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BCG (TICE strain), marketed as TICE® BCG or OncoTICE, is a live attenuated bacterial immunotherapy derived from the Bacillus of Calmette and Guérin (BCG) strain of Mycobacterium bovis. The TICE strain was originally developed at the University of Illinois from a strain that originated at the Pasteur Institute. It is administered intravesically (directly into the bladder) and works as an immunostimulant, triggering a local immune response that targets bladder cancer cells. Each vial contains 1 to 8 × 10⁸ colony forming units (CFU), equivalent to approximately 50 mg wet weight, in a freeze-dried preparation. BCG (TICE strain) is used for the treatment of non-muscle invasive bladder cancer (NMIBC), particularly in high-risk patients, and is considered the gold standard adjuvant intravesical treatment for intermediate- and high-risk NMIBC. In the BCG-TIME trial (sponsored by Queen's University), it is being evaluated both as a monotherapy and in combination with intravesical gemcitabine in elderly patients with high-risk NMIBC, alongside a novel biomarker assessment. The drug is a biologic (live bacterial preparation), with its biological target being the host immune system — specifically stimulating innate and adaptive immune responses within the bladder to prevent tumor recurrence and progression.
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