Methods of treating bladder cancer by combination therapy comprising the oncolytic adenovirus CG0070 and an immune checkpoint inhibitor
Inventors
Yeung, Alex Wah Hin • KUAN, Arthur
Assignees
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Publication Number
US-11497781-B2
Publication Date
2022-11-15
Expiration Date
Abstract
The present invention provides methods for treating an individual having solid or lymphatic tumor comprising locally administering to the site of the tumor an oncolytic virus, and systemically administering an immunomodulator (including a combination of immunomodulators). The methods may further comprise local administration to the site of the tumor a second immunomodulator (including a combination of immunomodulators). Also provided are compositions and kits for the cancer therapy methods.
Core Innovation
The invention provides a method of treating a solid or lymphatic tumor in an individual by combining an oncolytic virus and an immunomodulator. The method includes intravesically administering an effective amount of CG0070 and intravenously administering an effective amount of pembrolizumab, where the solid or lymphatic tumor is bladder cancer.
CG0070 is described as an oncolytic adenovirus with an E2F-1 tumor cell-specific promoter driving an essential replication gene, together with a heterologous immune-related gene encoding GM-CSF. The invention further defines treatment contexts in bladder cancer, including non-muscle invasive disease and subtypes such as carcinoma in situ, and patient-treatment history categories including resistance to BCG, progression after BCG treatment, and recurrent bladder cancer following BCG treatment.
The invention additionally includes regimen refinements that constrain administration timing and schedule for the intravesically administered CG0070 and the intravenously administered pembrolizumab. Further refinement includes introduction of a transduction enhancing agent, including DDM (N-dodecyl-β-D-maltoside), and additional locally delivered inactivated tumor cells.
Claims Coverage
The independent claim centers on treating bladder cancer with intravesical administration of the oncolytic virus CG0070 and intravenous administration of pembrolizumab, with the key inventive elements being local oncolytic delivery plus systemic immunomodulation.
Intravesical CG0070 administration for bladder cancer
An effective amount of an oncolytic virus administered intravesically, wherein the oncolytic virus is CG0070, and wherein the solid or lymphatic tumor is bladder cancer.
Intravenous pembrolizumab immunomodulation
An effective amount of an immunomodulator administered intravenously, wherein the immunomodulator is pembrolizumab.
Non-muscle invasive bladder cancer refinement
The method further comprising applying the treatment to non-muscle invasive bladder cancer, including carcinoma in situ.
BCG-related bladder cancer refinement
The method further comprising applying the treatment to individuals with bladder cancer who are resistant to BCG treatment, initially responsive but progress after BCG treatment, or who have recurrent bladder cancer following BCG treatment.
Administration timing and transduction enhancement refinements
The method further defines administration timing and schedule for CG0070 and pembrolizumab, and includes a transduction enhancing agent such as DDM (N-dodecyl-β-D-maltoside).
Overall, the claim coverage is centered on a combination therapy for bladder cancer that pairs intravesical CG0070 with intravenous pembrolizumab, with dependent refinements directed to non-muscle invasive settings, BCG-related clinical contexts, administration timing and schedule, and a transduction enhancing agent such as DDM.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating a solid or lymphatic tumor in an individual, wherein the tumor is bladder cancer, using intravesical CG0070 combined with intravenous pembrolizumab.
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