Immunotherapeutic vaccine and antibody combination therapy
Inventors
Slos, Philippe • Hortelano, Julie • Rittner, Karola • Preville, Xavier
Assignees
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Publication Number
US-12544415-B2
Publication Date
2026-02-10
Expiration Date
Abstract
The present invention relates to a combination product, composition(s) and kit of parts comprising at least (i) a therapeutic vaccine and (ii) one or more immune checkpoint modulator(s). The present invention also concerns a method for treating a proliferative or an infectious disease as well as a method for eliciting or stimulating and/or re-orienting an immune response, wherein said methods comprise administering to a subject in need thereof said combination product or said composition(s).
Core Innovation
The patent describes an immunotherapeutic combination product and a therapy for treating a proliferative or an infectious disease. The combination product includes a therapeutic vaccine and one or more immune checkpoint modulator(s). The therapeutic vaccine comprises a modified vaccinia virus Ankara (MVA) encoding membrane anchored Human papilloma Viruses 16 (HPV-16) non-oncogenic E6 and E7 antigens and encoding interleukin 2 (IL-2).
The immune checkpoint modulator(s) are capable of antagonizing at least partially the programmed cell death protein 1 (PD-1) pathway. The therapy is characterized by an administration sequence in which administering the therapeutic vaccine starts before administering the one or more immune checkpoint modulator(s). The therapeutic vaccine is administered a first time in a first administration separated by a period of time from a first administration of the immune checkpoint modulator(s), where the period of time is one day to eight week(s).
The description emphasizes a rationale related to T-cell exhaustion and immune tolerance, and it positions PD-1/PD-L1 and CTLA-4 antagonism in combination with the vectorized therapeutic vaccine. It also provides preferred vaccine designs based on MVA encoding model antigens and tumor antigens together with interleukin 2 (IL-2), including membrane-anchored HPV-16 E6/E7 non-oncogenic variants. Preclinical tumor model results are described, including reduced tumor volume and increased survival when the vaccine is combined with anti-PD-1 or anti-CTLA-4, along with immune markers and cytokine readouts such as IFN-gamma.
Claims Coverage
The independent claim covers a treatment method in which an MVA-based therapeutic vaccine encoding membrane anchored HPV-16 non-oncogenic E6/E7 antigens and IL-2 is administered before an immune checkpoint modulator that antagonizes the PD-1 pathway, with the first administrations separated by one day to eight week(s). The inventive portion focuses on the specific vaccine composition, the PD-1 pathway antagonism, and the defined treatment sequencing and timing window.
MVA vector vaccine with membrane anchored HPV-16 E6/E7 non-oncogenic antigens and IL-2
A therapeutic vaccine comprising a modified vaccinia virus Ankara (MVA) encoding membrane anchored Human papilloma Viruses 16 (HPV-16) non-oncogenic E6 and E7 antigens and encoding interleukin 2 (IL-2).
PD-1 pathway antagonizing immune checkpoint modulator
One or more immune checkpoint modulator(s) comprising a modulator capable of antagonizing at least partially programmed cell death protein 1 (PD-1) pathway.
Vaccine administered before PD-1 pathway modulator within a defined start-window
Administering the therapeutic vaccine starts before administering said one or more immune checkpoint modulator(s), wherein the period of time between the first administration of said therapeutic vaccine and the first administration of said one or more immune checkpoint modulator(s) is one day to eight week(s).
Overall, the claim set is directed to combination immunotherapy where an MVA encoding membrane anchored HPV-16 non-oncogenic E6/E7 and IL-2 is given first, followed by a PD-1 pathway antagonizing immune checkpoint modulator, with the first administrations separated by one day to eight week(s).
Stated Advantages
Prolonged survival.
Reduced mortality.
Reduction of tumor size.
Eliciting, stimulating, or redirecting an immune response including responses specific to the antigens.
Eliciting, stimulating, or redirecting CD4+ and/or CD8+ T cell response.
Increased IFN-gamma secretion.
Documented Applications
Treating a proliferative disease or an infectious disease by administering an effective amount of a combination product comprising an MVA vectorized therapeutic vaccine and one or more immune checkpoint modulators.
Treating cancer selected from renal cancer, prostate cancer, breast cancer, colorectal cancer, lung cancer, liver cancer, gastric cancer, bile duct carcinoma, endometrial cancer, pancreatic cancer, and ovarian cancer.
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