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US 12,754,182 B2Granted
IFNβ as a pharmacodynamic marker in VSV-IFNβ-NIS oncolytic therapy
AssigneesMayo Foundation for Medical Education and Research, Vyriad, Inc.
InventorsLuke Russell, Kah-Whye Peng, Stephen James Russell
Life of this patent
Estimating the term…
Abstract
The present invention generally relates to pharmacokinetic and pharmacodynamics markers for cancer therapeutic regimens and methods of treating cancer. Oncolytic virus probes that comprise a nucleic acid encoding soluble interferon beta (IFNβ) and methods for use thereof are provided.
Claims19
A method of determining the likelihood that a cancerous tissue in a subject having the cancerous tissue will respond to administration of an oncolytic virus cancer therapy regimen and treating said subject, the method comprising:
- (a) administering intratumorally to the cancerous tissue from about 105 tissue culture infectious dose 50 (TCID50) to about 3×109 TCID50 of a recombinant oncolytic virus probe that comprises a nucleic acid sequence that encodes a nucleocapsid (N) polypeptide, a nucleic acid sequence that encodes a phosphoprotein (P) polypeptide, a nucleic acid sequence that encodes a matrix (M) polypeptide, a nucleic acid sequence that encodes a glycoprotein (G) polypeptide, a nucleic acid sequence that encodes a viral polymerase (L) polypeptide, a nucleic acid that codes for soluble interferon beta (IFNβ),
- (b) measuring the circulating level of IFNβ in the subject after administration of the recombinant oncolytic virus probe to determine if the cancerous tissue will respond to the oncolytic virus cancer therapy regimen as (1) a strong responder, (2) an intermediate responder, or (3) a low responder or a non-responder, wherein a circulating IFNβ level in the subject greater than about 1000 pg/mL identifies the subject as the strong responder, a circulating IFNβ level in the subject between about 10 pg/mL to about 1000 pg/mL identifies the subject as the intermediate responder, and a circulating IFNβ level lower than about 10 pg/mL identifies the subject as the low responder or non-responder, and
- (c) administering the oncolytic virus cancer therapy regimen if the cancerous tissue is determined to be the strong responder, administering the oncolytic virus cancer therapy regimen and a cancer therapeutic agent other than the oncolytic virus cancer therapy regimen if the cancerous tissue is determined to be an intermediate responder, or administering a cancer therapeutic agent other than the oncolytic virus cancer therapy regimen if the cancerous tissue is determined to be a low responder or a non-responder.
Dependencies are inferred from the claim text.