FDA Clears Sonnet BioTherapeutics’ IND Application for SON-1010

Mar 16, 2022 By MarketDepth

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Cancer Research microscope test tubes

Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) announced today that the U.S. Food and Drug Administration (“FDA”) has cleared its Investigational New Drug (“IND”) application for SON-1010.

Shares Surge Premarket

Shares of Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) gained over 79% during the premarket hours.

Phase 1 Trials

SON-1010 is a proprietary version of Interleukin 12 (IL-12) configured using Sonnet’s Fully Human Albumin Binding (FHAB™) technology and the newly acquired IND clearance will allow Sonnet to initiate its First-in-Human Phase 1 trial in adult oncology patients in the second quarter of 2022.

“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.”

Pankaj Mohan, Ph.D., Founder and Chief Executive Officer

The company’s upcoming 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 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.”

Pankaj Mohan, Ph.D., Founder and Chief Executive Officer