Synthekine has reported positive initial data from a Phase Ia/Ib trial evaluating STK-012 in first-line, programmed death-ligand 1 (PD-L1)-negative nonsquamous non-small cell lung cancer (NSCLC).
In this trial, the therapy was administered along with standard of care (SoC) pembrolizumab and chemotherapy (PCT).
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STK-012 is an interleukin-2 (IL-2) receptor alpha/beta receptor biased partial agonist specifically designed to selectively activate antigen-activated T cells, known for their antitumour activity.
This approach avoids the broad stimulation of other lymphocyte populations such as natural killer cells, which are linked to the toxic effects of IL-2.
STK-012, when combined with SoC PCT, exhibited encouraging efficacy and safety outcomes.
The efficacy evaluable data set included 21 participants from a population with high immune resistance, comprising 17 individuals with PD-L1 expression of less than 1% and four individuals with PD-L1 expression of 1% or greater.
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By GlobalDataIn the trial, 15 of the 21 participants also exhibited loss-of-function mutations in tumour suppressor genes such as SMARCA4, STK11, and KEAP1, or displayed mucinous histology.
Synthekine chief medical officer Naiyer Rizvi said: “We set a high bar by enrolling first-line PD-L1-negative non-squamous NSCLC – a population marked by intrinsic immune resistance where standard-of-care therapies have consistently underperformed.
“The high response rate observed with STK-012 in this setting is particularly encouraging and supports its potential to convert immune desert tumours into responders when added to SoC. STK-012’s unique selectivity for antigen-activated T cells, while sparing bystander lymphocytes, enables delivery of the critical IL-2 signal without the associated toxicity.
“These compelling data position STK-012 for advancement into a randomised Phase II trial.”
The data was presented by Memorial Sloan Kettering Cancer Center Doctor of Medicine Adam Schoenfeld as a late-breaking oral presentation at the Society for Immunotherapy of Cancer Annual Meeting 2025, held in National Harbor, Maryland, US.
In April 2024, Synthekine reported positive initial data from a Phase Ia/Ib clinical trial of STK-012, a treatment for advanced solid tumours.
