CG Oncology to Present Results on Cretostimogene Grenadenorepvec at the Society of Urologic Oncology (SUO) 25th Annual Meeting
CG Oncology (NASDAQ: CGON) announced multiple presentations featuring cretostimogene at the Society of Urologic Oncology (SUO) 25th Annual Meeting from December 4-6, 2024, in Dallas. The presentations include a late-breaking abstract on the Phase 3 BOND-003 trial results, examining cretostimogene monotherapy in high-risk BCG-unresponsive NMIBC, presented by Dr. Mark D. Tyson.
Additionally, four Trials in Progress posters will be presented, covering: BOND-003 Cohort P for papillary NMIBC, PIVOT-006 Phase 3 study for intermediate-risk NMIBC, CORE-008 Phase 2 multi-arm study, and the Expanded Access Program. These presentations demonstrate the company's comprehensive development program for cretostimogene as a potential bladder-sparing therapeutic.
CG Oncology (NASDAQ: CGON) ha annunciato diverse presentazioni che metteranno in evidenza il cretostimogene durante il 25° Congresso Annuale della Society of Urologic Oncology (SUO), che si terrà dal 4 al 6 dicembre 2024 a Dallas. Le presentazioni includono un abstract di ultima ora sui risultati del trial di Fase 3 BOND-003, che esamina la monoterapia con cretostimogene nei pazienti ad alto rischio con NMIBC non responsivo al BCG, presentato dal Dr. Mark D. Tyson.
Inoltre, verranno presentati quattro poster sui Trials in Corso, che copriranno: il Coorte P di BOND-003 per NMIBC papillare, lo studio di Fase 3 PIVOT-006 per NMIBC a rischio intermedio, lo studio multi-braccio di Fase 2 CORE-008 e il Programma di Accesso Espanso. Queste presentazioni dimostrano il programma di sviluppo completo dell'azienda per il cretostimogene come potenziale terapia che preserva la vescica.
CG Oncology (NASDAQ: CGON) anunció diversas presentaciones que destacarán el cretostimogene en el 25° Congreso Anual de la Sociedad de Oncología Urológica (SUO), que se llevará a cabo del 4 al 6 de diciembre de 2024 en Dallas. Las presentaciones incluirán un resumen de última hora sobre los resultados del ensayo de Fase 3 BOND-003, que examina la monoterapia con cretostimogene en NMIBC de alto riesgo que no responde al BCG, presentado por el Dr. Mark D. Tyson.
Además, se presentarán cuatro carteles de Ensayos en Progreso, que cubrirán: la Cohorte P de BOND-003 para NMIBC papilar, el estudio de Fase 3 PIVOT-006 para NMIBC de riesgo intermedio, el estudio multi-brazo de Fase 2 CORE-008 y el Programa de Acceso Expandido. Estas presentaciones demuestran el programa de desarrollo integral de la empresa para el cretostimogene como una terapia potencial que preserva la vejiga.
CG Oncology (NASDAQ: CGON)는 2024년 12월 4일부터 6일까지 달라스에서 열리는 제25회 비뇨기 종양학회(SUO) 연례 회의에서 cretostimogene을 주제로 한 여러 발표를 진행한다고 발표했습니다. 발표 중에는 Dr. Mark D. Tyson이 발표한 3상 BOND-003 시험 결과에 대한 최신 초록이 포함되어 있으며, 이는 BCG에 비반응적인 고위험 NMIBC 환자에서 cretostimogene 단독요법을 조사합니다.
또한, BOND-003의 NMIBC 유두형을 위한 코호트 P, 중간 위험 NMIBC를 위한 PIVOT-006 3상 연구, CORE-008 2상 다기관 연구, 확장 접근 프로그램을 다루는 네 개의 진행 중인 시험 포스터도 발표될 예정입니다. 이러한 발표는 cretostimogene이 방광 보존 치료제로서의 잠재력을 가진 포괄적인 개발 프로그램을 보여줍니다.
CG Oncology (NASDAQ: CGON) a annoncé plusieurs présentations mettant en avant le cretostimogene lors de la 25ème Réunion Annuelle de la Société d'Oncologie Urologique (SUO), qui se déroulera du 4 au 6 décembre 2024 à Dallas. Les présentations incluront un résumé de dernière minute sur les résultats de l'
De plus, quatre affiches des Essais en Cours seront présentées, couvrant : la Cohorte P de BOND-003 pour les NMIBC papillaires, l'étude de Phase 3 PIVOT-006 pour les NMIBC à risque intermédiaire, l'étude multi-brins de Phase 2 CORE-008 et le Programme d'Accès Élargi. Ces présentations démontrent le programme de développement complet de l'entreprise pour le cretostimogene en tant que traitement potentiel préservant la vessie.
