Arcus Biosciences Announces Clinical Trial Collaboration Agreement to Evaluate Casdatifan in Combination with Volrustomig in Renal Cell Carcinoma
Arcus Biosciences (NYSE:RCUS) has announced a clinical trial collaboration agreement with AstraZeneca to evaluate casdatifan (AB521), Arcus's investigational HIF-2a inhibitor, in combination with volrustomig, AstraZeneca's investigational PD-1/CTLA-4 bispecific antibody, in patients with clear cell renal cell carcinoma (ccRCC). This marks the second clinical collaboration between the two companies.
The study, sponsored and operationalized by AstraZeneca, aims to assess the safety and early efficacy of the combination therapy in advanced ccRCC patients. Arcus believes casdatifan has best-in-class potential based on observed PK and PD profiles and emerging clinical data from their ARC-20 study. The collaboration seeks to improve outcomes for ccRCC patients by combining HIF-2a inhibition with volrustomig.
Under the Gilead and Arcus collaboration agreement, Gilead retains the right to opt-in to development and commercialization for casdatifan after Arcus delivers a qualifying data package.
Arcus Biosciences (NYSE:RCUS) ha annunciato un accordo di collaborazione per una sperimentazione clinica con AstraZeneca per valutare casdatifan (AB521), l'inibitore sperimentale di HIF-2a di Arcus, in combinazione con volrustomig, l'anticorpo bispecifico sperimentale PD-1/CTLA-4 di AstraZeneca, in pazienti con carcinoma renale a cellule chiare (ccRCC). Questo segna la seconda collaborazione clinica tra le due aziende.
Lo studio, sponsorizzato e gestito da AstraZeneca, mira a valutare la sicurezza e la prima efficacia della terapia combinata in pazienti avanzati con ccRCC. Arcus crede che casdatifan abbia un potenziale di eccellenza in base ai profili PK e PD osservati e ai dati clinici emergenti dal loro studio ARC-20. La collaborazione cerca di migliorare i risultati per i pazienti con ccRCC combinando l'inibizione di HIF-2a con volrustomig.
In base all'accordo di collaborazione tra Gilead e Arcus, Gilead mantiene il diritto di partecipare allo sviluppo e alla commercializzazione di casdatifan dopo che Arcus fornisce un pacchetto dati qualificato.
Arcus Biosciences (NYSE:RCUS) ha anunciado un acuerdo de colaboración en ensayos clínicos con AstraZeneca para evaluar casdatifan (AB521), un inhibidor experimental de HIF-2a de Arcus, en combinación con volrustomig, un anticuerpo bispecífico experimental PD-1/CTLA-4 de AstraZeneca, en pacientes con carcinoma renal de células claras (ccRCC). Esta es la segunda colaboración clínica entre ambas compañías.
El estudio, patrocinado y gestionado por AstraZeneca, tiene como objetivo evaluar la seguridad y la eficacia temprana de la terapia combinada en pacientes avanzados con ccRCC. Arcus cree que casdatifan tiene un potencial de clase líder basado en los perfiles PK y PD observados y datos clínicos emergentes de su estudio ARC-20. La colaboración busca mejorar los resultados para los pacientes con ccRCC combinando la inhibición de HIF-2a con volrustomig.
Bajo el acuerdo de colaboración entre Gilead y Arcus, Gilead conserva el derecho a optar por participar en el desarrollo y la comercialización de casdatifan después de que Arcus entregue un paquete de datos calificativo.
Arcus Biosciences (NYSE:RCUS)는 AstraZeneca와 임상 시험 협력 계약을 발표하여 Arcus의 실험적 HIF-2a 억제제인 casdatifan (AB521)과 AstraZeneca의 실험적 PD-1/CTLA-4 이중 특이성 항체인 volrustomig을 투명 세포 신세포암 (ccRCC) 환자에서 평가하기로 했습니다. 이는 두 회사 간의 두 번째 임상 협력입니다.
