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

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

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

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Andrea Vuturo
Vuturo Group for Genialis
andrea@vuturo.com
+1 (415) 689-8414

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™ Supermode l, 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