Sonnet BioTherapeutics announced positive safety data from an expansion cohort of its Phase 1 SB101 trial. The trial is evaluating SON-1010, a recombinant human interleukin-12 (rhIL-12) bound to Sonnet’s albumin-binding platform, in combination with trabectedin, for advanced leiomyosarcoma (LMS) and liposarcoma (LPS). The Safety Review Committee found no unexpected toxicities in the first seven patients receiving the maximum tolerated dose (MTD) of SON-1010, allowing for full enrollment of up to 18 patients.
This positive safety data is crucial for advancing the development of SON-1010 as a combination therapy for these aggressive sarcomas. Trabectedin, while approved, leaves room for improvement in efficacy. The combination with SON-1010 aims to leverage IL-12’s immune-stimulating properties to enhance trabectedin’s anti-tumor effects. This approach of combining established treatments with novel immunotherapies holds promise for improving patient outcomes in an area with a high unmet medical need.
The data reveals that adverse events related to either drug were mild or moderate, indicating good tolerability of the combination. An annual review of all 30 patients dosed with SON-1010, either as monotherapy or in combination, further reinforces the drug’s safety profile. Importantly, the review also showed that 83% of patients receiving high-dose SON-1010 monotherapy experienced clinical benefit, including a confirmed partial response in a patient with clear cell sarcoma. This suggests that SON-1010 might offer clinical benefit even as a standalone therapy. The ongoing expansion cohort will provide more data on the combination’s efficacy, using the RECIST criteria.
The positive safety profile and early signs of efficacy pave the way for a larger Phase 2 study. This study could potentially establish SON-1010 plus trabectedin as a new treatment option for earlier-stage STS. Considering the $2.1 billion global market for trabectedin and the persistent need for more effective sarcoma treatments, these positive developments could represent a significant advance in the field and a promising commercial opportunity for Sonnet.
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.
