Checkpoint inhibitor and a whole cell mycobacterium for use in cancer therapy
Inventors
AKLE, CHARLES • Grange, John • Bilyard, Kevin
Assignees
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Publication Number
US-10610578-B2
Publication Date
2020-04-07
Expiration Date
Abstract
An immunomodulator for use in the treatment, reduction, inhibition or control of a neoplastic disease in a patient intended to undergo checkpoint inhibition therapy, simultaneously, separately or sequentially with administration of the immunomodulator. The immunomodulator preferably comprises a whole cell Mycobacterium, for example, M. vaccae or M. obuense.
Core Innovation
The invention relates to a method of treating, reducing, inhibiting or controlling a melanoma in a human patient using a checkpoint inhibitor selected from anti-PD-1 antibody, human or humanized anti-PD-L1 antibody, and anti-CTLA-4 antibody. The method includes more than one intravenous administration of the checkpoint inhibitor to the patient and intradermal administration of multiple doses of whole cell, heat-killed Mycobacterium obuense.
The whole cell, heat-killed Mycobacterium obuense is administered in two or more intradermal doses in a therapeutically effective per-dose amount. The whole cell, heat-killed Mycobacterium obuense is administered simultaneously, separately or sequentially with respect to the checkpoint inhibitor, with both being administered on multiple days.
The method is directed to producing enhanced therapeutic efficacy relative to administration of the checkpoint inhibitor alone. The combination is asserted to provide synergistic enhanced therapeutic efficacy versus either agent alone, and an example in a pancreatic cancer xenograft context reports greater tumor growth reduction than either monotherapy.
Claims Coverage
The independent claim defines a melanoma-treatment method that combines multiple intravenous doses of a checkpoint inhibitor with intradermal dosing of whole cell, heat-killed Mycobacterium obuense. Its coverage centers on the multi-route, timed combination producing enhanced therapeutic efficacy relative to checkpoint inhibitor alone, with three inventive features identified.
Intravenous checkpoint inhibitor with intradermal whole cell, heat-killed Mycobacterium obuense
A method of treating, reducing, inhibiting or controlling a melanoma in a human patient by more than one intravenous administration of a checkpoint inhibitor selected from anti-PD-1 antibody, human or humanized anti-PD-L1 antibody, and anti-CTLA-4 antibody, further comprising intradermal administration of two or more doses of whole cell, heat-killed Mycobacterium obuense.
Simultaneous, separate, or sequential administration on multiple days
The whole cell, heat-killed Mycobacterium obuense is administered simultaneously, separately or sequentially with respect to the checkpoint inhibitor, wherein each of the whole cell, heat-killed Mycobacterium obuense and checkpoint inhibitor is administered on multiple days.
Enhanced therapeutic efficacy relative to checkpoint inhibitor alone
The method results in enhanced therapeutic efficacy relative to administration of the checkpoint inhibitor alone.
Across the independent claim, the main inventive thrust is the melanoma treatment regimen that combines repeated intravenous checkpoint inhibitor dosing with repeated intradermal dosing of whole cell, heat-killed Mycobacterium obuense administered simultaneously, separately, or sequentially, producing enhanced therapeutic efficacy versus checkpoint inhibitor alone.
Stated Advantages
Enhanced therapeutic efficacy relative to administration of the checkpoint inhibitor alone.
Synergistic enhanced therapeutic efficacy versus either agent alone.
Greater tumor growth reduction in the described example compared to either monotherapy.
Documented Applications
Treating, reducing, inhibiting or controlling melanoma in a human patient using a checkpoint inhibitor combined with intradermal whole cell, heat-killed Mycobacterium obuense.
A pancreatic cancer xenograft context in which anti-PD-L1 combined with heat-killed Mycobacterium obuense is reported to yield greater tumor size reduction than monotherapy.
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