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www.fdanews.com/articles/197067-sorrento-therapeutics-mount-sinai-partner-on-triple-covid-19-antibody-treatment

Sorrento Therapeutics, Mount Sinai Partner on Triple COVID-19 Antibody Treatment

May 11, 2020

California biotech firm Sorrento Therapeutics and New York City’s Mount Sinai Health System are teaming up to test and develop a triple antibody cocktail that could potentially treat or help prevent COVID-19.

The COVI-SHIELD cocktail would be administered as often as necessary, with each dose expected to provide antiviral protection for up to two months.

The partners anticipate the therapy will be offered as a prophylactic for those returning to work and as a therapeutic to those who have been exposed to SARS-CoV-2.

“Antibody cocktail therapy establishes a high barrier to development of treatment resistance while providing a protective therapy for the population at large,” the drugmaker said.

Sorrento said that it anticipates beginning phase 1 trials in the third quarter of the year. The company is also working on a novel cellular vaccine for COVID-19, STI-6991, and plans to start enrolling participants in a human trial as soon as mid-2020.

In another development for COVID-19 treatment research, Evelo Biosciences, Rutgers University and Robert Wood Johnson University have applied for the FDA’s permission to begin a phase 2 trial evaluating EDP1815, a monoclonal antibody, in hospitalized COVID-19 patients.

The study will evaluate if EDP1815 can prevent progression of COVID-19 symptoms and the development of COVID-related complications like cytokine storm. The trial will initially involve 60 patients admitted to the emergency room within 36 hours of testing positive for the virus.

Early clinical data suggest that the anti-inflammatory could control immune pathways associated with cytokine storm and resolve inflammation without causing complete immunosuppression. — James Miessler