STK-012 is an α/β biased IL-2 partial agonist designed to stimulate antigen-activated T cells while avoiding IL-2 associated toxicities
Positive Phase 1b data recently presented at SITC 2025, with a 50% response rate in PD-L1 negative non-squamous NSCLC patients, comparing favorably to 23 – 32% response rate expected with standard of care
MENLO PARK, Calif.--(BUSINESS WIRE)--Synthekine Inc., an engineered cytokine therapeutics company, today announced that the company has dosed the first patient in the SYNERGY-101 study. SYNERGY-101 is a global, randomized Phase 2 clinical trial evaluating STK-012 combined with pembrolizumab and chemotherapy (PCT) vs. PCT in first-line, PD-L1 negative nonsquamous non-small cell lung cancer (NSCLC).
“This marks a key milestone for Synthekine as we advance STK-012 into a randomized Phase 2 trial,” said Debanjan Ray, Chief Executive Officer of Synthekine. “Our promising Phase 1b data suggest that STK-012 may lead to a meaningful improvement in outcomes in PD-L1 negative NSCLC, a population with limited benefit from current therapies.”
Positive Phase 1b results presented at SITC 2025 showed a 50% response rate in PD-L1 negative nonsquamous NSCLC patients treated with STK-012 in combination with PCT, substantially higher than the 23–32% response typically seen with standard of care alone. Notably, similarly high response rates were observed in patients with immune-resistant tumor profiles, such as those patients with STK11 or KEAP1 mutations, which have a high prevalence in PD-L1 negative NSCLC.
“PD-L1 negative patients represent 30-40% of new nonsquamous NSCLC diagnoses and typically face poor prognosis on standard-of-care therapy, highlighting the need for new treatment options in this setting,” said Naiyer Rizvi, M.D., Chief Medical Officer of Synthekine. “SYNERGY-101 will help determine whether STK-012 can offer a new standard of care for this underserved population.”
For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT05098132.
About SYNERGY-101
SYNERGY-101 is a global, randomized Phase 2 study designed to evaluate the safety and efficacy of STK-012 in combination with PCT in first line, PD-L1 negative nonsquamous NSCLC patients. This trial aims to enroll approximately 105 patients, with a primary endpoint of overall response rate based on RECIST v1.1. Secondary endpoints include progression-free survival and safety.
About PD-L1 Negative Nonsquamous Non-Small Cell Lung Cancer
Lung cancer is the third-most common cancer in the United States and is a serious and life-threatening disease, which is expected to account for 20% of cancer deaths in 2025.1 Nonsquamous NSCLC is the most common form of lung cancer and PD-L1 negative patients account for 30 – 40% of these patients, who have a poor prognosis despite currently available standard-of-care therapies.
1Cancer Facts & Figures 2025, American Cancer Society (ACS), Atlanta, Georgia, 2025
About STK-012
STK-012 is a first-in-class α/β-IL-2 receptor biased partial agonist engineered to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity, while minimizing activation of other lymphocytes, such as natural killer (NK) cells or naïve T cells, which are associated with IL-2 related toxicity.
About Synthekine
Synthekine is harnessing the potential of cytokine therapeutics to develop selective immunotherapies designed to improve the treatment paradigm of cancer and inflammatory disease. Using insights on cytokine structure and function, the company engineers therapeutics designed to unlock the full efficacy potential of cytokines while avoiding their associated toxicities. Synthekine is applying principles of cytokine partial agonism and immunological specificity across multiple therapeutic areas to create a broad and deep pipeline of product candidates. These novel immunotherapies include modified cytokines and surrogate cytokine agonists. For more information, visit www.synthekine.com, and follow us on X @synthekine and LinkedIn.
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Jake Robison
Inizio Evoke Comms
619-849-5383
Jake.robison@inizioevoke.com
