On December 2, 2024 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that new data on UGN-102 (mitomycin) for intravesical solution, JELMYTO (mitomycin) for pyelocalyceal solution, and UGN-301(zalifrelimab intravesical solution) will be presented at the Society of Urologic Oncology (SUO) 2024 annual meeting being held in Dallas, Texas from December 4 – 6 (Press release, UroGen Pharma, DEC 2, 2024, View Source [SID1234648729]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are excited that the SUO has accepted data highlighting the potential of our investigational treatment, UGN-102, in development for patients with low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC), as well as the ongoing clinical value of JELMYTO for treating low-grade upper tract urothelial carcinoma (LG-UTUC)," said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. "These presentations underscore our ongoing commitment to addressing the critical unmet needs of patients with urothelial cancers, as well as our mission to provide innovative treatment options that seek to improve both outcomes and quality of life for those battling these challenging conditions."
Key details of UGN-102, JELMYTO and UGN-301 abstracts accepted by SUO:
Abstract Title
Schedule
Presenter
PRIMARY CHEMOABLATION OF RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE-INVASIVE BLADDER CANCER WITH UGN-102: A SINGLE-ARM, OPEN-LABEL, PHASE 3 TRIAL (ENVISION)
Poster 121
Date: 12/5
Time: 2:15-3:15 pm CT
Dr. Max Kates
LONG-TERM OUTCOMES OF PRIMARY CHEMOABLATION OF LOW-GRADE UPPER TRACT UROTHELIAL CARCINOMA (LG-UTUC) WITH UGN-101, A MITOMYCIN REVERSE THERMAL GEL
Poster 122
Date: 12/5
Time: 2:15-3:15 pm CT
Dr. Brian Hu
HOME INSTILLATION OF UGN-102 FOR PRIMARY CHEMOABLATION OF RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE-INVASIVE BLADDER CANCER: A SINGLE-ARM, OPEN-LABEL, PHASE 3B TRIAL
Poster 124
Date: 12/5
Time: 2:15 – 3:15 pm CT
Dr. Vincent Michael Bivins
A PHASE 1 DOSE-ESCALATION STUDY OF UGN-301 (ZALIFRELIMAB) IN PATIENTS WITH RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)
Poster 133
Date: 12/5
Time: 2:15 – 3:15 pm CT
Caretha L. Creasy
A PHASE 1 DOSE-ESCALATION STUDY OF UGN-301 (ZALIFRELIMAB) AS MONOTHERAPY AND IN COMBINATION WITH OTHER AGENTS IN PATIENTS WITH RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)
Poster 206
Date: 12/6
Time: 10:00 – 11:00 am CT
Caretha L. Creasy
For further information about UroGen’s ongoing clinical trials and programs, please visit our website at urogen.com to learn more or follow us on X (Twitter), @UroGenPharma.
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. UroGen completed the NDA submission in August, ahead of schedule. The FDA accepted the NDA for UGN-102 and assigned a PDUFA goal date of June 13, 2025.
About JELMYTO
JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with LG-UTUC. It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.
UGN-301
UGN-301 is our investigational, in-licensed, anti-CTLA-4 monoclonal antibody (zalifrelimab), prepared with reverse-thermal hydrogel for intravesical administration into the bladder. Intravesical administration of UGN-301 is designed to increase drug concentrations in the bladder without significant systemic exposure, potentially diminishing the systemic toxicity associated with CTLA-4 blockade. UroGen is evaluating UGN-301 as combination therapy for the intravesical treatment of high-grade NMIBC.