Anticancer agent comprising HVJ-E and immune checkpoint protein inhibitor
Inventors
Kaneda, Yasufumi • SAKURA, Kazuma • Nishikawa, Tomoyuki • Fukushima, Masanori • Nakajima, Toshihiro
Assignees
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Publication Number
US-11166995-B2
Publication Date
2021-11-09
Expiration Date
Abstract
The present invention provides an anticancer agent containing the following (1) and (2):(1) HVJ-E (hemagglutinating virus of Japan envelope),(2) an inhibitor of an immune checkpoint protein.
Core Innovation
The document describes an anticancer composition and method that combine inactivated HVJ-E with an immune checkpoint inhibitor. The immune checkpoint inhibitor is preferably an anti-PD-1 antibody, including the antibody RMP1-14, and the combination is described as producing cooperative tumor growth suppression and addressing limitations of checkpoint blockade used alone.
The problem being solved is that immune checkpoint blockade alone can fail to achieve sufficient therapeutic effect, and cooperative tumor control is desired. The document defines HVJ-E and the immune checkpoint inhibitor in the context of an anticancer agent and a combination agent/kit, and it describes immune checkpoint protein targets including PD-1/PD-L1/PD-L2 and CTLA-4.
In described mouse tumor model findings, combining HVJ-E with anti-PD-1 (RMP1-14) enhances tumor control relative to either agent alone. The enhanced effects are reported in melanoma (B16-F10), malignant pleural mesothelioma (AB22), and prostate cancer (TRAMP-C1) models, with survival improvement reported in the mesothelioma model.
Claims Coverage
The independent claim provides coverage for administering HVJ-E together with anti-PD-1 antibody RMP1-14 to slow cancer progression, with multiple inventive features tied to combination dosing and specific cancer indications.
Administering HVJ-E and anti-PD-1 antibody RMP1-14 with multiple doses to slow cancer progression
Administering multiple doses of an effective amount of HVJ-E and anti-PD-1 antibody RMP1-14 to a subject, thereby slowing the progression of melanoma, mesothelioma, or prostate cancer in the subject.
Administering HVJ-E and anti-PD-1 antibody RMP1-14 together as a single pharmaceutical composition
Administering HVJ-E and the anti-PD-1 antibody RMP1-14 to the subject together as a single pharmaceutical composition.
Administering HVJ-E and anti-PD-1 antibody RMP1-14 as separate first and second pharmaceutical compositions
Administering HVJ-E and the anti-PD-1 antibody RMP1-14 as separate, different first and second pharmaceutical compositions.
Slowing melanoma progression in a human with HVJ-E and RMP1-14 using multiple doses
Applying the method to a human with melanoma by administering multiple doses of an effective amount of HVJ-E and anti-PD-1 antibody RMP1-14 to slow melanoma progression.
Slowing mesothelioma progression in a human with HVJ-E and RMP1-14 using multiple doses
Applying the method to a human with mesothelioma by administering multiple doses of an effective amount of HVJ-E and anti-PD-1 antibody RMP1-14 to slow mesothelioma progression.
Slowing prostate cancer progression in a human with HVJ-E and RMP1-14 using multiple doses
For a human subject with prostate cancer, administering multiple doses of an effective amount of HVJ-E and the anti-PD-1 antibody RMP1-14 slows prostate cancer progression.
Overall, the claim set centers on combination administration of inactivated HVJ-E with anti-PD-1 antibody RMP1-14 to slow progression of melanoma, mesothelioma, or prostate cancer. Coverage includes both co-formulated administration and separate first and second pharmaceutical compositions, with dependent claims narrowing to human melanoma, human mesothelioma, and human prostate cancer.
Stated Advantages
Cooperative tumor growth suppression with improved tumor control compared with either HVJ-E or anti-PD-1 alone.
Survival improvement reported in the mesothelioma model.
Reduced efficacy observed for an isotype control antibody compared with the combination approach.
Documented Applications
Treatment/prophylaxis and a method for slowing the progression of melanoma, mesothelioma, or prostate cancer by administering multiple doses of HVJ-E and anti-PD-1 antibody RMP1-14.
Use of the combination in mouse tumor models for melanoma (B16-F10), malignant pleural mesothelioma (AB22), and prostate cancer (TRAMP-C1), showing enhanced tumor control.
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