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Publication Number
US-11554166-B2
Publication Date
2023-01-17
Expiration Date
Abstract
The present invention provides an immunomodulator for use in the treatment and/or control of a neoplastic disease in a patient intended to undergo immunogenic cell death therapy simultaneously, separately or sequentially with administration of the immunomodulator. The therapy can be selected from microwave irradiation, targeted radiotherapy, embolisation, cryotherapy, ultrasound, high intensity focused ultrasound, cyberknife, hyperthermia, radiofrequency ablation, cryoablation, electrotome heating, hot water injection, alcohol injection, embolization, radiation exposure, photodynamic therapy, laser beam irradiation, and combinations thereof.
Core Innovation
The invention is directed to a method for treating a solid tumour in a human patient by applying an ablative tumour disruption therapy to the solid tumour to induce damage to the solid tumour or one or more cells of the solid tumour and release of tumour antigens. The ablative tumour disruption therapy is targeted radiotherapy of the solid tumour, and the targeted radiotherapy is fractionated. The tumour is thereby regressed or stabilized.
In combination with the ablative tumour disruption therapy, an immunomodulator composition is administered intradermally. The immunomodulator composition consists of non-pathogenic heat-killed whole cell Mycobacterium obuense, and an effective amount is administered in multiple intradermal doses. The intradermal administration is simultaneous, separately, or sequentially with the induction of tumour damage, and is administered prior to and after the ablative tumour disruption therapy.
The described approach is also directed to treating solid metastatic cancer by applying an ablative disruption therapy to solid metastatic cancer tissue at a site different from that of a solid primary tumour. The ablative disruption therapy is targeted radiotherapy with fractionation, and is used to induce damage and release of tumour antigens. An intradermal immunomodulator composition consisting of non-pathogenic heat-killed whole cell Mycobacterium obuense is administered in multiple doses prior to and after the ablative disruption therapy to regressed or stabilize the solid primary tumour and/or the solid metastatic cancer tissue.
Claims Coverage
The document provides two independent claims directed to treating a solid tumour and treating solid metastatic cancer. Across these claims, the main inventive content comprises fractionated targeted radiotherapy as an ablative tumour disruption therapy and intradermal administration of a non-pathogenic heat-killed whole cell Mycobacterium obuense immunomodulator composition in multiple doses before and after the radiotherapy.
Fractionated targeted radiotherapy as ablative tumour disruption therapy
Applying an ablative tumour disruption therapy to the solid tumour, wherein the ablative tumour disruption therapy is targeted radiotherapy of the solid tumour, and wherein the targeted radiotherapy comprises a dose of radiation that is fractionated, the therapy inducing damage to the solid tumour or one or more cells of the solid tumour and release of tumour antigens.
Intradermal immunomodulator of non-pathogenic heat-killed Mycobacterium obuense with before-and-after timing
Simultaneously, separately, or sequentially with the induction of damage, intradermally administering to the human patient an effective amount of an immunomodulator composition consisting of non-pathogenic heat-killed whole cell Mycobacterium obuense, wherein the immunomodulator composition is intradermally administered in multiple doses and is intradermally administered prior to and after the ablative tumour disruption therapy, wherein the solid tumour is thereby regressed or stabilized.
Ablative disruption therapy to metastatic tissue at a different site with fractionated targeted radiotherapy
Applying an ablative disruption therapy to solid metastatic cancer tissue at a site different to that of a solid primary tumour, wherein the ablative disruption therapy induces damage to the solid metastatic cancer tissue and release of tumour antigens, wherein the ablative disruption therapy is targeted radiotherapy, and wherein the targeted radiotherapy comprises a dose of radiation that is fractionated.
Intradermal heat-killed Mycobacterium obuense immunomodulator with multiple dosing before-and-after radiotherapy for metastatic/primary regression or stabilization
Simultaneously, separately, or sequentially with the ablative disruption therapy, intradermally administering to the human patient an effective amount of an immunomodulator composition consisting of non-pathogenic heat-killed whole cell Mycobacterium obuense, wherein the immunomodulator composition is intradermally administered in multiple doses and is intradermally administered prior to and after the ablative disruption therapy, and wherein the solid primary tumour and/or the solid metastatic cancer tissue is thereby regressed or stabilized.
The claim coverage centers on fractionated targeted radiotherapy used as an ablative tumour disruption therapy to induce tumour damage and release of tumour antigens, together with intradermal administration of an immunomodulator composition consisting of non-pathogenic heat-killed whole cell Mycobacterium obuense given in multiple doses prior to and after the radiotherapy to achieve regression or stabilization.
Stated Advantages
The solid tumour is thereby regressed or stabilized.
The solid primary tumour and/or the solid metastatic cancer tissue is thereby regressed or stabilized.
Documented Applications
A clinical example protocol for previously treated colorectal cancer using IMM-101 with cyberknife SBRT and subsequent dose schedules, reporting tumor regression by week 12 and disease stabilization after continued IMM-101.
Preclinical mouse data showing improved tumour volume reduction with irradiation plus IMM-101 in a Balb/c Renca tumor context.
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