Synthekine has entered a clinical trial partnership and supply agreement with Merck (MSD) to investigate STK-012 in combination with Keytruda (pembrolizumab) and chemotherapy in patients with first-line, programmed cell death receptor-1 (PD-L1) negative nonsquamous non-small cell lung cancer (NSCLC).
The partnership will focus on the ongoing SYNERGY-101 randomised Phase II trial, which aims to assess the efficacy and safety in this patient population.
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STK-012 is a first-in-class α/β-IL-2 receptor biased partial agonist designed to selectively stimulate antigen-activated T cells.
Under the agreement, MSD will supply its anti-PD-1 therapy Keytruda for inclusion in the study. The global, randomised SYNERGY-101 trial began enrolling patients in November 2025, with the first patient already dosed.
The study’s objective is to compare the combination of STK-012, standard dose pembrolizumab, and chemotherapy against standard dose pembrolizumab plus chemotherapy alone.
Both companies retain all commercial rights to their own compounds for future use in combination regimens or as monotherapies.
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By GlobalDataSynthekine CEO Debanjan Ray said: “In our Phase Ib study, STK-012 in combination with pembrolizumab and chemotherapy has shown promising efficacy in first-line PD-L1 negative NSQ NSCLC patients, with a 50% response rate in this population presented at the Society for Immunotherapy of Cancer Annual Meeting 2025.
“We are excited to collaborate with MSD on our randomised Phase II study to further demonstrate the potential of this combination to deliver improved clinical outcomes for these patients, who receive limited benefit from current standard of care therapies.”
Synthekine develops selective immunotherapies using engineered cytokines to potentially improve treatment paradigms in inflammatory diseases and cancer.
Earlier this year, a partnership comprising Moderna and MSD reported that their personalised cancer vaccine, intismeran autogene, combined with Keytruda (pembrolizumab), led to a significant extension in recurrence-free survival for melanoma patients after resection in a Phase IIb study.
