Sonnet BioTherapeutics Announces Pharmacokinetic and Pharmacodynamic Data in a Phase 1 Dose-Escalation Trial of SON-1010

• 24 healthy volunteers have been dosed in study SB102 to assess the safety, PK, and PD of SON-1010 without the background of prior chemotherapy
• PK data shows an extended half-life of SON-1010 of approximately 112 hours, compared to 12 hours for rhIL-12
• Simulation of the controlled and prolonged induction of IFNg and minimal related adverse events suggest that dose escalation can continue

Excerpt from the Press Release:

PRINCETON, NJ / ACCESSWIRE / January 19, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the “Company” or “Sonnet”), a clinical-stage company developing targeted immunotherapeutic drugs, announced today that pharmacokinetic (PK) profile simulation of SON-1010 dosing has been completed in its randomized, placebo-controlled Phase 1 clinical trial in healthy volunteers. Historically, the therapeutic application of cytokines has been limited by relatively short half-lives and off-target toxicities that are typically associated with peak plasma levels. SON-1010 is a proprietary version of recombinant human interleukin-12 (rhIL‑12), configured using Sonnet’s Fully Human Albumin Binding (F_HAB^®) technology, which has been shown to extend PK and to reduce peak drug levels for improving pharmacodynamic (PD) toxicity. The F_HAB technology was designed to promote targeting to the tumor microenvironment (TME), particularly when levels of Secreted Protein Acidic and Rich in Cysteine (SPARC) are elevated in the TME. Study SB102 is a single-ascending dose trial in healthy volunteers (NCT05408572) that was initiated in July, 2022 to address the safety, PK, and PD of SON-1010 in subjects without interference from prior chemotherapy. The Safety Review Committee has found no significant safety concerns to date and has approved advancing to each higher dose level.

“We have evaluated the drug levels and cytokine responses in the SB102 study,” said Richard Kenney, M.D., Sonnet’s Chief Medical Officer. “The PK and PD from 3 cohorts have been formally simulated to predict the levels of the most responsive cytokines. Interferon gamma (IFNg) levels rose after SON-1010 dosing as expected, but with lower peak elevations and much longer decay than those observed historically for rhIL-12, which correlates with better tumor control in preclinical models. Linking IL-12 to the F_HAB is designed to permit use of higher doses of this cytokine without triggering unacceptable toxicity, allowing us to safely induce a successful local immune response to IL-12 in the TME.”

Typical dose-related increases were seen with SON-1010 using a validated electrochemi­luminescence assay (Meso Scale Discovery^®) after subcutaneous administration.

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