US 2024/0189422 A1 · COMBINATION CANCER THERAPY

Abstract

A method and combination for treating a cancer patient by combining two distinct immuno-therapy solutions for administration to a patient within a common time period, comprising a checkpoint inhibitor antibody component such as a PD-1 or PD-L1 antibody administered by infusion, and a TAA/ecdCD40L vaccine component administered subcutaneously, wherein an initial antibody component administered is followed by at least several successive antibody boosts and an initial vaccine component administered is followed by at least several successive vaccine boosts, both the initial and boosts of each administered within at least said common time period, wherein the combined administration of said two distinct immuno-therapy solutions provides for an enhanced therapeutic effect, over that of the therapeutic effect of either of the two distinct immuno-therapy component solutions when administered alone as monotherapy.

Claims16

Dependent claims

A pharmaceutical immuno-oncology combination for use in treatment of cancer in an individual, said combination comprising:

(i) a checkpoint inhibitor, wherein the checkpoint inhibitor is an anti-PD-1 or an anti-PD-L1 inhibitory antibody;
and,
(ii) an expression vector encoding a vaccine component (TAA/ecdCD40L), wherein the TAA/ecdCD40L is a fusion protein of Mucin-1 (MUC1, TAA) and the extracellular domain of a CD40 ligand (ecd), wherein the ecd excludes at least the transmembrane domain that inhibits secretion;
wherein:
(a) the checkpoint inhibitor and the vaccine component are both to be administered to the individual including additional boosts of the same;
(b) the administration generates an immune response against cancerous antigen in an individual by effecting a reduction of a total population of CD11b positive cells in the cancerous tumor and increases the magnitude of the antitumor immune response in the individual;
and
(c) the checkpoint inhibitor and the vaccine components are administered as a combination at effective amounts over a common time period to produce through their biological interaction an enhanced synergistic immune response greater than an immune response by the checkpoint inhibitor administered as a monotherapy.

5 more elements

A pharmaceutical combination for treating cancerous tumor tissue, comprising at least two immuno-therapeutic components adapted for administration to a patient over a common time period for generating a biological interaction between the two components to provide for a synergistic increased immune response, the immuno-therapeutic combination comprising:

an antigen non-specific PD-1 or PD-L1 antibody therapy component active for the cancer type to be treated and adapted to be administered to the patient including additional boosts of the antibody therapy component, and
a MUC-1/ecdCD40L antigen specific vaccine therapy component adapted to be administered to the patient including additional boosts of the MUC-1/ecdCD40L antigen specific vaccine therapy component,
wherein said two components are administered as a combination immunotherapy, to reduce a statistically significant percentage of a total of CD11b positive cells present in the cancerous tumor tissue and generate an immune response to (i) induce a prolongation of survival in the patient, and (ii) induce an influx in MUC-1 antigen specific CD8 T cells that traffick into the cancerous tumor tissue, enabling an overall synergistic increase in the patient's immune response to suppress tumor growth by more than the combined effects seen when each of the vaccine therapy component and antibody therapy component is given alone as monotherapy.

Dependencies are inferred from the claim text.

Combination cancer therapy

Life of this patent

Combination cancer therapy

Life of this patent

Abstract

Claims16