• No dose limiting toxicity re­lated to the inves­ti­ga­tional treat­ment re­ported at 30 days post treat­ment of the first patient of the sec­ond dose-level
• The trial is a dose escalation study eval­u­ating safety and feasibility of a CAR T-cell ther­apy in patients with acute myeloid leukemia or mul­ti­ple myeloma.

Mont-Saint-Guibert, Belgium (Press Release) Celyad (Paris:​CYAD) (Brussels:​CYAD) (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and devel­op­ment of engi­neered cell ther­a­pies, with clin­i­cal pro­grams in cardiovascular dis­ease and immuno-oncology, to­day an­nounced the com­ple­tion of the 30-day safety follow-up of the first patient en­rolled in the sec­ond cohort in the Phase I clin­i­cal trial eval­u­ating the safety and feasibility of its NKG2D CAR T-cell ther­apy, in cancer patients suffer­ing from acute myeloid leukemia (AML) or mul­ti­ple myeloma (MM).

Dr. Christian Homsy, CEO of Celyad, said: “The NKG2D CAR T-Cell Phase I trial is pro­gress­ing well. No safety issue were re­ported since the beginning of the trial. We look for­ward to recruiting the next patients in this sec­ond dose cohort”.

Dr. Frédéric Lehmann, Head of Immuno-oncology at Celyad, added: “Our NKG2D CAR T-Cell Phase I study is ad­vanc­ing at a nice pace and ac­cord­ing the initial plans. No safety issue were re­ported after the first dose cohort and the sec­ond one knows a good start. I am grateful to our Phase 1 in­ves­ti­ga­tors who have positioned us so well for this mile­stone”.

The Phase I/IIa trial is de­signed to assess the safety and feasibility of NKG2D CAR T-Cells, with sec­ond­ary end­points in­­clud­ing clin­i­cal ac­­tiv­ity in two dif­fer­en­t haema­to­logical indi­ca­tions. Data readouts from the first 12 patients treated in the Phase I portion are ex­pec­ted in mid-2016. Once the rec­om­mended dose is de­ter­mined, the IIa phase of the trial will en­roll 12 addi­tional patients.

About CAR-NKG2D

Celyad’s lead immuno-oncology prod­uct can­di­date, CAR-NKG2D, is a chi­meric an­ti­gen re­cep­tor (CAR) T-Cell au­tol­o­gous ther­apy to treat cancer. The CAR tech­nology devel­oped by Celyad uses human natural killer cell (NK cell) re­cep­tor which, unlike traditional CAR tech­nolo­gies such as those targeting the CD19 an­ti­gen, has the poten­tial to target ligands present on a broad range of solid tumors and blood can­cers.

The re­search under­lying this tech­nology was originally con­ducted by Dartmouth College Pro­fessor Charles Sentman, and has been pub­lished in nu­mer­ous peer-reviewed pub­li­ca­tions such as Journal of Immunology in 2009, Cancer Re­search in 2006, and Blood in 2005. CAR-NKG2D has an active Inves­ti­ga­tional New Drug (IND) appli­ca­tion with the FDA for a Phase I clin­i­cal trial in cer­tain hema­to­logic cancers.

CAR-NKG2D entered a Phase I clin­i­cal trial in April 2015. The full data readout from the Phase I dose escalation trial is ex­pec­ted in mid-2016. The trial is de­signed to assess the safety and feasibility of NKG2D CAR T-cell in cer­tain acute myeloid leukemia and mul­ti­ple myeloma patients as pri­mary end­points, with sec­ond­ary end­points in­­clud­ing clin­i­cal ef­fi­cacy.

About Celyad

Founded in 2007, and based in Belgium, Celyad is a leader in engi­neered cell ther­apy with clin­i­cal pro­grams initially targeting indi­ca­tions in cardiology and on­col­ogy. Celyad is devel­op­ing its lead cardiovascular dis­ease prod­uct can­di­date, C-Cure®, for the treat­ment of ischemic heart failure, and has com­pleted en­roll­ment of a Phase III trial in Europe and Israel. In addi­tion, the Com­pany is devel­op­ing a novel port­folio of CAR T-cell ther­a­pies that uti­lize human Natural Killer cell re­cep­tors for the treat­ment of nu­mer­ous blood and solid can­cers. Its lead on­col­ogy prod­uct can­di­date, NKG2D CAR T-cell, entered a Phase I clin­i­cal trial in April 2015.

