• 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 (Press Release) – 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.

Conference Call In­for­ma­tion

The call will begin promptly at 16:00 CET. To par­tic­i­pate in the conference call, please call one of the fol­low­ing num­bers ten min­utes prior to com­mence­ment of the call:

• Standard Inter­na­tional: +44 (0) 2071 928338
• Netherlands, Amsterdam: +31 (0) 207956614
• UK, London: +44 (0) 8444819752
• US, New York: 1-646-741-3167
• US, toll free: 1-877-870-9135
• Event Plus Passcode: 6366579#

A live webcast of the call can be accessed from the Events and Presentations section of the Com­pany’s website, https://ir.kiadis.com/events-and-presentations.

About Kiadis’ K-NK-Cell Therapies

Kiadis’ K-NK plat­form is de­signed to de­liver potent NK cells to help patients. Kiadis’ 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’ 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 wide range of in­di­ca­tions.

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

About Kiadis

Founded in 1997, Kiadis is build­ing a fully integrated bio­pharma­ceu­tical com­pany com­mit­ted to devel­op­ing inno­va­tive ther­a­pies for patients with life-threatening dis­eases. With head­quar­ters in Amster­dam, The Netherlands, and ac­­tiv­i­ties across the United States, Kiadis is reimagining med­i­cine by leveraging the nat­u­ral strengths of humanity and our collective im­mune sys­tem to source the best cells for life.

Kiadis is listed on the regulated mar­ket of Euro­next Amsterdam and Euro­next Brussels since July 2, 2015, under the symbol KDS. Learn more at www.kiadis.com.

Forward Looking State­ments

Certain state­ments, beliefs and opinions in this press re­lease are for­ward-looking, which reflect Kiadis Pharma’s or, as appro­pri­ate, Kiadis Pharma’s of­fi­cers’ cur­rent ex­pec­ta­tions and pro­jec­tions about future events. By their nature, for­ward-looking state­ments in­volve a num­ber of known and un­known risks, un­cer­tainties and assump­tions that could cause actual re­­sults, per­for­mance, achieve­ments or events to differ ma­teri­ally from those ex­pressed, antic­i­pated or im­plied by the for­ward-looking state­ments. These risks, un­cer­tainties and assump­tions could ad­versely affect the out­come and fi­nan­cial effects of the plans and events de­scribed herein. A mul­ti­tude of factors in­clud­ing, but not lim­ited to, changes in demand, reg­u­la­tion, com­pe­ti­tion and tech­nology, can cause actual events, per­for­mance, achieve­ments or re­­sults to differ sig­nif­i­cantly from any antic­i­pated or im­plied de­vel­op­ment. Forward-looking state­ments con­tained in this press re­lease re­gard­ing past trends or ac­­tiv­i­ties should not be taken as a rep­re­sen­ta­tion that such trends or ac­­tiv­i­ties will con­tinue in the future. As a re­­sult, Kiadis Pharma ex­pressly disclaims any obli­ga­tion or un­der­­tak­ing to re­lease any up­date or revisions to any for­ward-looking state­ments in this press re­lease as a re­­sult of any change in ex­pec­ta­tions or pro­jec­tions, or any change in events, con­di­tions, assump­tions or cir­cum­stances on which these for­ward-looking state­ments are based. Neither Kiadis Pharma nor its advisers or rep­re­sentatives nor any of its sub­sid­i­ary un­der­­tak­ings or any such person’s of­fi­cers or em­ploy­ees guar­an­tees that the assump­tions under­lying such for­ward-looking state­ments are free from errors nor does either ac­cept any re­spon­si­bil­ity for the future accuracy of the for­ward-looking state­ments con­tained in this press re­lease or the actual oc­cur­rence of the antic­i­pated or im­plied de­vel­op­ments. You should not place undue reliance on for­ward-looking state­ments, which speak only as of the date of this press re­lease.

Sarclisa® is a registered trade­mark of Sanofi. For im­por­tant safety in­for­ma­tion for Sarclisa, please click here.

References

1. Kazandjian. Multiple myeloma epidemiology and sur­vival: A unique malig­nan­cy. Semin Oncol. 2016;43(6):676-681. doi:10.1053/j/seminoncol.2016.11.004
2. National Cancer In­sti­tute. Myeloma Cancer Stat Facts. Available at: www.seer.cancer.gov/statfacts/html/mulmy.html. Accessed on July 7, 2020.

Source: Kiadis.