STK-012 demonstrated a differentiated safety profile and monotherapy efficacy in the Phase Ia study for solid tumours. Credit: SciePro / Shutterstock.com.

Synthekine has dosed the first subject in the Phase Ib portion of a clinical trial of STK-012 to treat solid tumours.

The open-label, non-randomised, multicentre dose expansion part of the trial is currently enrolling participants.

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In addition to evaluating the tolerability, safety, and pharmacokinetics of the α/β biased IL-2 STK-012 monotherapy, the study will assess the therapy’s anti-tumour activity.

Participants with specific types of solid tumours, such as renal cell carcinoma and non-small cell lung cancer, will be part of the trial.

Dosing in the Phase Ib portion commenced after the company concluded the Phase Ia dose escalation part of the trial in advanced solid tumour patients.

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According to the Phase Ia data, STK-012 demonstrated a differentiated safety profile and monotherapy efficacy.

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Synthekine chief medical officer Naiyer Rizvi said: “IL-2 is critical for T-cell activation and promoting anti-tumour immunity.

“STK-012 is built from unique insights into IL-2 biology and is the first α/β biased IL-2 with clinical results.

“We have observed encouraging single-agent activity with STK-012 in dose escalation and are excited to begin our cohort expansion studies.”

The company created STK-012 for the selective stimulation of antigen-activated T-cells associated with potent anti-tumour activity.

In January 2023, it secured $100m in a Series C funding round led by The Column Group, with new and current investors taking part. 

Synthekine used the proceeds to progress its therapeutic pipeline, led by STK-012.