Claims for Patent: 9,618,514

Summary for Patent: 9,618,514

Title:	Methods of evaluating patients using E-cadherin and vimentin
Abstract:	Methods for the selection, evaluation, and/or treatment of a patient having cancer with an inhibitor of a glutamine-utilizing enzyme or a glutamine-depleting agent, by evaluating E-cadherin or vimentin expression are disclosed.
Inventor(s):	Choe; Sung Eun (Lexington, MA), Hurov; Jonathan (Cambridge, MA), Ulanet; Danielle (Cambridge, MA)
Assignee:	AGIOS PHARMACEUTICALS, INC (Cambridge, MA)
Application Number:	14/428,456
Patent Claims:	1. A method of treating a patient having cancer, the method comprising: acquiring an evaluation of or evaluating a patient sample, wherein the sample is evaluated for i) E-cadherin expression levels and ii) vimentin expression levels; and if E-cadherin expression levels are low, and vimentin expression levels are high, as compared to a reference standard, then administering to the patient in need thereof a therapeutically effective amount of an inhibitor of a glutamine-utilizing enzyme or a glutamine-depleting agent. 2. The method of claim 1, wherein the sample is evaluated for low or decreased pyruvate carboxylase expression compared to a reference standard. 3. The method of claim 1, wherein the level of E-cadherin expression is at least a 1.5, 2, 5, 10, 15, 20, 25, 50, 75, 100 fold decrease in expression compared to the reference standard. 4. The method of claim 1, wherein the level of vimentin expression is a 1.5, 2, 5, 10, 15, 20, 25, 50, 75, 100 fold increase compared to the reference standard. 5. The method of claim 1, wherein the level of E-cadherin expression is measured by the evaluation of the level of RNA that encodes E-cadherin. 6. The method of claim 1, wherein the level of vimentin expression is measured by the evaluation of the level of RNA that encodes vimentin. 7. The method of claim 1, wherein the level of E-cadherin expression is evaluated by the level of E-cadherin protein expression. 8. The method of claim 1, wherein the level of vimentin expression is evaluated by the level of vimentin protein expression. 9. The method of claim 1, wherein the patient is administered a therapeutically effective amount of an inhibitor of a glutamine-utilizing enzyme. 10. The method of claim 9, wherein the inhibitor of a glutamine-utilizing enzyme inhibits a glutaminase. 11. The method of claim 10, wherein the glutaminase is GLS1 or glutaminase C(GAC). 12. The method of claim 11, wherein the inhibitor is bis-2-(5-phenylacetamido-1,2,4-thiadiazol-2-yl)ethyl sulfide (BPTES). 13. The method of claim 1, wherein the patient is administered a therapeutically effective amount of a glutamine depleting agent. 14. The method of claim 13, wherein the glutamine depleting agent is an asparaginase or a glutaminase. 15. The method of claim 1, wherein the cancer is lung cancer. 16. The method of claim 15, wherein the lung cancer is non-small cell lung cancer. 17. A method of evaluating a patient having cancer for treatment with an inhibitor of glutamine-utilizing enzyme or a glutamine-depleting agent, the method comprising: evaluating a patient sample, wherein the sample is evaluated for i) a low level of E-cadherin expression compared to a reference standard and ii) a high level of vimentin expression compared to a reference standard; and determining to treat the patient with the inhibitor of glutamine-utilizing enzyme or the glutamine-depleting agent. 18. The method of claim 17, wherein the sample is evaluated for low or decreased pyruvate carboxylase expression compared to a reference standard. 19. The method of claim 17, wherein the level of E-cadherin expression is at least a 1.5, 2, 5, 10, 15, 20, 25, 50, 75, 100 fold decrease in expression compared to the reference standard. 20. The method of claim 17, wherein the level of vimentin expression is a 1.5, 2, 5, 10, 15, 20, 25, 50, 75, 100 fold increase compared to the reference standard. 21. The method of claim 17, wherein the level of E-cadherin expression is measured by the evaluation of the level of RNA that encodes E-cadherin. 22. The method of claim 17, wherein the level of vimentin expression is measured by the evaluation of the level of RNA that encodes vimentin. 23. The method of claim 17, wherein the level of E-cadherin expression is evaluated by the level of E-cadherin protein expression. 24. The method of claim 17, wherein the level of vimentin expression is evaluated by the level of vimentin protein expression. 25. The method of claim 17, wherein the patient is evaluated for treatment with an inhibitor of a glutamine-utilizing enzyme. 26. The method of claim 25, wherein the inhibitor of a glutamine-utilizing enzyme inhibits a glutaminase. 27. The method of claim 26, wherein the glutaminase is GLS1 or glutaminase C(GAC). 28. The method of claim 26, wherein the inhibitor is bis-2-(5-phenylacetamido-1,2,4-thiadiazol-2-yl)ethyl sulfide (BPTES). 29. The method of claim 17, wherein the patient is administered a therapeutically effective amount of a glutamine depleting agent. 30. The method of claim 29, wherein the glutamine depleting agent is an asparaginase or a glutaminase. 31. The method of claim 17, wherein the cancer is lung cancer. 32. The method of claim 31, wherein the lung cancer is non-small cell lung cancer.

Details for Patent 9,618,514

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	01/10/1978		2039-02-26