• Phase 1 clin­i­cal trial eval­u­ating the off-the-shelf anti-BCMA CAR T can­di­date CYAD-211 for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma (r/r MM) ex­pected to begin by year-end 2020
• CYAD-211 rep­re­sents the com­pany’s first allo­geneic CAR T clin­i­cal can­di­date using shRNA tech­nology

{{image}}Mont-Sain-Guibert, Belgium (Press Release) – Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clin­i­cal-stage bio­technol­ogy com­pany focused on the dis­cov­ery and de­vel­op­ment of chi­meric an­ti­gen re­cep­tor T cell (CAR T) ther­a­pies for cancer, to­day an­nounced that the com­pany’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion for CYAD-211, the com­pany’s first-in-class short hairpin RNA (shRNA)-based allo­geneic CAR T can­di­date and sec­ond non-gene edited off-the-shelf pro­gram, is in effect with the U.S. Food and Drug Admin­istra­tion (FDA). The com­pany’s lead allo­geneic can­di­date from its next-gener­a­tion CYAD-200 series, CYAD-211 targets B-cell maturation an­ti­gen (BCMA) for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma (r/r MM). CYAD-211 is engi­neered to co-express a BCMA-targeting chi­meric an­ti­gen re­cep­tor and a single shRNA, which in­ter­feres with the ex­pres­sion of the CD3ζ component of the T-cell re­cep­tor (TCR) complex.

“The FDA’s permission to begin the Phase 1 clin­i­cal trial of our lead shRNA-based allo­geneic can­di­date CYAD-211 is a watershed moment for our or­ga­ni­za­tion,” commented Filippo Petti, Chief Exec­u­tive Of­fi­cer of Celyad Oncology. “Today’s an­nouncement dem­onstrates our ability to ad­vance in parallel mul­ti­ple off-the-shelf prod­uct can­di­dates based on dif­fer­en­ti­ated non-gene edited allo­geneic tech­nolo­gies into the clinic. In addi­tion, our team has de­liv­ered on incredible timelines for the CYAD-211 pro­gram, moving the project from concept to an ef­fec­tive IND in under two years. We are ex­cited to have the CYAD-211 IND in effect to ini­ti­ate the Phase 1 trial by year-end 2020 for this first-in-class CAR T can­di­date for patients with mul­ti­ple myeloma and look for­ward to accelerating the de­vel­op­ment of addi­tional shRNA-based allo­geneic can­di­dates from our CYAD-200 series to­wards clin­i­cal trials.”

Celyad Oncology’s shRNA-based Platform for Allogeneic CAR T

Celyad Oncology is ad­vanc­ing a pipe­line of pro­pri­e­tary, non-gene edited allo­geneic CAR T can­di­dates from its CYAD-200 series, which is underpinned by its shRNA tech­nology plat­form. The shRNA plat­form coupled with the com­pany’s all-in-one vector ap­proach provides flexibility, versatility, and ef­fi­cien­cy to the design of novel, off-the-shelf CAR T can­di­dates through a single step engi­neer­ing process. Next-generation can­di­dates exploring the breadth and depth of the Celyad Oncology shRNA plat­form are cur­rently under pre­clin­i­cal de­vel­op­ment. Combining shRNA knockdown with addi­tional functional components in a single CAR T con­struct may also offer thera­peutic op­tionality to the non-gene edited allo­geneic CYAD-200 series of prod­uct can­di­dates. In 2018, Celyad Oncology signed an ex­clu­sive agree­ment with Horizon Discovery Group for the use of its SMARTvector shRNA tech­nology for the de­vel­op­ment of allo­geneic CAR T ther­a­pies.

About Celyad Oncology

Celyad Oncology is a clin­i­cal-stage bio­technol­ogy com­pany focused on the dis­cov­ery and de­vel­op­ment of chi­meric an­ti­gen re­cep­tor T cell (CAR T) ther­a­pies for cancer. The Com­pany is devel­op­ing a pipe­line of allo­geneic (off-the-shelf) and au­tol­o­gous (personalized) CAR T cell ther­apy can­di­dates for the treat­ment of both hema­to­logical malig­nan­cies and solid tumors. Celyad Oncology was founded in 2007 and is based in Mont-Saint-Guibert, Belgium and New York, NY. The Com­pany has re­ceived fund­ing from the Walloon Region (Belgium) to sup­port the ad­vancement of its CAR T cell ther­apy pro­grams. For more in­for­ma­tion, please visit www.celyad.com.

Forward-Looking State­ment

This re­lease may con­tain for­ward-looking state­ments, within the meaning of appli­cable se­cu­ri­ties laws, in­clud­ing the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995. Forward-looking state­ments may in­clude state­ments re­gard­ing: the safety and clin­i­cal ac­­tiv­ity of Celyad Oncology’s pipe­lines and fi­nan­cial con­di­tion, re­­sults of op­er­a­tion and business outlook. Forward-looking state­ments may in­volve known and un­known risks and un­cer­tainties which might cause actual re­­sults, fi­nan­cial con­di­tion, per­for­mance or achieve­ments of Celyad Oncology to differ ma­teri­ally from those ex­pressed or im­plied by such for­ward-looking state­ments. Such risk and un­cer­tainty in­cludes the ex­pected date of the Phase 1 trial initiation by year-end 2020, our de­vel­op­ment of addi­tional shRNA-based allogenic can­di­dates from our CYAD-200 series to­wards clin­i­cal trial, and the duration and severity of the COVID-19 pan­dem­ic and gov­ern­ment measures implemented in re­sponse thereto. A fur­ther list and description of these risks, un­cer­tainties and other risks can be found in Celyad Oncology’s U.S. Se­cu­ri­ties and Ex­change Com­mis­sion (SEC) filings and re­ports, in­clud­ing in its Annual Report on Form 20-F filed with the SEC on March 25, 2020 and sub­se­quent filings and re­ports by Celyad Oncology. These for­ward-looking state­ments speak only as of the date of pub­li­ca­tion of this doc­u­ment and Celyad Oncology’s actual re­­sults may differ ma­teri­ally from those ex­pressed or im­plied by these for­ward-looking state­ments. Celyad Oncology 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.

Source: Celyad Oncology.