On Oct. 6, 2021, Lumen Bioscience announced new development funding from the US Army for its Covid-19 monoclonal antibody drug cocktail. The support is provided by the US Army Medical Research and Development Command (USAMRDC), operating through the Medical Technology Enterprise Consortium (MTEC).

This announcement builds on a previous Army grant to Lumen that funded preclinical development of LMN-301, an investigational product directed at treating and preventing the gastrointestinal (GI) manifestations of Covid-19. These symptoms are an important aspect of the disease but have received less attention than the respiratory and immunological aspects due to the lack of scalable technologies for treating such infections. Lumen’s spirulina-based GMP manufacturing and delivery technology is uniquely suited for such applications.

It has been definitely established that the virus infects the GI tract and leading studies show that such symptoms appear in a majority of patients with Covid-19. The Lumen Bio product under development, LMN-301, is a cocktail of antibody-like proteins that bind to the spike protein of SARS-CoV-2 and prevent it from infecting the ACE2-presenting cells that line the GI tract. The contract extension will fully fund a Phase 2 clinical trial among Covid-19 patients. A portion of the funds will also support a significant expansion of Lumen’s existing cGMP manufacturing plant.

Lumen plans to carry out the clinical trial in Brazil in collaboration with the widely respected TOGETHER Trial research consortium. This consortium was established with funding support from FastGrants, the Bill & Melinda Gates Foundation and the Rainwater Charitable Foundation, and is led by Dr. Edward Mills and Dr. Gilmar Reis.

The Phase 2 clinical trial is expected to commence enrollment in late winter following clearance by regulators and research ethics committees.