CG Oncology (NASDAQ: CGON) gab bekannt, dass mehrere Präsentationen, die cretostimogene präsentieren, auf dem 25. jährlichen Treffen der Society of Urologic Oncology (SUO) vom 4. bis 6. Dezember 2024 in Dallas stattfinden werden. Zu den Präsentationen gehört ein Spontanabstrakt über die Ergebnisse der Phase 3 BOND-003-Studie, die die Monotherapie mit cretostimogene bei hochriskantem NMIBC untersucht, die von Dr. Mark D. Tyson präsentiert wird.
Darüber hinaus werden vier
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Includes Late-Breaking Abstract on Results of Phase 3 BOND-003 Trial of Cretostimogene Monotherapy in High-Risk BCG-Unresponsive NMIBC and Four Trials in Progress Posters
IRVINE, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that four Trials in Progress Posters highlighting cretostimogene, in addition to the recently announced late breaking abstract on BOND-003, will be presented at the Society of Urologic Oncology (SUO) 25th Annual Meeting taking place at the Sheraton Dallas Hotel in Dallas, TX, from December 4 - 6, 2024.
Details on the late-breaking abstract and posters are as follows:
Late-Breaking Abstract:
Topline Results from BOND-003: A Phase-3 Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High-Risk BCG-Unresponsive NMIBC with CIS
Podium Presentation
Presenter: Mark D. Tyson, M.D., Urologic Oncologist at Mayo Clinic, Scottsdale, AZ
Presentation Date & Time: December 5, 2024 at 11:45 AM Central Daylight Time
Location: The Sheraton Dallas Hotel, Dallas, TX
Trial in Progress Posters:
BOND-003- Cohort P: A Multi-national, Single-arm Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High-Risk, Papillary Only, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Poster Number: 125
Presenter: Mark D. Tyson, M.D., Urologic Oncologist at Mayo Clinic, Scottsdale, AZ
Presentation Date & Time: December 5, 2024 from 2:15-3:15 PM Central Daylight Time
Location: The Sheraton Dallas Hotel, Dallas, TX
PIVOT-006: A Phase 3, Randomized Study of Adjuvant Intravesical Cretostimogene Grenadenorepvec versus Surveillance for the Treatment of Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Poster Number: 126
Presenter: Robert S. Svatek, M.D., Urologic Oncologist at University of Texas Health Science Center, San Antonio, TX
Presentation Date & Time: December 5, 2024 from 2:15-3:15 PM Central Daylight Time
Location: The Sheraton Dallas Hotel, Dallas, TX
CORE-008: A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle Invasive Bladder Cancer
Poster Number: 235
Presenter: Trinity J. Bivalacqua, M.D., Ph.D., Urologic Oncologist at University of Pennsylvania, Philadelphia, PA
Presentation Date & Time: December 6, 2024 from 1:45-2:45 PM Central Daylight Time
Location: The Sheraton Dallas Hotel, Dallas, TX
The Cretostimogene Grenadenorepvec Expanded Access Program in Patients with Non-Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin
Poster Number: 236
Presenter: Sarah P. Psutka, M.D. M.Sc., Urologic Oncologist at University of Washington, Seattle, WA
Presentation Date & Time: December 6, 2024 from 1:45-2:45 PM Central Daylight Time
Location: The Sheraton Dallas Hotel, Dallas, TX
About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) therapy. Cretostimogene is also being evaluated in a Phase 3 monotherapy clinical trial (PIVOT-006) in patients with intermediate-risk NMIBC. In addition, cretostimogene is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer. Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
About CG Oncology
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com.
Forward Looking Statements
CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, the potential therapeutic benefits of cretostimogene in combination with nivolumab in Muscle Invasive Bladder Cancer, the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients; and the anticipated timing of BOND-003 topline data. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: additional patient data related to cretostimogene in combination with nivolumab that continues to become available may be inconsistent with the data produced as of the data cutoff, and further analysis of existing data and analysis of new data may lead to conclusions different from those established as of the date hereof; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; potential delays in the commencement, enrollment and completion of clinical trials; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts:
Media
Sarah Connors
Vice President, Communications and Patient Advocacy, CG Oncology
(508) 654-2277
sarah.connors@cgoncology.com
Investor Relations
Chau Cheng
Vice President, Investor Relations, CG Oncology
(949) 342-8939
chau.cheng@cgoncology.com
FAQ
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