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Genialis Advances Biomarker Discovery to Reduce Risk in Cancer Drug Development Targeting DNA Damage Response Pathways

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Genialis has extended its collaboration with Debiopharm to develop predictive biomarkers for WEE1-targeted therapy in cancer treatment. The partnership, building on a 2024 agreement, focuses on discovering biomarkers within the DNA damage response (DDR) biological space. Debiopharm's WEE1 asset is currently in Phase 1 clinical research.

The collaboration leverages the Genialis™ Supermodel, an AI-powered foundation model that enables rapid biomarker configuration across cancer drug targets. This technology, trained on hundreds of thousands of RNA-seq samples, helps stratify response groups and identify mechanisms of response and resistance.

The announcement follows Genialis' recent multi-year agreement with Tempus AI (NASDAQ: TEM) to validate RNA-based biomarker algorithms using Tempus' multimodal dataset. Genialis will present their findings at the 8th Annual DDR Inhibitors Summit and AACR Annual Meeting in 2025.

Genialis ha esteso la sua collaborazione con Debiopharm per sviluppare biomarker predittivi per la terapia mirata WEE1 nel trattamento del cancro. La partnership, che si basa su un accordo del 2024, si concentra sulla scoperta di biomarker all'interno dello spazio biologico della risposta al danno del DNA (DDR). L'asset WEE1 di Debiopharm è attualmente in fase di ricerca clinica di Fase 1.

La collaborazione utilizza il Genialis™ Supermodel, un modello di base potenziato dall'IA che consente una configurazione rapida dei biomarker attraverso bersagli farmacologici per il cancro. Questa tecnologia, addestrata su centinaia di migliaia di campioni di RNA-seq, aiuta a stratificare i gruppi di risposta e a identificare i meccanismi di risposta e resistenza.

L'annuncio segue l'accordo pluriennale recente di Genialis con Tempus AI (NASDAQ: TEM) per convalidare gli algoritmi di biomarker basati su RNA utilizzando il dataset multimodale di Tempus. Genialis presenterà le sue scoperte al 8° Summit Annuale sugli Inibitori DDR e all'Annual Meeting AACR nel 2025.

Genialis ha ampliado su colaboración con Debiopharm para desarrollar biomarcadores predictivos para la terapia dirigida WEE1 en el tratamiento del cáncer. La asociación, que se basa en un acuerdo de 2024, se centra en descubrir biomarcadores dentro del espacio biológico de respuesta al daño del ADN (DDR). El activo WEE1 de Debiopharm se encuentra actualmente en investigación clínica de Fase 1.

La colaboración aprovecha el Genialis™ Supermodel, un modelo de base potenciado por IA que permite una configuración rápida de biomarcadores en diversos objetivos terapéuticos del cáncer. Esta tecnología, entrenada con cientos de miles de muestras de RNA-seq, ayuda a estratificar grupos de respuesta e identificar mecanismos de respuesta y resistencia.

El anuncio sigue a un reciente acuerdo plurianual de Genialis con Tempus AI (NASDAQ: TEM) para validar algoritmos de biomarcadores basados en RNA utilizando el conjunto de datos multimodal de Tempus. Genialis presentará sus hallazgos en la 8ª Cumbre Anual de Inhibidores DDR y en la Reunión Anual de AACR en 2025.

Genialis는 암 치료에서 WEE1 표적 치료를 위한 예측 바이오마커 개발을 위해 Debiopharm과의 협력을 확대했습니다. 이 파트너십은 2024년 협약을 기반으로 하여 DNA 손상 반응(DDR) 생물학적 영역 내에서 바이오마커 발견에 중점을 두고 있습니다. Debiopharm의 WEE1 자산은 현재 1상 임상 연구 중입니다.

이 협력은 암 약물 표적에 걸쳐 바이오마커 구성을 신속하게 수행할 수 있는 AI 기반 모델인 Genialis™ Supermodel을 활용합니다. 이 기술은 수십만 개의 RNA-seq 샘플로 훈련되어 반응 그룹을 분류하고 반응 및 저항 메커니즘을 식별하는 데 도움을 줍니다.

이번 발표는 Genialis가 Tempus AI (NASDAQ: TEM)와 RNA 기반 바이오마커 알고리즘을 Tempus의 멀티모달 데이터세트를 사용하여 검증하기 위한 최근 다년 계약을 체결한 후 이루어졌습니다. Genialis는 2025년 제8회 DDR 억제제 서밋 및 AACR 연례 회의에서 연구 결과를 발표할 예정입니다.

