On Sept. 24, 2020, Lumen Bioscience and the US Army Medical Research and Development Command, announced an agreement to develop a rapid, scalable, and inexpensive biologic drug cocktail to treat gastrointestinal (GI) infection in Covid-19 patients and potentially block disease transmission. Covid-19 is an important force readiness issue for the US military: in a prominent example, the US aircraft carrier Theodore Roosevelt was forced to return to port after an outbreak earlier this year.

The nearly $4 million grant funds rapid development of an oral SARS-CoV-2 treatment and preventative product candidates through FDA Investigational New Drug (IND) submission and initial engineering work for a large-scale cGMP manufacturing plant. By spring 2021 the program aims to initiate Phase 2 clinical trials and complete siting and engineering work for a 1-billion-dose-per-year production facility, with cGMP manufacturing to commence in summer 2021.

The Lumen product under development is derived from camelid antibodies, also known as nanobodies, VHHs, and single-domain antibodies. Using them to neutralize infectious diseases in the GI tract is a mature technology, first demonstrating efficacy in a human clinical trial in 2013, and various research groups have announced the identification of high-potency VHHs against SARS-CoV-2. Lumen’s novel technology is the first to potentially allow for the cost-effective manufacturing of these unique biologic proteins at pandemic scale.