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ALVR109 shows antiviral activity and has been suggested to be a safe and effective treatment for COVID-19

 


The effector profile of SARS-CoV-2 virus-specific T cell therapy ALVR109 was polyclonal, multifunctional, and showed cytolytic activity against allogeneic or non-autologous viral targets. 2020ASH Annual Meeting..1

These findings suggest that ALVR109 may be a safe and effective treatment for coronavirus disease (COVID-19) in 2019.

After a single in vitro simulation, reactive SARS-CoV-2 specific T cells proliferated well and the number of T cells increased by an average of 9.3 ± 1.1 times. Proliferated virus-specific T cells were mainly composed of CD3 T cells, which were a mixture of CD8 cytotoxic T cells and CD4 helper T cells.

In addition, cells were able to specifically kill self-targets expressing viral antigens and had no activity against uninfected self or allogeneic targets. Specifically, the cytolytic activity of virus-specific T cells left uninfected targets and selectively killed virus-expressing targets.

“These data show the exquisite selectivity of these cells for the virus and support this effort for clinical use in high-risk COVID-19 patients,” said a lead study at Baylor College of Medicine. The author and postdoc, Dr. Spyridoula Vasileiou, said. Virtual presentation of data.

SARS-CoV-2 is a positive-strand RNA virus with approximately 80% sequence homology with SARS-CoV and 52% with MERS-CoV.

COVID-19 caused by SARS-CoV-2 resulted in more than 66,000,000 confirmed cases worldwide as of December 5, 2020.2 In the United States, more than 14 million cases of COVID-19 have been confirmed, and as of December 5, 2020, approximately 277,000 people have died.3

Approximately 20% of patients infected with COVID-19 develop severe illness, leading to acute respiratory distress syndrome and hospitalization in the intensive care unit. Older age (> 65 years), comorbidities such as obesity, hypertension, diabetes, coronary heart disease, and weakened immunity are risk factors associated with poor outcomes. In addition, SARS-CoV-2 infection increased the mortality rate of immunocompromised patients who received allogeneic stem cell transplantation by up to 20%.

In October 2020, the FDA approved Remdesivir, the first treatment for COVID-19. However, there remains an unmet need for effective treatment options.

Increasing evidence suggests that T cells play a protective role in the prevention of COVID-19. T cell deficiency and dysregulation have been reported in elderly patients and patients with severe and mild COVID-19 (P <.0001 and P <.01, respectively), showing the importance of cell-mediated immunity in the fight against disease.

To that end, researchers evaluated whether adopted T cells could provide therapeutic benefits.

In this study, researchers first evaluated the endogenous T cell response to COVID-19 in individuals who recovered from the virus without hospitalization. The researchers then evaluated the immune activity against potential SARS-CoV-2 target antigens to identify those with immune dominance recognition by immunologists.

In doing so, researchers exposed convalescent donor-derived peripheral blood mononuclear cells to a duplicate peptide library across candidate antigens, which was subsequently propagated in Exvivo. The results were cell profiled to characterize specificity and effector function.

Once the most commonly recognized viral antigens have been identified in the majority of individuals, researchers proceed to the manufacturing phase.

To identify immune-dominant target antigens, researchers duplicate peripheral blood mononuclear cells from convalescent donors across candidate structural, non-structural, and attached SARS-CoV-2 proteins. Cultured with a mixture of peptide libraries. Subsequently, virus-specific cells were proliferated with activated cytokines.

Following the expansion, researchers evaluated the immune response to each of the individual stimulating antigens. Researchers have found that the majority of screened donors are immunogenic (n = 8) and a subset of immunodominant structural and non-structural proteins that elicited the greatest response based on an enumeration of interferon gamma-secreting cells. Has been identified.

For this reason, three structural proteins and two non-structural proteins were used for production in preclinical studies.

” [reactive SARS-CoV-2–specific T cells that underwent expansion in vitro] Has a phenotype consistent with effector function and memory capacity, as evidenced by upregulation of activation markers CD69 and CD28, and expression of central and effector memory markers with minimal PD-1 or TIM3 expression. “Vasileiou said.

By cytokine staining, researchers have shown that immune responsiveness is multifunctional and mediated by the CD4 and CD8 T cell subsets (14.45% and 4.77%, respectively). In addition, the majority of interferon gamma-producing cells also produced TNF-α (9.4%), a feature associated with excellent clinical outcomes in vivo.

“Almost 15% of the virus-specific population can simultaneously secrete two or more cytokines in response to viral antigen stimulation, and again

It’s versatile and has the potential to produce effective antiviral effects in vivo, “says Vasileiou.

“Based on this preclinical data, we will advance this product to the clinic and use it in inpatients with COVID-19, who are at the highest risk of poor outcome,” Vasileiou concludes.

This study evaluates three doses of SARS-CoV-2 virus-specific T cell therapy, ALVR109––1 x10.7, 2 x 107, And 4 x 107 Cells-Patients are then randomized to standard treatment or an optimized dose of ALVR109 in addition to standard treatment.

reference:

1. Vasileiou S, Kuvarekar M, Workineh A, etc. Allogeneic off-the-shelf SARS-Cov-2 specific T cells are used to treat patients at high risk for COVID-19. Announcement location: 2020 ASH Annual Meeting & Exposition; December 4-8, 2020. virtual. Summary 612.

2. COVID-19 dashboard by the Center for Systems Science and Engineering (CCSE) at Johns Hopkins University (JHU). Johns Hopkins University Medicine. Updated December 5, 2020. Accessed December 5, 2020. https: //bit.ly/37K8tjY.

3. CDC COVID Data Tracker: US COVID-19 cases and state-specific deaths. Centers for Disease Control and Prevention. Updated December 5, 2020. Accessed December 5, 2020. https: //bit.ly/32ulDj8.

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