Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11318193-B2
Publication Date
2022-05-03
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, embolization, 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 relates to a method for treating a tumour in a human patient, specifically a tumour that is pancreatic cancer. An ablative tumour disruption therapy is applied to induce damage to the tumour or one or more tumour cells and release of tumour antigens, where the ablative tumour disruption therapy is targeted radiotherapy comprising a dose of radiation that is fractionated.
The invention combines the ablative, antigen-releasing targeted radiotherapy with intradermal administration of an immunomodulator composition consisting of non-pathogenic heat-killed whole cell Mycobacterium obuense. The immunomodulator is administered simultaneously, separately, or sequentially with the induction of damage, and is provided in an effective amount as multiple intradermal doses administered prior to and after the ablative tumour disruption therapy.
The disclosed approach is applicable to metastatic pancreatic cancer by applying fractionated targeted radiotherapy to metastatic cancer tissue at a site different from a primary pancreatic tumour, with the primary pancreatic tumour and/or metastatic cancer tissue thereby regressed or stabilized.
Claims Coverage
The independent claim coverage includes three independent methods for pancreatic cancer and metastatic pancreatic cancer that share a common combination structure: fractionated targeted ablative radiotherapy to induce tumour disruption and tumour antigen release, together with intradermal immunomodulator administration of non-pathogenic heat-killed whole cell Mycobacterium obuense in multiple doses before and after the radiotherapy. The main inventive features comprise the ablative, targeted, fractionated radiotherapy and the timing and form of intradermal immunomodulator co-administration, with metastasis handled by treating metastatic tissue at a different site than a primary pancreatic tumour.
Fractionated targeted ablative tumour disruption therapy inducing antigen release
Applying an ablative tumour disruption therapy to the tumour to induce damage to the tumour or one or more tumour cells and release of tumour antigens, wherein the ablative tumour disruption therapy is targeted radiotherapy and the targeted radiotherapy comprises a dose of radiation that is fractionated.
Intradermal immunomodulator of non-pathogenic heat-killed whole cell Mycobacterium obuense before and after radiotherapy
Simultaneously, separately, or sequentially with the induction of damage to the tumour or one or more tumour cells, intradermally administering to the human patient an effective amount of an immunomodulator composition consisting of non-pathogenic heat-killed whole cell Mycobacterium obuense, wherein 0.01 mg to 1 mg of the non-pathogenic heat-killed whole cell Mycobacterium obuense is intradermally administered per dose, wherein the immunomodulator composition is intradermally administered in multiple doses and is intradermally administered prior to and after the ablative tumour disruption therapy.
Metastatic treatment at a different site with fractionated targeted radiotherapy
Applying an ablative disruption therapy to metastatic cancer tissue at a site different from that of a primary pancreatic tumour, wherein the ablative disruption therapy induces damage to the 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 immunomodulator for metastatic pancreatic cancer prior to and after ablative radiotherapy
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 0.01 mg to 1 mg of the non-pathogenic heat-killed whole cell Mycobacterium obuense is intradermally administered per dose, wherein the immunomodulator composition is intradermally administered in multiple doses and is intradermally administered prior to and after the ablative disruption therapy.
Stereotactic ablative radiotherapy to metastatic tissue with fractionated dose
Applying stereotactic ablative radiotherapy to metastatic cancer tissue at a site different from that of a primary pancreatic tumour, wherein the stereotactic ablative radiotherapy induces damage to the metastatic cancer tissue and release of tumour antigens, and wherein the stereotactic ablative radiotherapy comprises a dose of radiation that is fractionated.
Intradermal immunomodulator prior to and after stereotactic ablative radiotherapy for regression or stabilization
Simultaneously, separately, or sequentially with the stereotactic ablative radiotherapy, intradermally administering to the human patient an effective amount of an immunomodulator composition consisting of non-pathogenic heat-killed whole cell Mycobacterium obuense, wherein 0.01 mg to 1 mg of the non-pathogenic heat-killed whole cell Mycobacterium obuense is intradermally administered per dose, wherein the immunomodulator composition is intradermally administered in multiple doses and is intradermally administered prior to and after the stereotactic ablative radiotherapy.
Across the independent claims, the coverage centers on treating pancreatic cancer, including metastatic pancreatic cancer, by applying fractionated targeted ablative radiotherapy to induce damage and release of tumour antigens, while intradermally administering an immunomodulator consisting of non-pathogenic heat-killed whole cell Mycobacterium obuense in multiple doses prior to and after the radiotherapy, resulting in regression or stabilization of the tumour or metastatic cancer tissue.
Stated Advantages
The tumour is thereby regressed or stabilized.
Documented Applications
Treating a tumour in a human patient where the tumour is pancreatic cancer using targeted radiotherapy fractionated ablative tumour disruption therapy combined with intradermal non-pathogenic heat-killed whole cell Mycobacterium obuense immunomodulator administration.
Treating metastatic pancreatic cancer in a human patient by applying fractionated targeted ablative disruption therapy to metastatic cancer tissue at a site different from that of a primary pancreatic tumour and administering the non-pathogenic heat-killed whole cell Mycobacterium obuense immunomodulator prior to and after the ablative disruption therapy.
Interested in licensing this patent?