The Supply Brain

Breakthroughs in immunotherapy, such as chimeric antigen receptor T cell (CAR-T) therapy  and checkpoint inhibition antibodies, have led to a rejuvenated interest in the human immune system. Insights from basic immunology research drive approaches and innovations in the exploding immunotherapy field (Figure 1). Studies of tumor-infiltrating lymphocytes helped shed light on the complex tumor microenvironment and the mechanisms of cancer immune evasion. Discoveries of neo-antigens, unique biomarkers, and optimization of combination immunotherapy (Figure 1) have led to improved efficacy and patient outcomes. However, we still don’t fully understand the complex relationship between immunity and disease, especially when it comes to cell activation, cytotoxicity, regulation, and memory.

Immune Cell-based Therapies for COVID-19: Current Clinical Trial Landscape Data

One element of COVID-19 is a hyper-response of the patient’s immune system, which in turn leads to lung injury and acute respiratory distress syndrome.¹ At the same time, appropriate immune response is decreased due to immune evasion by the virus. ^1,2 Treatment with immune cell-based adoptive therapies is being investigated to combat inflammation to fight SARS-CoV-2 (i.e., T regulatory and NK cells).² Here, we review the current clinical trial landscape utilizing immune cell-based therapies.

In late 2019, cases of Coronavirus Disease 2019 (COVID-19) began to emerge out of Wuhan, China. Since then, the disease has proven to be highly contagious and has rapidly spread around the world, becoming a global pandemic. COVID-19 is caused by the Severe Acute Respiratory Distress Syndrome Conoravirus 2 (SARS-CoV-2). SARS-CoV-2 attacks host cells by the binding of its spike protein to the angiotensin I converting enzyme 2 (ACE2) receptor on cell membranes (1). ACE2 receptors are primarily found on lung alveolar type II cells and capillary endothelial cells in the lungs, which helps to explain the prevalence of respiratory distress associated with COVID-19 (2). In addition to the lungs, ACE2 receptors have also been identified in the heart, liver, kidney, and digestive organs which may help to explain why severe COVID-19 patients display myocardial injury, arrhythmia, acute kidney injury, shock, and death from multiple organ dysfunction/failure (1).

De-Risking the Path to Cell & Gene Therapy Commercialization Part 1: You Need Access to a Robust and Reliable Donor Pool

When cell and gene therapy researchers step into the lab each morning, we envision transforming what may be an early stage experiment into a clinical success. Therapeutics developers spend years working tirelessly to generate pre-clinical data so that, when the time comes, their Investigational New Drug (IND) application (or equivalent outside the USA) will be accepted by the appropriate regulatory agency, allowing the therapy to enter clinical trials. However, IND approval is just the first of many significant hurdles that therapeutics developers face on the path to commercialization.