Benzinga - by Vandana Singh, Benzinga Editor. Sonnet BioTherapeutics Holdings Inc (NASDAQ: SONN) shares are trading higher after the company announced that the IND for SB221, the Phase 1b/2a trial of SON-1010 (IL12-FHAB) in combination with Roche Holding AG's (OTC: RHHBY) atezolizumab, has been accepted, and the study can begin in the U.S. for platinum-resistant ovarian cancer (PROC).
The trial consists of a modified 3+3 dose-escalation design in Part 1 to establish the maximum tolerated dose (MTD) of SON-1010 with a fixed dose of atezolizumab.
Clinical benefit in PROC will be confirmed in an expansion group to establish the recommended Phase 2 dose (RP2D).
Part 2 of the study will then investigate SON-1010 monotherapy, its use in combination with atezolizumab, or the standard of care (SOC) for PROC in a randomized comparison to show proof-of-concept.
SB221 is a global Phase 1b/2a multicenter, dose-escalation and randomized POC study to assess the safety, tolerability, PK, PD, and efficacy of SON-1010 administered subcutaneously (SC), either alone or in combination with atezolizumab given intravenously (IV).
Price Action: SONN shares are up 23.78% at $0.40 at publication Wednesday.
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