Synthekine Inc., a leader in engineered cytokine therapeutics, has announced promising initial findings from a Phase 1a/1b trial of their novel drug STK-012, an α/β biased IL-2 partial agonist. STK-012 is designed to stimulate specific T cells associated with tumor-fighting abilities, while avoiding the toxic effects often seen with IL-2 therapies.
In the Phase 1a dose escalation phase, involving 47 patients with advanced solid tumors, STK-012 exhibited a favorable safety profile with no dose-limiting toxicities or capillary leak syndrome. Notably, multiple objective responses were achieved with STK-012 monotherapy, correlating with an increase in interferon-gamma and selectively expanding tumor-specific T cells.
“The limited efficacy and unacceptable toxicity of previous IL-2 analogues have hindered the realization of IL-2’s potential in solid tumors,” said Dr. Naiyer Rizvi, chief medical officer of Synthekine. “The promising results with STK-012, demonstrating both efficacy and avoidance of severe toxicities, are particularly encouraging.”
Following the successful completion of the Phase 1a portion, Synthekine has initiated the Phase 1b dose expansion cohorts to further evaluate STK-012 in specific solid tumor types, including renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC).
One case study presented at the AACR conference showcased a Stage IV ccRCC patient who received STK-012 monotherapy. The patient had previously undergone two treatment lines, including immune checkpoint therapy, but achieved a confirmed partial response with STK-012, significantly reducing their tumor size.
These positive initial results demonstrate the potential of STK-012 as a promising treatment option for patients with advanced solid tumors. Ongoing studies will further elucidate its efficacy and safety profile, providing valuable insights into its potential clinical impact.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
