CG Oncology Announces Nature Medicine Publication of Phase 1b Study Results Evaluating Cretostimogene Grenadenorepvec in Combination with Nivolumab in Muscle-Invasive Bladder Cancer
CG Oncology announced the publication of Phase 1b study results in Nature Medicine, evaluating cretostimogene grenadenorepvec combined with nivolumab in muscle-invasive bladder cancer (MIBC). The results were also presented at the Society for Immunotherapy of Cancer 2024. This marks the second Nature Medicine publication for cretostimogene this year, following June 2024's publication of CORE-001 phase 2 study results. The drug shows potential as a bladder-sparing therapeutic, featuring a dual mechanism that selectively targets cancer cells while boosting immune response against bladder tumors. The company expects to share topline results from their BOND-003 registrational study in High-Risk Non-Muscle Invasive Bladder Cancer later this year.
CG Oncology ha annunciato la pubblicazione dei risultati dello studio di Fase 1b su Nature Medicine, che valuta la combinazione di cretostimogene grenadenorepvec con nivolumab nel cancro della vescica muscolo-invasivo (MIBC). I risultati sono stati presentati anche alla Society for Immunotherapy of Cancer 2024. Questo segna la seconda pubblicazione su Nature Medicine per il cretostimogene quest'anno, dopo la pubblicazione dei risultati dello studio di fase 2 CORE-001 a giugno 2024. Il farmaco mostra potenziale come terapia risparmiatrice di vescica, presentando un meccanismo duplice che colpisce selettivamente le cellule tumorali mentre potenzia la risposta immunitaria contro i tumori della vescica. L'azienda prevede di condividere i risultati preliminari del loro studio registrativo BOND-003 nel cancro della vescica non muscolo-invasivo ad alto rischio entro la fine di quest'anno.
CG Oncology anunció la publicación de los resultados del estudio de Fase 1b en Nature Medicine, evaluando el cretostimogene grenadenorepvec combinado con nivolumab en cáncer de vejiga músculo-invasivo (MIBC). Los resultados también se presentaron en la Society for Immunotherapy of Cancer 2024. Este es el segundo artículo en Nature Medicine para el cretostimogene este año, después de la publicación de los resultados del estudio de fase 2 CORE-001 en junio de 2024. El fármaco muestra potencial como tratamiento que preserva la vejiga, con un mecanismo dual que ataca selectivamente las células cancerosas al tiempo que refuerza la respuesta inmune contra los tumores de la vejiga. La empresa espera compartir los resultados preliminares de su estudio registrativo BOND-003 en cáncer de vejiga no músculo-invasivo de alto riesgo a finales de este año.
CG Oncology는 Nature Medicine에 근육 침습성 방광암(MIBC)에서 nivolumab과 함께 cretostimogene grenadenorepvec의 효과를 평가한 1b상 연구 결과를 발표했습니다. 이 결과는 2024년 암 면역요법 학회에서도 발표되었습니다. 이는 올해 cretostimogene에 대한 두 번째 Nature Medicine 발표로, 2024년 6월에 진행된 CORE-001 2상 연구 결과 발표에 이어지는 것입니다. 이 약물은 방광 보호 치료제로서의 가능성을 보여주며, 암세포를 선택적으로 타겟하고 방광 종양에 대한 면역 반응을 강화하는 이중 메커니즘을 특징으로 합니다. 회사는 올해 말 고위험 비근육 침습성 방광암에 대한 BOND-003 등록 연구의 주요 결과를 공유할 계획입니다.
CG Oncology a annoncé la publication des résultats de l'étude de Phase 1b dans Nature Medicine, évaluant la combinaison de cretostimogene grenadenorepvec avec nivolumab dans le cancer de la vessie musculo-invasif (MIBC). Les résultats ont également été présentés lors de la Society for Immunotherapy of Cancer 2024. Cela marque la deuxième publication de Nature Medicine pour le cretostimogene cette année, après la publication des résultats de l'étude de phase 2 CORE-001 en juin 2024. Le médicament montre un potentiel en tant que traitement épargnant la vessie, avec un mécanisme double qui cible sélectivement les cellules cancéreuses tout en renforçant la réponse immunitaire contre les tumeurs de la vessie. L'entreprise prévoit de partager les résultats préliminaires de son étude enregistrante BOND-003 dans le cancer de la vessie non musculo-invasif à haut risque plus tard cette année.
