- 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 AgreementSanofi
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 MyelomaMultiple 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.
Dutch Translation/Nederlandse
vertalingAmsterdam, 8 juli 2020 –
Kiadis Pharma N.V. (“Kiadis” of de
“Onderneming”) (Euronext Amsterdam en Brussel: KDS), een
biofarmaceutische onderneming in de klinische fase gericht op
ontwikkeling van innovatieve Natural Killer Cell-therapieën voor
patiënten met levensbedreigende aandoeningen, heeft een
licentieovereenkomst gesloten met Sanofi voor Kiadis’ nog niet
eerder bekendgemaakte preklinische K-NK004-programma. De
overeenkomst geeft Sanofi het recht om Kiadis' CD38 knock-out
(CD38KO) K-NK-cel medicijn te combineren met Sanofi’s Sarclisa®
anti-CD38 monoklonale antilichamen. Sarclisa® is recentelijk door
de FDA goedgekeurd voor patiënten met multipel myeloom (ziekte van
Kahler). Bovendien heeft Sanofi de exclusieve rechten verkregen
voor het gebruik van Kiadis' K-NK-platform voor twee niet nader
genoemde preklinische programma's.
Kiadis ontvangt een bedrag ineens van € 17,5 miljoen en heeft
het recht op totale betalingen tot potentieel € 857,5 miljoen,
zodra Sanofi vooraf vastgestelde mijlpalen heeft behaald. Kiadis
zal daarnaast tot lage dubbelcijferige royalty's ontvangen op de
omzet van producten die door Sanofi worden ontwikkeld als onderdeel
van de overeenkomst.
Natural killer (NK)-cellen vormen de eerste verdedigingslinie
van het menselijk lichaam tegen kanker en infecties. Antilichamen
werken in het menselijk lichaam samen met NK-cellen voor het doden
van tumorcellen. Anti-CD38-antilichamen voor de behandeling van
multipel myeloom (ziekte van Kahler), zoals Sarclisa®, doden echter
niet alleen de tumorcellen die CD38 tot expressie brengen, maar ook
de eigen NK-cellen van de patiënt, aangezien deze ook CD38 tot
expressie brengen. Kiadis’ CD38KO K-NK-cellen brengen CD38 niet tot
expressie en zijn daarmee resistent tegen dit effect. Een
combinatietherapie met zowel anti-CD38 antilichamen als CD38KO
K-NK-cellen herstelt daarmee de natuurlijke synergie tussen
NK-cellen en antilichamen en optimaliseert de anti-tumor
effectiviteit.
Arthur Lahr, CEO van Kiadis, zegt in reactie:
“Het is met trots dat we deze samenwerking met Sanofi bekendmaken.
Deze alliantie markeert de start van ons nog niet eerder
bekendgemaakte K-NK004-programma en breidt de toepassing van onze
K-NK-medicijnen uit naar multipel myeloom. Sanofi heeft het door de
FDA goedgekeurde anti-CD38-antilichaam Sarclisa® op de markt voor
de behandeling van deze ziekte en bezit een diepgaande kennis van
NK-celbiologie en synergie met antilichamen. De overeenkomst
getuigt daarmee van het baanbrekende potentieel van ons K-NK
natural killer cell-platform voor de behandeling van
levensbedreigende aandoeningen.”
John Reed, MD, PhD, global head of research and
development van Sanofi, zegt: “De licentie van Kiadis
'CD38KO K-NK-cellen is voor Sanofi bijzonder interessant. We zullen
deze celtherapie gaan combineren met ons onlangs door de FDA
goedgekeurde medicijn voor patiënten met moeilijk te behandelen
multipel myeloom. We hopen zo patiënten met deze bloedkanker meer
opties te kunnen bieden. Bij Sanofi zetten we ons in voor
baanbrekende behandelingen om grote medische problemen aan te
pakken. Innovatieve allianties zoals die met Kiadis kunnen de
klinische voordelen van onze geneesmiddelen vergroten, door
combinatie met synergetische geneesmiddelen, om resultaten voor
patiënten te verbeteren.”
De overeenkomst met SanofiSanofi heeft de
exclusieve wereldwijde rechten gekregen om Kiadis' CD38KO
K-NK-cellen te ontwikkelen en op de markt te brengen in combinatie
met op CD38-gerichte moleculen voor de behandeling van multipel
myeloom en andere CD38-positieve bloedkankers. Onlangs ontving
Sanofi goedkeuring van de Amerikaanse Food and Drug Administration
(FDA) voor Sarclisa®, een monoklonaal antilichaam dat zich richt op
CD38, voor de behandeling van multipel myeloom (Ziekte van Kahler).
Daarnaast heeft Sanofi de exclusieve rechten verkregen om het
K-NK-platform van Kiadis te gebruiken voor twee andere niet nader
genoemde preklinische programma's. De licentie omvat geen rechten
op K-NK002 en K-NK003 of op andere huidige en toekomstige
Kiadis-programma's.
Conform de voorwaarden van deze overeenkomst is Sanofi
verantwoordelijk voor en draagt het alle kosten in verband met
onderzoek, ontwikkeling, productie, regulatoire activiteiten en
verkoop van de gelicentieerde K-NK-programma's. Kiadis heeft de
exclusieve rechten behouden om PM21-deeltjes aan Sanofi te leveren
en universele donoren voor Sanofi te selecteren, bekostigd door
Sanofi.
Dit bericht is een vertaling van het
originele Engelstalige persbericht. In geval van verschillen ten
gevolge van vertaling of verschillen in interpretatie, geldt het
originele Engelstalige persbericht als leidend.
Kiadis Contacts:
Kiadis: Maryann
Cimino, Sr. Manager, Corporate AffairsTel: +1 (617)
710-7305m.cimino@kiadis.com |
Optimum Strategic
Communications:Mary Clark, Supriya MathurTel: +44 203 950
9144kiadis@optimumcomms.com LifeSpring Life Sciences
Communication (NL)Leon MelensTel: +31 (0)6 538 16
427lmelens@lifespring.nl |
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 KiadisFounded 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.
1 Kazandjian. Multiple myeloma epidemiology and survival: A
unique malignancy. Semin Oncol. 2016;43(6):676-681.
doi:10.1053/j/seminoncol.2016.11.0042 National Cancer
Institute. Myeloma Cancer Stat Facts. Available at:
www.seer.cancer.gov/statfacts/html/mulmy.html. Accessed on July 7,
2020.