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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.”

Kiadis announces pub­li­ca­tion in Blood high­light­ing proof-of-con­cept to enhance poten­cy of anti-CD38 anti­bod­ies with Kiadis’ K-NK004, recent­ly licensed by Sanofi

CD38KO NK cell ther­a­py has the poten­tial to max­i­mize the effi­ca­cy of anti-CD38 against mul­ti­ple myelo­ma

Amsterdam, The Netherlands, July 22, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive cell ther­a­peu­tics for life-threat­en­ing dis­eases, today announces pub­li­ca­tion of an arti­cle in Blood, Journal of the American Society of Hematology. The arti­cle describes the syn­er­gy of mbIL21 expand­ed NK cells (FC21-NK) mod­i­fied with a CD38 gene knock­out togeth­er with an anti-CD38 mon­o­clon­al anti­body (mAb) for enhanced killing of mul­ti­ple myelo­ma cells.

The pub­li­ca­tion describes the use of the CRISPR/Cas9 sys­tem to delete CD38 (CD38KO) in ex vivo expand­ed periph­er­al blood K-NK cells, with 82% knock out effi­cien­cy. These CD38KO K-NK cells were com­plete­ly resis­tant to anti-CD38 anti­body-induced frat­ri­cide. In addi­tion, as com­pared to wild type NK cells, the CD38KO K-NK cells showed supe­ri­or per­sis­tence in immune defi­cient mice pre-treat­ed with anti-CD38 anti­body, and enhanced ADCC activ­i­ty against CD38-express­ing mul­ti­ple myelo­ma cell lines and pri­ma­ry mul­ti­ple myelo­ma cells. Additionally, analy­sis demon­strat­ed that CD38KO K-NK cells have unique meta­bol­ic repro­gram­ming with high­er mito­chon­dr­i­al res­pi­ra­to­ry capac­i­ty, impor­tant in a hypox­ic tumor micro-envi­ron­ment. Taken togeth­er, these find­ings pro­vide proof-of-con­cept that adop­tive immunother­a­py using ex vivo expand­ed CD38KO K-NK cells has the poten­tial to boost anti-CD38 anti­body activ­i­ty in mul­ti­ple myelo­ma.

Dean Lee, MD, PhD, co-author of the arti­cle, Director of the Cellular Therapy and Cancer Immunology Program at Nationwide Children’s Hospital and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard Solove Research Institute com­ment­ed, “This work was a great oppor­tu­ni­ty to col­lab­o­rate with Gabriel Ghiaur, MD, PhD, co-author of the arti­cle and Assistant Professor of Oncology at The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University. By com­bin­ing the CRISPR/Cas9 tech­nol­o­gy with the FC21-NK cell plat­form we were able to pro­duce and test an engi­neered NK cell ther­a­peu­tic to address a rec­og­nized hur­dle in immunother­a­py of mul­ti­ple myelo­ma. The ease and effi­cien­cy of this approach increas­es its poten­tial to be trans­lat­ed to the clin­ic.”

Robert Friesen, chief sci­en­tif­ic offi­cer of Kiadis com­ment­ed, “We are excit­ed to see the pub­lished results of this sci­en­tif­ic study, the proof-of-con­cept that tar­get­ed knock­out of CD38 in high­ly stim­u­lat­ed NK cells can be syn­er­gis­ti­cal­ly applied to anti­body treat­ments for the poten­tial ben­e­fit of patients with mul­ti­ple myelo­ma.”

Arthur Lahr, chief exec­u­tive offi­cer of Kiadis, added “This pub­li­ca­tion demon­strates that CD38KO K-NK cells are resis­tant to killing by anti-CD38 anti­bod­ies, and demon­strates how CD38KO K-NK cells improve poten­cy of anti-CD38 anti­bod­ies. This data drove Sanofi’s excite­ment to license KNK004 for com­bi­na­tion with Sarclisa®, to pro­vide bet­ter treat­ment options for mul­ti­ple myelo­ma patients. This data show­cas­es the sci­en­tif­ic ratio­nale under­pin­ning the col­lab­o­ra­tion with Sanofi, and should enhance the under­stand­ing of the poten­tial of this com­bi­na­tion.”

