On March 16, 2022 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for SON-1010, a proprietary version of Interleukin 12 (IL-12) configured using Sonnet’s Fully Human Albumin Binding (FHAB) technology (Press release, Sonnet BioTherapeutics, MAR 16, 2022, View Source [SID1234610175]). This will allow Sonnet to initiate its First-in-Human Phase 1 trial in adult oncology patients in the second quarter of 2022.
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"The FDA’s acceptance of the IND for SON-1010 is an important milestone in the development of our lead FHAB asset, signifying the evolution of Sonnet into a clinical biopharmaceutical company," said Pankaj Mohan, Ph.D., Founder and Chief Executive Officer. "We are excited about the progress we have made with our FHAB platform, which we believe will set the stage for improved efficacy of monospecific and bispecific cytokines, each differentiated by tumor targeting and retention in the tumor microenvironment."
The planned Phase 1 trial will be a multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SON-1010 in adult patients with advanced solid tumors. "We have worked hard to establish a dose range for this extended PK form of IL-12 that can be tested safely and may provide an enhanced therapeutic index," said Richard Kenney, M.D., Sonnet’s Chief Medical Officer. "The goal of this strategy is to carefully adjust the body’s cells and cytokines to enhance the innate immune response to tumors." The study, utilizing a standard 3+3 oncology design in at least 5 cohorts, will establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) using monthly subcutaneous injections of SON-1010. The primary endpoint will assess the safety and tolerability of SON-1010, with key secondary endpoints planned to measure PK, PD, immunogenicity, and anti-tumor activity.