The partnership is aimed at creating antibody products that could act as a “protective shield” against infection by the virus that causes COVID-19, SARS-CoV-2. COVI-SHIELD is expected to deliver a mixture of three antibodies that combined recognize three specific regions of the SARS-CoV-2 Spike protein.
The organizations believe that, if approved, COVI-SHIELD could be given for people returning to work and as a therapy for people exposed to the virus. The product is designed to be dosed as often as necessary, with each dose providing antiviral protection for up to two months.
Carlos Cordon-Cardo, the 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 about 15,000 people who may have had COVID-19 and recovered. They were looking for antibodies against the virus.
The screening leveraged a diagnostic test developed by Florian Krammer, professor of Microbiology at Icahn and authorized under an emergency use authorization by the U.S. Food and Drug Administration (FDA). Sorrento has access to plasma containing antibodies against COVID-19 in order to identify and produce monoclonal antibodies that have 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.”
This approach to preventing COVID-19 is gaining ground while the industry works to develop a vaccine against the disease or drugs are tested or developed. To date, 10 plasma companies globally have joined the CoVIg-19 Plasma Alliance, founded to accelerate development of a plasma-derived hyperimmune globulin therapy against COVID-19. The founding companies include Biotest, BPL, CSL Behring, LFB, Octapharma and Takeda, but has since added ADMA Biologics, BioPharma Plasma, GC Pharma and Sanquin.
The Alliance is also collaborating with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) to evaluate the safety, tolerability and efficacy of the hyperimmune therapy in adults with COVID-19. The trial is expected to launch this summer.
Sorrento is wrapping up the requirements to file an Investigational New Drug (IND) application to the FBI for the triple antibody combination therapy, with plans to initiate Phase I trials in the third quarter of this year.
“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,” said Henry Ji, chairman and chief executive officer of Sorrento Therapeutics. “Unfortunately, with coronaviruses, mutations are part of the equation and could render therapies ineffective over time. 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 an antibody-centric biopharma company typically focused on therapies for cancer and infectious diseases. Its immuno-oncology platforms include fully human antibodies (G-MAB library), clinical stage immuno-cellular therapies such as CAR-T and DAR-T, Intracellular targeting antibodies (iTAbs), antibody-drug conjugates (ADC) and clinical stage oncolytic virus, Seprehvir. Its antiviral therapies include COVIDTRAP, ACE-MAB, COVI-MAB, COVI-SHIELD and COVI-CELL.