Ultra-Rapid, Low-Cost Neutralizing Antibody Therapeutic for COVID-19
Lumen Bioscience, a clinical-stage biopharmaceutical company, has started rapid development of a low-cost, orally delivered cocktail of antibodies against SARS-CoV-2 (the virus that causes COVID-19) to prevent and treat infection of the gastrointestinal (GI) tract.
While the respiratory symptoms of COVID-19 are widely known, the virus also attacks the lining of the GI tract. Its ability to replicate and persist there is well documented. In fact, in one leading study a majority of non-hospitalized COVID-19 patients had both GI and respiratory symptoms, and 25% reported only GI symptoms with no accompanying respiratory symptoms. Furthermore, recent studies indicate that SARS-CoV-2 may persist in the GI tract long after respiratory symptoms have resolved, potentially contributing to “long-haul Covid”. In rare cases, the direct consequences of this infection can be severe, ultimately leading to necrosis and requiring gut segment resection. And high GI viral loads have been implicated as an important possible contributor to the out-of-control immune reaction that characterizes the most severe cases.
With support from USAMRDC’s Military Infectious Diseases Research Program (MIDRP) and MTEC, Lumen Bioscience is developing a new product (LMN-301) to fill this gap in the U.S. response to COVID-19: a low-cost, orally delivered cocktail of antibodies against SARS-CoV-2 to directly prevent and treat infection of the GI tract. A GI-targeted therapy to eliminate this viral reservoir could not only reduce overall viral burden, inhibit disease progression, and accelerate viral clearance, but also prevent this common route of infection and block the potentially significant fecal-oral transmission route.
Lumen Bioscience has completed several initial milestones culminating in a cocktail of high-potency antibodies that neutralize SARS-CoV-2. Importantly, these early results demonstrate strong resistance to GI proteases and high-yield in Lumen’s unique ultra-low-cost cGMP manufacturing system. The program is now working through final antibody cocktail assembly based on final cGMP process run data and evaluation in live-virus neutralization assays. Lumen Bioscience is preparing an Investigational New Drug (IND) application with an eye toward a treatment/prophylaxis Phase 2 clinical trial in Summer 2021. Brian Finrow, the co-founder and CEO of Lumen Bioscience, stated, “We are pleased to have this opportunity to make a meaningful contribution to the COVID-19 response and to showcase the unique cost efficiency and speed advantages of Lumen’s novel drug development environment.” A full description of Lumen’s technology platform is now available on bioRxiv.
This project was funded through MTEC’s Request for Proposals for the Development of Treatments for COVID-19 (Solicitation #20-09-COVID-19).
About Lumen Bioscience:
Lumen Bioscience discovers, develops, and manufactures biologic drug candidates for several prevalent, worldwide diseases—many of which currently lack any effective treatments. Lumen’s unique drug development and manufacturing platform offers the potential to transform the biologics industry through increased speed, mass-market scale, and exponentially lower costs than current approaches. In turn, this opens up an entirely new dosing modality: direct delivery of antibodies and other biologics to diseased tissues such as the GI tract, skin, and airways. This allows higher doses to be targeted where needed while simultaneously reducing the risk of unwanted side-effects. Lumen’s current pipeline includes investigational biologic drugs for C. difficile infection, COVID-19, norovirus, traveler’s diarrhea, and inflammatory bowel disease.