FDA Accepts IND for NK Cell Therapy CYNK-001 to Treat Patients with COVID-19

The FDA cleared the investigational new drug (IND) application for the use of CYNK-001 in adults with coronavirus disease 2019 (COVID-19), according to Celularity, the agent’s manufacturer.¹

The company also announced that it will immediately begin a phase I/II clinical study of CYNK-001 in collaboration with Sorrento Therapeutics, which will include up to 86 patients with COVID-19.

“We are confident that our strategic relationship with Sorrento will help assure our ability to meet the scale requirements for our efforts in COVID-19,” Robert Hariri, MD, PhD, CEO for Celularity, said in a press release.

Individuals who are enrolled in the trial will receive infusions of natural killer (NK) cells, which the company believes could kill cells infected with the virus and address the resulting inflammation caused by the immune system. 

Infectious Disease Research Institute (IDRI), a nonprofit based in Seattle, says it is coordinating the trial, which will take place at medical centers in the US.²

“To date, efforts to treat COVID-19 cases have been primarily focused on antiviral medications,” Corey Casper, MD, MPH, clinical professor of global health and medicine at the University of Washington and interim president and CEO at IDRI, said in a press release. “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.”

CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells. The company suggests that using such cells eliminates the risk of an immune system reaction that other kinds of donor cells can cause. 

The therapy is already being tested in patients with acute myeloid leukemia and multiple myeloma in early-stage studies, and as a potential treatment option for various solid tumors.

In January, the FDA cleared Celularity’s investigational new drug (IND) application for CYNK-001 in patients with glioblastoma multiforme (GBM).³ The clinical trial is anticipated to be the first clinical trial in the US to investigate intratumoral administration of an allogeneic NK cell therapy.

“The FDA clearance of our IND validates the versatility of our allogeneic, off-the-shelf, placental-derived NK cell therapy platform to generate novel clinical candidates against a broad range of devastating cancers,” Hariri said in a press release. “This IND represents a significant step toward a potential immunotherapy option that is more accessible and tolerable to patients with glioblastoma multiforme.”

According to the company, they expect to initiate first-in-human clinical testing of CYNK-001 administered either intravenously or intratumorally. The study is anticipated to evaluate the safety, feasibility, and tolerability of multiple doses of CYNK-001 in patients with relapsed GBM.

Nonclinical safety and efficacy data were presented at the 2019 Society for Neuro-Oncology (SNO) Annual meeting, demonstrating that a single administration of CYNK-001 was well-tolerated and showed enhanced in vivo anti-tumor activity against GBM.

References:

1. Sorrento to Provide Manufacturing Support to Celularity as CYNK-001 NK Cell Trial for COVID-19 Begins Enrolling Patients [news release]. San Diego, CA. Published April 2, 2020. globenewswire.com/news-release/2020/04/02/2010998/0/en/SORRENTO-TO-PROVIDE-MANUFACTURING-SUPPORT-TO-CELULARITY-AS-CYNK-001-NK-CELL-TRIAL-FOR-COVID-19-BEGINS-ENROLLING-PATIENTS.html. Accessed April 2, 2020.

2. Xconomy National. Celularity to Test Natural Killer Cell Therapy for Cancer Against COVID. Xconomy National website. Published April 2, 2020. xconomy.com/national/2020/04/02/celularity-to-test-natural-killer-cell-therapy-for-cancer-against-covid/. Accessed April 2, 2020.

3. Celularity Announces FDA Clearance of Landmark IND for CYNK-001, an Allogeneic, Off-the-Shelf Cyropreserved NK Cell Therapy [news release]. Warren, NJ. Published January 22, 2020. businesswire.com/news/home/20200122005061/en/Celularity-Announces-FDA-Clearance-Landmark-IND-CYNK-001. Accessed April 2, 2020.