Kiadis appoints Ray Barlow, Ph.D. as Chief Business Officer and Govert Schouten, Ph.D. as Head of Innovation to Kiadis Management Team

  • Senior exec­u­tives with exten­sive biotech­nol­o­gy and phar­ma­ceu­ti­cal indus­try, sci­ence, inno­va­tion and busi­ness devel­op­ment expe­ri­ence 
  • Bringing unique capa­bil­i­ties to unlock broad poten­tial of Kiadis plat­form 

Amsterdam, The Netherlands, July 13, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive NK-cell ther­a­peu­tics for patients with life-threat­en­ing dis­eases, today announces that it has appoint­ed Ray Barlow, Ph.D. as chief busi­ness offi­cer and Govert Schouten, Ph.D. as head of inno­va­tion. As of today, Barlow and Schouten will report to Kiadis’ CEO, Arthur Lahr, and will be mem­bers of the Company’s Management Team. Marcel Zwaal, the Company’s senior vice pres­i­dent of cor­po­rate devel­op­ment, will be leav­ing the Company to pur­sue oth­er oppor­tu­ni­ties.

Dr. Barlow is respon­si­ble for all cor­po­rate busi­ness devel­op­ment ini­tia­tives, includ­ing out-licens­ing, phar­ma and biotech part­ner­ships, devel­op­ment and com­mer­cial­iza­tion col­lab­o­ra­tions, and poten­tial merg­ers and acqui­si­tions. Dr. Schouten is respon­si­ble for Kiadis’ intel­lec­tu­al prop­er­ty, sci­en­tif­ic and aca­d­e­m­ic col­lab­o­ra­tions, gov­ern­ment grants and in-licens­ing of sci­ence and IP to build Kiadis’ K-NK tech­nol­o­gy plat­form.

Arthur Lahr, chief exec­u­tive offi­cer of Kiadis, com­ment­ed, “Kiadis’ K-NK-cell ther­a­py plat­form has almost unlim­it­ed poten­tial for the treat­ment of can­cers, infec­tious dis­eases and oth­er life-threat­en­ing dis­eases. Ray and Govert have through­out their careers led hun­dreds of deals with phar­ma, biotech and acad­e­mia, and brought in hun­dreds of mil­lions in licens­ing fees and gov­ern­ment grants. They can make a huge con­tri­bu­tion to unlock the val­ue of our plat­form, for prod­ucts that we bring to mar­ket on our own or with the help of a big­ger phar­ma­ceu­ti­cal com­pa­ny. I want to thank Marcel for all of his con­tri­bu­tions to acquire and posi­tion our K-NK tech­nol­o­gy and wish him all the best in his future endeav­ors. We wel­come Ray and Govert and look for­ward to their con­tri­bu­tions to build our pipeline and our K-NK-cell ther­a­py plat­form.”

With more than 20 years of expe­ri­ence in the bio­phar­ma­ceu­ti­cal indus­try, Ray Barlow has served in var­i­ous lead­er­ship roles includ­ing most recent­ly as chief exec­u­tive offi­cer at e-ther­a­peu­tics PLC where he led the turn­around of the busi­ness and gen­er­at­ed its first com­mer­cial deals. Previously, Dr. Barlow worked at Amgen as exec­u­tive direc­tor of cor­po­rate devel­op­ment and pri­or to that at Crucell Vaccines where he man­aged busi­ness deals in infec­tious dis­eases and vac­cines. Prior to join­ing Crucell, Ray found­ed and led his own busi­ness, BD Solutions Ltd, advis­ing clients on cor­po­rate devel­op­ment and com­mer­cial­iza­tion strate­gies. Dr. Barlow start­ed his career at AstraZeneca where he held a num­ber of senior R&D, Business Development and Commercial roles over a 12-year peri­od. Dr. Barlow holds a Ph.D. in macro­mol­e­c­u­lar sci­ence from the University of Manchester, UK, a BSc in Chemistry from the University of Leeds, UK, and an MBA from Manchester Business School, UK.

