Peptide vaccines and pembrolizumab for treating breast cancer

Inventors

Peterkin, Doris • Cohen, Marc A.

Assignees

Oncopep Inc

Abstract

The disclosure features, inter alia, combination therapies comprising pembrolizumab and one or more immunogenic XBP1-, CD138-, and CS1-derived peptides. The therapies herein can be used, e.g., for inducing an immune response in a subject having a cancer, and treating a cancer such as breast cancer, e.g., triple negative breast cancer.

Core Innovation

The invention relates to combination immunotherapy for breast cancer in which pembrolizumab (anti–PD-1) is administered together with immunogenic MHC class I–binding peptides derived from XBP1 and peptides derived from CD138 and CS-1. The peptides include a non-spliced XBP1 peptide and a spliced XBP1 peptide, each of 35 amino acids or less in length and comprising SEQ ID NO: 1 or SEQ ID NO: 2, respectively. The CD138 and CS-1 peptides are each of 35 amino acids or less in length and comprise SEQ ID NO: 3 and SEQ ID NO: 4.

The described approach is directed to inducing immune responses, including T cell activation and antibody production, using the specified MHC class I–binding peptides in combination with pembrolizumab. The peptides are described as immunogenic and as being derived from targets including XBP1 (non-spliced and spliced), CD138, and CS-1, which are referenced as relevant to breast cancer. The treatment is positioned for subjects having, or at risk of developing, breast cancer, including triple negative breast cancer.

The document further describes patient selection based on tumor expression of XBP1, CD138, and/or CS1, where the subject has or is at risk of developing breast cancer. In addition, it provides formulation and composition options including separate versus combined administration of the components. Concepts including peptide-fusion proteins are also discussed in the context of the combination immunotherapy.

Claims Coverage

The partial content provides one independent claim (clm-00001), which contains five main inventive features: pembrolizumab administration and a defined set of four peptide components (non-spliced XBP1, spliced XBP1, CD138, and CS-1), each with explicit SEQ ID references and length limitations, in a method of treating subjects with, or at risk of developing, breast cancer.

Across the independent claim, the inventive core is the combined administration of pembrolizumab with four defined immunogenic MHC class I–binding peptides (non-spliced XBP1, spliced XBP1, CD138, and CS-1), each constrained to 35 amino acids or less and defined by specific SEQ ID NOs, applied to subjects having or at risk of developing breast cancer.

Stated Advantages

Documented Applications