The Infectious Disease Research Institute (IDRI) has announced that the first COVID-19
patient has received treatment using a novel immune therapy that was developed by New Jersey-based Celularity Inc. as
part of a national clinical trial. The first patient has been administered CYNK-001, Celularity’s investigational placentaderived immunotherapy containing Natural Killer (NK) cells. Participating sites include Hackensack University Medical
Center and Atlantic Health in New Jersey, MultiCare Health System in Washington State, Banner University Medical Center
Phoenix in Arizona, the University of Arkansas in Arkansas, and UC Davis and UC Irvine in California, with the first patient
receiving treatment at UC Irvine in California. While there have been numerous treatments for COVID-19 that have been
studied, to date all available treatments are modestly effective and there is a urgent need for new approaches to COVID-19
as the pandemic continues across the world.
The treatment is driven by an infusion of CYNK-001 immune cells known as Natural Killer or “NK cells” which have been
safely given to patients in Celularity’s studies for treatment of leukemia and multiple myeloma. Low NK cell counts have
been associated with severe cases of COVID-19, so the study investigators theorize that delivering NK cells will encourage
the body to mount an immune response that safely destroys the virus and controls infection. Celularity’s CYNK-001 is the
only cryopreserved allogeneic, off-the-shelf NK cell therapy derived from human placental CD34+ cells.
“This pivotal clinical trial takes a unique and novel approach to the treatment of COVID-19. By providing a critical type of
immune cell, known as a natural killer cell, to patients ill with COVID-19, we hope this treatment will both kill the SARS-CoV2 virus and also coordinate a more effective immune response to control the infection and prevent damage to the vital
organs,” said Corey Casper, M.D., MPH, the Principal Investigator on the study.
The first phase of the trial will evaluate the safety and efficacy of multiple doses of CYNK-001 and will be administered to up
to 14 patients in three doses over the course of seven days. Physicians at the participating sites will identify patients for
enrollment based on Celularity’s specific eligibility criteria, and the first infusions took place on Thursday, September 3. The
second phase of the trial will measure multiple doses of CYNK-001 against a control group receiving only best supportive
care for a similar degree of infection.
The study seeks to determine whether treatment with CYNK-001 controls the viral infection, improves symptoms, and
reduces the progression to severe outcomes such as the need for intensive care support or death. Researchers anticipate
the study will conclude in the Fourth Quarter 2021, but preliminary data may be available in advance. To date, four patients
have received CYNK-001 for treatment of COVID-19 as part of an expanded access program under the permission of the
Food and Drug Administration. All patients were critically ill and had failed all available treatments for COVID-19. Two of the
four patients had improvements in their respiratory status and all four patients tolerated the treatment without any
negative effects. Investigators are therefore encouraged and are looking to quickly enroll participants in the trial to formally
and rigorously test the effectiveness of this treatment regimen.
Casper, who is also a Clinical Professor of Global Health and Medicine (Infectious Disease) at the University of Washington
and an Affiliate Professor at the Fred Hutch Cancer Research Center in Seattle, also noted that “of the other therapies
currently available, antiviral medications have been shown to be modestly effective, while anti-inflammatory approaches
For media inquiries, please contact:
Aaron Blank/Emi Hashisaki, The Fearey Group for IDRI
(206) 343-1543, IDRI@feareygroup.com
FOR IMMEDIATE RELEASE
help patients with advanced disease. The use of immunotherapy could help patients in the critical period after they are
hospitalized and before they are critically ill and could therefore be an enormous asset to providers on the front lines.”
“We are pleased to have IDRI as our collaborator on what we believe is the first NK cell-based immunotherapy trial
targeting COVID-19,” said Robert j. Hariri, M.D., Ph.D., Celularity’s founder, Chairman and CEO. Hariri added, “The
collaboration enabled a very rapid scale up, allowing us to administer CYNK-001 to COVID-19 to the first patients within five
weeks of obtaining Investigational New Drug clearance from the FDA.”
Patients who are interested in this clinical trial should discuss their interest and eligibility with their treating clinician(s) who
will determine if participation is appropriate. For more information on this clinical trial, please visit
https://clinicaltrials.gov/ct2/show/NCT04365101?term=CYNK001&draw=2&rank=2.
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About IDRI
As a nonprofit global health organization, IDRI (Infectious Disease Research Institute) takes a comprehensive approach to
combat infectious diseases, combining the high-quality science of a research organization with the product development
capabilities of a biotech company to create vaccines and therapeutics. IDRI combines passion for improving human health
with the understanding that it is not just what our scientists know about disease, but what we do to change its course that
will have the greatest impact. Founded in 1993, IDRI has 55 employees headquartered in Seattle with more than 100
partners/collaborators around the world. For more information, visit www.idri.org
About Celularity
Celularity, headquartered in Florham Park, N.J., is a clinical-stage biotechnology company leading the next evolution in
cellular medicine with the development of off-the-shelf allogeneic cellular therapies derived from the postpartum human
placenta. Celularity’s innovative approach harnesses the unique therapeutic potential of cells derived from the postpartum
placenta therapeutics, including investigational CAR-T, genetically-modified and unmodified NK cells, and pluripotent stem
cell therapies to target unmet and underserved clinical needs in cancer, and infectious and degenerative diseases. To learn
more, please visit www.celularity.com.