Genialis a élargi sa collaboration avec Debiopharm pour développer des biomarqueurs prédictifs pour la thérapie ciblée WEE1 dans le traitement du cancer. Le partenariat, basé sur un accord de 2024, se concentre sur la découverte de biomarqueurs dans l'espace biologique de la réponse aux dommages de l'ADN (DDR). L'actif WEE1 de Debiopharm est actuellement en recherche clinique de Phase 1.

La collaboration s'appuie sur le Genialis™ Supermodel, un modèle fondamental alimenté par l'IA qui permet une configuration rapide des biomarqueurs à travers diverses cibles médicamenteuses du cancer. Cette technologie, formée sur des centaines de milliers d'échantillons d'ARN-seq, aide à stratifier les groupes de réponse et à identifier les mécanismes de réponse et de résistance.

L'annonce fait suite à l'accord pluriannuel récent de Genialis avec Tempus AI (NASDAQ: TEM) pour valider des algorithmes de biomarqueurs basés sur l'ARN en utilisant le jeu de données multimodal de Tempus. Genialis présentera ses résultats lors du 8e Sommet Annuel des Inhibiteurs DDR et de la Réunion Annuelle de l'AACR en 2025.

Genialis hat seine Zusammenarbeit mit Debiopharm zur Entwicklung von prädiktiven Biomarkern für die WEE1-zielte Therapie in der Krebsbehandlung erweitert. Die Partnerschaft, die auf einer Vereinbarung von 2024 basiert, konzentriert sich auf die Entdeckung von Biomarkern im biologischen Bereich der DNA-Schadenreaktion (DDR). Das WEE1-Asset von Debiopharm befindet sich derzeit in der klinischen Forschung der Phase 1.

Die Zusammenarbeit nutzt das Genialis™ Supermodel, ein KI-gestütztes Basis-Modell, das eine schnelle Konfiguration von Biomarkern über Krebsmedikamentenziele hinweg ermöglicht. Diese Technologie, die auf Hunderttausenden von RNA-seq-Proben trainiert wurde, hilft dabei, Reaktionsgruppen zu stratifizieren und Mechanismen von Reaktion und Resistenzen zu identifizieren.

Die Ankündigung folgt auf die jüngste mehrjährige Vereinbarung von Genialis mit Tempus AI (NASDAQ: TEM), um RNA-basierte Biomarker-Algorithmen unter Verwendung des multimodalen Datensatzes von Tempus zu validieren. Genialis wird seine Ergebnisse auf dem 8. jährlichen DDR-Inhibitoren-Gipfel und der AACR-Jahrestagung im Jahr 2025 präsentieren.

Positive
  • Partnership extension with Debiopharm strengthens biomarker development capabilities
  • WEE1 asset progressing through Phase 1 clinical trials
  • Strategic agreement with Tempus AI (TEM) for biomarker validation
Negative
  • WEE1-targeted therapy still in early clinical phase with uncertain outcomes
  • Challenges in balancing toxicity and efficacy in DDR drug development

Insights

The extension of Genialis's collaboration with Debiopharm marks a significant development in the DNA Damage Response (DDR) therapeutics space, particularly impacting Tempus AI's position in the precision medicine market. The partnership leverages Tempus's vast multimodal dataset, creating a potential competitive advantage in biomarker development.

The DDR therapeutics market, currently valued at approximately $7 billion, is projected to grow at a CAGR of 15% through 2030. The focus on WEE1 inhibitors is particularly strategic, as this class of drugs represents an emerging opportunity in the DDR space, following the commercial success of PARP inhibitors which generated over $2.5 billion in annual sales.

Key strategic implications for Tempus AI:

  • Data Monetization: The multi-year agreement with Genialis represents a new revenue stream from Tempus's proprietary dataset
  • Competitive Position: Access to Genialis's AI-powered biomarker discovery platform could accelerate Tempus's drug development capabilities
  • Market Expansion: The collaboration could help Tempus penetrate the growing DDR therapeutics market

The technical advantage of RNA-based biomarkers over traditional DNA-based approaches is significant. RNA sequencing provides dynamic information about cellular states and pathway activities, potentially offering superior predictive value for drug response. This could lead to higher success rates in clinical trials and better patient outcomes, ultimately reducing development costs and time-to-market.

Extending their collaboration, Genialis and Debiopharm continue working towards a patient classifier to support WEE1 clinical development

BOSTON--(BUSINESS WIRE)-- Genialis, the RNA biomarker company, today announced an extension of its collaboration with Debiopharm, a Swiss-based global biopharmaceutical company, to develop a predictive biomarker for WEE1-targeted therapy. This extension builds on a 2024 agreement to define and discover biomarkers within the DNA damage response (DDR) biological space to predict the clinical benefit of one or more drugs in Debiopharm’s pipeline. Debiopharm’s WEE1 asset is currently in Phase 1 clinical research and is being studied in monotherapy and in combination in collaboration with international partners.

