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

SAN DIEGO, May 26, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced 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). 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.

“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.”

About Sorrento Therapeutics, Inc. 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP, ACE-MAB, COVI-MAB, COVI-GUARD, COVI-SHIELD and COVI-KILLER.