cancer that is a non-squamous cell carcinoma. 17. The method of claim 10, wherein PD-L1 status is detected using immunohistochemistry. 18. The method of claim 9, wherein the isolated antibody or fragment thereof comprises a VL having the amino acid sequence of SEQ ID NO: 1; and a VH having the amino acid sequence of SEQ ID NO: 2.

Details for Patent 10,336,823

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2033-09-11
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2033-09-11
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2033-09-11