On November 1, 2022 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN), a clinical-stage company developing targeted immunotherapeutic drugs, reported that the company will host a webcast to share initial clinical data from its SB101 clinical study with SON-1010 in oncology patients (NCT05352750) and its SB102 clinical study with SON-1010 in healthy volunteers (NCT05408572) on Wednesday, November 2, 2022 at 8:30 am ET (Press release, Sonnet BioTherapeutics, NOV 1, 2022, View Source [SID1234622759]).
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Webcast presenters will include:
Richard Kenney, M.D., Chief Medical Officer
Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Office
The webcast at 8:30 am ET, with an accompanying presentation, will be accessible under News & Events, IR Calendar in the Investors section of the company’s website. The archived audio webcast will be available on Sonnet’s website following the call.
This first-in-human study is primarily designed to evaluate the safety of multiple ascending doses of SON-1010 in cancer patients and will be conducted at several sites across the United States. While the optimal dose is unknown at this stage, the potential to target tumors, the extended PK mechanism and our preclinical data suggest the therapeutic dose may be lower compared to native human IL-12. The study, utilizing a standard 3+3 oncology design in at least five cohorts, should establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) using monthly subcutaneous injections of SON-1010. The primary endpoint explores the safety and tolerability of SON-1010, with key secondary endpoints intended to measure PK, PD, immunogenicity and anti-tumor activity. This study will form the basis for potential combinations with other types of immunotherapies and the future development of bispecific candidates using the FHAB platform.
About the SB102 Phase 1 Trial
The SB102 study is designed to robustly evaluate the safety, PK and PD of single ascending doses of SON-1010, using larger groups of healthy volunteers, and is being conducted at a single site in Australia. The study is done in a blinded fashion, comparing a single dose of SON-1010 to placebo utilizing five cohorts. Both PK and PD will be closely followed during dose escalation in this double-blind, placebo-controlled study, along with an assessment of the cellular immune responses at each dose using sophisticated fluorescence activated cell sorting (FACS) analysis. The primary endpoint explores the safety and tolerability of SON-1010, with key secondary endpoints intended to measure PK, PD and immunogenicity.