Owkin Announces First Patient Dosed in Phase I Trial of OKN4395 for Solid Tumors
Owkin, a leader in AI-driven biotech, has reached a significant milestone in its innovative journey with the dosing of the first patient in the Phase I clinical trial of OKN4395. The trial, which commenced on January 22, 2025, is set to evaluate this groundbreaking first-in-class triple inhibitor targeting EP2, EP4, and DP1 receptors in patients with advanced solid tumors.
AI-Optimized Approach to Drug Development
Owkin’s proprietary K1.0 Operating System played a pivotal role in advancing OKN4395 from early asset selection through to clinical development. The AI platform was used to build a deep biological understanding of the EP2/EP4/DP1 targets, which helped to optimize the clinical development strategy for OKN4395. The AI system has also integrated advanced techniques such as indication selection, external control arms (digital twins) to gain early insights into anti-tumor activity, and biomarker-driven patient subtyping to enhance the likelihood of clinical success.
Dr. Thomas Clozel, CEO and Co-founder of Owkin, emphasized the importance of this milestone, stating, “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 achievement underscores our ability to rapidly translate promising assets into AI-optimized clinical programs.”
Owkin A First-in-Class Triple Inhibitor: OKN4395
OKN4395 is a novel and first-in-class compound designed to selectively inhibit the EP2, EP4, and DP1 receptors. These receptors are involved in the immune-suppressive pathways that certain cancers exploit to evade the immune system. Prostaglandins E2 (PGE2) and D2 (PGD2) are naturally occurring molecules in the body that act as ligands for these receptors. Hyperactivity in the PGE2/EP2/EP4 and PGD2/DP1 pathways allows cancers to bypass immune responses, contributing to tumor growth and resistance to treatment.
The inhibition of these pathways by OKN4395 offers a unique approach to restoring immune function, making it a potentially transformative therapy for patients with advanced solid tumors. By targeting both the EP2/EP4 and DP1 receptors, OKN4395 aims to interrupt critical immunosuppressive mechanisms, potentially offering a new therapeutic option for cancers that currently lack effective treatments.
INVOKE Study: A Global Phase I Trial
The ongoing INVOKE study (OKN-4395-121) is a global, multicenter, Phase Ia/1b, first-in-human, open-label trial evaluating the safety, tolerability, and early anti-tumor activity of OKN4395 in patients with advanced solid tumors. The trial is designed to assess OKN4395 both as a monotherapy and in combination with pembrolizumab, a well-established checkpoint inhibitor.
In the Phase I a portion of the study, the primary focus is on evaluating the safety and tolerability of OKN4395 through dose escalation. This phase aims to identify the optimal dose levels for subsequent studies. The Phase I b portion will expand to include four additional cohorts, with a primary goal of assessing the preliminary anti-tumor activity of OKN4395 and further investigating its safety profile. In addition, the trial will include exploratory analyses to evaluate the molecular and immunological effects of the treatment, providing invaluable insights into the mechanism of action of this novel compound.
The INVOKE study is expected to generate critical data on how OKN4395 interacts with the immune system and whether it can effectively target and inhibit the pathways that allow tumors to escape immune surveillance. This will be crucial in determining the future role of OKN4395 in cancer treatment.
Table of Contents
Transforming Cancer Treatment with AI-Driven Drug Development
Owkin’s commitment to leveraging AI in drug discovery and development is central to its success in advancing OKN4395. The K1.0 Operating System integrates machine learning and data analytics to optimize the entire drug development process, from target identification to clinical trial design. This AI-powered approach not only accelerates the development of novel compounds but also increases the precision and effectiveness of treatments for complex diseases such as cancer.
The use of digital twins and biomarker-driven patient subtyping in the clinical trial design enhances the probability of success by allowing researchers to better predict how patients will respond to treatment. These advancements in personalized medicine hold the potential to revolutionize the way cancers are treated by providing more effective and tailored therapies to individual patients.
Looking Ahead: The Future of OKN4395
As the INVOKE study progresses, the potential for OKN4395 to make a meaningful impact on the treatment of advanced solid tumors becomes increasingly clear. The novel triple inhibition mechanism it employs could offer new hope for patients whose cancers have proven resistant to conventional therapies.
Owkin’s use of AI to drive drug discovery and clinical development is transforming the landscape of oncology treatments. By continuously optimizing the development process with data-driven insights and advanced technologies, Owkin is positioning itself as a leader in the future of AI-powered biotechnology.
As the clinical trial continues to enroll patients and gather data, Owkin remains optimistic about the potential of OKN4395 to improve patient outcomes and provide a much-needed treatment option for those battling difficult-to-treat cancers. With ongoing advancements in AI and biotechnology, the future of cancer treatment is brighter than ever.
About OKN4395
- OKN4395 is the first Owkin development program to leverage K1.0, Owkin’s AI-powered Operating System, from asset selection to clinical development optimization
- This asset is a highly selective triple inhibitor of EP2/EP4 and DP1, with a first-in-class profile targeting select solid tumors in patients with high unmet need
- >100,000 patients per year in the US, EU4 and UK initially addressable through Phase Ib indications
- The INVOKE study (OKN-4395-121; NCT06789172) is sponsored by Epkin (an Owkin company)
