Celularity, a New Jersey company developing experimental cancer treatments derived from human placentas, has received the FDA’s blessing to kick off human testing of its lead immunotherapy for cases of COVID-19 disease.
The trial, designed to evaluate Celularity drug candidate CYNK-001, will enroll about 100 patients with COVID-19 infection causing pneumonia. Those enrolled will receive infusions of natural killer (NK) cells, a type of white blood cell, which the company anticipates could kill cells infected with the virus and address the resulting inflammation caused by the immune system.
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Warren, NJ-based Celularity creates its treatments by engineering cells from postpartum placentas. Using such cells eliminates the risk of an immune system reaction that can occur with the use of other kinds of donor cells, the company says.
Cell therapies on the market today use T cells to spur patients’ adaptive immune system, which learns to remember threats and eliminates them when they return. NK cells, however, are part of our innate immune system, which can kick in to defend against foreign invaders without such prior instruction.
Celularity is already testing CYNK-001 in patients with acute myeloid leukemia and multiple myeloma in early-stage studies. In January, Celularity said the FDA cleared it to start human tests of the program in patients with glioblastoma multiforme, an aggressive and untreatable form of brain cancer.
Seattle nonprofit Infectious Disease Research Institute says it is coordinating the trial, slated to take place at medical centers in the US.
“To date, efforts to treat COVID-19 cases have been primarily focused on antiviral medications,” IDRI CEO Corey Casper said in a statement. “While these are important, patients with serious disease may not respond completely to antiviral medications because they are experiencing damage already inflicted on the body’s vital organs.” Casper is also a clinical professor of global health and medicine at the University of Washington.
In other words, at some point the severity of the damage caused by the virus is what needs to be treated for a patient to recover, rather than a reduction or elimination of the infection itself.
The leading potential COVID-19 treatment is an experimental Gilead Sciences (NASDAQ: GILD) antiviral drug, remdesivir, which is being tested in five late-stage trials.
Celularity, a Celgene spinoff, raised $250 million from investors including Celgene, which is now part of Bristol-Myers Squibb (NYSE: BMY); United Therapeutics (NASDAQ: UTHR); Sorrento Therapeutics (NASDAQ: SRNE), Human Longevity, Genting Group, the Dreyfus Family Office, Section 32, and Heritage Group. And in April last year, the firm leased a 147,000 square-foot campus in Florham Park, NJ to serve as headquarters and cell therapy manufacturing facilities.