imiquimod/zalifrelimab (UGN-302) / UroGen - LARVOL DELTA

Treatment of recurrent non-muscle invasive bladder cancer with UGN-301 (zalifrelimab) alone and in combination: A phase 1 dose escalation study. (ASCO-GU 2026) - P1 | "This phase 1 study (NCT05375903) assessed safety, pharmacokinetics, and recommended phase 2 dose (RP2D) of UGN-301 alone or combined with either a fixed dose of intravesical UGN-201 (imiquimod; toll-like receptor 7 agonist) or gemcitabine (gem) for recurrent NMIBC... 20 patients received UGN-301 monotherapy (100 mg [n = 3], 300 mg [n = 6], 500 mg [n = 8], and 700 mg [n = 3]; Arm A), 11 received UGN-201/UGN-301 (300 mg [n = 3], 500 mg [n = 8]; Arm B), and 10 received gem/UGN-301 (300 mg [n = 3], 500 mg [n = 7]; Arm C)... Intravesical UGN-301 in RTgel provided sustained bladder exposure to zalifrelimab with minimal systemic absorption, limiting CTLA-4-related toxicity. UGN-301 alone or with UGN-201 or gem showed favorable safety and preliminary efficacy, supporting further evaluation of 500 mg UGN-301. Assessment of response duration in combination arms is ongoing."

P1 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

UroGen Pharma Reports First Quarter 2021 Financial Results and Recent Corporate Developments (Businesswire) - “Jelmyto® net product revenue of $7.5 million for the first quarter of 2021; The ATLAS trial is expected to enroll approximately 630 patients and is evaluating UGN-102 as a primary non-surgical treatment compared to standard of care – transurethral resection of bladder tumor (TURBT) – in patients diagnosed with LG-IR-NMIBC; Expanded immuno-oncology pipeline with the announcement of two strategic research collaborations during the first quarter of 2021…UroGen and MD Anderson expect to advance the UGN-302 program [UGN-201 (imiquimod) TLR 7/8 + UGN-301 (zalifrelimab) CTLA-4] in the first half of 2021 through nonclinical studies for UGN-301 and UGN-201, as well as a potential human study for UGN-201.”

Clinical • Enrollment status • New trial • Sales • Bladder Cancer • Genito-urinary Cancer • Oncology • Urothelial Cancer

UroGen Pharma Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Corporate Developments (Businesswire) - “UGN-302 [UGN-201 (imiquimod) TLR 7/8 + UGN-301 (zalifrelimab) CTLA-4]: UroGen and MD Anderson expect to progress the UGN-302 program in the first half of 2021, which includes potential non-clinical studies for UGN-301 and UGN-201, as well as potential clinical studies for UGN-201.”

Clinical • Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer