Claims for Patent: 10,010,587

Summary for Patent: 10,010,587

Title:	IL-2R.beta.-selective agonists in combination with an anti-CTLA-4 antibody or an anti-PD-1 antibody
Abstract:	The invention relates to (among other things) method of administering to a patient suffering from a cancer, the method comprising the steps of: (a) an IL-2R.beta.-activating amount of a long acting, IL-2R.beta.-selective agonist; and (b) a CTLA-4 pathway-inhibiting amount of an anti-CTLA-4 antibody or a PD-1 pathway-inhibiting amount of an anti-PD-1 antibody.
Inventor(s):	Addepalli; Murali Krishna (Secunderabad, IN), Charych; Deborah H. (Albany, CA), Kantak; Seema (Pacifica, CA), Lee; Steven Robert (San Leandro, CA)
Assignee:	Nektar Therapeutics (San Francisco, CA)
Application Number:	15/120,214
Patent Claims:	1. A method of treating a patient suffering from a solid cancer, the method comprising: (a) administering to the patient an effective, IL-2R.beta.-activating amount of a long acting, interleukin-2 receptor beta (IL-2R.beta.)-selective agonist of a formula: ##STR00003## or a pharmaceutically acceptable salt form thereof, where IL-2 is interleukin-2, and n ranges from 3 to 4000; and (b) administering to the patient an effective, CTLA-4 pathway-inhibiting amount of an anti-CTLA-4 antibody, wherein step (a) is carried out after step (b); or administering to the patient an effective, PD-1 pathway-inhibiting amount of an anti-PD-1 antibody, wherein step (a) is carried out before, after or simultaneously with step (b). 2. The method of claim 1, wherein the patient is a human. 3. The method of claim 1, wherein administering steps (a) and (b) both comprise parenteral administering. 4. The method of claim 1, wherein the solid cancer is selected from the group consisting of breast cancer, ovarian cancer, colon cancer, colorectal cancer, gastric cancer, malignant melanoma, liver cancer, small cell lung cancer, non-small cell lung cancer, thyroid cancers, kidney cancer, cancer of the bile duct, brain cancer, cervical cancer, maxillary sinus cancer, bladder cancer, esophageal cancer, Hodgkin's disease and adrenocortical cancer. 5. The method of claim 1, wherein the cancer is colon cancer. 6. The method of claim 1, wherein the cancer is breast cancer. 7. The method of claim 1, wherein step (b) comprises administering to the patient an effective, PD-1 pathway-inhibiting amount of an anti-PD-1 antibody and step (a) is carried out prior to step (b). 8. The method of claim 1, wherein step (b) comprises administering to the patient an effective, PD-1 pathway-inhibiting amount of an anti-PD-1 antibody and step (a) is carried out after step (b). 9. The method of claim 1, wherein step (b) comprises administering to the patient an effective, PD-1 pathway-inhibiting amount of an anti-PD-1 antibody and steps (a) and (b) are carried out simultaneously. 10. The method of claim 1, wherein step (b) comprises administering to the patient an effective, CTLA-4 pathway-inhibiting amount of an anti-CTLA-4 antibody. 11. The method of claim 1, wherein step (b) comprises administering to the patient an effective, PD-1 pathway-inhibiting amount of an anti-PD-1 antibody. 12. The method of claim 1, wherein the long acting, IL-2R.beta.-selective agonist is comprised in a composition that contains no more than about ten mole percent of compounds having a formula ##STR00004## or a pharmaceutically acceptable salt thereof, where IL-2 is interleukin-2, and n ranges from 3 to 4000. 13. The method of claim 1, wherein each branched polyethylene glycol moiety comprised in the long acting, IL-2R.beta.-selective agonist has a molecular weight of about 20 kilodaltons. 14. The method of claim 1, wherein the interleukin-2 is aldesleukin, and further wherein step (b) comprises administering to a human an effective PD-1 pathway-inhibiting amount of an anti-PD-1 antibody. 15. The method of claim 1, wherein the interleukin-2 is aldesleukin, and further wherein step (b) comprises administering to a human an effective, CTLA-4 pathway-inhibiting amount of an anti-CTLA-4 antibody, wherein step (a) is carried out after step (b).

Details for Patent 10,010,587

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Clinigen, Inc.	PROLEUKIN	aldesleukin	For Injection	103293	05/05/1992		2034-02-21