• The trial is a dose escalation study eval­u­ating safety and feasibility of T-cell Natural Killer Receptor NKG2D in patients with acute myeloid leukemia or mul­ti­ple myeloma
• No dose limiting toxicity re­ported of the last patient of the sec­ond dose level
• First patient of third dose level (10^7 cells) started cell processing

Mont-Saint-Guibert, Belgium (Press Release) – Celyad (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 21-day safety follow-up of the last patient en­rolled in the sec­ond dose level in the Phase I/IIa clin­i­cal trial eval­u­ating the safety and feasibility of its NKR-2 T-cell ther­apy using T-cells with NKG2D re­cep­tor in cancer patients suffer­ing from acute myeloid leukemia (AML) or mul­ti­ple myeloma (MM).

Dr. Christian Homsy, CEO of Celyad, said: “The NKR-2 Phase I trial is pro­gress­ing well. No prod­uct re­lated safety issue were re­ported since the beginning of the trial. We look for­ward to treating the next patient who will be the first of the third dose cohort”.

Dr. Frédéric Lehmann, Head of Immuno-oncology at Celyad, added: “We are pleased of the pro­gres­sion of this study which re­mains en­cour­ag­ing so far with no safety issue re­ported and a good en­rol­ment of patients along the first two cohorts. We are grateful to our Phase 1 in­ves­ti­ga­tors at the Dana Farber Cancer In­sti­tute for their work to achieve this mile­stone”.

NKR stands for Natural Killer Receptor. NKG2D CAR T-cells are now called NKR-2 T-cells and the prod­uct devel­op­ment name is NKR-2.

Existing CAR-T cells are engi­neered using con­structs encoding an anti­body single chain variable fragment, the signalling domain of CD3 zeta and one or more co-stimulatory domain(s). While very favourable out­comes have been pre­sented using CD19 based con­structs, cur­rent CAR-T target a lim­ited set of cancers. NKR-2 was gen­er­ated by fusion of the native human NKG2D re­cep­tor gene with the human CD3 zeta cyto­plasmic signalling domain and uses the natural co-stimulatory mol­e­cule DAP10. This new gen­er­a­tion con­struct allows the targeting of a much broader set of cancers via the recognition of eight well char­ac­ter­ized NKG2D ligands, MICA, MICB and ULBP 1-6. Those ligands are ex­pressed on most blood and solid tumors.

The Phase I trial is de­signed to assess the safety and feasibility of NKR-2, in two dif­fer­en­t haema­to­logical indi­ca­tions. The safety follow-up period post-infusion has been de­creased to 21 days after ap­prov­al by the U.S. Food and Drug Admin­istra­tion (FDA) and Institutional Review Board (IRB). Data readouts from the first 12 patients treated in the Phase I portion are ex­pec­ted in mid-2016, once a rec­om­mended dose is de­ter­mined.

About NKR-2

Celyad’s lead immuno-oncology prod­uct can­di­date, NKR-2, is a T-Cell encoded to express the Natural Killer activating re­cep­tor, NKG2D. The tech­nology devel­oped by Celyad uses a human natural killer cell (NK cell) re­cep­tor which, unlike traditional CAR tech­nolo­gies, targeting the CD19 an­ti­gen, has the poten­tial to target ligands ex­pressed 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. NKR-2 has an active Inves­ti­ga­tional New Drug (IND) appli­ca­tion with the FDA for a Phase I clin­i­cal trial in cer­tain hema­to­logic cancers.

NKR-2 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 NKR-2 in acute myeloid leukemia and mul­ti­ple myeloma patients, 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 next gen­er­a­tion 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, NKR-2 (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 NKR-2-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 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 NKR-2. These data may not con­tinue for these subjects or be repeated or ob­served in on­go­ing or future stud­ies involving our NKR-2 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 NKR-2; 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, NKR-2, C-Cath_ez^TM, OnCyte, Celyad, 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.