CERC-002

An anti-LIGHT (homologous to Lymphotoxin, exhibits inducible expression and competes with HSV glycoprotein D for binding to herpesvirus entry mediator, a receptor expressed on Tlymphocytes) (part of the Tumor Necrosis Super Family 14)), fully human, monoclonal antibody 1

CERC-002

Targeting Cytokine Storm Induced COVID-19 Acute Respiratory Distress Syndrome (ARDS)

CERC-002 is an anti-LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for HVEM, a receptor expressed by T lymphocytes (part of the Tumor Necrosis Super Family 14)), fully human, monoclonal antibody being developed as anti-LIGHT treatment for COVID-19 ARDS in hospitalized patients.

LIGHT is a newly recognized cytokine with inflammatory actions encoded by the TNFSF14 gene. LIGHT, like many cytokines, appears to be involved in the dysregulated immune response, or “cytokine storm”. Secreted by neutrophils, macrophages and other inflammatory cells during an immune system response to infection,

LIGHT has been shown to play a key role in viral pneumonia. Compared to other cytokines, LIGHT is unique as it has a dual mechanism of action; exerting its effects by activating both T Cells and B Cells as well as upregulating other inflammatory cytokines.

It plays an important role in regulating immune responses in the lung, gut and skin and is “upstream” (or proximal) in the inflammatory cascade to many well recognized cytokines like IL-1, IL-6, IL-10, IL-13, TNF and GM-CSF. It has also been implicated in promoting scar (fibrosis) formation in the lung after infection.


Targeting Severe Pediatric Onset Crohn’s Disease

CERC-002 is an anti-LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for HVEM, a receptor expressed by T lymphocytes (part of the Tumor Necrosis Super Family 14)), fully human, monoclonal antibody being developed as a treatment for Pediatric Crohn’s Disease.


CERC-002

CERC-002 is currently enrolling patients in a Phase Ib Escalating Dose, Open-Label, Signal-Finding Study to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody CERC-002 in Adults With Moderate to Severe Active Crohn's Disease Who Previously Failed Treatment With an Anti-TNFα Agent, With and Without Loss of Function Mutations in Decoy Receptor 3 (Anti-LIGHT in Anti-TNFα-Resistant Crohn's Disease [TRaCk LIGHT]). This is a precursor trial before going into Pediatric patients.

Attributes
of CERC-002

  • First in Class
  • Fully Human Monoclonal Antibody
  • Novel Free-LIGHT assay for biomarker-enabled development
  • Subcutaneous Dosing

About COVID-19 Acute Respiratory Distress Syndrome (ARDS)

COVID-19 usually begins as an upper respiratory tract infection; however, for some patients, the SARS-CoV-2 virus enters the lower respiratory tract and causes direct injury to the lungs by filling the alveoli (air sacs) with excess fluid. As decrease in oxygenation occurs in the blood, breathing becomes distressed and organs become oxygen-deficient. The lungs attempt to heal, but the resulting inflammatory response / cytokine storm often ends up damaging the lungs further.

This severe inflammatory disease of the lungs is called the acute respiratory distress syndrome (ARDS). ARDS is a condition most commonly associated with illnesses such as sepsis and bacterial pneumonia—and now with COVID-19. When a patient presents with symptoms associated with ARDS—shortness of breath, chest pain, rapid heart rate and reduced blood oxygen levels—they are transported to the intensive care unit (ICU) to be monitored and possibly treated with artificial or mechanical ventilation.


About Pediatric Onset Crohn’s Disease

Pediatric Crohn’s disease is a rare, inflammatory bowel disease characterized by severe, chronic inflammation of the intestinal wall or any portion of the gastrointestinal tract. Common symptoms of pediatric Crohn’s disease are cramping, abdominal pain, and chronic episodes of watery diarrhea; blood may at times be seen in the diarrhea. In pediatric Crohn’s disease, the immune system responds to a stimulus or ‘trigger’, often an infection, but the response is abnormal. The immune system does not shut off as it is supposed to and instead mistakenly targets the gastrointestinal system, and the large and small intestines in particular. This sustained and abnormal immune system activity causes chronic inflammation and irritation of the tissues of the gastrointestinal tract, resulting in the signs and symptoms of pediatric Crohn’s disease.

Crohn’s disease is a common disorder, affecting as many as 780,000 people in the United States. The disorder is most common in individuals between 15-35, with approximately 25% diagnosed by age 20. The Crohn’s and Colitis Foundation of America estimates there may be as many as 80,000 children in the United States with IBD.