COVI-SHIELD vs. COVID-19

SAN DIEGO & NEW YORK—Having cocktails in San Diego or New York—the homes of Sorrento Therapeutics Inc. and Mount Sinai Health System, respectively—is certainly an attractive image for many people. However, the two organizations have partnered for a very different twist on that theme, with plans to investigate and develop an antibody “cocktail” called COVI-SHIELD that could potentially treat COVID-19, the disease caused by the SARS-CoV-2 virus.

As suggested by the name of the potential treatment, this collaboration between Mount Sinai and Sorrento seek to generate an antibody product (or products) that can serve as a protective shield against SARS-CoV-2 coronavirus infection, with the cocktail of therapeutics theoretically blocking and neutralizing the activity of the virus in both naïve at-risk populations and in recently infected individuals.

As currently conceptualized, COVI-SHIELD would deliver a cocktail of three antibodies which together would recognize three unique regions of the SARS-CoV-2 spike protein.

To get to this point, Dr. Carlos Cordon-Cardo of Mount Sinai and his team screened approximately 15,000 individuals who may have had and recovered from COVID-19 for the presence of anti-COVID-19 antibodies, using a diagnostic test developed by Dr. Florian Krammer, a professor of microbiology at the Icahn School of Medicine at Mount Sinai, and authorized for use in Mount Sinai’s laboratory under an FDA Emergency Use Authorization. Cordon-Cardo, for his part, is Mount Sinai’s Irene Heinz Given and John LaPorte Given Professor and chair of the Pathology, Molecular and Cell-Based Medicine Department at the Icahn School of Medicine at Mount Sinai.

As part of the Sorrento-Mount Sinai collaboration terms, Sorrento will have access to plasma containing antibodies against COVID-19 for the purpose of identification and production of monoclonal antibodies with potential neutralizing activity against SARS-CoV-2.

“We’re working with pharma and biotech partners, such as Sorrento, to bring much-needed therapies to the clinic,” said Erik Lium, executive vice president and chief commercial innovation officer of the Mount Sinai Health System. “We look forward to advancing the development of an effective antibody cocktail with Sorrento.”

According to the partners, antibody cocktail therapy “establishes a high barrier to development of treatment resistance while providing a protective therapy for the population at large,” so, if COVI-SHIELD is approved, they anticipate that it would be offered for administration as a prophylactic for those returning to work and as a therapeutic to those who have been exposed to SARS-CoV-2. They says that COVI-SHIELD prevention and treatment is designed to be administered as often as necessary.

“It is our belief that as we re-open the country and the economy, we will see local flare-ups of infectious spread of SARS-CoV-2. Unfortunately, with coronaviruses, mutations are part of the equation and could render therapies ineffective over time,” stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics. “It is our intention to develop a triple antibody prophylactic and therapeutic agent that would shield healthcare workers and at-risk patients. This therapy is designed to be resistant to future virus mutations and, if approved, should be made available in support of testing, tracing, vaccination and other therapeutic approaches to allow for efficient management of viral infection by protecting those most at risk for up to two months at a time.”

Sorrento is completing all IND filing requirements for the triple antibody combination therapy, and expects to commence Phase 1 trials of the drug candidate in the third quarter of 2020.