- New data will be presented in an e-poster today at the Virtual
Edition of the 46th EBMT Annual Meeting
Amsterdam, The Netherlands, August 29,
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 that new data supporting the Company’s NK cell therapy is
being presented at the 46th Annual Meeting of the European Society
for Blood and Marrow Transplantation (EBMT). The poster presents
data from 13 patients treated with relapsed/refractory acute
myeloid leukemia (R/R AML) who received treatment with FC21
expanded NK-cells during a Phase I study conducted by Lucia Mariano
da Rocha Silla, MD, PhD, at Hospital de Clínicas de Porto Alegre
(HCPA) in Brazil. In this study, sponsored by the Brazilian
Agencies for Research development, the adoptive transfer of
haploidentical expanded NK cells to restore NK cell numbers and
anti-leukemia function in patients with relapsed/refractory AML was
investigated.
Abstract
#A-1137-0005-00784: Phase
I Study of Adoptive Transfer of Haploidentical Expanded NK
Cells
Patients with relapsed, refractory, or
CNS-positive AML respond poorly to chemotherapy. Naturally
occurring NK cells have anti-leukemic activity but are deficient in
numbers and function in AML patients and are ablated by high dose
chemotherapy. The adoptive transfer of haploidentical expanded
cells to restore NK cell number and anti-leukemic function in
patients with relapsed/refractory AML was studied.
In this Phase I study, haploidentical donors
were selected after HLA and KIR typing. NK cells were expanded on
feeder cells and cryopreserved for infusion at the assigned dose
level, then thawed and infused three times per week over 2 weeks,
for a total of six doses, following fludarabine, cytarabine, and
G-CSF (FLAG) treatment. Patients were treated in 3 dose cohorts of
106, 5x106, and 107 NK cells/kg/infusion. Response was assessed at
day 30.
In this study, 13 patients, ages 2 – 61 years,
with primary refractory (n=5) or relapsed (n=8) AML were treated
(one patient was treated twice). Patients had a median of five
prior therapies, and nine had undergone prior stem cell
transplantation. Four patients had disease in the central nervous
system (CNS), including one patient with bone and nerve root
disease and one with probable mycetoma. The FC21-NK-cell therapy
was well tolerated with manageable toxicity. Complete response and
overall response rates were 50% and 78.6%, respectively, including
unexpected CNS responses that were associated with localized
inflammation. Median overall survival and disease-free survival
after treatment were 231 and 186 days, respectively. The data show
that repeated infusions of cryopreserved FC21-NK cells are
well-tolerated and demonstrate encouraging systemic and CNS
responses in this heavily pretreated and fragile population of
high-risk AML patients.
Dr. Silla commented, “In this highly
refractory patient population, these data are very encouraging as
the outcomes suggested potent activity of FC21-NK cells,
particularly given that all 13 of these patients were R/R to prior
FLAG therapy. Additionally, the positive impact on the four
patients with microbial diseases associated with their AML was very
promising and demonstrates the potential benefits of non-targeted
NK-cell therapy in this patient population.”
Arthur Lahr, chief executive officer of Kiadis,
commented, “We are very pleased to see the encouraging outcomes
from this completed study. This provides further support that
FC21-NK cells used to treat R/R AML patients, complicated with CNS
disease and serious infections, were well tolerated and can
potentially serve as a treatment for these patients, especially
older and frail AML patients who have few options available.”
The e-poster titled “Phase I Study of Adoptive
Transfer of Haploidentical Expanded NK Cells” can be found on the
Kiadis website at https://www.kiadis.com/publications-posters/.
About Relapsed/Refractory Acute Myeloid
Leukemia (R/R AML)
Acute myelogenous leukemia (AML) is the most
common type of acute leukemia in adults and has the lowest survival
rate of all leukemias. AML relapse affects nearly half of all
leukemia patients who achieved remission after initial treatment
and can continue to occur several months to several years after
treatment with the majority of relapses occurring within two to
three years of the initial treatment. Patients with relapsed or
refractory leukemia have limited treatment options and poor
survival rates.
The goal of treatment for acute myeloid leukemia
(AML) is to put the leukemia into complete remission and to keep it
that way. Unlike conventional chemotherapy options, which primarily
target dividing cells, immunotherapeutic therapies aim at directing
an immune response against tumor cells. Natural Killer (NK) cells
are effector lymphocytes of the innate immune system capable of
exerting anti-AML activity. The K-NK cell platform is a cell-based
immunotherapy to treat patients with advanced blood cancer.
Kiadis contacts
Kiadis: Maryann
Cimino, Sr. Manager, Corporate Affairs Tel: +1 (617) 710-7305
m.cimino@kiadis.com |
LifeSpring LifeSciences
Communication:Leon Melens (Amsterdam)Tel: +31 538 16
427lmelens@lifespring.nl Optimum Strategic
Communications: Mary Clark, Supriya Mathur Tel: +44 203
950 9144 kiadis@optimumcomms.com |
Dutch Translation/Nederlandse
vertaling
Kiadis nv ('Kiadis') is een
Nederlands beursgenoteerd biotechbedrijf dat nieuwe geneesmiddelen
ontwikkelt tegen ernstige ziekten. Het maakt daarbij gebruik van
Natural Killer-cellen (NK-cellen), grote witte bloedlichamen die de
eerste verdedigingslinie in het menselijk afweersysteem vormen
tegen kankercellen en infecties. Kiadis maakt bekend dat nieuwe
studiedata met haar NK-celtherapie worden gepresenteerd op de 46e
jaarlijkse bijeenkomst van de European Society for Blood and Marrow
Transplantation (EBMT).
