Kiadis announces U.S. FDA approval of the Abigail Wexner Research Institute at Nationwide Children’s Hospital’s IND for a COVID-19 clin­i­cal tri­al with off-the-shelf K-NK cells using Kiadis’ pro­pri­etary plat­forms

Amsterdam, The Netherlands, September 14, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive cell-based med­i­cines for the treat­ment of life-threat­en­ing dis­eases, today announces a col­lab­o­ra­tion with the Abigail Wexner Research Institute (AWRI) at Nationwide Children’s Hospital to devel­op Kiadis-NK cells (K-NK cells) as a post-expo­sure pre-emp­tive ther­a­py for COVID-19. The U.S. Food and Drug Administration (FDA) approved AWRI’s inves­ti­ga­tion­al new drug appli­ca­tion (IND) for a study in an adult pop­u­la­tion with off-the-shelf nat­ur­al killer (NK) cells pro­duced with Kiadis’ pro­pri­etary Universal Donor and PM21 tech­nolo­gies. Kiadis and AWRI are devel­op­ing the plan for ini­ti­a­tion of the clin­i­cal study.

Kiadis has exclu­sive­ly licensed from AWRI intel­lec­tu­al prop­er­ty relat­ed to NK cells for treat­ment of micro­bial infec­tions, includ­ing SARS-CoV-2. The Company has recent­ly ini­ti­at­ed the pre­clin­i­cal and clin­i­cal devel­op­ment of its K-NK-ID101 COVID-19 pro­gram and is expect­ing to receive US gov­ern­ment fund­ing for this pro­gram.

Arthur Lahr, CEO of Kiadis com­ment­ed, “This is the sec­ond IND approved by the U.S. FDA for K-NK cells pro­duced with our PM21 plat­form, and the sec­ond IND approved for K-NK cells based on our Universal Donor off-the-shelf plat­form. We are excit­ed to study whether K-NK cells have the anti-viral prop­er­ties, safe­ty pro­file and man­u­fac­tur­ing scal­a­bil­i­ty to be wide­ly deployed as an off-the-shelf glob­al coun­ter­mea­sure against COVID-19 and future pan­dem­ic threats. This FDA approval marks rapid progress with our K-NK-ID101 COVID-19 pro­gram and demon­strates the poten­tial expan­sion with our K-NK cells into infec­tious dis­ease.”

“The coro­n­avirus pan­dem­ic has had a sig­nif­i­cant impact on our world, but has also cre­at­ed oppor­tu­ni­ties for inno­va­tion and for­ward think­ing,” says Dean Lee, MD, PhD, Director of the Cellular Therapy and Cancer Immunotherapy pro­gram at Nationwide Children’s Hospital. “Data from patients with COVID-19 have demon­strat­ed an impor­tant role for NK cells in this dis­ease. Our pre­vi­ous col­lab­o­ra­tions with Kiadis in devel­op­ing NK cells for can­cer enabled us to design a nov­el Phase I/II clin­i­cal tri­al that meets FDA rig­or in test­ing whether adop­tive trans­fer of NK cells is safe and effec­tive in mit­i­gat­ing pro­gres­sion of this virus in high-risk patients.”

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