What You Should Know:
– Owkin, an AI-powered biotech company, today announced the dosing of the first patient in its Phase I clinical trial of OKN4395, a novel cancer therapy designed to restore immune function in patients with advanced solid tumors.
– OKN4395 represents a novel approach to cancer treatment by targeting multiple immunosuppressive pathways simultaneously.
OKN4395 Background
OKN4395 is a first-in-class asset that selectively inhibits three immunosuppressive receptors: EP2, EP4, and DP1. These receptors are known to play a role in tumor progression and resistance to immunotherapy. By blocking these pathways, OKN4395 aims to unleash the power of the immune system to fight cancer.
The INVOKE Study (OKN-4395-121)
The Phase Ia/1b clinical trial, known as INVOKE, is a global, multicenter, open-label study evaluating OKN4395 in patients with advanced solid tumors.
- Phase Ia: Assesses the safety and tolerability of OKN4395 as a monotherapy and in combination with pembrolizumab (an immunotherapy drug).
- Phase Ib: Expands into four cohorts to evaluate preliminary anti-tumor activity, safety, and conduct extensive exploratory analyses.
Owkin’s proprietary K1.0 Operating System played a crucial role in the development of OKN4395, from asset selection to clinical trial design. The AI platform was used to:
- Gain a deeper understanding of the target pathways: Analyze complex biological data to identify and validate the EP2/EP4/DP1 targets.
- Optimize indication selection: Identify the most promising cancer types for OKN4395 treatment.
- Utilize digital twins: Create virtual control arms to gain early insights into anti-tumor activity in Phase I.
- Enhance patient stratification: Identify biomarkers to predict patient response and improve clinical trial success rates.
“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,” said Thomas Clozel, MD, CEO & Co-founder of Owkin.