De zogeheten poster betreft data van behandeling
van 13 patiënten met recidiverende/refractaire acute myeloïde
leukemie (R/R AML), of terugkerende beenmergkanker, met FC21
geëxpandeerde NK-cellen tijdens een fase I-onderzoek uitgevoerd
door Lucia Mariano da Rocha Silla, MD, PhD, in Hospital de Clínicas
de Porto Alegre (HCPA) in Brazilië, gesponsord door de Brazilian
Agencies for Research Development.
Abstract #A-1137-0005-00784: Fase
I-studie adoptieve overdracht van haplo-identieke geëxpandeerde
NK-cellen
Patiënten met recidiverende refractaire acute
myeloïde leukemie reageren slecht op chemotherapie. Natuurlijk
voorkomende NK-cellen van patiënten kunnen antileukemische werking
hebben, maar worden gedood en verzwakt door de hoge doses
chemotherapie die deze patiënten krijgen. De toediening van buiten
de patiënt geëxpandeerde NK cellen als behandeling van leukemie
werd in deze studie bestudeerd.
In deze fase I-studie werden haplo-identieke
donoren geselecteerd na HLA- en KIR-typering. NK-cellen werden
geëxpandeerd op voedercellen en ingevroren, vervolgens ontdooid en
per infuus gedurende twee weken toegediend, na een voor-behandeling
met fludarabine, cytarabine en G-CSF (FLAG). Patiënten werden
behandeld in 3 groepen van 106, 5x106 en 107 NK-cellen/kg per
doses, en elke patiënt kreeg 5 of 6 doses. De respons werd
beoordeeld op dag 30.
In de studie werden 13 patiënten in de leeftijd
van 2-61 jaar met primaire refractaire (n=5) of recidiverende (n=8)
AML behandeld (één patiënt werd tweemaal behandeld). Patiënten
hadden gemiddeld vijf eerdere behandelingen gehad en negen hadden
een eerdere stamceltransplantatie ondergaan. Vier patiënten hadden
een ziekte in het centrale zenuwstelsel (CZS), waaronder één
patiënt met bot- en zenuwwortelziekte en één met schimmelinfectie
in de hersenen. De FC21-NK-celtherapie werd goed verdragen. De
volledige respons en de algehele respons waren respectievelijk 50%
en 78,6%, inclusief CZS-responsen. De mediane totale overleving was
231 dagen, ziektevrije overleving was 186 dagen. De gegevens tonen
aan dat herhaalde infusies van ingevroren FC21-NK-cellen goed
worden verdragen en bemoedigende systemische en CZS-reacties laten
zien in deze zwaar voor-behandelde en kwetsbare populatie van
hoog-risico AML-patiënten.
Dr. Rocha Silla, MD,
PhD, van het Hospital de Clínicas de Porto Alegre (HCPA) in
Brazilië, zegt:
“Voor een ernstig refractaire patiëntenpopulatie
als deze zijn deze resultaten zeer bemoedigend. De resultaten
wijzen op een krachtige werking van FC21-NK-cellen, vooral omdat
alle 13 patiënten recidiverend/refractair waren na een eerdere
FLAG-therapie. Bovendien zijn de positieve resultaten op bacteriële
en schimmel infecties bij vier patiënten veelbelovend. De studie
toont de mogelijke waarde van NK-celtherapie bij deze
patiëntenpopulatie. "
Arthur Lahr, chief executive officer van
Kiadis, vult aan:
“Dit zijn bemoedigende resultaten voor de
werking van FC-21NK-cellen bij de behandeling van ernstig zieke
patiënten met acute leukemie. Diverse patiënten hadden ernstige
complicaties aan het centraal zenuwstelsel en ernstige infecties.
De NK cellen lieten een krachtige respons zien, bij patiënten waar
diverse eerdere behandelingen hadden gefaald. Deze NK cel therapie
zal verder worden ontwikkeld voor deze vaak oudere en kwetsbare
AML-patiënten waarvoor momenteel weinig behandelopties voorhanden
zijn."
De e-poster met de titel "Phase I Study of
Adoptive Transfer of Haploidentical Expanded NK Cells" is te vinden
op de Kiadis-website op
https://www.kiadis.com/publications-posters/.
Dit persbericht vormt een vertaling van
het gepubliceerde Engelstalige persbericht. Bij eventuele
verschillen is de tekst van het Engelstalige persbericht altijd
bepalend.
About Kiadis’ K-NK-cell Based
Medicines
Kiadis’ NK-cell programs consist of
off-the-shelf and haplo donor cell-based medicines for the
treatment of liquid and solid tumors as adjunctive and stand-alone
therapies and infectious diseases.
The Company’s NK-cell PM21 particle technology
enables improved ex vivo expansion and activation of anti-cancer
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. The Kiadis off-the-shelf K-NK
platform can make NK-cell based product rapidly and economically
available for a broad patient population across a potentially wide
range of indications.
Kiadis is clinically developing K-NK003 for the
treatment of relapse/refractory acute myeloid leukemia. The Company
is also developing K-NK002, which is administered as an adjunctive
immunotherapeutic on top of HSCT and provides functional, mature
and potent NK-cells from a haploidentical family member.
Furthermore, Kiadis is developing K-NK-ID101 for the treatment of
COVID-19. In addition, the Company has pre-clinical programs
evaluating NK-cell based medicines for the treatment of solid
tumors and infectious diseases.
About Kiadis
Founded in 1997, Kiadis is building a fully
integrated biopharmaceutical company committed to developing
innovative cell-based medicines 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’ or, as
appropriate, Kiadis’ 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 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 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.