Claims for Patent: 9,468,643

Summary for Patent: 9,468,643

Title:	PDE5 inhibitor compositions and methods for immunotherapy
Abstract:	The invention features methods and compositions featuring a PDE5 inhibitor for treating or preventing immunological-mediated disease in a subject.
Inventor(s):	Borrello; Ivan M. (Baltimore, MD), Serafini; Paolo (Miami Shores, FL), Noonan; Kimberly A. (Baltimore, MD), Bronte; Vincenzo (Abano Terme, IT)
Assignee:	The Johns Hopkins University (Baltimore, MD)
Application Number:	14/281,363
Patent Claims:	1. A method of treating cancer in a human patient having myeloid suppressor cell mediated immunosuppression, comprising: administering adoptive cell transfer therapy comprising lymphocytes to the patient; and administering a therapeutically effective amount of a phosphodiesterase-5 inhibitor compound to the patient. 2. The method of claim 1, wherein the patient comprises tumor-infiltrating myeloid suppressor cells. 3. The method of claim 1, wherein the phosphodiesterase-5 inhibitor compound is sildenafil, vardenafil, or tadalafil. 4. The method of claim 1, wherein the phosphodiesterase-5 inhibitor compound is administered daily. 5. The method of claim 1, wherein the cancer is multiple myeloma, a lymphoma, melanoma, breast, stomach, head and neck, ovarian, colon, prostate, lung, or cervical cancer. 6. The method of claim 5, wherein the cancer is multiple myeloma or head and neck cancer. 7. The method of claim 5, wherein the cancer is colon cancer. 8. The method of claim 1, wherein the lymphocytes are tumor infiltrating lymphocytes. 9. A method of treating cancer in a human patient, comprising administering to the patient a therapeutically effective amount of a phosphodiesterase-5 inhibitor compound daily, wherein: the patient comprises myeloid suppressor cells; the myeloid suppressor cells are responsible for immune suppression in the patient; the immune suppression is associated with the cancer; and the phosphodiesterase-5 inhibitor compound is sildenafil, vardenafil, or tadalafil. 10. The method of claim 9, further comprising administering an anticancer agent to the patient, wherein the anticancer agent is anthracycline, taxane, an alkylating agent, cis-platin, arabinofuranosyl cytosine, 5-fluorouracil, altretamine, busulfan, chlorambucil, cyclophosphamide, ifosfamide, mechlorethamine, melphalan, thiotepa, cladribine, floxuridine, gemcitabine, thioguanine, pentostatin, methotrexate, 6-mercaptopurine, cytarabine, carmustine, lomustine, streptozotocin, carboplatin, oxaliplatin, iproplatin, tetraplatin, lobaplatin, JM216, JM335, fludarabine, aminoglutethimide, flutamide, goserelin, leuprolide, megestrol acetate, cyproterone acetate, tamoxifen, anastrozole, bicalutamide, dexamethasone, diethylstilbestrol, prednisone, bleomycin, dactinomycin, daunorubicin, doxirubicin, idarubicin, mitoxantrone, losoxantrone, mitomycin-c, plicamycin, paclitaxel, docetaxel, CPI-11, epothilones, topotecan, irinotecan, 9-amino camptothecan, 9-nitro camptothecan, GS-211, etoposide, teniposide, vinblastine, vincristine, vinorelbine, procarbazine, asparaginase, pegaspargase, methoxtrexate, octreotide, estramustine, hydroxyurea, tamoxifen, raloxifene, toremifene, exemestane, letrozole, anastrozole, megestrol, trastuzumab, goserelin acetate, fulvestrant, doxorubicin, epirubicin, or cyclophosphonamide. 11. The method of claim 9, further comprising administering an anticancer vaccine to the patient, wherein the vaccine is a DNA-based vaccine, a protein-based vaccine, a whole cell tumor vaccine, or a dendritic cell-based vaccine. 12. The method of claim 9, wherein the myeloid suppressor cells are tumor-infiltrating myeloid suppressor cells. 13. The method of claim 3, wherein the phosphodiesterase-5 inhibitor compound is tadalafil, and the tadalafil is administered orally at a dose of 5 mg, 10 mg, or 20 mg. 14. The method of claim 13, wherein the tadalafil is administered orally at a dose of 20 mg. 15. The method of claim 3, wherein the phosphodiesterase-5 inhibitor compound is vardenafil, and the vardenafil is administered orally at a dose of 5 mg, 10 mg, or 20 mg. 16. The method of claim 3, wherein the phosphodiesterase-5 inhibitor compound is sildenafil, and the sildenafil is administered orally at a dose of 25 mg, 50 mg, or 100 mg.

Details for Patent 9,468,643

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	01/10/1978		2025-01-07
Servier Pharmaceuticals Llc	ONCASPAR	pegaspargase	Injection	103411	02/01/1994		2025-01-07
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2025-01-07
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2025-01-07
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2025-01-07