Non-muscle-invasive bladder cancer (NMIBC) is the most common form of bladder cancer, comprising roughly 75% of all newly diagnosed bladder cancer in the USA and includes carcinoma in situ (CIS), Ta and T1 lesions. Together Ta and T1 lesions are termed papillary cancers. NMIBC is the subject of therapy with our lead product candidate, inodiftagene.
Non-muscle-invasive bladder cancer subtypes have a low metastatic potential. The object of treatment of patients with NMIBC is to prevent recurrence and progression to more invasive disease. They are resected and treated with adjuvant intravesical therapy. Inodiftagene vixteplasmid (BC-819) is an experimental intravesical therapy. Muscle-invasive bladder cancers that are diagnosed de novo or originate from the progression of NMIBC signify a greater risk of metastatic disease and are treated with complete bladder resection. Prevention of progression, and of the need for bladder removal, is the key therapeutic goal.
Inodiftagene vixteplasmid is designed to be included in early treatment for patients diagnosed with NMIBC. The treatment is being tested in two settings: in patients who have been treated with BCG and for whom a single course of treatment has failed; and in patients who have been treated with BCG and for whom two courses of treatment have failed. Disease in the latter population is termed BCG-unresponsive, and standard approaches to therapy for this group is bladder resection. The intravesical approach is well suited for inodiftagene treatment, with instillation into the bladder allowing direct contact of high drug concentration without systemic exposure.