Sorrento Receives FDA IND Clearance to Initiate a Phase I Clinical Trial of its CD38 Antibody-Drug Conjugate (ADC) STI-6129 for Patients with Amyloidosis

On May 26, 2020 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported it has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application for STI-6129, a CD38-targeting antibody drug conjugate (ADC) (Press release, Sorrento Therapeutics, MAY 26, 2020, View Source [SID1234558450]). STI-6129 utilizes several technology platforms that are under development by Sorrento Therapeutics, including a CD38 specific antibody identified from its fully human G-MAB antibody library, its proprietary drug payload Duostatin 5 and its site-specific C-LOCK conjugation technology.

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"That the FDA cleared our STI-6129 IND application to proceed to human trials is another important milestone for Sorrento," stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics. "Together with our CD38 CAR-T program, this has the potential to provide additional therapeutic options for patients in need. We are looking forward to further evaluating the safety and efficacy of STI-6129 in clinical trials."

Sorrento intends to initiate a phase I multicenter, open-label, dose-escalation clinical trial in patients with advanced relapsed and/or refractory systemic amyloid light chain (AL) amyloidosis with a primary objective to identify a phase 2 dose for STI-6129 based on its safety, preliminary efficacy and pharmacokinetic profile.

"This is Sorrento’s first ADC utilizing our site-specific C-LOCK conjugation technology that is advancing into clinical evaluation," said Dr. Hui Li, head of Sorrento’s ADC business unit, Levena Biopharma. "STI-6129 demonstrated an improved therapeutic index in animal models, as compared to traditional non-selective conjugates, and we look forward to potentially expanding its utilization into additional ADC programs."