- Sonnet BioTherapeutics Holdings Inc (NASDAQ: SONN) has a preclinical nonhuman primate GLP repeat-dose study of SON-1010, a proprietary version of Interleukin 12 (IL-12) configured using Sonnet's Fully Human Albumin Binding (FHAB) platform.
- The FHAB technology targets the tumor and lymphatic tissue, providing a mechanism for dose sparing.
- The study's objectives were to evaluate the toxicity of SON-1010 in the primates using a subcutaneous, repeat-dose regimen at three different dose levels versus untreated controls and to evaluate the potential reversibility of any adverse findings.
- The NHP data demonstrates that SON-1010 appears to be safe and is eliciting the expected immune responses.
- After repeated administration, no observed adverse event level was more than 50 times the anticipated equivalent human clinical dose in NHP, with no evidence of cytokine release syndrome.
- Pharmacokinetic (PK) analysis of serum samples confirmed an enhanced profile of IL12-FHAB over recombinant human IL-12, with a half-life of around 40 hours in NHP.
- A significant increase in Interferon-γ, a key pleiotropic cytokine associated with anti-tumor mechanisms, was observed following dosing with IL12-FHAB.
- By Day 38, all study subjects recovered to baseline (pre-study) values.
- Repeat dosing administration was tolerated at all dose levels examined.
- Given that IL12-FHAB has an extended half-life, tolerable doses can be given at longer dosing intervals.
- The company will provide GMP material for the initiation of the clinical trial in 2H 2021.
- Price Action: SONN shares are up 5.6% at $1.71 during the premarket session on the last check Monday.
Sonnet Bio's Interleukin 12 Candidate For Solid Tumor Shows Encouraging Action Preclinical Studies