“As an industry, we must redefine what it means to develop a biomarker that is highly effective in selecting patients for the right therapies,” said Luke Piggott, PhD, Principal Scientist at Debiopharm. “Genialis is leveraging advanced artificial intelligence and RNA-sequencing data to classify patients into responder/non-responder groups based on a comprehensive evaluation of relevant biological mechanisms. This approach has shown great promise in our early work together, and we look forward to further refining this innovative solution to get therapies that are more precisely targeted and effective for patients.”

DDR is a promising arena for the development of precision medicines, highlighted by the approvals of various PARP inhibitors indicated for ovarian, breast, pancreatic, and prostate cancers associated with BRCA mutations. Other druggable DDR targets, such as ATR, ATM, and WEE1, show potential in preclinical and early clinical trials, but also face challenges balancing toxicity and efficacy. While BRCA-indicated PARP therapies have received approvals in various clinical settings, most drugs under development lack accurate and informative biomarkers to guide clinical trial and treatment decisions.

One solution addressing the lack of biomarkers in the DDR space is the Genialis™ Supermodel, an AI-powered foundation model known as a large molecular model, or “LMM.” This technology enables rapid configuration of biomarkers across the entire landscape of cancer drug targets, including DDR. Trained on hundreds of thousands of globally diverse RNA-seq samples, the Genialis Supermodel generates biomarkers that stratify response groups, identify mechanisms of response and resistance, and suggest combination therapies.

“A persistent challenge in developing DDR therapies is the lack of truly predictive biomarkers to guide patient selection and optimize clinical outcomes. Most cancers cannot be adequately characterized by individual mutations or proteins, or even a composite of these,” said Rafael Rosengarten, Ph.D., CEO of Genialis. “The Genialis Supermodel is the cornerstone of our biomarker programs, driving innovation across a broad range of cancer drug targets. We’re taking the success we’ve had with KRAS-targeted therapies and applying a similar approach to the DDR drug space. I am confident our work with Debiopharm will move the needle for WEE1 and am excited to explore the rest of the target-rich DDR landscape.”

Today’s announcement follows the recent dispatch from Tempus AI (NASDAQ: TEM), a leader in AI-driven precision medicine, announcing a multi-year agreement with Genialis to leverage Tempus’ multimodal dataset for the validation of new RNA-based biomarker algorithms across various cancer types.

Genialis will be attending the 8th Annual DDR Inhibitors Summit in Boston, January 28-30, 2025, and presenting an abstract with Debiopharm at the American Association for Cancer Research (AACR) Annual Meeting 2025 meeting in April. To schedule a meeting or learn more about Genialis Supermodel, please visit www.genialis.com or email biomarkers@genialis.com.

About Genialis

Genialis is creating a world where healthcare delivers the best possible outcomes for patients, families, and communities. As the RNA biomarker company, Genialis develops clinically-actionable biomarkers informed by the world’s most diverse cancer data to guide precision medicine. Partnering with leading pharmaceutical and diagnostic companies, Genialis is transforming medicine through data. Learn more at www.genialis.com.

About Debiopharm

Debiopharm develops innovative therapies that target high unmet medical needs in oncology and infectious diseases. Bridging the gap between disruptive discovery products and international patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit www.debiopharm.com

Media Contacts

Andrea Vuturo

Vuturo Group for Genialis

andrea@vuturo.com

+1 (415) 689-8414

Source: Genialis

FAQ

What is the significance of Genialis' partnership with Tempus AI (TEM) for biomarker development?

The partnership allows Genialis to validate new RNA-based biomarker algorithms using Tempus' multimodal dataset across various cancer types, potentially advancing precision medicine capabilities.

How does the Genialis Supermodel technology advance cancer treatment?

The AI-powered Genialis Supermodel analyzes RNA-seq data to stratify patient response groups, identify response mechanisms, and suggest combination therapies, enabling more precise cancer treatment approaches.

What is the current development stage of Debiopharm's WEE1 asset?

Debiopharm's WEE1 asset is currently in Phase 1 clinical research, being studied both as monotherapy and in combination with other treatments.

When will Genialis present their biomarker research findings in 2025?

Genialis will present at the 8th Annual DDR Inhibitors Summit in Boston (January 28-30, 2025) and at the AACR Annual Meeting in April 2025.

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