Claims for Patent: 9,896,509

Summary for Patent: 9,896,509

Title:	Use of antagonists of the interaction between HIV GP120 and .alpha.4.beta.7 integrin
Abstract:	Methods are provided for the treatment of a HIV infection. The methods can include administering to a subject with an HIV infection a therapeutically effective amount of an agent that interferes with the interaction of gp120 and .alpha.4 integrin, such as a .alpha.4.beta.1 or .alpha.4.beta.7 integrin antagonist, thereby treating the HIV infection. In several examples, the .alpha.4 integrin antagonist is a monoclonal antibody that specifically binds to a .alpha.4, .beta.1 or .beta.7 integrin subunit or a cyclic hexapeptide with the amino acid sequence of CWLDVC. Methods are also provided to reduce HIV replication or infection. The methods include contacting a cell with an effective amount of an agent that interferes with the interaction of gp120 and .alpha.4 integrin, such as a .alpha.4.beta.1 or .alpha.4.beta.7 integrin antagonist. Moreover, methods are provided for determining if an agent is useful to treat HIV.
Inventor(s):	Arthos; James (Bethesda, MD), Goode; Diana (Bellingham, MA), Cicala; Claudia (Bethesda, MD), Fauci; Anthony S. (Bethesda, MD)
Assignee:	The United States of America, as Represented by the Secretary, Department of Health and Human Services (Washington, DC)
Application Number:	15/227,879
Patent Claims:	1. A method for the treatment of a human subject infected with human immunodeficiency virus (HIV), comprising: administering to the human subject infected with HIV a therapeutically effective amount of an .alpha.4.beta.7 monoclonal antibody which specifically inhibits binding of a gp120 V2 loop to a .alpha.4.beta.7 integrin heterodimer, or an antigen binding fragment thereof, thereby treating the human subject infected with HIV. 2. The method of claim 1, wherein the monoclonal antibody is a .alpha.7 integrin subunit monoclonal antibody. 3. The method of claim 2, wherein the .alpha.7 integrin subunit monoclonal antibody is a humanized form of FIB504 monoclonal antibody, humanized form of FIB27 monoclonal antibody or fragments thereof. 4. The method of claim 1, wherein the HIV is HIV type 1 (HIV-1). 5. The method of claim 1, wherein the HIV is HIV type 2 (HIV-2). 6. The method of claim 1, wherein the antibody is not natalizumab. 7. The method of claim 1, wherein the subject does not have multiple sclerosis or Crohn's disease. 8. The method of claim 1, wherein the subject is a newborn infant. 9. The method of claim 1, wherein the .alpha.4.beta.7 monoclonal antibody is MLN02. 10. The method of claim 1, wherein the .alpha.4.beta.7 monoclonal antibody is administered with an additional agent. 11. The method of claim 10, wherein the additional agent is an anti-viral agent. 12. The method of claim 1, wherein the .alpha.4.beta.7 monoclonal antibody is a humanized .alpha.4.beta.7 monoclonal antibody. 13. The method of claim 1, wherein the antigen binding fragment is a Fab, Fab', (Fab'2), Fv, or a single chain Fv (scFv). 14. The method of claim 1, wherein the .alpha.4.beta.7 monoclonal antibody is a human monoclonal antibody. 15. The method of claim 14, wherein the human monoclonal antibody binds .alpha.4.beta.7 with an affinity constant of at least 1.times.10.sup.8 M.sup.-1. 16. The method of claim 1, wherein the human subject infected with HIV is seropositive for HIV. 17. The method of claim 1, wherein the human cell in in vivo. 18. A method for inhibiting human immunodeficiency virus (HIV) infection, comprising: contacting a human cell in presence of a human immunodeficiency virus with an effective amount of a human .alpha.4.beta.7 monoclonal antibody which specifically inhibits binding of a LDV sequence in a gp120 V2 loop to a .alpha.4.beta.7 integrin heterodimer, thereby inhibiting HIV infection. 19. The method of claim 18, wherein the method inhibits HIV infection in gut-associated lymphoid tissue. 20. A pharmaceutical composition comprising a therapeutically effective amount of an .alpha.4.beta.7 monoclonal antibody which specifically inhibits binding of a gp120 V2 loop to a .alpha.4.beta.7 integrin heterodimer, a therapeutically effective amount of an anti-retroviral agent, and a carrier, wherein the anti-retroviral agent inhibits entry or replication of a human immunodeficiency virus. 21. The pharmaceutical composition of claim 20, wherein the antiretroviral agent is a reverse transcriptase inhibitor, a protease inhibitor, a fusion inhibitor, or an integrase inhibitor.

Details for Patent 9,896,509

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	11/23/2004		2026-12-07