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Publication Number
US-11596660-B2
Publication Date
2023-03-07
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 disclosed invention provides a method of treating bladder cancer in an individual or preserving bladder in an individual by intravesically administering an oncolytic virus. The method includes administering the oncolytic virus once per week for six weeks during an induction phase, followed by intravesically administering an effective amount once per week for three weeks every three or six months during a maintenance phase, with the start of the induction phase and the start of the maintenance phase separated by about three months or about six months.
The oncolytic virus comprises a viral vector that uses a tumor cell-specific promoter operably linked to a viral gene essential for replication of the oncolytic virus, and includes a heterologous gene encoding an immune-related molecule. In particular embodiments described in the document, the tumor cell-specific promoter includes an E2F-1 promoter, the viral gene essential for replication includes E1A/E1B/E4 elements, and the immune-related molecule is primarily GM-CSF.
The document frames the overall problem as the need to treat non-muscle invasive bladder cancer while preserving bladder and managing treatment options in BCG-unresponsive/refractory/relapsing NMIBC, including bladder cancer types such as pure CIS and CIS+Ta/T1. The disclosed method is described in connection with clinical trial assessment of intravesical CG0070 efficacy and tolerability, including complete response rates and observed adverse events.
Claims Coverage
The independent claims identified in the provided material include one independent claim: clm-00001. Claim clm-00001 includes three inventive features covering an intravesical induction and maintenance dosing schedule, a time separation between induction and maintenance starts, and an oncolytic-virus design combining a tumor cell-specific promoter linked to a viral gene essential for replication with a heterologous immune-related gene.
Intravesical induction and maintenance regimen for bladder cancer treatment or bladder preservation
Intravesically administering to the individual an effective amount of an oncolytic virus once per week for six weeks during an induction phase, and subsequently intravesically administering to the individual an effective amount of the oncolytic virus once per week for three weeks every three or six months during a maintenance phase.
Time separation between induction and maintenance phases
Wherein the start of the induction phase and the start of the maintenance phase are separated by about three months or about six months.
Tumor cell-specific replication control and heterologous immune-related gene
Wherein 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, and a heterologous gene encoding an immune-related molecule.
Across independent claim clm-00001, the core inventive features are the intravesical weekly induction followed by weekly maintenance, the about three- or six-month separation between induction and maintenance starts, and the oncolytic-virus viral vector architecture using a tumor cell-specific promoter to control replication-essential viral genes together with a heterologous gene encoding an immune-related molecule.
Stated Advantages
Bladder preservation.
Reduced need for cystectomy.
Improved quality of life.
Documented Applications
Intravesical treatment of bladder cancer, including BCG-unresponsive/refractory/relapsing non-muscle invasive bladder cancer (NMIBC), including pure CIS and CIS+Ta/T1, using intravesical CG0070.
Method includes patient contexts such as cystectomy refusal/ineligibility and TURBT-naïve Ta/T1, as described in the document.
Clinical trial assessment of intravesical CG0070 efficacy and tolerability in Phase II and an overview of a Phase III regimen.
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