Methods of treating bladder cancer with an oncolytic virus
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Publication Number
US-11338003-B2
Publication Date
2022-05-24
Expiration Date
Abstract
The present invention provides methods for treating an individual having bladder cancer comprising intravesically administering to the individual an oncolytic virus. Also provided are pharmaceutical compositions and kits for treating bladder cancer.
Core Innovation
The invention relates to a method of treating bladder cancer in an individual or preserving bladder in an individual by intravesically administering an oncolytic virus. The method includes an induction phase followed by a maintenance phase, where the oncolytic virus is administered once per week for six weeks during induction and then administered once per week for three weeks every six months during maintenance.
The oncolytic virus comprises a viral vector that includes a tumor cell-specific promoter operably linked to a viral gene essential for replication of the oncolytic virus. The method further requires a heterologous gene encoding an immune-related molecule, and in the described example context the tumor cell-specific promoter is an E2F-1 tumor cell-specific promoter.
The disclosed approach is supported by patient treatment context focused on non-muscle invasive bladder cancer settings and bladder preservation, including populations such as BCG-unresponsive, BCG-refractory, or relapsing carcinoma in situ (CIS) ± Ta/T1. The regimen concept includes weekly dosing schedules across induction and maintenance phases, with phase start separation of about 3 months or about 6 months, and is described alongside clinical trial results indicating complete response outcomes at 6 months and an adverse event profile in a Phase II setting.
Claims Coverage
The only independent claim identified in the provided material combines three main inventive elements governing intravesical use, induction/maintenance timing, tumor-selective replication control via a tumor cell-specific promoter linked to a replication-essential viral gene, and immune modulation via a heterologous immune-related gene, with dependents narrowing specific constructs, timing separation, dosing constraints, and optionally pretreatment and eligible patient population.
Weekly intravesical induction and maintenance regimen for bladder treatment or bladder preservation
Intravesically administering to the individual an effective amount of the oncolytic virus once per week for six weeks during an induction phase, and subsequently administering the oncolytic virus once per week for three weeks every six months during a maintenance phase, wherein the start of the induction phase and the start of the maintenance phase are separated by about 3 months or about 6 months.
Tumor cell-specific promoter controlling replication of the oncolytic virus
The oncolytic virus comprises a viral vector comprising a tumor cell-specific promoter operably linked to a viral gene essential for replication of the oncolytic virus.
Heterologous immune-related gene in the oncolytic viral vector
The oncolytic virus comprises a heterologous gene encoding an immune-related molecule.
The core claimed coverage requires an intravesical oncolytic virus dosing regimen with induction and maintenance phases separated by about 3 months or about 6 months, together with tumor cell-specific control of replication and a heterologous gene encoding an immune-related molecule.
Stated Advantages
Treating bladder cancer in an individual.
Preserving bladder in an individual.
Documented Applications
Intravesical treatment of bladder cancer, including settings addressing non-muscle invasive bladder cancer and bladder sparing, such as BCG-unresponsive, BCG-refractory, or relapsing CIS ± Ta/T1.
A regimen used in a Phase II clinical trial context with reported complete response outcomes at 6 months and adverse event grading.
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