Sorrento Announces IND Filing for COVI-DROPS, an Intranasal Formulation of a High Potency Neutralizing Antibody Against SARS-CoV-2

• IND filing today for STI-2099 (COVI-DROPS) for a phase 1 safety and pharmacokinetic study in healthy volunteers and outpatients with mild COVID-19 disease with or without a simultaneous intravenous injection of COVI-AMG.
  
  
• Initial trial is expected to be followed by a phase 2 trial in both mild and moderate COVID-19 patients, either as a stand-alone nasal application or as a combination nasal and intravenous administration.
  

SAN DIEGO, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today that it is filing an investigational new drug application (IND) for intranasal (IN) COVI-DROPS (STI-2099) to study the safety and pharmacokinetics in both healthy volunteers and patients with mild COVID-19.

As Sorrento previously announced, in preclinical studies, high potency STI-2099 demonstrated a 100% neutralizing effect (both in vitro and in vivo) and at a very low dose prevented SARS-CoV-2 from infecting healthy cells and causing COVID-19-like disease in Syrian golden hamsters.

A single intra-nasal administration of STI-2099 12 hours after infection prevented disease-associated weight loss in treated hamsters. The impact of the treatment was observed within 24 hours of STI-2099 treatment, demonstrating unique disease treatment properties as compared to intravenously administered antibodies.

“We believe STI-2099 has the potential to be broadly deployable for early treatment in an outpatient setting. The intranasal route is expected to be enabled by the high potency of the antibody and is quite promising against this highly contagious respiratory pathogen,” stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics. “In addition, it is now understood that COVID-19 is a local and systemic disease; therefore, we believe the best course of action would be to attack this highly contagious pathogenic virus both locally and systemically.”

About Sorrento Therapeutics, Inc. 
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. 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 ("ADCs"), and clinical stage oncolytic virus ("Seprehvir"). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVI-GUARD, COVI-AMG, COVI-SHIELD and COVI-DROPS; and diagnostic test solutions, including COVI-TRACK, COVI-STIX and COVI-TRACE.