MA-DEBIOPHARM

Genialis, the RNA-biomarker company, and Debiopharm, a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, have reached an agreement to define and discover biomarkers within the DNA Damage Repair (DDR) biology space to predict the clinical benefit of one or more drugs in Debiopharm’s pipeline. The initial phase kicked off this month, deploying Genialis’ biology-first, machine learning-enabled ResponderIDTM framework to develop predictive biomarkers for DDR-directed therapies.

“Debiopharm continues to lead the oncology field in adopting artificial intelligence solutions at various stages across our preclinical and clinical development programs. Genialis’ expertise and cutting-edge technologies are an ideal fit to help us make the smartest translational decisions and advance our drugs to reach the right patients,” said Bertrand Ducrey, CEO of Debiopharm.

Many cancers exhibit deficiencies in one or more DNA damage response pathways. Various classes of approved and investigational drugs aim to exploit known sensitivities; however, the heterogeneous biology of DNA damage response means that one drug only fits some, and combinations may prove essential. Biomarkers will help select patients whose cancer biologies are best suited to treatment with the right drug targeting the active disease mechanism.

“DNA damage response is among the most exciting biological domains of cancer drug development today and an area in which Debiopharm is working on several exciting molecules,” said Carolina Haefliger, Head of Translational Medicine at Debiopharm. “Genialis’ biology-first approach allows us to collaborate in a truly scalable way, incorporating novel AI-based solutions in our programs.”

Using biomarkers increases the odds of advancing an oncology clinical asset to the next trial phase by 5-12 fold¹. However, post-approval, many of the best drugs achieve clinical benefit in only 30-40 percent of patients, and even those existing targeted therapies considered successful and supported by a biomarker can benefit from further refinement of patient tailoring strategies.

“Genialis’ RNA biomarkers have proved especially well-suited to support the development of new drugs targeting complex biological systems,” said Mark Uhlik, Vice President of Biomarker Discovery at Genialis. “Debiopharm is working on some really promising molecules, and Genialis' biomarkers will help ensure these drugs have the best possible chance of clinical success.”

Genialis is based in Boston, Mass., and will attend PMWC in Santa Clara, Calif., from January 23-25, 2024. To request a meeting or for more information on ResponderID, please email biomarkers@genialis.com or visit www.genialis.com.

Debiopharm is headquartered in Lausanne, Switzerland, and will be presenting at the 7th Annual DDR Inhibition Conference in Boston from January 29-30, 2024.

About DNA-Damage Repair (DDR)

When cells have damaged DNA, they need to undergo a repair process called DDR to be able to survive. Cancer cells use their hyperactive DDR response to divide and grow uncontrollably, which promotes cancer expansion. Inhibition of DDR, particularly in combination with other anticancer agents, induces an overall arrest in the uncontrollable cancer cell cycle. This ultimately activates a self-destruction program in cancer cells. DDR inhibitors are currently being tested in preclinical and clinical studies.

About Genialis

Genialis, the RNA biomarker company, is creating a world where healthcare delivers the best possible outcomes for patients, their families and communities. ResponderID™, Genialis’ machine-learning-driven disease modeling framework, delivers actionable biomarkers and optimally positions novel drugs to accelerate translational research, streamline drug development and ensure the best possible clinical care. Genialis is trusted by pharma and diagnostics partners, and together, we are transforming medicine through data. For more information, please visit www.genialis.com

About Debiopharm

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to develop tomorrow’s standard of care to cure cancer & infectious diseases and improve patient quality of life. Debiopharm’s main activities include drug development, drug manufacturing and digital health investment. The company believes in the future digital biology where AI is the main engine for this transformation.

For more information, please visit www.debiopharm.com

¹ Parker JL et al, 2021: doi:10.1002/cam4.3732

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