Govert Schouten brings near­ly 25 years of expe­ri­ence in the phar­ma­ceu­ti­cal and biotech­nol­o­gy indus­try to Kiadis. Most recent­ly, Dr. Schouten was the founder of Idmon Consulting B.V., a con­sult­ing firm pro­vid­ing cor­po­rate devel­op­ment, strat­e­gy and busi­ness devel­op­ment ser­vices. Prior to that, Dr. Schouten was co-founder and chief busi­ness offi­cer of myTomorrows (Impatients N.V.), chief exec­u­tive offi­cer of Mucosis B.V., and vice pres­i­dent, head of busi­ness devel­op­ment and mem­ber of the exec­u­tive com­mit­tee of Crucell Vaccines. Dr. Schouten holds a Master’s degree in behav­ioral sci­ences and a Ph.D. in tumor virol­o­gy from Leiden University, The Netherlands.

Kiadis licens­es pre­vi­ous­ly undis­closed pre-clin­i­cal K-NK-cell pro­grams to Sanofi, with total poten­tial deal val­ue of €875 mil­lion, plus roy­al­ties

  • Combination of Kiadis’ CD38 knock out K-NK cells with Sanofi’s anti-CD38 anti­body Sarclisa® enables opti­mal tumor cell killing, and offers a poten­tial first-in-class treat­ment for patients with mul­ti­ple myelo­ma
  • Kiadis receives €17.5 mil­lion up front pay­ment; poten­tial for up to €857.5 mil­lion in pre­clin­i­cal, clin­i­cal, reg­u­la­to­ry and com­mer­cial mile­stone pay­ments, and up to dou­ble-dig­it roy­al­ties 
  • Kiadis to hold con­fer­ence call with investors and ana­lysts at 16:00 CET today

Amsterdam, The Netherlands, July 8, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive nat­ur­al killer cell ther­a­pies for patients with life-threat­en­ing dis­eases, today announces the exclu­sive license of Kiadis’ pre­vi­ous­ly undis­closed K-NK004 pro­gram to Sanofi. The agree­ment cov­ers Kiadis’ pro­pri­etary CD38 knock out (CD38KO) K-NK ther­a­peu­tic for com­bi­na­tion with anti-CD38 mon­o­clon­al anti­bod­ies, includ­ing Sarclisa®, Sanofi’s recent­ly approved ther­a­py for patients with mul­ti­ple myelo­ma. Additionally, Sanofi has obtained exclu­sive rights to use Kiadis’ K-NK plat­form for two undis­closed pre-clin­i­cal pro­grams.

As part of the agree­ment, Kiadis will receive a €17.5 mil­lion up front pay­ment and will be enti­tled to receive up to €857.5 mil­lion upon Sanofi’s achieve­ment of pre­clin­i­cal, clin­i­cal, reg­u­la­to­ry and com­mer­cial mile­stones. Kiadis will also receive up to low dou­ble-dig­it roy­al­ties based on com­mer­cial sales of approved prod­ucts result­ing from this agree­ment.  

Natural killer (NK) cells are the human body’s first line of defense against can­cer and infec­tions. Antibodies work syn­er­gis­ti­cal­ly with NK cells to kill tumor cells in a process called anti­body-depen­dent cell-medi­at­ed cyto­tox­i­c­i­ty (ADCC). Treatment of mul­ti­ple myelo­ma with anti-CD38 anti­bod­ies, such as Sarclisa®, deplete the patients’ own NK cells, as nat­ur­al NK cells also express CD38. Kiadis’ CD38KO K-NK cells are NK cells that have been mod­i­fied to pre­vent expres­sion of CD38, and are thus resis­tant to this effect. Therefore, adjunc­tive infu­sion of CD38KO K-NK cells will rein­vig­o­rate the nat­ur­al syn­er­gy between NK cells and anti­bod­ies to kill tumor cells, opti­miz­ing effi­ca­cy.

