Seattle, WA, September 24, 2020 – Lumen Bioscience, a clinical-stage biopharmaceutical company developing biologic drugs for highly prevalent diseases, and the US Army Medical Research and Development Command (USAMRDC), operating through the Medical Technology Enterprise Consortium (MTEC), today 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.
“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,” said Brian Finrow, Lumen’s co-founder and CEO. “This platform builds on 25 years of research by others in the field of camelid antibody engineering, and our unique cGMP manufacturing system makes an important contribution to this legacy: a scalable, cost-effective way to make and deliver these biologic drugs to disease targets in the GI tract.”
It was recognized early in the pandemic that the “respiratory” virus that causes Covid-19 also infects the GI tract. In one widely cited study,[i] a majority of Covid-19 patients presented with both GI and respiratory symptoms, and 25% had only GI symptoms. These symptoms can be both severe and wide-ranging[ii], in some cases requiring surgical resection[iii]. GI infection by the virus is also thought to contribute to liver damage[iv] and acute respiratory distress syndrome (ARDS)[v], both common long-term symptoms of severe Covid-19. This is not surprising: 25% of MERS[vi] cases and 16-73% of SARS[vii] cases in the 2002-2003 outbreak also presented with significant GI symptoms, and it is widely accepted that the original 2003 SARS virus transmitted efficiently through the fecal-oral route[viii], a phenomenon that could also explain recurring Covid-19 superclusters. Lumen’s GI-targeted therapy may therefore not only reduce overall viral burden, inhibit disease progression, and accelerate recovery, but also prevent a potentially significant source of Covid-19 transmission.
The Lumen grant is issued under MTEC solicitation MTEC-20-09-COVID-19_Treatment_MIDRP and is funded by the USAMRDC.
About camelid antibodies
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.
The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC) that serves those who serve our nation. For more information, visit: www.mtec-sc.org.
[i] Han, Chaoqun, et al. "Digestive symptoms in COVID-19 patients with mild disease severity: clinical presentation, stool viral RNA testing, and outcomes." The American journal of gastroenterology (2020).
[ii] Lin, Lu, et al. "Gastrointestinal symptoms of 95 cases with SARS-CoV-2 infection." Gut (2020).
[iii] Bhayana, Rajesh, et al. "Abdominal imaging findings in COVID-19: preliminary observations." Radiology (2020).
[iv] Chai, Xiaoqiang, et al. "Specific ACE2 expression in cholangiocytes may cause liver damage after 2019-nCoV infection." biorxiv (2020).
[v] Gul, Fahad, et al. "Meta-analysis of outcomes of patients with COVID-19 infection with versus without gastrointestinal symptoms." Baylor University Medical Center Proceedings. Taylor & Francis, 2020.
[vi] Assiri, Abdullah, et al. "Epidemiological, demographic, and clinical characteristics of 47 cases of Middle East respiratory syndrome coronavirus disease from Saudi Arabia: a descriptive study." The Lancet infectious diseases 13.9 (2013).
[vii] World Health Organization. Consensus document on the epidemiology of severe acute respiratory syndrome (SARS). No. WHO/CDS/CSR/GAR/2003.11. World Health Organization, 2003.
[viii] Gormley, Michael, et al. "Pathogen cross-transmission via building sanitary plumbing systems in a full scale pilot test-rig." PloS one 12.2 (2017).