• Human trials begin to­day in California using Celularity's CYNK-001 inves­ti­ga­tional immuno­therapy as part of a national clin­i­cal trial that will en­roll approx­i­mately 86 adults who tested COVID-19 pos­i­tive
• CYNK-001 is the only cryo­pre­served allo­geneic, off-the-shelf NK cell ther­apy devel­oped from pla­cen­tal hema­to­poietic stem cells.

Warren, NJ (Press Release) – Celularity an­nounced to­day that the first patient was dosed in a Phase I/II study of human pla­cen­tal hema­to­poietic stem cell derived NK cells (CYNK-001) for the treat­ment of adults with COVID-19 as part of a national clin­i­cal trial. The patient was treated at UC Irvine in California, the first CA site to open for patient en­roll­ment with sup­port from a COVID-19 Project grant awarded to Celularity by the California In­sti­tute for Regenerative Medicine (CIRM). Par­tic­i­pat­ing trial 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 in California. The Prin­ci­pal In­ves­ti­ga­tor is Corey Casper, M.D., MPH, of the Infectious Disease Re­search In­sti­tute (IDRI) ClinicalTrials.gov Identifier: NCT04365101.

"Through this col­lab­o­ration with our part­ner sites, we were able to rapidly scale and com­mence 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. "We are op­ti­mis­tic that the study's ini­tial find­ings will dem­onstrate CYNK-001 as a safe and ef­fec­tive, as well as rapidly deployable and scal­able ap­proach to the treat­ment of COVID-19 patients, giving them the im­mune cells that are crit­i­cal in fight­ing this in­fec­tion."

The trial will eval­u­ate the safety and clin­i­cal ef­fi­cacy of CYNK-001 in SARS-CoV-2 pos­i­tive subjects as measured by clear­ance of the SARS-CoV-2 and im­prove­ment in clin­i­cal symp­toms or im­prove­ment in radiological eval­u­a­tion of dis­ease re­lated chest x-ray. The pri­mary objective of the Phase I portion of the study is to eval­u­ate the safety, tol­er­a­bil­ity, and ef­fi­cacy of mul­ti­ple CYNK-001 in­tra­venous (IV) in­fusions in COVID-19 patients and will be admin­istered to up to 14 patients in three doses over the course of seven days.

The Phase II portion of the study is a ran­dom­ized, open-label, multi-site study measuring mul­ti­ple doses of CYNK-001 against a con­trol group experiencing a similar degree of in­fec­tion with best sup­port­ive care, with two co-primary end­points. The first co-primary end­point is to de­ter­mine the virologic ef­fi­cacy of CYNK-001 in facilitating the clear­ance of SARS-CoV-2 from mucosal specimens and/or periph­eral blood. The sec­ond co-primary end­point is to assess the im­pact of treat­ment with CYNK-001 on clin­i­cal symp­toms among patients with COVID-19 re­lated lower res­pira­tory tract in­fec­tion.

Celularity has treated patients with severe COVID-19 and on ventilator sup­port under compassionate use pro­grams in the U.S. CYNK-001 was well tol­er­ated and may be asso­ci­ated with clin­i­cal ben­e­fit in selected cases.

About NK Cells

NK cells are innate im­mune cells with an im­por­tant role in early host re­sponse against var­i­ous path­o­gens. Multiple NK cell re­cep­tors are in­volved in the rec­og­ni­tion of infected cells. Studies in humans and mice have estab­lished that there is robust activation of NK cells during viral in­fec­tion, re­gard­less of the virus class, and that the depletion of NK cells aggravates viral path­o­genesis.

About CYNK-001

CYNK-001 is the only cryo­pre­served allo­geneic, off-the-shelf NK cell ther­apy devel­oped from pla­cen­tal hema­to­poietic stem cells. CYNK-001 is being in­ves­ti­gated as a po­ten­tial treat­ment op­tion in adults with COVID-19, as well as 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). On 1 April, the U.S. Food and Drug Admin­istra­tion cleared the Com­pany's Inves­ti­ga­tional New Drug (IND) appli­ca­tion for the use of CYNK-001 in adults with COVID-19.

About COVID-19

The virus causing COVID-19 is called severe acute res­pira­tory syn­drome coro­na­virus 2 (SARS-CoV-2) and is a novel coro­na­virus that has not been pre­vi­ously identified. COVID-19 has be­come a global pan­dem­ic, with over 3.6 mil­lion con­firmed cases and over 250,000 deaths re­ported to date world­wide.

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, in­clud­ing CAR-T, ge­net­ic­ally-modified and unmodified NK cell, and pluripotent stem cell inves­ti­ga­tional ther­a­pies targeting unmet and underserved clin­i­cal needs in can­cer, and infectious and de­gen­er­a­tive dis­eases.

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.