Celyad’s ordinary shares are listed on Euro­next Brussels and Euro­next Paris under the ticker symbol CYAD and Celyad’s American Depositary Shares are listed on the NASDAQ Global Market under the ticker symbol CYAD.

To learn more about Celyad, please visit www.celyad.com

Forward looking state­ments

In addi­tion to historical facts or state­ments of cur­rent con­di­tion, this press re­lease con­tains for­ward-looking state­ments, in­­clud­ing state­ments about the poten­tial safety and feasibility of NKG2D CAR T-cell ther­apy and C-Cure and the clin­i­cal poten­tial of the Com­pany’s tech­nology plat­form generally and the timing of future clin­i­cal trials, which reflect our cur­rent ex­pec­ta­tions and pro­jec­tions about future events, and in­volve cer­tain known and un­known risks, un­cer­tain­ties and assump­tions that could cause actual re­­sults or events to differ ma­teri­ally from those ex­pressed or im­plied by the for­ward-looking state­ments.

In par­tic­u­lar it should be noted that the 30-day safety data described in the re­lease are pre­lim­i­nary in nature and the Phase 1 trial is not com­pleted. There is lim­ited data con­cern­ing safety and feasibility of NKG2D CAR T-cell ther­apy. These data may not con­tinue for these subjects or be repeated or ob­served in on­go­ing or future stud­ies involving our NKG2D CAR T-cell ther­apy, C-Cure or other prod­uct can­di­dates. It is possible that safety issues or adverse events may arise in the future.

These for­ward-looking state­ments are fur­ther qualified by im­por­tant factors, which could cause actual re­­sults to differ ma­teri­ally from those in the for­ward-looking state­ments, in­­clud­ing risks asso­ci­ated with con­ducting clin­i­cal trials; the risk that safety, bioactivity, feasibility and/or ef­fi­cacy dem­onstrated in earlier clin­i­cal or pre-clinical stud­ies may not be rep­li­cated in sub­se­quent stud­ies; risk asso­ci­ated with the timely sub­mission and ap­prov­al of antic­i­pated regu­la­tory filings; the suc­cess­ful initiation and com­ple­tion of clin­i­cal trials, in­­clud­ing Phase III clin­i­cal trials for C-Cure® and Phase I clin­i­cal trial for NKG2D CAR T-cell; risks asso­ci­ated with the satisfaction of regu­la­tory and other re­quire­ments; risks asso­ci­ated with the actions of regu­la­tory bodies and other gov­ern­mental author­i­ties; risks asso­ci­ated with obtaining, main­taining and pro­tecting in­tel­lec­tual property, our ability to enforce our pat­ents against in­fringers and defend our pat­ent port­folio against chal­lenges from third parties; risks asso­ci­ated with com­pe­ti­tion from others devel­op­ing prod­ucts for similar uses; risks asso­ci­ated with our ability to man­age op­er­at­ing ex­penses;, and risks asso­ci­ated with our ability to obtain addi­tional fund­ing to sup­port our business ac­­tiv­i­ties and estab­lish­ and main­tain stra­te­gic business alliances and business ini­tia­tives. A fur­ther list and description of these risks, un­cer­tain­ties and other risks can be found in the Com­pany’s Se­cu­ri­ties and Ex­change Com­mis­sion filings and re­ports, in­­clud­ing in the Com­pany’s pros­pectus filed with the SEC on June 19, 2015 and future filings and re­ports by the Com­pany. Given these un­cer­tain­ties, the reader is advised not to place any undue reliance on such for­ward-looking state­ments. These for­ward-looking state­ments speak only as of the date of pub­li­ca­tion of this doc­u­ment. The Com­pany expressly disclaims any obli­ga­tion to up­date any such for­ward-looking state­ments in this doc­u­ment to reflect any change in its ex­pec­ta­tions with regard thereto or any change in events, con­di­tions or cir­cum­stances on which any such state­ment is based, unless re­quired by law or reg­u­la­tion.

C3BS-CQR-1, C-Cure, NKG2D CAR T-cell, C-Cath_ez^TM, OnCyte, Celyad, Cardio3 BioSciences and the Cardio3 BioSciences, Celyad, C-Cath_ez^TM, CHART-1, CHART-2 and OnCyte logos are signs inter­na­tionally pro­tected under appli­­cable Intellectual Property Laws. Mayo Clinic holds equity in Celyad as a re­­sult of in­tel­lec­tual property licensed to the Com­pany.

Source: Celyad.