Sonnet Shares Surge As FDA Clears Its First Human Trial For Solid Tumor Candidate

• The FDA has signed off Sonnet BioTherapeutics Holdings Inc's (NASDAQ:SONN) Investigational New Drug (IND) application for SON-1010, a proprietary version of Interleukin 12 (IL-12) configured using Sonnet's Fully Human Albumin Binding (FHAB) technology. 
• Sonnet will initiate its First-in-Human Phase 1 trial in adult oncology patients in Q2 of 2022. 
• The study will establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) using monthly subcutaneous injections of SON-1010. 
• The primary endpoint will assess the safety and tolerability of SON-1010, with key secondary endpoints planned to measure pharmacodynamics, pharmacodynamics, immunogenicity, and anti-tumor activity.
• In August last year, Sonnet BioTherapeutics completed the discovery phase for its next preclinical pipeline candidate, SON-1410, its second bispecific compound integrating Interleukin 12.
• The target indications for SON-1410 will be melanoma and renal cancers.
• The company aims to file an IND in Q2 of 2022.
• Price Action: SONN shares are up 84.6% at $0.51 during the premarket session on the last check Wednesday.