Owkin doses first patient in AI-optimized trial

FRANCE – Owkin, a leading AI-driven biotechnology company, has taken a major step in its drug development efforts.

On January 22, 2025, the company dosed its first patient in the Phase I clinical trial of OKN4395, a groundbreaking drug that introduces a novel triple inhibition mechanism targeting EP2, EP4, and DP1 receptors.

These receptors are known to suppress the immune system, particularly in cancer patients. The trial aims to evaluate the clinical significance of this first-in-class treatment, which has the potential to restore immune function and provide transformative options for patients with advanced solid tumors.

Dr. Thomas Clozel, Owkin’s CEO and Co-founder, expressed his enthusiasm about this milestone, emphasizing the importance of the company’s AI-driven approach.

“OKN4395 reflects not only a decade of discovery efforts by Idorsia and its collaborators but also exemplifies the transformative power of Owkin’s K1.0 Operating System.

This milestone underscores our ability to rapidly translate a promising asset into an AI-optimized clinical program,” he said.

The success of OKN4395 is closely tied to Owkin’s proprietary K1.0 Operating System, an advanced AI platform that played a pivotal role in the drug’s development.

By gaining a deep understanding of the biological mechanisms underlying EP2, EP4, and DP1 inhibition, Owkin was able to optimize the clinical development strategy.

The AI system was used to select indications, create digital twins to assess early anti-tumor activity, and identify biomarkers to enhance the likelihood of clinical success.

OKN4395 specifically targets the PGE2/EP2/EP4 and PGD2/DP1 pathways, which are often hyperactive in certain cancers.

These pathways enable tumors to evade the immune system, promoting growth and resistance to treatment.

By selectively inhibiting all three receptors, OKN4395 has the potential to counteract these effects and restore immune activity, offering new hope for patients battling advanced cancers.

The ongoing INVOKE study, a global first-in-human clinical trial, is evaluating the safety, tolerability, and anti-tumor activity of OKN4395.

The trial involves testing the drug both as a monotherapy and in combination with pembrolizumab, a well-established immunotherapy drug.

In addition to its progress with OKN4395, Owkin has recently made significant advances in healthcare innovation.

Earlier this month, the company announced a collaboration with Absci to explore generative AI for drug discovery, aiming to accelerate and improve the drug development process.

In December 2024, Owkin published a report titled State of the Nation: Opportunities and Challenges for Digital Pathology and AI Solutions, which revealed that 55% of pathologists and oncologists experience high levels of stress or burnout due to heavy workloads.

The report highlighted the potential of AI to alleviate these challenges by streamlining diagnostic processes and improving patient care.

Owkin has also been actively forming strategic partnerships to enhance its capabilities. Notably, the company teamed up with AstraZeneca to develop an AI-powered tool for pre-screening gBRCA mutations in breast cancer patients, demonstrating its commitment to advancing precision medicine.