Arthur Lahr, chief exec­u­tive offi­cer of Kiadis, com­ment­ed, “We are proud to announce this col­lab­o­ra­tion with Sanofi, which marks the start of the pre­vi­ous­ly undis­closed K-NK004 pro­gram and expands the appli­ca­tion of our K-NK plat­form into mul­ti­ple myelo­ma. The agree­ment with Sanofi –  with their world-class exper­tise and approved anti-CD38 mon­o­clon­al anti­body, Sarclisa, in mul­ti­ple myelo­ma and deep under­stand­ing of NK-cell biol­o­gy – is a tes­ta­ment to the ground­break­ing poten­tial of our K-NK nat­ur­al killer cell plat­form to treat life-threat­en­ing dis­eases.”

John Reed, Global Head of Research and Development at Sanofi, com­ment­ed, “The licens­ing of Kiadis’ CD38KO K-NK cells is par­tic­u­lar­ly excit­ing for Sanofi since we will be study­ing this cell-based ther­a­peu­tic with our recent­ly FDA approved treat­ment for patients with dif­fi­cult-to-treat mul­ti­ple myelo­ma, in hopes of bring­ing even more options to these patients with this hema­to­log­ic can­cer. At Sanofi, we are com­mit­ted to pio­neer­ing treat­ments that address unmet health­care chal­lenges. Innovative col­lab­o­ra­tions, such as this part­ner­ship with Kiadis, have the poten­tial to expand the clin­i­cal ben­e­fits of our med­i­cines by com­bin­ing them with syn­er­gis­tic part­nered ther­a­peu­tics to deliv­er improved out­comes for patients.”

About the Sanofi-Kiadis License Agreement
Sanofi has received exclu­sive world­wide rights to research, devel­op and com­mer­cial­ize K-NK004 based on Kiadis’ CD38KO K-NK cells in com­bi­na­tion with CD38-tar­get­ing mol­e­cules for the treat­ment of mul­ti­ple myelo­ma and oth­er CD38 pos­i­tive blood can­cers. Recently, Sanofi received U.S. Food and Drug Administration (FDA) approval for Sarclisa, a mon­o­clon­al anti­body that tar­gets CD38, for the treat­ment of mul­ti­ple myelo­ma.  Additionally, Sanofi has obtained exclu­sive rights to use Kiadis’ K-NK plat­form for two oth­er pre­vi­ous­ly undis­closed pre-clin­i­cal pro­grams. The license does not include rights to K-NK002 and K-NK003 or to any oth­er cur­rent and future Kiadis pro­grams.

Under the terms of this agree­ment, Sanofi will be respon­si­ble for and bear all costs relat­ed to the research and devel­op­ment, man­u­fac­tur­ing, reg­u­la­to­ry and com­mer­cial activ­i­ties relat­ed to the licensed K-NK pro­grams. Kiadis has retained exclu­sive rights to and will sup­ply PM21 par­ti­cles and select uni­ver­sal donors for Sanofi, paid for by Sanofi.

About Multiple Myeloma
Multiple myelo­ma is the sec­ond most com­mon hema­to­log­ic malig­nan­cy,1 affect­ing more than 130,000 patients in the United States; approx­i­mate­ly 32,000 Americans2 are diag­nosed with mul­ti­ple myelo­ma each year. Despite avail­able treat­ments, mul­ti­ple myelo­ma remains an incur­able malig­nan­cy, and is asso­ci­at­ed with sig­nif­i­cant patient bur­den. As patients relapse, they can become refrac­to­ry to ther­a­pies they have received. There is a need for new agents so that patients and physi­cians can have options as the dis­ease pro­gress­es over time.

