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Sonnet BioTherapeutics Announces Successful Completion of Two IND-Enabling Toxicology Studies with SON-1210 in Non-Human Primates

  • SON-1210 elicited no serious adverse events in repeat, subcutaneous dosing in a GLP toxicology study
  • SON-1210 was well-tolerated using dosing levels at least 50x higher than the highest anticipated human clinical dose level
  • Data show controlled induction of IFNg with no signs of cytokine release syndrome or off-target toxicity

Excerpt from the Press Release:

PRINCETON, NJ / ACCESSWIRE / February 1, 2023 / Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the “Company” or “Sonnet”), a clinical-stage company developing targeted immunotherapeutic drugs, announced today that two IND-enabling toxicology studies have been completed in non-human primates (NHPs) using its lead bifunctional therapeutic candidate. SON-1210 is a proprietary, bispecific version of human Interleukins 12 (IL-12) and 15 (IL-15), configured using Sonnet’s Fully Human Albumin Binding (FHAB®) platform.

“We continue to be very excited about the progress of our pipeline development activities and in particular, the potential of our bifunctional FHAB compounds that target the tumor microenvironment by binding albumin, which was designed to enhance the pharmacokinetic profile in humans”, commented John Cini, PhD, Sonnet’s co-founder and Chief Scientific Officer. “To that end, SON-1210 is Sonnet’s most advanced bifunctional asset and secondary lead FHAB-derived compound that is evolving towards clinical development. The data generated from these IND-enabling toxicology studies represent an important milestone in this process and we remain confident in our technology platform.”

Pankaj Mohan, PhD, Sonnet’s founder and Chief Executive Officer added, “Data analysis and reporting for both of these studies will enable the preparation of regulatory filings to begin during the first half of 2023 for first-in-human trials of SON-1210.

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