UroGen -Model UGN-301 + UGN-201 (TLR 7 Agonist) -High-Grade Non-Muscle-Invasive Bladder Cancer (NMIBC)
UGN-301 is UroGen’s in-licensed anti-CTLA-4 antibody (zalifrelimab). UGN-201 is our proprietary formulation of imiquimod, a toll-like receptor 7 (TLR 7) agonist. When combined, these medicines stimulate both the innate (UGN-201) and adaptive (UGN-301) immune responses, both of which are important for fully harnessing the power of the immune system to fight cancer.
Bladder cancers are described as muscle invasive or non-muscle invasive (NMIBC) based on whether they have invaded into the wall of the bladder. High-grade (HG) NMIBC is associated with an increased risk of recurrence and progression. Transurethral resection of bladder tumor (TURBT) followed by intravesical bacillus Calmette-Guérin (BCG) is currently the standard of care for treatment of high-grade NMIBC.
Treatment with BCG indicates that bladder cancer can be sensitive to immunomodulation—using the body’s immune system to attack cancer cells. However, some patients who experience BCG resistance or lack of response need to transition to other options like intravesical chemotherapy and systemic immunotherapies.
Challenges posed by these treatments can be severe. Recurrence rates are high with the standard of care, and systemic immunotherapies pose substantial risks—including side effects that range from mild to potentially life-threatening. Without alternatives that overcome these challenges, the highest-risk patients are left with radical bladder removal surgery as the best remaining option.
Urogen is evaluating the combination of UGN-301 with hydrogel + UGN-201 as a local immunotherapy for the treatment of high-grade NMIBC