Infectious Disease

The novel T cell remedy guarantees the therapy of COVID-19 in high-risk sufferers

December 06, 2020

3 min read

Source / information

Source:

Vasileiou S. et al. Abstract 612. Presented at: ASH Annual Meeting and Exposition (virtual meeting); December 5th to 8th, 2020.

Disclosure:
Vasileiou reports on an advisory role and research funding from AlloVir. In the summary you will find all relevant financial information for all other researchers.

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An off-the-shelf virus-specific T-cell therapy showed the proof of concept for a clinical study for the treatment of severe COVID-19 infections. This emerges from study results that were presented at the virtual ASH annual conference and exhibition.

“The impact of COVID-19 disease so far has been enormous. By November, nearly 53 million cases were confirmed worldwide, and more than 10 million cases were reported in the US by early December.” Spyridoula Vasileiou, PhD, Researchers at the Center for Cell and Gene Therapy at Baylor College of Medicine said during a presentation. “About 20% of infected patients develop a serious illness that can lead to respiratory or multiple organ failure, as they age and other comorbidities such as obesity, diabetes and [being immunocompromised] have been identified as the main risk factors for poor outcomes, ”said Vasileiou. “In particular the death rates [among] Immunocompromised transplant patients were up to 20% and treatment options have been limited, with only one FDA-approved antiviral agent. [Meanwhile]Other modalities such as convalescent plasma and monoclonal antibodies have received emergency approval. There remains an unmet medical need for effective treatment options. “

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Data on the protective function of T cells in people exposed to SARS-CoV-2 is increasing, with people with more severe cases of COVID-19 more likely to have T cell deficits or deficits.

Spyridoula Vasileiou, PhD

Spyridoula Vasileiou

Vasileiou and colleagues have previously demonstrated the feasibility, safety, and clinical activity of commercially available virus-specific T cells for the treatment of viral infections and / or diseases associated with a range of viruses including BK virus, cytomegalovirus, and others.

Based on their previous work, this group of researchers tried to investigate the potential of targeting COVID-19 using commercially available T cells that recognized SARS-CoV-2.

As a source of protective virus-specific T cells, the researchers used peripheral blood mononuclear cells from convalescents who had been exposed to the virus with their own immune systems and cleared it naturally. To determine which specific viral proteins induced these protective T cells that are responsible for virus elimination, Vasileiou and colleagues examined the immunogenicity of 17 antigens and identified a combination of structural and non-structural proteins that were immunodominant and thus for virus-specific T. -Cells were further developed in the laboratory production.

Using their robust manufacturing platform, the researchers were able to consistently selectively amplify these COVID-19-specific T cells and achieve a mean 9.3-fold (± 1.1) expansion of virus-specific T cells in eight donors tested. The expanded populations consisted almost exclusively of CD3 + T cells (97.1%) with a combination of cytotoxic CD8 + (10.2%) and helper CD4 + (85.5%) T cells whose phenotype was one Had a profile consistent with virus elimination ability – as demonstrated by expression of CD25, CD69 and CD28 – and memory potential, the researchers determined.

“When we examined the effector profile of reactive cells, we found that they were polyclonal, polyfunctional and cytolytic to viral targets with no autoreactivity or alloreactivity,” said Vasileiou.

“This provides preclinical evidence of the safety and potential for clinical benefit associated with off-the-shelf infusion of these virus-specific T cells,” she told Healio.

Vasileiou and colleagues are currently conducting a randomized proof-of-concept study with dose determination and proof-of-concept to evaluate the safety and effectiveness of COVID-19 virus-specific T-cell therapy in 40 high-risk patients.

“The AlloVir-sponsored study will be conducted in two phases,” she said. “We will have a break-in period to determine the maximum tolerated dose of virus-specific T cells, and we plan to test three different cell doses. We will then move on to the randomized phase in which patients are supplied with virus-specific T cells either alone or as standard. The primary endpoint will be safety, but we will also examine the clinical effect of the therapy using the WHO grading scale to assess patient status daily while in hospital. Finally, we will examine the immune effects and persistence of the infused cells over time. This study recently opened and is actively recruiting patients. ”

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ASH annual conference and exhibition

ASH annual conference and exhibition

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