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

The FDA has signed off Sonnet BioTherapeutics Holdings Inc's 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.