Synthekine's STK-012 IL-2 Shows Promising Phase 1a/1b Results in Advanced Solid Tumor Treatment

Initial clinical trials for STK-012, an innovative engineered cytokine by Synthekine Inc., have shown promising results in treating advanced solid tumors. The drug, which targets CD25+ antigen-activated T cells, has demonstrated a positive safety profile with no dose-limiting toxicities or capillary leak syndrome observed during the dose escalation phase. 

Notably, STK-012 has induced multiple objective responses in patients who had previously progressed on immunotherapy, highlighting its potential as a therapeutic agent. The Phase 1a/1b trial data, presented at the AACR Annual Meeting 2024, included 47 patients and showcased the drug's efficacy, pharmacokinetics, and pharmacodynamics. The drug's design is to induce interferon-gamma and selectively expand antigen-activated T cells without causing severe toxicities associated with traditional IL-2 treatments. 

Synthekine's Chief Medical Officer, Naiyer Rizvi, M.D., expressed enthusiasm over the results and the absence of severe toxicities, indicating the drug's potential to improve cancer treatment paradigms. The Phase 1b portion of the study, initiated in September 2023, is currently enrolling patients with non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC) to further evaluate the drug's efficacy at the recommended phase 2 dose. A case study of a patient with Stage IV RCC treated with STK-012 was also highlighted, showing a significant reduction in target lesion size. The drug's initial Phase 1a monotherapy dose escalation data revealed that most patients had received prior treatments, and treatment-related adverse events were manageable and generally mild to moderate in severity. 

The drug showed selectivity for T cells expressing IL-2Rα (CD25) and induced a dose-proportional increase in interferon-gamma and activated CD8 T cells, with limited expansion of NK cells and Tregs. Among the efficacy evaluable subjects, partial responses were observed, and the durability of these responses was noted. Synthekine is focused on developing selective immunotherapies to enhance cancer and inflammatory disease treatment. The company's approach involves engineering cytokines to maximize their therapeutic potential while minimizing toxicity. Their pipeline includes modified cytokines, cytokine-enhanced cell therapies, and surrogate cytokine agonists, all aimed at creating innovative treatments. 

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