CG Oncology hat die Veröffentlichung der Ergebnisse der Phase-1b-Studie in Nature Medicine angekündigt, in der die Kombination von cretostimogene grenadenorepvec mit nivolumab bei muskelinvasivem Blasenkrebs (MIBC) untersucht wird. Die Ergebnisse wurden auch auf der Society for Immunotherapy of Cancer 2024 präsentiert. Dies ist die zweite Veröffentlichung von Nature Medicine für cretostimogene in diesem Jahr, nach der Veröffentlichung der Ergebnisse der CORE-001-Studie der Phase 2 im Juni 2024. Das Medikament zeigt Potenzial als blasen-sparende Therapie und verfügt über einen dualen Wirkmechanismus, der gezielt Tumorzellen angreift und gleichzeitig die Immunantwort gegen Blasentumoren stärkt. Das Unternehmen plant, später in diesem Jahr die wichtigsten Ergebnisse seiner registrierenden Studie BOND-003 bei hochriskantem nicht-muskelinvasivem Blasenkrebs zu veröffentlichen.
- Second Nature Medicine publication in 2024, demonstrating scientific validation
- Drug shows dual mechanism of action: cancer cell destruction and immune response enhancement
- Selective targeting of cancer cells while preserving healthy tissue
- Upcoming topline results from BOND-003 registrational study
- None.
Insights
The publication of Phase 1b study results in Nature Medicine represents significant validation for CG Oncology's cretostimogene grenadenorepvec. The dual mechanism of action - selective cancer cell destruction and immune response amplification - shows promise in both monotherapy and combination settings. The second Nature Medicine publication this year strengthens the clinical evidence portfolio.
The combination therapy with nivolumab in muscle-invasive bladder cancer (MIBC) builds upon previous success with pembrolizumab in non-muscle invasive bladder cancer (NMIBC). The bladder-sparing approach could potentially transform the treatment landscape, offering alternatives to radical cystectomy. The upcoming BOND-003 registrational study results will be important for market potential and regulatory pathway.
The selective targeting of cancer cells while preserving healthy tissue suggests a favorable safety profile, which is essential for combination therapies. This could position cretostimogene as a versatile backbone treatment across different bladder cancer stages and therapeutic combinations.
– Phase 1b study results were published simultaneously in Nature Medicine and presented at the Society for Immunotherapy of Cancer 2024 –
– Encouraging data adds to the body of evidence supporting potential use of cretostimogene as a backbone bladder-sparing therapeutic for bladder cancer –
IRVINE, Calif., Nov. 11, 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 the publication in Nature Medicine of Phase 1b investigator-sponsored study results evaluating intravesical cretostimogene grenadenorepvec in combination with Bristol Myers Squibb’s immune checkpoint inhibitor nivolumab, in muscle-invasive bladder cancer (MIBC). The publication is now available online and will be in a future print edition of Nature Medicine. The results were also presented at the Society for Immunotherapy of Cancer (SITC) 2024 by Dr. Roger Li, M.D., urologic oncologist at Moffitt Cancer Center.
This is the second publication in Nature Medicine evaluating the safety and efficacy of cretostimogene grenadenorepvec this year. In June 2024, Nature Medicine published the final results from CORE-001, a phase 2 study of cretostimogene grenadenorepvec in combination with another checkpoint inhibitor, pembrolizumab, in high-risk Bacillus Calmette Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).
“The recent Nature Medicine publications underscore cretostimogene’s compelling safety profile and provide preliminary evidence supporting the potential use as a combination therapy for patients with different types of bladder cancer,” said Vijay Kasturi, MD, Chief Medical Officer, CG Oncology. “Cretostimogene’s dual mechanism of action positions it to potentially work well as either a monotherapy or in combination because it selectively replicates and destroys cancer cells while simultaneously amplifying the immune response against bladder tumors. Cretostimogene targets bladder cancer cells, without harming normal cells in the bladder. We are encouraged by cretostimogene’s strong body of clinical evidence to date, and we look forward to sharing topline results from our BOND-003 registrational study in High-Risk Non-Muscle Invasive Bladder Cancer later this year.”
About the Phase 1b Study
The Phase 1b study examined the safety and efficacy of combining cretostimogene grenadenorepvec with nivolumab in patients with MIBC who were ineligible for cisplatin chemotherapy. Of the 21 patients enrolled and treated, there were no dose-limiting toxicity and no grade 3 or higher treatment-related adverse events (TRAE). Early indications of efficacy for the combination treatment include a pathologic complete response rate of
In December 2023, the Food and Drug Administration granted Fast Track and Breakthrough Therapy Designations for cretostimogene in the same patient population supported by data from the Phase 3 BOND-003 trial. Data to-date shows a
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 MIBC, 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
What are the results of CG Oncology's (CGON) Phase 1b study with cretostimogene and nivolumab?
When will CG Oncology (CGON) release BOND-003 study results?
How does CG Oncology's (CGON) cretostimogene treatment work?
