MD Anderson and UroGen Pharma announce strategic research collaboration to advance investigational treatment for high-grade bladder cancer

Collaboration will focus on UGN-302 as an investigational treatment for high-grade non-muscle invasive bladder cancer

Âé¶¹Ó³»­ MD Anderson Cancer Center and UroGen Pharma Ltd. today announced a strategic three-year collaboration agreement to advance combinatorial intravesical immunotherapy, which is delivered directly into the bladder, for the treatment of high-grade non-muscle invasive bladder cancer (HG-NMIBC).

UroGen¡¯s approach involves the local delivery of potent immunomodulators (UGN-201, a TLR 7/8 agonist and UGN-301, an anti-CTLA-4 antibody). UGN-301, an immune checkpoint inhibitor, is delivered using UroGen¡¯s proprietary RTGelTM platform to increase dwell time, which has been shown to significantly improve the effectiveness of intravesical therapy.

¡°We are pleased to enter into this collaboration with MD Anderson and its immunotherapy platform, which brings unique translational and clinical expertise in immuno-oncology,¡± said Mark Schoenberg, M.D., chief medical officer of UroGen Pharma. ¡°This agreement will help UroGen potentially bring next-generation immunotherapy to bladder cancer patients with a significant unmet need and limited clinical options other than bladder removal.¡±

Under the agreement, MD Anderson and UroGen will collaborate on the design and conduct of non-clinical and clinical studies with oversight from a joint steering committee. UroGen will provide funding, developmental candidates, and other support.

UroGen¡¯s investigational candidates, UGN-201 and UGN-301, are being developed to ablate tumors by non-surgical means in the treatment of HG-NMIBC. Non-clinical data suggest treatment with the combination of UGN-201 and an anti-CTLA4 antibody, delivered using UroGen's proprietary RTGel platform, may result in improved survival and decreased tumor size.

¡°Immune checkpoint inhibitors have become important treatment options for many patients with bladder cancer, and we look forward to working with UroGen to advance new immunotherapy strategies with intravesical delivery,¡± said , chair of Immunology, executive director of the immunotherapy platform and co-director of the at MD Anderson. ¡°This novel delivery approach has the potential to limit the adverse events seen with systemic immunotherapy treatment while providing clinical benefit, which would represent a major advancement to patient care.¡±