Human Interleukin-12 Phase 1 Study Results Announced
Sonnet BioTherapeutics Holdings, Inc. announced today that the safety of SON-1010 dosing in several study cohorts had been formally reviewed in both Phase 1 clinical trials and that dose escalation is continuing as early data becomes available.
"We have now dosed 12 cancer patients at increasing drug levels in the SB101 study and 24 healthy volunteers in SB102," said Richard Kenney, M.D., Sonnet's Chief Medical Officer, in a press release on November 2, 2022.
SON-1010 is a proprietary version of human interleukin-12 (IL-12), configured using Sonnet's Fully Human Albumin Binding (FHAB®) platform.
SB101 is a multiple-dose trial for adult patients with advanced solid tumors (NCT05352750) that commenced in April 2022 and has now started treating the fourth dose cohort.
SB102 is a single-ascending dose trial in healthy volunteers (NCT05408572) that started in July and is dosing the third cohort.
Safety Review Committees found no safety concerns and approved advancing to the next higher dose levels for both studies.
"No dose-limiting toxicities have occurred to date using this novel approach to enhance the safety of cytokine-based immunotherapy, and we are starting to get encouraging data back on the pharmacokinetic and pharmacodynamic responses."
"By linking the IL-12 cytokine to an albumin-binding domain that can target tumor tissue and extend the cytokine half-life in the body, we believe our proprietary FHAB technology will allow us to use higher doses of cytokines without triggering unacceptable toxicity."
"This could be the key to inducing a successful local immune response to Il-12 in the tumor microenvironment."
The data will be presented at a webinar at 8:30 am ET today.