Sonnet BioTherapeutics (SONN) announced today that it successfully completed it’s Non-Human Primate Study of SON-1010. Their drug SON-1010, a proprietary fully human Interleukin 12 (IL-12) therapeutic candidate configured using Sonnet’s Fully Human Albumin Binding (FHAB) platform.
Sonnet’s FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose-sparing and an opportunity to improve the safety and efficacy profile of IL-12, as well as other immunomodulators.
The objectives of this dose range-finding study were twofold: to confirm the enhanced PK profile of SON-1010 in comparison to recombinant human IL-12 (demonstrated previously in a humanized mouse model), and to perform a dose escalation to inform and de-risk the design of follow-on NHP studies needed for the SON-1010 IND filing with the FDA.
“We are excited by these data that indicate a potentially broad therapeutic window for SON-1010, our proprietary FHAB-Interleukin 12 drug candidate. IL-12 is widely viewed as holding promise as a therapeutic in the oncology setting, however, this application has been limited by its toxicity and pharmacokinetic profile. We believe today’s announcement represents another important step forward towards unlocking the therapeutic potential of IL-12, as well as other compounds in our pipeline.”Pankaj Mohan, Ph.D., Founder and CEO
The data from this study indicate that in healthy cynomolgus macaques of both sexes, a single dose of SON-1010 is well tolerated at dosage levels greater than 50 times the anticipated exposure in human clinical trials. Additionally, SON-1010 elicited a prolonged and potent on-target PD effect as measured by, Interferon-γ (IFN-γ), a key biomarker of antitumor activity. On-target and transient changes in clinical chemistry and pathology parameters were observed, but resolved completely within 14 to 21 days post-dosing. Signs of cytokine imbalance, or uncontrolled increase of pro-inflammatory cytokines, including TNF-α, IL-1β, and IL-6 were notably absent from all dose levels tested in the study. Pharmacokinetic analysis of serum samples from the study animals indicated a mean half-life of 40.0 (±6.9) hours for subcutaneous dose routes and 27.45 (±2.8) hours for intravenous dose routes.
These results build on those from a prior study using the B16F10 mouse model of melanoma, where the mouse version of SON-1010 showed a 20-fold reduction in the dosage required to achieve a similar therapeutic effect compared to mouse IL-12. Taken together, the observed extended half-life, improved therapeutic window and reduced dosing requirement, made possible by Sonnet’s FHAB technology, represent key advantages of SON-1010 as a potential immune oncology therapeutic.
John Cini, Ph.D., Co-founder and Chief Scientific Officer, added, “We designed our FHAB technology to leverage the therapeutic properties of otherwise toxic immune modulating compounds, by optimizing their tolerability and adding a targeted delivery mechanism. This study is an important milestone for SON-1010, and we believe further validates the fundamental strengths of our drug development platform.”
Results from the second phase of this NHP study, which includes a repeat dose regimen in healthy cynomolgus macaques, are expected in the coming weeks. Collectively, these data will be applied to advance SON-1010 to potential first-in-human Phase I clinical testing in patients with solid tumors, specifically lung cancer and head and neck cancers, with an IND submission anticipated during the second half of 2021.
Is Sonnet BioTherapeutics (SONN) a good investment
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