I suspect we will be approved before they get star

I suspect we will be approved before they get started in P1

Sorrento And Mount Sinai Health System To Jointly Develop COVI-SHIELD™ Antibody Therapy Targeting SARS-CoV-2 Infection (COVID-19)
May 8, 2020 at 9:20 AM EDT

SAN DIEGO, May 8, 2020 /PRNewswire/ --Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento" and Mount Sinai Health System ("Mount Sinai" have agreed to join forces in the investigation and development of an antibody cocktail (COVI-SHIELD™) to potentially treat COVID-19.



Carlos Cordon-Cardo, MD, PhD, Irene Heinz Given and John LaPorte Given Professor and Chair of Pathology, Molecular and Cell-Based Medicine at the Icahn School of Medicine at Mount Sinai and his team screened approximately fifteen thousand individuals who may have had and recovered from COVID-19 for the presence of anti-COVID-19 antibodies. The screening used a diagnostic test developed by Florian Krammer, PhD, 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. 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.

The collaboration between Mount Sinai and Sorrento aims to generate antibody products that would act as a "protective shield" against SARS-CoV-2 coronavirus infection, potentially blocking and neutralizing the activity of the virus in naïve at-risk populations as well as recently infected individuals. It is expected that each dose of COVI-SHIELD, if approved, will deliver a cocktail of three antibodies which together would recognize three unique regions of the SARS-CoV-2 Spike protein.

Antibody cocktail therapy establishes a high barrier to development of treatment resistance while providing a protective therapy for the population at large. If approved, it is anticipated that COVI-SHIELD will 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. COVI-SHIELD prevention and treatment is designed to be administered as often as necessary, with each dose expected to provide antiviral protection for up to two months.

"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."

"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, Inc., before adding "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.