AstraZeneca가 후원하고 운영하는 본 연구는 진행성 ccRCC 환자에서 조합 치료의 안전성과 초기 효능을 평가하는 것을 목표로 합니다. Arcus는 casdatifan이 관찰된 PK 및 PD 프로필과 ARC-20 연구의 신흥 임상 데이터를 기반으로 최상의 잠재력을 가지고 있다고 믿고 있습니다. 이 협력은 HIF-2a 억제를 volrustomig와 결합하여 ccRCC 환자의 결과를 개선하는 것을 목표로 합니다.
Gilead와 Arcus 간의 협력 계약에 따라 Gilead는 Arcus가 적격 데이터 패키지를 제공한 후 casdatifan의 개발 및 상용화에 참여할 권리를 보유합니다.
Arcus Biosciences (NYSE:RCUS) a annoncé un accord de collaboration pour un essai clinique avec AstraZeneca afin d'évaluer casdatifan (AB521), l'inhibiteur expérimental HIF-2a d'Arcus, en combinaison avec volrustomig, l'anticorps bispécifique expérimental PD-1/CTLA-4 d'AstraZeneca, chez des patients atteints de carcinome rénal à cellules claires (ccRCC). Cela marque la deuxième collaboration clinique entre les deux entreprises.
L'étude, sponsorisée et mise en œuvre par AstraZeneca, vise à évaluer la sécurité et l'efficacité précoce de la thérapie combinée chez des patients avancés atteints de ccRCC. Arcus estime que casdatifan a un potentiel de premier plan basé sur les profils PK et PD observés et les données cliniques émergentes de leur étude ARC-20. La collaboration vise à améliorer les résultats pour les patients atteints de ccRCC en combinant l'inhibition de HIF-2a avec volrustomig.
Selon l'accord de collaboration entre Gilead et Arcus, Gilead conserve le droit de participer au développement et à la commercialisation de casdatifan après qu'Arcus ait fourni un ensemble de données qualifié.
Arcus Biosciences (NYSE:RCUS) hat eine Kooperationsvereinbarung für klinische Studien mit AstraZeneca angekündigt, um casdatifan (AB521), einen experimentellen HIF-2a-Inhibitor von Arcus, in Kombination mit volrustomig, einem experimentellen PD-1/CTLA-4-bispezifischen Antikörper von AstraZeneca, bei Patienten mit klarzelligem Nierenzellkarzinom (ccRCC) zu bewerten. Dies ist die zweite klinische Zusammenarbeit zwischen den beiden Unternehmen.
Die von AstraZeneca gesponserte und betriebene Studie zielt darauf ab, die Sicherheit und die frühe Wirksamkeit der Kombinationstherapie bei Patienten mit fortgeschrittenem ccRCC zu bewerten. Arcus glaubt, dass casdatifan basierend auf den beobachteten PK- und PD-Profilen sowie den neu auftretenden klinischen Daten aus ihrer ARC-20-Studie ein Potenzial der Spitzenklasse hat. Die Zusammenarbeit soll die Ergebnisse für ccRCC-Patienten durch die Kombination von HIF-2a-Hemmung mit volrustomig verbessern.
Im Rahmen des Kooperationsvertrags zwischen Gilead und Arcus behält sich Gilead das Recht vor, sich nach Lieferung eines qualifizierten Datenpakets von Arcus an der Entwicklung und Vermarktung von casdatifan zu beteiligen.
- Clinical trial collaboration agreement with AstraZeneca for combination therapy in ccRCC
- Potential for best-in-class treatment based on casdatifan's observed profiles and emerging clinical data
- AstraZeneca to sponsor and operationalize the study, reducing costs for Arcus
- Second clinical collaboration with AstraZeneca, indicating strong partnership
- None.
Insights
This collaboration between Arcus and AstraZeneca to evaluate casdatifan (HIF-2a inhibitor) with volrustomig (PD-1/CTLA-4 bispecific antibody) in clear cell renal cell carcinoma (ccRCC) is a significant development. Here's why:
- Combining a HIF-2a inhibitor with immunotherapy is a novel approach that could potentially enhance efficacy in ccRCC treatment.
- Casdatifan has shown promising PK/PD profiles and clinical data, suggesting "best-in-class" potential.
- Volrustomig has demonstrated encouraging efficacy as monotherapy in first-line advanced ccRCC.
- The combination aims to drive deeper and more durable responses, which could significantly improve patient outcomes.
