The blocking antibodies were further tested for their ability to inhibit SARS-CoV-2 virus infection in an in vitro SARS-CoV-2 virus infection model. The testing happened pursuant to a preclinical testing agreement for COVID-19 therapeutic candidates that were previously announced on March 31, 2020. 

The STI-1499 antibody managed to completely block the SARS-CoV-2 infection,  neutralizing the virus infectivity at a very low antibody dose. STI-1499 became the prime candidate for more testing and development. Initial biochemical and biophysical analyses also indicate STI-1499 is a potentially strong antibody drug candidate. 

Sorrento believes that STI-1499 will likely be the first antibody in the antibody cocktail, COVI-SHIELD™, it is developing, as was recently announced.

STI-1499 is also expected to be developed as a stand-alone therapy, COVI-GUARD™, because of the high potency it has exhibited in experiments to date.

Sorrento plans to request priority evaluation and accelerated review from regulators to determine the best pathway to make any potential treatment available as soon as possible.

Sorrento Therapeutics Manufacturing Facility

Sorrento’s existing state-of-the-art cGMP antibody manufacturing facility in San Diego is expected to be able to produce up to two hundred thousand doses per month and the Company intends to produce a million doses at risk while seeking FDA approval for any STI-1499 product candidate.

Government and Pharmaceutical Support 

The Company is seeking potential government support and pharmaceutical partners to further scale up STI-1499 manufacturing capacity with a goal of potentially providing tens of millions of doses in a short period of time to meet the vast projected demand.

Dr. Henry Ji, Chairman and CEO of Sorrento, said, “Our STI-1499 antibody shows exceptional therapeutic potential and could potentially save lives following receipt of necessary regulatory approvals. We at Sorrento are working day and night to complete the steps necessary to get this product candidate approved and available to the waiting public,”

Sorrento Therapeutics

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 (“ADCs”)
• Clinical stage oncolytic virus (“Seprehvir®”)

Sorrento is also developing potential coronavirus antiviral therapies and vaccines including: COVIDTRAP™, ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™ and COVI-CELL™. 

Sorrento’s life-enhancing therapies for patients is demonstrated by its effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”) and ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX is completing a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. 

ZTlido® was approved by the FDA on February 28, 2018.

Prohost Observations

On March 31, 2020, we learned that Sorrento signed a research testing agreement with The University of Texas Medical Branch at Galveston for the preclinical testing of Sorrento’s COVID-19 therapeutic product candidates. Dr. Slobodan Paessler, DVM, Ph.D., John S. Dunn Distinguished Chair in Biodefense and Scientific Director of the Animal Biosafety Laboratory 3 at the Galveston National Laboratory, will be supervising the research.

The project will be performed in Dr. Paessler’s laboratory at the University of Texas Medical Branch (UTMB), one of only two maximum containment laboratories on a university campus in the United States and one of just a few such Biosafety Level 4 (BSL4) laboratories currently operating in the U.S.

Dr. Paessler specializes in viral pathogenesis and therapeutic agent development, and he and Dr. Cheng Huang’s laboratory most recently obtained a COVID-19 viral isolate and have established the infection cell model for the SARS-CoV-2 virus.

Dr. Henry Ji also stated that, “Dr. Paessler is a world-renowned expert in infectious diseases and the development of animal models to test new therapeutic candidates, and his team has direct access to one of the few high containment laboratories in the country. We are committed to advancing Sorrento’s proprietary COVID-19 product candidates as quickly and safely as possible with the hope that they can offer effective, life-saving care to patients and healthcare providers worldwide.”

Sorrento Stock

On Friday the stock closed at $6.76, UP $4.14. After hours, it traded at $7.05, UP $0.29.

We like promising news.

Although promising and encouraging, Sorrento’s antibody results are coming from in vitro preclinical trials. The trial results and the story behind them are nevertheless encouraging and tempting.  

What is also encouraging is Sorrento’s pipeline which comprises several products and vaccines.

To read more of our coverage of SARS-CoV-2 (COVID-19) please click here.