The Division of Research Innovation and Ventures (DRIVe) at the Biomedical Advanced Research and Development Agency (BARDA) is partnering with Lumen Bioscience on the development of an intranasal antibody cocktail against SARS-CoV-2, the virus that causes COVID-19. This effort is aligned with the goals of DRIVe’s Beyond the Needle program, which aims to make vaccines and therapeutics easier to administer and more widely available by removing the need for needles, syringes, vials, and cold-chain distribution.
Among the many medical countermeasures (MCMs) for emerging infectious diseases, immunotherapy (i.e., administration of convalescent plasma or monoclonal antibodies) has played an important role in treatment and prevention efforts. While immunotherapy is generally highly effective, its widespread application during public health emergencies has been impeded by its high cost of production and the challenges of administration (often intravenous infusion). Lumen Bioscience has developed a novel, rapid, scalable manufacturing platform to produce antibody cocktails and previously formulated these products for oral administration.
Lumen Bioscience invented an integrated antibody drug development and manufacturing platform utilizing spirulina, a type of microalgae found in food and nutritional supplements, to deliver therapeutic proteins to individuals as a countermeasure against COVID-19. Lumen Bioscience can select an antibody to engineer and introduce into the spirulina chromosome, which will then express the antibodies. Spirulina containing the antibodies can be spray dried (small, evenly distributed particles from a liquid are turned into a powder and then dried into a fine mist that can be inhaled) to create a shelf-stable, edible or inhalable drug that requires no cold chain (a low temperature-controlled supply chain). This novel approach allows for fewer logistical challenges related to production, storage, and distribution of the product. Spirulina has a well-established safety profile and is relatively inexpensive as a manufacturing platform.
Through this Beyond the Needle partnership, Lumen Bioscience will develop and optimize an intranasal formulation of their anti-SARS-CoV-2 antibody cocktail and evaluate its efficacy for treatment and prevention of COVID-19. In addition, the company will integrate the intranasal antibody manufacturing processes into its existing development-scale current good manufacturing process (cGMP) facility and confirm the suitability of the product for potential future Investigational New Drug (IND)-enabling studies. If successful, the scalable manufacturing platform, combined with a therapeutic capable of self-delivery via the respiratory mucosa, could provide a highly novel, cost-effective, rapidly deployable MCM to address emerging infectious disease threats, thereby strengthening our nation’s public health security preparedness posture.