Combinations of checkpoint inhibitors and oncolytic virus for treating cancer
AssigneesRegeneron Pharmaceuticals, Inc., Vyriad, Inc.
InventorsGiuseppe Gullo, Stephen J. Russell
Life of this patent
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Abstract
The present disclosure relates to methods for inhibiting the growth of a tumor in a patient in need thereof. The methods comprise administering to the patient an oncolytic virus in combination with a therapeutically effective amount of a PD-1 inhibitor (e.g., cemiplimab or a bioequivalent thereof) and optionally, a therapeutically effective amount of a CTLA-4 inhibitor (e.g., ipilimumab or a bioequivalent thereof). In some embodiments, the administration of the combination results in enhanced tumor inhibition as compared to administration of either antibody or the virus alone. In some embodiments, the oncolytic virus is a recombinant vesicular stomatitis virus (VSV), such as VV1.
Claims45
A method of treating or inhibiting the growth of a tumor, comprising:
- (a) selecting a patient with a cancer;
- and
- (b) administering to the patient in need thereof a combination therapy comprising:
- (i) a therapeutically effective amount of an oncolytic virus;
- and
- (ii) a therapeutically effective amount of an antibody or antigen-binding fragment thereof that binds specifically to programmed death 1 (PD-1), wherein the anti-PD-1 antibody or antigen-binding fragment thereof comprises three heavy chain complementarity determining regions (HCDR1, HCDR2 and HCDR3) of a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:
- 1 and three light chain complementarity determining regions (LCDR1, LCDR2 and LCDR3) of a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:
- 2.
The method of any one of claims 1-11, wherein the anti-PD-1 antibody or antigen-binding fragment thereof comprises HCVR comprising the amino acid sequence of SEQ ID NO:
- 1;
- and LCVR comprising the amino acid sequence of SEQ ID NO:
- 2.
A combination of an oncolytic virus and an antibody or antigen-binding fragment thereof that binds specifically to programmed death 1 (PD-1), wherein the combination is for use in a method of treating or inhibiting the growth of a tumor, the method comprising:
- (a) selecting a patient with a cancer;
- and
- (b) administering to the patient in need thereof a combination therapy comprising:
- (i) a therapeutically effective amount of an oncolytic virus;
- and
- (ii) a therapeutically effective amount of an antibody or antigen-binding fragment thereof that binds specifically to programmed death 1 (PD-1), wherein the anti-PD-1 antibody or antigen-binding fragment thereof comprises three heavy chain complementarity determining regions (HCDR1, HCDR2 and HCDR3) of a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:
- 1 and three light chain complementarity determining regions (LCDR1, LCDR2 and LCDR3) of a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:
- 2.
A combination of an oncolytic virus, an antibody or antigen-binding fragment thereof that binds specifically to programmed death 1 (PD-1), and a CTLA-4 inhibitor comprising ipilimumab or a bioequivalent thereof, wherein the combination is for use in a method of treating or inhibiting the growth of a tumor, the method comprising:
- (a) selecting a patient with a cancer;
- and
- (c) administering to the patient in need thereof a combination therapy comprising:
- (i) a therapeutically effective amount of an oncolytic virus;
- (ii) a therapeutically effective amount of an antibody or antigen-binding fragment thereof that binds specifically to programmed death 1 (PD-1), wherein the anti-PD-1 antibody or antigen-binding fragment thereof comprises three heavy chain complementarity determining regions (HCDR1, HCDR2 and HCDR3) of a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO:
- 1 and three light chain complementarity determining regions (LCDR1, LCDR2 and LCDR3) of a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO:
- 2;
- and
- (iii) a therapeutically effective amount of a CTLA-4 inhibitor comprising ipilimumab or a bioequivalent thereof.
A kit comprising an oncolytic virus and an antibody or antigen-binding fragment thereof that binds specifically to programmed death 1 (PD-1), in combination with written instructions for use of a therapeutically effective amount of a combination of the oncolytic virus and the anti-PD-1 antibody or antigen-binding fragment thereof for treating or inhibiting the growth of a tumor of a patient.
A kit comprising an oncolytic virus, an antibody or antigen-binding fragment thereof that binds specifically to programmed death 1 (PD-1), and a CTLA-4 inhibitor comprising ipilimumab or a bioequivalent thereof, in combination with written instructions for use of a therapeutically effective amount of a combination of the oncolytic virus, the anti-PD-1 antibody or antigen-binding fragment thereof, and the CTLA-4 inhibitor for treating or inhibiting the growth of a tumor of a patient.
Dependencies are inferred from the claim text.