Our mission is to help people facing serious and often life-threatening diseases, through the use of our proprietary IC14 immunomodulatory monoclonal antibody (mAb), which targets a master regulator of the damaging immune responses to pathogens and injury.
Unlike mAbs that target single downstream cytokines in the inflammatory cascade, IC14 targets an upstream master regulator of the immune response. This target receptor, called CD14, alerts the immune system to the presence of a wide range of pathogens, including viruses. It also amplifies this response by alerting the immune system to signs of damage that result from stressed or dying cells. Thus, CD14 is a single point at which a wide range of downstream pathways and damaging cytokines may be controlled.
IC14 is the only clinical-stage drug targeting CD14. It is currently in clinical development in the USA in respiratory distress caused by COVID-19 (COVID-ARDS), in Amyotrophic Lateral Sclerosis or Motor Neurone Diseases (ALS-MND), and at an earlier stage in ocular, cardiovascular, renal and other diseases.
IC14 has potential for multiple pipeline applications, in a single product.
|Preclinical||Phase 1||Phase 2|
|* COVID-ARDS funded and conducted by NIH and BARDA, etc.|
The target of IC14, CD14, initially detects the RNA from the coronavirus and initiates an appropriate innate immune response to kill and clear infected cells. This effect is independent of the viral type or strain. As infected cells die, they spill proteins and lipids that in turn are recognised by CD14 as signs of damage that further activate and attract immune cells to the affected tissue.
Dysregulated CD14 signalling thus leads to a self-amplifying network of responses and eventually to a “cytokine storm”, spreading from the lungs to the kidneys, heart, liver and central nervous system, resulting in multiple organ failure and death.
Using IC14 to temporarily block CD14 at the key upstream intersection connecting these feed-forward loops back into the immune system may permit the resolution of inflammation and the establishment of tissue homeostasis.
Two clinical studies studying IC14 in COVID-19 patients are currently underway at more than 40 US clinical centers.
- The COVID-19 Anti-CD14 Treatment Trial (CaTT) will treat 300 patients with early signs of acute respiratory distress, and is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The CaTT clinical study is expected to report on efficacy in Q4 2021.
- The I-SPY COVID-19 Trial is an Adaptive Platform Trial for Critically Ill Patients. It will treat 125 ventilated patients with established respiratory distress and is sponsored by the Quantum Leap Healthcare Collaborative. The I-SPY platform study is expected to report on efficacy in Q3 2021.
CD14 is a versatile detector of sterile damage (not caused by an infection) from acute causes such as head injury or stroke, and chronic causes such as progressive ageing, poor diet and lifestyle choices, or faulty genes. CD14 activates innate immune cells to kill and remove the affected cells.
Unless resolved, these background signals may self-amplify and grow over time, and kill the brain cells that enable memory (as seen in Alzheimer’s disease) and muscle function (as seen in ALS-MND or Parkinson’s disease).
Using IC14 to temporarily dampen CD14 activation in these patients may stop this process and greatly slow or even stop disease progression. IC14 has a favourable clinical safety profile in both critical care patients and patients with ALS-MND treated for up to 12 months.
The objective of a clinical trial is to find out if a treatment is safe and effective. Implicit Bioscience periodically runs clinical trials for IC14, currently in the USA. The selection of trial candidates is managed directly by our clinical research partners. To stay up to date with our latest news, which may include opportunities to get involved in the future, please subscribe here.