CYNK-001, the com­pany's allo­geneic, off-the-shelf, cryo­pre­served Natural Killer cell ther­apy to be used in Phase I/II study

{{image}}Warren, NJ (Press Release) – Celularity Inc. ("Celularity" or the "Com­pany"), a clin­i­cal-stage com­pany devel­op­ing allo­geneic cel­lu­lar ther­a­pies from human pla­cen­tas, to­day an­nounced the U.S. Food and Drug Admin­istra­tion (FDA) has cleared the Com­pany's Inves­ti­ga­tional New Drug (IND) appli­ca­tion for the use of its pro­pri­e­tary CYNK-001 in adults with COVID-19. With this, Celularity will com­mence a Phase I/II clin­i­cal study in­clud­ing up to 86 patients with COVID-19. The Com­pany be­lieves CYNK-001 is the first immuno­therapy IND cleared by the FDA to treat COVID-19 infected adults.

"This IND rep­re­sents a sig­nif­i­cant step to­ward a po­ten­tial treat­ment of patients infected with COVID-19 virus, which is spreading globally at unanticipated rates," said Robert Hariri, M.D., Ph.D., Founder, Chairman and CEO at Celularity. "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." Dr. Hariri also thanked the FDA's Center for Biologics Evaluation and Re­search (CBER) in his state­ment, "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."

CYNK-001 is the only cryo­pre­served allo­geneic, off-the-shelf Natural Killer (NK) cell ther­apy being devel­oped from pla­cen­tal hema­to­poietic stem cells and is being in­ves­ti­gated as a po­ten­tial treat­ment op­tion for var­i­ous hema­to­logic can­cers and solid tumors. NK cells are a unique class of im­mune cells, innately ca­pa­ble of targeting can­cer cells and inter­acting with adaptive im­mu­ni­ty. CYNK-001 cells derived from the pla­cen­ta are intrinsically safe and versatile and are cur­rently being in­ves­ti­gated as a treat­ment for acute myeloid leukemia (AML), mul­ti­ple myeloma (MM), and glio­blas­toma multiforme (GBM).

"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. "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."

About Celularity

Celularity, head­quar­tered in Warren, N.J., is a clin­i­cal-stage cell thera­peutics com­pany de­livering trans­for­ma­tive allo­geneic cel­lu­lar ther­a­pies derived from the postpartum human pla­cen­ta. Using pro­pri­e­tary tech­nology in com­bi­na­tion with its IMPACT™ plat­form, Celularity is the only com­pany har­nessing the purity and versatility of pla­cen­tal-derived cells to de­vel­op and manu­fac­ture inno­va­tive and highly scal­able off-the-shelf treat­ments for patients with can­cer, in­flam­ma­tory and age-related dis­eases. To learn more, please visit www.celularity.com.

Forward-Looking State­ments:

This press re­lease con­tains for­ward-looking state­ments. These for­ward-looking state­ments are based on ex­pec­ta­tions and are subject to cer­tain factors, risks, and un­cer­tainties that may cause actual re­­sults, the out­come of events, timing and per­for­mance to differ ma­teri­ally from those ex­pressed or im­plied by such state­ments. The in­for­ma­tion con­tained in this press re­lease is be­lieved to be cur­rent as of the date of the original issue. Celularity ex­pressly disclaims any obli­ga­tion or un­der­­tak­ing to re­lease pub­licly any up­dates or revisions to any for­ward-looking state­ments con­tained herein to reflect any change in our ex­pec­ta­tions with regard thereto or any change in events, con­di­tions or cir­cum­stances on which any such state­ments are based.

Source: Celularity.