Layers of the urinary bladder wall and cross section of the detrusor muscle. Credit: Tilifa Ocaufa.

Anchiano Therapeutics has commenced a Phase II Codex trial examining the efficacy and safety of inodiftagene vixteplasmid (BC-819) for the treatment of patients with non-muscle-invasive bladder cancer (NMIBC).

Inodiftagene vixteplasmid is a gene therapy and a recombinant DNA plasmid designed to direct the expression of a potent toxin specifically in malignant cells without affecting normal tissue.

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The multicentre, open-label, single-arm trial aims to enrol 140 patients with NMIBC that have high-grade stage Ta or T1 papillary tumours or carcinoma in situ (CIS) and whose disease is unresponsive to bacillus calmette-guerin (BCG) therapy.

“BCG-unresponsive NMIBC represents an area of high unmet medical need with limited standard treatment options.”

Anchiano will administer 20mg of inodiftagene vixteplasmid as monotherapy via instillation into the urinary bladder for ten weeks, which will be followed by treatment every three weeks for up to two years or until disease recurrence.

The trial’s primary objective is complete response rate in patients with clinically isolated syndrome (CIS).

It is expected to observe patients with complete response for at least one year following the beginning of response.

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Interim analysis will then be conducted on data from the first 35 CIS patients.

Anchiano Therapeutics chief medical officer Dr David Kerstein said: “BCG-unresponsive NMIBC represents an area of high unmet medical need with limited standard treatment options, outside of surgical removal of the bladder.

“NMIBC is a cancer that has been lacking in new therapies for two decades, and we are excited to embark on this important next step in the development of inodiftagene vixteplasmid.”