Claims for Patent: 10,626,463

Summary for Patent: 10,626,463

Title:	Biomarker associated with risk of melanoma reoccurrence
Abstract:	The present invention provides a method of predicting the risk of reoccurrence of melanoma in a patient from whom melanoma tissue was previously removed which comprises the following: a. obtaining a RNA-containing sample of the previously removed melanoma tissue containing RNA from the patient; b. treating the sample to determine from the RNA contained in the sample the level of expression of a plurality of preselected genes; and c. comparing the level of expression of each gene of the plurality of pre-selected genes to a predetermined reference level of expression for each such gene; wherein a higher level of expression of the plurality of pre-selected genes in the sample as compared with the predetermined reference level of expression of such genes indicates that the patient has a reduced risk of reoccurrence of melanoma.
Inventor(s):	Saenger; Yvonne (New York, NY), Sivendran; Shanthi (Gettysburg, PA), Chang; Rui (New York, NY), Difeo; Analisa (Port Washington, NY)
Assignee:	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI (New York, NY)
Application Number:	14/419,409
Patent Claims:	1. A treatment method comprising: a) obtaining a sample of previously removed melanoma tissue containing RNA from a patient previously afflicted with melanoma; b) determining by direct multiplexed measurement of gene expression with color-coded probe pairs from the RNA contained in the sample the level of expression of a plurality of genes comprising CD2, KLRK1, ITK, and HLAE; c) predicting that the patient has an increased risk of reoccurrence of melanoma when the level of expression of said plurality of genes in the sample is determined to be lower than a predetermined reference level of expression of said plurality of genes; and d) administering an anti-melanoma immunotherapy agent to the patient predicted to have an increased risk of reoccurrence of melanoma. 2. The method of claim 1, wherein the sample is a fixed, wax-embedded tissue specimen. 3. The method of claim 2, wherein the expression level of each gene of the plurality of genes is normalized relative to the expression level of one or more reference genes. 4. The method of claim 3, wherein the expression level of each of the plurality of genes is normalized relative to the expression level of at least one of the following genes: ABCF1, ACTB, ALAS1, CLTC, G6PD, GAPDH, GUSB, HPRT1, LDHA, PGK1, POLR1B, POLR2A, RPL19, RPLPO, SDHA, TBP and TUBB. 5. The method of claim 1, wherein the immunotherapy is an oncolytic immunotherapy. 6. The method of claim 5, wherein the oncolytic immunotherapy comprises a virus. 7. The method of claim 6, wherein the virus is derived from HSV-1. 8. The method of claim 5, wherein the oncolytic immunotherapy is a vaccine. 9. The method of claim 8, wherein the vaccine is talimogene laherparepvec (T-VEC). 10. A treatment method comprising: a) obtaining a sample of melanoma tissue containing RNA from a patient that currently has melanoma or was previously afflicted with melanoma; b) assaying the sample to determine from the RNA contained in the sample the level of expression of a plurality of genes, wherein the genes comprise CD2, KLRK1, ITK, and HLAE; c) predicting that the patient has an increased risk of melanoma progression when the level of expression of said plurality of genes in the sample is lower than a predetermined reference level of expression of said plurality of genes; and d) administering an anti-melanoma immunotherapy to the patient predicted to have an increased risk of melanoma progression. 11. The method of claim 10, wherein the expression level is determined from direct multiplexed measurement of gene expression with color-coded probe pairs. 12. A treatment method comprising: a) obtaining a sample of previously removed melanoma tissue containing RNA from a patient previously afflicted with melanoma; b) determining by direct multiplexed measurement of gene expression with color-coded probe pairs from the RNA contained in the sample the level of expression of a plurality of genes comprising CD2, KLRK1, ITK, HLAE, IFNAR1, LCK, CD4, LGMN, and IFI27; c) predicting that the patient has a reduced risk of reoccurrence of melanoma when the level of expression of said plurality of genes in the sample is higher than a predetermined reference level of expression of said plurality of genes; and d) administering a reduced amount or less frequent dose of anti-melanoma immunotherapy to said patient predicted to have a reduced risk of reoccurrence of melanoma. 13. A treatment method comprising: administering an anti-melanoma immunotherapy agent to a human patient previously afflicted with melanoma who has an increased risk of reoccurrence of melanoma because the level of expression of CD2, KLRK1, ITK, and HLAE in a sample of previously removed melanoma tissue containing RNA from said human patient as determined by direct multiplexed measurement of gene expression with color-coded probe pairs from the RNA contained in the sample is lower than a predetermined reference level of expression of CD2, KLRK1, ITK, and HLAE.

Details for Patent 10,626,463

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen, Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518	10/27/2015		2032-08-03