Claims for Patent: 10,421,811

Summary for Patent: 10,421,811

Title:	Compositions comprising coformulation of anti-PD-L1 and anti-CTLA-4 antibodies
Abstract:	Provided herein are compositions comprising coformulation of anti-PD-L1 and anti-CTLA-4 antibodies, or antigen-binding fragments thereof, and methods of making and using such compositions. In various aspects, stable coformulations of the anti-PD-L1 antibody durvalumab (MEDI4736) and the anti-CTLA-4 antibody tremelimumab are provided.
Inventor(s):	Du; Jiali (Gaithersburg, MD), Shah; Ambarish (Gaithersburg, MD)
Assignee:	MEDIMMUNE, LLC (Gaithersburg, MD)
Application Number:	15/495,388
Patent Claims:	1. A composition comprising durvalumab, or an antigen-binding fragment thereof, and tremelimumab, or an antigen-binding fragment thereof, wherein the concentration of durvalumab, or an antigen-binding fragment thereof, is about 18.7 mg/mL to about 44.4 mg/mL and wherein the concentration of tremelimumab, or an antigen-binding fragment thereof, is about 2.2 mg/mL to about 12.5 mg/mL. 2. The composition of claim 1, wherein the concentration of durvalumab, or an antigen-binding fragment thereof, is about 18.7 mg/mL, 36.3 mg/mL, 40.0 mg/mL, 42.8 mg/mL, or 44.4 mg/mL. 3. The composition of claim 1, wherein the concentration of tremelimumab, or an antigen-binding fragment thereof, is about 2.2 mg/mL, 2.9 mg/mL, 4.0 mg/mL, 5.5 mg/mL, or 12.5 mg/mL. 4. The composition of claim 1, wherein the combined concentration of durvalumab, or an antigen-binding fragment thereof, and tremelimumab, or an antigen-binding fragment thereof, is about 31.2 mg/mL to about 46.6 mg/mL. 5. The composition of claim 1, wherein the combined concentration of durvalumab, or an antigen-binding fragment thereof, and tremelimumab, or an antigen-binding fragment thereof, is about 31.2 mg/mL, 41.8 mg/mL, 44.0 mg/mL, 45.7 mg/mL, or 46.6 mg/mL. 6. The composition of claim 1, wherein the concentration ratio of durvalumab to tremelimumab is from about 15:10 to about 20:1. 7. The composition of claim 6, wherein the concentration ratio of durvalumab to tremelimumab is about 20:1. 8. The composition of claim 1, further comprising Histidine, Histidine-HCl, or a combination thereof. 9. The composition of claim 8, wherein the concentration of the Histidine, Histidine-HCl, or a combination thereof, is from about 20 mM to about 25 mM. 10. The composition of claim 1, further comprising trehalose dihydrate. 11. The composition of claim 10, wherein the concentration of the trehalose dihydrate is from about 254 mM to about 269 mM. 12. The composition of claim 1, further comprising Ethylenediaminetetraacetic acid (EDTA). 13. The composition of claim 12, wherein the concentration of EDTA is from about 0.03 mM to about 0.17 mM. 14. The composition of claim 1, further comprising polysorbate 80 (PS80). 15. The composition of claim 14, wherein the concentration of polysorbate 80 is about 0.02 percent weight/volume (% w/v). 16. The composition of claim 1, having a pH of about 6.0. 17. A pharmaceutical composition comprising or consisting of about 44.4 mg/mL durvalumab, or an antibody fragment thereof, about 2.2 mg/mL tremelimumab, or an antibody fragment thereof, about 25 mM Histidine/Histidine-HCl, about 269 mM Trehalose dehydrate, about 0.03 mM EDTA, and about 0.02% w/v PS80 at a pH of about 6.0. 18. The composition of claim 1, formulated for intravenous injection. 19. A kit comprising the composition of claim 1, and instructions for use in the treatment of a solid tumor, cancer, lung cancer, or non-small cell lung cancer (NSCLC).

Details for Patent 10,421,811

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Astrazeneca Uk Ltd	IMFINZI	durvalumab	Injection	761069	05/01/2017		2036-04-25