Kiadis Pharma files first inves­ti­ga­tion­al new drug appli­ca­tion with the U.S. FDA for nat­ur­al killer (NK) cell ther­a­py pro­duced with PM21

IND sup­ports the Company’s planned NK-REALM Phase 1/2 study which will eval­u­ate K-NK002 in 63 patients with blood can­cer under­go­ing a hap­loiden­ti­cal hematopoi­et­ic stem cell trans­plant (HSCT)

Amsterdam, The Netherlands, April 9, 2020 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny, today announced that it has filed an Investigational New Drug (IND) appli­ca­tion with the U.S. Food and Drug Administration (FDA) for the Company’s nat­ur­al killer cell ther­a­py prod­uct K-NK002. The IND cov­ers the pro­duc­tion of K-NK002 using Kiadis Pharma’s pro­pri­etary PM21 tech­nol­o­gy plat­form that enables high dose, low cost, scal­able and indus­tri­al pro­duc­tion of NK-cell ther­a­py with­out the risk of resid­ual tumor cells in the final prod­uct. The Company plans to ini­ti­ate a Phase 1/2 study with lead­ing trans­plant cen­ters in the U.S. to eval­u­ate K-NK002 once it receives FDA approval for the IND.  

Kiadis Pharma is devel­op­ing K-NK002 as an adjunc­tive ther­a­py to the cur­rent hap­loiden­ti­cal HSCT stan­dard of care with the goal of improv­ing relapse rates. The Phase 1/2 study, called NK-REALM (hap­loiden­ti­cal NK-cells to pre­vent post-trans­plant RElapse in AML and MDS), will eval­u­ate the use of K-NK002 as an adjunc­tive ther­a­py for blood can­cer patients under­go­ing a hap­loiden­ti­cal HSCT with the cur­rent stan­dard of care, post-trans­plant cyclophos­phamide (PTCy) pro­to­col. The study, which will be con­duct­ed with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), will enroll 63 patients at lead­ing trans­plant cen­ters in the U.S. The study is designed to con­firm ear­li­er proof-of-con­cept data in 24 patients, which showed that adjunc­tive treat­ment with K-NK002 has the poten­tial to sub­stan­tial­ly improve out­comes for patients in need of HSCT.

Arthur Lahr, CEO of Kiadis Pharma, com­ment­ed, “The fil­ing of this IND is an impor­tant step for­ward for Kiadis in bring­ing K-NK cell ther­a­py to patients in need. Under nor­mal cir­cum­stances, the FDA would take 30 to 60 days to review an IND, but giv­en the cur­rent envi­ron­ment it is dif­fi­cult to project a date for IND approval. Once approved, we are ready to imme­di­ate­ly ini­ti­ate the tri­al with the BMT CTN, and ramp up pro­duc­tion of clin­i­cal mate­ri­als.”

About Kiadis Pharma’s K-NK-Cell Therapies 
Kiadis Pharma’s K-NK plat­form is designed to deliv­er potent NK cells to help each patient, with­out the need for genet­ic engi­neer­ing. Kiadis Pharma’s pro­grams con­sist of off-the-shelf and hap­loiden­ti­cal donor NK-cell ther­a­py prod­ucts for the treat­ment of liq­uid and sol­id tumors as adjunc­tive and stand-alone ther­a­pies. 

The Company’s PM21 par­ti­cle tech­nol­o­gy enables improved ex vivo expan­sion and acti­va­tion of cyto­tox­ic NK cells sup­port­ing mul­ti­ple high-dose infu­sions. Kiadis Pharma’s pro­pri­etary off-the-shelf NK-cell plat­form is based on NK cells from unique uni­ver­sal donors and can make NK-cell ther­a­py prod­uct rapid­ly and eco­nom­i­cal­ly avail­able for a broad patient pop­u­la­tion across a poten­tial­ly wide range of indi­ca­tions.

Kiadis Pharma is devel­op­ing K-NK002, which is admin­is­tered as an adjunc­tive immunother­a­peu­tic on top of HSCT, and K-NK003 for the treat­ment of relapse/refractory acute myeloid leukemia. In addi­tion, Kiadis Pharma has pre-clin­i­cal pro­grams eval­u­at­ing NK-cell ther­a­py for the treat­ment of sol­id tumors.