Claims for Patent: 10,179,816

Summary for Patent: 10,179,816

Title:	Pharmaceutical compositions comprising an antibody which binds the human anti-Mullerian hormone receptor type II
Abstract:	The invention relates to novel pharmaceutical compositions including, as active ingredient, an antibody binding the human anti-Mullerian hormone type II receptor (AMHR-II) and an anticancer agent, as well as the therapeutic applications of these compositions.
Inventor(s):	Gaucher; Christine (Equedin, FR), Navarro-Teulon; Isabelle (Saint Gely du Fesc, FR)
Assignee:	LABOTATOIRE FRANCAIS DU FRACTIONNEMENT ET DES BIOTECHNOLOGIES (Les Ulis, FR) ICM INSTITUT REGIONAL DU CANCER DE MONTPELLIER (Montpellier, FR) I.N.S.E.R.M. (INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE) (Paris, FR) UNIVERSITE DE MONTPELLIER (Montpellier, FR)
Application Number:	15/333,519
Patent Claims:	1. Pharmaceutical composition comprising, as active ingredient, in combination with a pharmaceutically acceptable vehicle, an anticancer agent chosen among olaparib, rucaparib and bevacizumab, and a mutated humanized 12G4 monoclonal antibody binding the human anti-Mullerian hormone type II receptor (AMHR-II) comprising: a) a light chain comprising: a variable region the amino acid sequence of which is represented by SEQ ID NO: 7 or SEQ ID NO: 8, a constant region the amino acid sequence of which is represented by SEQ ID NO: 3 b) a heavy chain comprising: a variable region the amino acid sequence of which is represented by SEQ ID NO: 9 or SEQ ID NO: 10, a constant region the amino acid sequence of which is represented by SEQ ID NO: 6. 2. Composition according to claim 1, in which said antibody possesses affinity for AMHR-II characterized by a K.sub.D less than 10.sup.-7 M. 3. Pharmaceutical composition according to claim 1, in which the antibody is produced by the 3C23K. 4. Pharmaceutical composition according to claim 1, in which said antibody is a recombinant antibody produced by animal transgenesis. 5. Pharmaceutical composition according to claim 1, comprising the mutated 12G4 monoclonal antibody produced by the 3C23K clone, and olaparib. 6. Pharmaceutical composition according to claim 1, comprising the mutated 12G4 monoclonal antibody produced by the 3C23K clone, and rucaparib. 7. Pharmaceutical composition according to claim 1, in a formulation intended for administration by the intravenous or intraperitoneal route. 8. Pharmaceutical composition according to claim 1, in which the therapeutically effective quantity of antibody administered to a patient is in a range from about 0.07 mg to about 35000 mg. 9. Pharmaceutical composition according to claim 1, in which the therapeutically effective quantity of anticancer agent administered to a patient is in a range from about 10 mg to about 700 mg. 10. Pharmaceutical composition according to claim 1, in which the dose of antibody administered to a patient is about 70 mg and the dose of anticancer agent administered to the patient is about 110 mg. 11. Pharmaceutical composition according to claim 1, comprising the mutated 12G4 monoclonal antibody produced by the 3C23K clone, and bevacizumab. 12. Method for treating a pathology associated with the human anti-Mullerian hormone type II receptor (AMHR-II) comprising the administration of a therapeutically effective quantity of the composition comprising: an anticancer agent chosen among olaparib, rucaparib and bevacizumab, and a mutated humanized 12G4 monoclonal antibody binding the human anti-Mullerian hormone type II receptor (AMHR-II) comprising or constituted by: a) a light chain comprising or constituted by: a variable region the amino acid sequence of which is represented by SEQ ID NO: 7 or SEQ ID NO: 8, a constant region the amino acid sequence of which is represented by SEQ ID NO: 3 b) a heavy chain comprising or constituted by: a variable region the amino acid sequence of which is represented by SEQ ID NO: 9 or SEQ ID NO: 10, a constant region the amino acid sequence of which is represented by SEQ ID NO: 6. 13. The method of claim 12 wherein the quantity of the antibody administered to a patient is in a range from about 0.07 mg to about 35000 mg. 14. The method of claim 12 wherein the quantity of antibody administered is from 0.1 mg/kg to 100 mg/kg. 15. The method of claim 12 wherein the quantity of anticancer agent administered to a patient is in a range from about 20 mg to about 350 mg. 16. The method of claim 12 wherein the quantity of anticancer agent administered to a patient is about 110 mg. 17. Method for treating a pathology, according to claim 12, in which the pathology associated with the human anti-Mullerian hormone type II receptor (AMHR-II) is cancer. 18. Method for treating a pathology according to claim 12, in which the cancer is an ovarian cancer. 19. Method for treating a pathology according to claim 12, in which the cancer is an endometrial cancer. 20. Method for treating a pathology according to claim 12, in which the cancer is a mixed Mullerian malignant tumor of the uterus.

Details for Patent 10,179,816

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2031-12-23