Yet another group is targeting the important (and deadly) topic of COVID-19 Acute Respiratory Distress Syndrome (ARDS) as this remains one of the most common ways patients afflicted with severe to critical SARS-CoV-2 pass away. To lower the death rate, a number of ventures are investigating various therapies and treatments in clinical trials. The most recent announcement comes from Immune Regulation Ltd, a U.S. and UK-based clinical stage biotechnology company that signed a Teaming Agremeent with DynPort Vaccine Company LLC (DVC: a GDIT Company) to jointly investigate the possibility of the company’s drug product ILR201104 to treat COVID-19 related ARDS in U.S.-based clinical trials.
As the morbidity and mortality rates get much higher with severe to critical COVID-19 cases associated with ARDS, the underlying science of this process becomes a worldwide topic. COVID-19 infection is associated with a dynamic of recruitment of key blood cells to the lung, such as neutrophils, which are required to fight the virus. But with high-risk patients, this natural response can turn deadly as the action of inflammatory molecules released by neutrophils can lead to overwhelming inflammation (ARDS) that can leave patients with dangerously low levels of blood oxygen. A horrific death can be imminent thereafter.
The Investigational Product
IRL201104 is a first-in-class compound and is a peptide derived from endogenous immuno-regulatory protein (mTB chaperonin 60.1). In models of lung inflammation, the investigational product uniquely reduces the infiltration of three key cells involved in both allergic and non-allergic inflammation: eosinophils, neutrophils and lymphocytes.
Chaperonin 60.1 is a key immunomodulatory protein secreted by Mycobacterium tuberculosis, and is one of the strategies that mTB uses to ensure the bacteria can survive for decades within the human lung. As delineated on the Immune Regulation website, this immune ‘resetting strategy’ by mTB modulates the human immune system by regulating the activity of key immune cells. Hence those patients with tuberculosis, or who have had the BCG vaccination, have been shown to be association with a 5-fold reduction in the prevalence of risk of developing asthma or allergy.
At least one clinical study has been conducted with this investigational drug reports the sponsor. Out of 62 subjects receiving at least one dose of IRL201104, no serious adverse events, or adverse events were reported that led to withdrawal. There were a few adverse events and no dose response seen in terms of frequency or severity of adverse events reported. There were no safety concerns attributable to IRL201104 as assessed by vital signs, 12 lead, ECG, ECG telemetry, laboratory (hematology, clinical chemistry, urinalysis) safety test and physical examination, reports the sponsor via their website. Local tolerability was also satisfactory.
In a range of preclinical in vivo studies, a single administration of ‘1104 prevented the infiltration of inflammatory cells into the lung. This effect is seen consistently using a variety of allergens, despite the compound being metabolized within a few hours (blood half-life, 10 minutes). ‘1104 was also shown to increase the expression of A20, a key regulator of the inflammatory response.
Applicability of IRL201104
Immune Regulation’s drug candidate IRL201104 has been shown to quickly and markedly reduce the excessive infiltration of neutrophils in the lungs in a preclinical model of acute lung inflammation. A single dose of IRL201104 has been shown to reduce neutrophil infiltration quickly and maintain this effect for at least 24 hours. This may mean that a short course of treatment with IRL201104 would be able to provide a marked reduction in the numbers of infiltrating neutrophils into the lung, potentially reducing the overwhelming inflammatory response and restoring the levels of blood oxygen.
DynPort Vaccine Company LLC, part of General Dynamics, manages product development programs for U.S. and international government agencies, and provides consulting, technical and program management services to companies in the biotechnology and pharmaceutical industries. At DynPort, they help the government protect soldiers and civilians against emerging diseases and possible bioterror threats. On their website, they claim, “We’re doing important work, protecting our nation’s health and security.” Jonathan Rigby, Group CEO of Immune Regulation, reports, “We are very pleased to be working on a therapeutic approach that can potentially reduce COVID-19 related ARDS. Doing this in partnership with a world class company like DVC, significantly improves are chances of a successful outcome and we are delighted by the prospect.” DVC’s President Gary Nabors reports that they will embrace the “unique solution to the problem of ARDS, which is fatal in patients with advanced COVID-19.”
About Immune Regulation
Immune Regulation Limited is a US and UK based clinical stage biotechnology company, pioneering new technologies for regulating and resetting the immune system and developing novel first-in-class therapies for inflammatory and immunological diseases.
Immune Regulation’s first-in-class immune resetting therapies have demonstrated unique efficacy and safety in pre-clinical and human studies without suppressing the immune system. These therapies exhibit short pharmacokinetic activity but reset the immune system from a pro-inflammatory to a regulatory state to induce disease remission in patients with allergic and immune mediated diseases, without the negative effects of chronic current therapies.
At Immune Regulation our aim is to develop novel, safe and effective therapies that reset the immune system, transforming the lives of patients with inflammatory and immunological diseases.
About DynPort Vaccine Company
DynPort Vaccine Company, a General Dynamics Information Technology Company, was founded in 1997 to develop vaccines and therapeutics for US Government customers. Based in Frederick, MD, the company has focused on the advanced development of medical countermeasures for biodefense and emerging infectious diseases, and chemical warfare agents. DVC holds contracts with the US Department of Defense, and Health and Human Services.