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Owkin Announces First Patient Dosed in Phase I AI-optimized Clinical Trial of OKN4395, a First-in-Class EP2/EP4/DP1 Triple Inhibitor for Patients with Solid Tumors

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Owkin Announces First Patient Dosed in Phase I AI-optimized Clinical Trial of OKN4395, a First-in-Class EP2/EP4/DP1 Triple Inhibitor for Patients with Solid Tumors
News

News

Owkin Announces First Patient Dosed in Phase I AI-optimized Clinical Trial of OKN4395, a First-in-Class EP2/EP4/DP1 Triple Inhibitor for Patients with Solid Tumors

2025-01-30 17:40 Last Updated At:17:51

PARIS--(BUSINESS WIRE)--Jan 30, 2025--

Owkin, the first end-to-end AI-biotech that uses agentic AI to revolutionize drug discovery, development, and diagnostics, today announced that the first patient has been dosed in its Phase I clinical trial of OKN4395 on January 22, 2025. OKN4395 builds upon well-characterized EP2/EP4 inhibition, through a newly identified and equipotent inhibition of DP1. The clinical significance of this first-in-class triple inhibition is being evaluated in this trial.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250130436779/en/

AI-optimized study design

Owkin’s proprietary K1.0 Operating System was instrumental in advancing OKN4395 from asset selection through to clinical development. By building a detailed biological understanding of the EP2/EP4/DP1 targets and their complex mechanisms of action, Owkin’s AI operating system was used to optimize the clinical development strategy. The program integrates Owkin’s expertise in AI-driven indication selection, external control arms (digital twins) for early anti-tumor activity insights in Phase I, and biomarker-led patient subtyping to enhance the probability of clinical success.

Thomas Clozel, MD, CEO & Co-founder of Owkin, said: "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."

A first-in-class asset: OKN4395

Prostaglandins E 2 and D 2 (or PGE 2, PGD 2 ) are hormone-like molecules produced naturally in the body, and are the natural ligands for prostanoid receptors EP2, EP4, and DP1, respectively. The PGE 2 /EP2/EP4 and PGD 2 /DP1 pathways are both known to be immunosuppressive 1,2. Well-described in oncology, hyperactivity of the PGE 2 /EP2/EP4 pathway in certain cancers allows them to avoid the immune system’s effector mechanisms, leading to progression and resistance through tumor growth or metastasis 1.

OKN4395 is the first compound in the clinic to selectively inhibit EP2, EP4, and DP1 receptors. This novel mechanism offers the potential to restore immune function, providing transformative treatment options for patients with advanced solid tumors.

The INVOKE Study (OKN-4395-121)

INVOKE is a global, multicenter, Phase Ia/1b, first-in-human, open-label trial evaluating OKN4395 in patients with advanced solid tumors. Phase Ia primarily assesses safety and tolerability through dose escalation of OKN4395 as both a monotherapy and in combination with pembrolizumab. Phase Ib will expand into a further four cohorts, and assess preliminary anti-tumor activity, as well as safety and extensive exploratory analyses.

References

Tumor being attacked (Photo: Business Wire)

Tumor being attacked (Photo: Business Wire)

EP2_4 Receptor (Photo: Business Wire)

EP2_4 Receptor (Photo: Business Wire)

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Trump says federal government should 'take over' DC, backing congressional GOP push

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WASHINGTON (AP) — President Donald Trump on Wednesday threw his support behind congressional efforts for a federal takeover of the nation's capital, saying he approves putting the District of Columbia back under direct federal control.

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Trump said he liked District of Columbia Mayor Muriel Bowser personally, but complained about the city's governance.

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He argued that he can't have sights of homelessness when he hosts foreign leaders in Washington. “You just can’t let that happen,” Trump said. “You can’t have tents on all your beautiful — your once magnificent plaza and lawns.”

President Donald Trump, followed by Elon Musk, arrives on Air Force One, Wednesday, Feb. 19, 2025, at Joint Base Andrews, Md, after returning from Florida. (AP Photo/Mark Schiefelbein)

President Donald Trump, followed by Elon Musk, arrives on Air Force One, Wednesday, Feb. 19, 2025, at Joint Base Andrews, Md, after returning from Florida. (AP Photo/Mark Schiefelbein)

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