Sonnet BioTherapeutics Announces Progress in Two Phase 1 Dose-Escalation Trials of SON-1010

• The SB101 and SB102 studies have together dosed 19 subjects to date
• This early review of safety sets the stage for further dose escalation
• Additional safety and cytokine-specific data are expected during the fourth calendar quarter of 2022

Excerpt from the Press Release:

PRINCETON, NJ / ACCESSWIRE / September 21, 2022 / Sonnet BioTherapeutics Holdings, Inc., (NASDAQ:SONN) a clinical-stage company developing targeted immunotherapeutic drugs, announced today that initial safety has been formally reviewed in both Phase 1 clinical trials of SON-1010(IL12-FHAB) in adults and that dose escalation is continuing. SB101 is a multiple-dose trial for patients with advanced solid tumors that commenced in April (NCT05352750) and has now started treating the third dose cohort. SB102 is a single-ascending dose trial in healthy volunteers (NCT05408572) that started in July and is dosing the second cohort. Safety Review Committees met to discuss the findings after each cohort, found no safety concerns to prevent moving forward, and approved advancing to the next higher dose levels for both studies.

“We are excited to have now dosed 9 cancer patients in the SB101 study and 10 healthy volunteers in the SB102 study,” said Richard Kenney, M.D., Sonnet’s Chief Medical Officer. “No dose-limiting toxicities have occurred to date using this novel approach to enhance the safety of cytokine-based immunotherapy. Compounds like this have shown great promise in animal models of cancer treatment for decades, yet the developmental progress of IL-12 in human trials has typically been frustrated by toxicity before the therapeutic dose can be reached. By linking an albumin-binding domain to cytokines for targeting tumor tissue and extending the cytokine half-life in the body, we believe our proprietary F_HAB technology may offer the key to inducing a successful local immune response in the tumor microenvironment.”

“As the first FHAB technology-derived candidate dosed in patients, the successful start of clinical trials with SON-1010 represents a significant step forward in Sonnet’s full-spectrum approach to immunotherapy,” said Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Officer. “These studies are expected to form the basis for combinations with other types of immunotherapies that could have a synergistic effect on cancer and that we expect will support potential licensing activities.”

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