(THE TREATMENT OF COVID-19 CONTINUED)
For a patient with moderate to severe symptoms, the therapeutic goals can be adjusted. Here, the goal is to prevent the much-talked-about cytokine storm. For these patients, Sorrento has developed an oral Bruton tyrosine kinase (BTK) inhibitor which is now in clinical trials in the U.S. and Brazil. If successful, this treatment could lead to quick discharge times for hospitalized patients. Lastly, for patients with severe COVID-19 who require mechanical ventilation in an ICU, Sorrento is developing a rescue therapy that will build on all of the prior agents and enhance the body’s natural ability to fight infection while stopping the infection’s deleterious effects on an over-stimulated immune system. This novel approach utilizes mesenchymal stem cell (MSC) therapy derived from adipose tissue and is being evaluated at three doses. This treatment has already shown exciting results from early clinical trials. Sorrento believes that in the case of COVID-19, each patient is unique in the way his or her immune system interacts with the virus. Through an assortment of therapeutic options, the spectrum of COVID-19 diseases can be prevented, halted and reversed.
Cellular Medicine and the New Frontier
Andrew Pecora, MD, Chief Executive Officer, Outcomes Matter Innovations and Director, Celularity In 2020, the U.S. National Cancer Institute estimated that 1,806,590 cancer cases would be diagnosed and 606,520 people will die from the condition. Cancer is a perpetual emergency that we have learned to live with, and one that has already benefited from novel approaches to standard treatment including biologics, small molecules and, now, human cells transformed into effective therapeutics. CAR T-cell therapy is one of the novel, cell-based treatments proven to be effective in treating blood cancers such as acute lymphocytic leukemia (ALL) and a variety of types of B-cell lymphomas. Researchers predict that we are on the verge of more breakthroughs in cell-based cancer treatments including improving CAR T-cell therapy through further genetic modifications, as well as adding natural and genetically modified natural killer (NK) Cells. The cellular medicine company Celularity has focused on utilizing the human placenta as a source of cells naturally enriched with the requisite biologic properties (stemness) to develop therapeutics including a next-generation CAR T and NK cell therapies to effectively treat cancer. Dr. Robert J. Hariri, Celularity’s founder, chairperson and CEO, made the surprising discovery that post-birth placentas can provide the world’s richest source of cells endowed with stemness, enabling the creation of a broad array of T-cell- and NK cell-mediated therapeutics for cancer treatment. These source cells can be turned into genetically modified T-cells that target specific antigens and NK cells that may act against a wide array of cancer cells and virally infected cells. Best of all, these cells can serve as a universal donor for all patients and, because they are frozen, these therapies can be made immediately available for use off-the-shelf. The placenta from a single birth “can create hundreds, to potentially hundreds of thousands, of doses of therapeutics,” Dr. Hariri said. It is this scalability that could pave the way to a therapeutic regimen that may be used to treat the masses. Celularity is in the process of developing therapeutic agents from these placental-derived immune cells (NK, CAR T, non-genetically and genetically modified), the latest of which is a clinical trial of a placental-derived NK cell treatment, called CYNK-001, in adult glioblastoma. The U.S. Food and Drug Administration (FDA) granted CYNK-001 “orphan drug status” in April 2021, effectively moving it one step closer to being used to treat glioblastoma patients. Non-genetically modified NK cells are also currently being evaluated for patients with acute myelogenous leukemia, while genetically modified NK cells are being developed for solid tumors including gastric cancer. Celularity is also submitting an Investigational New Drug (IND) Application later this year to begin a CY-CAR-19 (CAR T) program to treat CD19 expressing B-cell lymphomas. The Celularity platform of CAR T-cells and NK cells will enable the company to conduct combination immune effector cell therapy protocols using T-cells, NK cells and other biologics to harness the full potential of the immune system to eventually eradicate all forms of cancer.
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