Model ALVR109 - Allogeneic, Off-The-Shelf, SARS-CoV-2-Specific T cell (VST) Therapy Candidate for COVID-19
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COVID-19: A Global Public Health Crisis and Role of T cells in Controlling SARS-CoV-2 Infections
SARS-CoV-2 infection causes the severe and life-threatening viral disease, COVID-19, creating a global public health crisis. Studies to date estimate that the risk of mortality is up to 500% higher in patients 65 years of age or greater than in those aged 30 to 59 years. Other risk factors for severe COVID-19 include chronic lung or heart disease, hypertension, diabetes and underlying immune compromise.
Early evidence suggests that T cells play an important role in the body’s fight against COVID-19 and demonstrates that COVID-19 leads to depletion of endogenous T cells leading to acute immune deficiency, making infected individuals susceptible to developing, overwhelming and sometimes fatal pneumonia. Beyond the lungs, COVID-19 is a multi-organ disease that affects the heart, kidneys, brain, liver, and gastrointestinal tract, as well as causing blood clots. Over 80% of hospitalized patients with COVID-19 are lymphopenic, with reduced CD8+ and CD4+ T cell counts. These reductions in T cell counts correlate negatively with survival. Reduced T cell counts have been observed to be prevalent in older COVID-19 patients and those with severe illness, regardless of age. As further data on the immunogenicity of SARS-CoV-2 continues to emerge, the important protective role of SARS-CoV-2-specific T cells is increasingly being recognized.
Current clinical management of the disease relies almost entirely on supportive care measures. A number of investigational approaches are under development, including preventative vaccines, antibody-based therapies and antivirals. There is an urgent need to rapidly develop an effective therapy for COVID-19.
Clinical Development Program
ALVR109 is the result of rapid and efficient development of new VST therapy candidates, in collaboration with Baylor College of Medicine, and in response to emerging viral pathogens.
We plan to sponsor a proof-of-concept single center, open-label clinical trial for the treatment of high-risk COVID-19 patients. Learn more about clinical trials for ALVR109 here.
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