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

Designed as an alpha/beta-biased interleukin-2 (IL-2) partial agonist, STK-012 is designed to selectively stimulate antigen-activated T cells. These cells are linked to potent anti-tumour activity and alleviate stimulation of toxicity causing natural killer cells.

The open-label, multicentre trial is estimated to enrol 135 advanced solid tumour patients

The dose-escalation segment of the trial will analyse STK-012 as a single agent as well as along with pembrolizumab. 

On concluding this portion, the company plans to commence the expansion cohorts with STK-012. 

Synthekine CEO Debanjan Ray said: “STK-012 is a highly differentiated IL-2 partial agonist tuned to expand the therapeutic index of IL-2 by biasing towards efficacy driving antigen-activated T cells and away from toxicity causing lymphocytes, such as natural killer (NK) cells. 

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By GlobalData

“STK-012 is the first programme from our broad portfolio of biased cytokines to enter the clinic, and its rapid progress into clinical investigation further highlights our team’s tremendous ability to execute efficiently and move our pipeline forward.”

According to preclinical data, a mouse surrogate of STK-012 showed to attain greater tumour regression as against wild-type mouse IL-2 as well as a non-alpha-IL-2 agent, indicating a separate method to IL-2 biasing. 

Furthermore, STK-012’s mouse surrogate in toxicity models was demonstrated to be well tolerated and did not cause capillary leak syndrome (CLS), as compared to the same comparators.

IL-2 partial agonist also averted lymphopenia, activation of NK cell as well as induction of CLS in non-human primate studies, as aldesleukin and a non-alpha-IL-2 agent did.