Novel Cancer Agent To Be Investigated for Coronavirus Treatment

Another cancer therapy may be helpful in treating patients with coronavirus disease 2019 (COVID-19). On April 2, 2020, the FDA granted an investigational new drug application (NDA) to CYNK-001 for the treatment of adults with COVID-19, according to Celularity Inc., the manufacturer of the immunotherapy.¹

CYNK-001 will be evaluated in an upcoming phase I/II clinical trial including up to 86 patients with COVID-19.

"With our initial clinical study, we will gain an understanding of the impact CYNK-001 can have on patients recently diagnosed with COVID-19. We are hopeful to contribute to flattening the COVID-19 curve, expanding on the promising early results we've seen in our clinical studies in devastating cancers to patients with coronavirus,” said Robert Hariri, MD, PhD, Founder, Chairman and CEO at Celularity, in a statement.

The drug is a cryopreserved allogenic, off-the-shelf Natural Killer (NK) cell therapy that is being developed from placental hematopoietic stem cells. NKs are immune cells that can target cancer cells and affect immunity.

Celularity states that CYNK-001 is safe and versatile. In fact, it is also being investigated for the treatment of acute myeloid leukemia, multiple myeloma, and glioblastoma multiforme.

Last week, the Society for Immunotherapy in Cancer (SITC) published a statement on the promise of tocilizumab for COVID-19.

"Studies have established that there is robust activation of NK cells during viral infection regardless of the virus class," says Celularity's Chief Scientific Officer, Xiaokui Zhang, PhD, in the statement.

"CYNK-001 demonstrates a range of biological activities expected of NK cells, including expression of activating receptors such as NKG2D, DNAM-1 and the natural cytotoxicity receptors NKp30, NKp44 and NKp46, which bind to stress ligands and viral antigens on infected cells. They also show the expression of cytolytic molecules perforin and granzyme B, which kill recognized infected cells. These functions suggest that CYNK-001 could provide a benefit to COVID-19 patients in terms of limiting SARS-CoV-2 replication and disease progression by eliminating the infected cells."

Hairi also commended the FDA’s Center for Biologics Evaluation and Research (CBER) for their tireless work in bringing therapies to patients.

"While most of its work occurs out of the public's eye, CBER embodies the public service ideal amidst the current crisis. Thanks to the women and men of CBER for their tireless effort to guide us through the IND process,” he said.

Reference

Celularity, Inc. Celularity Announces FDA Clearance of IND Application for CYNK-001 in Coronavirus, First in Cellular Therapy. April 2, 2020. https://www.prnewswire.com/news-releases/celularity-announces-fda-clearance-of-ind-application-for-cynk-001-in-coronavirus-first-in-cellular-therapy-301034141.html. Accessed April 2, 2020.