As noted recently in an article published by Cancer Network, the FDA has cleared CYNK-001 for use in COVID-19 patients.
When the investigational new drug (IND) application is submitted to the FDA, the entity submitting the application must wait thirty calendar days before initiating clinical trials.
Now that the manufacturer, Celularity, has received clearance it will collaborate with Sorrento Therapeutics to begin the phase I/II clinical study immediately.
The study will involve eighty-six COVID-19 patients. These patients will be infused with cells called natural killer (NK) cells believed to have the capacity to kill cells that are infected by the virus. They may also respond to the inflammation resulting from immune system response.
The trial will be held at various U.S. medical facilities. It will be coordinated by the Infectious Disease Research Institute of Seattle (IDRI).
CYNK-001 Versus Antiviral Medications
A possible explanation for lack of response in COVID-19 patients was offered by Dr. Corey Casper, IDRI’s CEO. He said that to date, the focus has been on antiviral drugs. Although he did acknowledge that antiviral drugs are necessary.
However, patients whose disease has progressed may only partially respond to antiviral drugs. That may be due to the damage that has already occurred to the patient’s vital organs.
About CYNK-001
Cryopreserved is the cooling and storing of tissues, cells or organs at extremely low temperatures. CYNK-001 is a cryopreserved allogeneic (from a donor) natural killer therapy derived from placental stem cells.
A Celularity spokesman commented that using these stem cells may avoid the immune system response that occurs from donor cells.
CYNK-001 Testing in Other Trials
Early stage CYNK-001 testing is already in progress for multiple myeloma and acute myeloid leukemia as well as a therapeutic option for several types of solid tumors.
CYNK-001 for Glioblastoma Multiform
Celularity’s IND application for CYNK-001 treating glioblastoma multiforme (GBM), a disease primarily affecting the brain, was also recently cleared by the FDA.
The GBM trial is a novel approach and first in the U.S. designed to investigate intratumoral (within a tumor) treatment of allogeneic natural killer cell therapy.
The CYNK-001 trial will be the first-in-human testing in a clinical setting. It will be administered either intratumorally or intravenously to patients whose GBM has relapsed. Researchers will evaluate the feasibility, tolerability and safety of multiple CNYK-001 doses.
Celularity’s spokesman also emphasized the versatility of its cell therapy. The company views it as a more tolerable option for patients with glioblastoma multiforme.
