IFNbeta as a Pharmacodynamic Marker in VSV-IFNbeta-NIS Oncolytic Therapy
AssigneesMayo Foundation for Medical Education and Research, Vyriad, Inc.
InventorsLuke Russell, Kah-Whye Peng, Stephen James Russell
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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.
Claims48
A method of determining the likelihood that a cancerous tissue in a subject having the cancerous tissue will respond to administration of a cancer therapy regimen, the method comprising:
- (a) administering intratumorally to the cancerous tissue a subtherapeutic diagnostic dose of an oncolytic virus probe that comprises a nucleic acid that codes for soluble interferon beta (IFNβ), and
- (b) measuring the circulating level of IFNβ in the subject after administration of the oncolytic virus to determine if the cancerous tissue is a strong responder, an intermediate responder, a low responder or a non-responder.
The method of any one of the preceding claims, wherein the oncolytic virus probe is vesicular stomatitis virus (VSV).
The method of claim 12, wherein the oncolytic virus probe has the construct of N-P-M-IFNβ-G-NIS-L.
The method of any one of the preceding claims, wherein the circulating level of IFNβ are measured in the subject between about 12 hours to about 45 days after administration of the oncolytic virus.
The method of any one of the preceding claims, wherein the circulating level of IFNβ is measured by an immunological assay.
The method of any one of the preceding claims, wherein the cancerous tissue is a solid tumor or a hematological malignancy.
The method of any one of the preceding claims, wherein the cancerous tissue is a head and neck cancer, colon cancer, rectal cancer, pancreatic cancer, bladder cancer, breast cancer, hepatocellular cancer, lung cancer, medulloblastoma, atypical teratoid/rhabdoid tumor, a leukemia, a lymphoma, or a myeloma.
A method of treating cancer in a subject, comprising:
- (a) identifying the likelihood that the cancerous tissue in a subject having the cancerous tissue will respond to administration of a cancer therapy regimen, according to the method of any of the preceding claims, and
- (b) administering the cancer therapy regimen if the cancerous tissue is determined to be a strong or intermediate responder.
A method of treating a subject having been diagnosed with cancer, the method comprising:
- administering to the subject a first dose of an oncolytic virus cancer therapy regimen that comprises a nucleic acid encoding interferon beta (IFNβ), and administering at least a second dose of the oncolytic virus cancer therapy regimen if the subject has been identified as a strong responder or an intermediate responder to the oncolytic virus cancer therapy regimen.
Dependencies are inferred from the claim text.