This collaboration leverages the strengths of both companies and could accelerate the development of a potentially first- and best-in-class treatment for ccRCC. The involvement of AstraZeneca, a major player in oncology, adds credibility to the potential of this combination therapy.
This collaboration agreement is strategically significant for Arcus Biosciences:
- It validates the potential of casdatifan, enhancing investor confidence in Arcus's pipeline.
- Partnering with AstraZeneca, a global pharma leader, provides access to resources and expertise, potentially accelerating development.
- This is the second collaboration between Arcus and AstraZeneca, indicating a strong relationship and mutual confidence.
- The agreement structure allows AstraZeneca to sponsor and operationalize the study, likely reducing Arcus's financial burden.
Importantly, Gilead's opt-in right for casdatifan adds another layer of potential value. If the data is promising, it could trigger Gilead's involvement, potentially leading to a lucrative deal for Arcus. This collaboration enhances Arcus's position in the competitive oncology space and could be a significant value driver for the company.
- Arcus and AstraZeneca to evaluate their respective molecules in combination to establish a potential first- and best-in-class treatment for clear cell renal cell carcinoma (ccRCC)
- This is the second clinical collaboration between Arcus and AstraZeneca
“We believe casdatifan has best-in-class potential, based on the observed PK and PD profiles and the emerging clinical data from our ARC-20 study in patients with ccRCC,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “This agreement will enable Arcus and AstraZeneca to collaborate and assess the potential for the novel combination of casdatifan with volrustomig to improve outcomes for patients with ccRCC.”
“Renal cell carcinoma is a known CTLA-4-responsive tumor type, and our first-in-human study with volrustomig monotherapy demonstrated encouraging efficacy in first-line advanced ccRCC,” said Cristian Massacesi, chief medical officer and oncology chief development officer, AstraZeneca. “We are excited by the potential to build on this by combining HIF-2a inhibition with volrustomig to drive deeper and more durable responses for patients.”
As part of this collaboration, AstraZeneca will sponsor and operationalize a study to evaluate the safety and early efficacy of the casdatifan plus volrustomig combination in patients with advanced ccRCC.
This is the second clinical collaboration between Arcus and AstraZeneca. In 2020, the companies announced a clinical collaboration for PACIFIC-8, a registrational Phase 3 study of domvanalimab, an Fc-silent anti-TIGIT antibody, added to backbone global standard-of-care durvalumab, an anti-PD-L1 antibody, in patients with unresectable Stage III non-small cell lung cancer.
Under the Gilead and Arcus collaboration agreement, Gilead has the right to opt-in to development and commercialization for casdatifan after Arcus’s delivery of a qualifying data package.
About Casdatifan (AB521)
Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor involved in oxygen sensing in multiple organs as well as in tumors. Clear cell RCC is almost universally associated with HIF-2a dysregulation as a result of genetic abnormalities in the VHL pathway. This creates a situation of pseudohypoxia and the abnormal increase in HIF-2a-mediated expression of a wide array of proteins involved in cancer cell proliferation and survival, treatment resistance and angiogenesis. Casdatifan is being evaluated in ARC-20, a Phase 1/1b study in cancer patients, and STELLAR-009, a Phase 1b/2 study in combination with zanzalintinib in patients with advanced solid tumors, including ccRCC.
Casdatifan and domvanalimab are investigational molecules. Approval from any regulatory authority for any use of these molecules globally has not been received, and their safety and efficacy have not been established.
About RCC
According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the
About Arcus Biosciences
Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, HIF-2a, CD73, dual A2a/A2b receptor, CD39, and AXL. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the potential of casdatifan alone and in combination with volrustomig. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: difficulties or delays in initiating or conducting clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; the emergence of adverse events or other undesirable side effects; difficulties associated with the management of the collaboration activities or expanded clinical programs; changes in the competitive landscape for Arcus’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent Quarterly Report on Form 10Q filed with the
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Investor Inquiries:
Pia Eaves
VP of Investor Relations & Strategy
(617) 459-2006
peaves@arcusbio.com
Media Inquiries:
Holli Kolkey
VP of Corporate Communications
(650) 922-1269
hkolkey@arcusbio.com
Source: Arcus Biosciences
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