UroGen Announces New Data Presentations at the Society of Urologic Oncology 2024 Annual Meeting Highlighting Urothelial Cancer Portfolio Aimed at Addressing Unmet Needs
UroGen Pharma (URGN) announced new data presentations at the Society of Urologic Oncology 2024 annual meeting in Dallas, featuring updates on UGN-102, JELMYTO, and UGN-301. The presentations focus on treatments for low-grade intermediate-risk non-muscle-invasive bladder cancer and upper tract urothelial carcinoma. The data includes results from phase 3 trials of UGN-102, long-term outcomes of JELMYTO, and phase 1 studies of UGN-301 in various treatment scenarios.
UroGen Pharma (URGN) ha annunciato nuove presentazioni di dati alla riunione annuale della Society of Urologic Oncology 2024 a Dallas, presentando aggiornamenti su UGN-102, JELMYTO e UGN-301. Le presentazioni si concentrano sui trattamenti per il cancro alla vescica non muscolo-invasivo a basso grado e rischio intermedio e sul carcinoma uroteliale delle vie urinarie superiori. I dati includono i risultati degli studi di fase 3 di UGN-102, i risultati a lungo termine di JELMYTO e gli studi di fase 1 di UGN-301 in vari scenari terapeutici.
UroGen Pharma (URGN) anunció nuevas presentaciones de datos en la reunión anual de la Society of Urologic Oncology 2024 en Dallas, con actualizaciones sobre UGN-102, JELMYTO y UGN-301. Las presentaciones se centran en tratamientos para el cáncer de vejiga no musculoesquelético de bajo grado y riesgo intermedio, así como para el carcinoma urotelial de las vías urinarias superiores. Los datos incluyen resultados de ensayos de fase 3 de UGN-102, resultados a largo plazo de JELMYTO y estudios de fase 1 de UGN-301 en varios escenarios de tratamiento.
UroGen Pharma (URGN)은 댈러스에서 열리는 2024년 비뇨기 종양학회 연례 회의에서 UGN-102, JELMYTO, UGN-301에 대한 새로운 데이터 발표를 발표했습니다. 발표 내용은 저등급 중간 위험 비근육 침습성 방광암 및 상부 요로 유두세포 암종 치료에 중점을 두고 있습니다. 데이터에는 UGN-102의 3상 시험 결과, JELMYTO의 장기 결과, 다양한 치료 시나리오에서의 UGN-301 1상 연구 결과가 포함됩니다.
UroGen Pharma (URGN) a annoncé de nouvelles présentations de données lors de la réunion annuelle de la Society of Urologic Oncology 2024 à Dallas, avec des mises à jour sur UGN-102, JELMYTO et UGN-301. Les présentations se concentrent sur les traitements du cancer de la vessie non musculo-invasif à faible grade et risque intermédiaire ainsi que du carcinome urothélial des voies urinaires supérieures. Les données comprennent les résultats des essais de phase 3 de UGN-102, les résultats à long terme de JELMYTO et les études de phase 1 de UGN-301 dans divers scénarios de traitement.
UroGen Pharma (URGN) hat neue Datenpräsentationen auf dem jährlichen Treffen der Society of Urologic Oncology 2024 in Dallas angekündigt, die Updates zu UGN-102, JELMYTO und UGN-301 enthalten. Die Präsentationen konzentrieren sich auf Behandlungen von nicht-muskelinvasivem Blasenkarzinom mit niedrigem Grad und intermediärem Risiko sowie oberem Harntrakt-urothelialem Karzinom. Die Daten umfassen Ergebnisse aus Phase-3-Studien zu UGN-102, langfristige Ergebnisse von JELMYTO und Phase-1-Studien zu UGN-301 in verschiedenen Behandlungsszenarien.
- Multiple clinical trial data presentations at a major medical conference showing pipeline progress
- Advancement of UGN-102 to Phase 3 trials indicates late-stage development progress
- Development of home instillation capability for UGN-102 could improve treatment accessibility
- None.
"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.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat LG-UTUC and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer are designed to ablate tumors by non-surgical means. UroGen is headquartered in
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential benefits of UGN-102 and UGN-301; the future development of UGN-301; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: our development plans for UGN-301 may change for a variety of reasons, including data and other program considerations; even though the NDA for UGN-102 has been accepted for filing by the FDA, there is no guarantee that such NDA will be sufficient to support approval of UGN-102 on the timeframe expected, or at all; the ability to maintain regulatory approval; complications associated with commercialization activities; the labeling for any approved product; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology may not perform as expected; and UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 6, 2024 (which is available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241202620871/en/
INVESTOR CONTACT:
Vincent Perrone
Senior Director, Investor Relations
vincent.perrone@UroGen.com
609-460-3588 ext. 1093
MEDIA CONTACT:
Cindy Romano
Director, Corporate Communications
cindy.romano@urogen.com
609-460-3583 ext. 1083
Source: UroGen Pharma Ltd.
FAQ
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