Kiadis Submits Response to the European Medicines Agency's Day 180 Second List of Outstanding Issues
May 22 2019 - 02:11PM
Amsterdam, The Netherlands, May
22, 2019 - Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company")
(Euronext Amsterdam and Brussels: KDS), a clinical-stage
biopharmaceutical company, today announced that it has submitted a
response to the European Medicines Agency's (EMA) second Day 180
list of outstanding issues for ATIR101. Kiadis submitted a
marketing authorization application (MAA) to the EMA in 2017
seeking approval of ATIR101 as an adjunctive immunotherapy for
hematopoietic stem cell transplant (HSCT) in adults with late-stage
blood cancer.
The second Day 180 List of Issues was focused on one remaining
major observation. In drafting the company's response, Kiadis has
thoroughly analyzed this observation and have created multiple
analyses of existing clinical data to address this observation,
including analyses of various (pooled) ATIR and historical control
data.
"We received the EMA's day 180
second list of outstanding issues in the fourth quarter of 2018,
and have spent the past few months conducting additional analysis
of existing data to support our response," said Arthur Lahr, CEO,
of Kiadis Pharma. "With this submission complete, we aim to receive
an opinion from Committee for Medicinal Products for Human Use
(CHMP) in 2019. If the CHMP opinion is positive, it would enable us
to receive a conditional marketing approval from the European
Commission, followed by commercial use of ATIR101 in a first
patient in a European country at the end of 2019."
For more information, please
contact:
Kiadis
Pharma:
Amy Sullivan, SVP, Corporate Affairs
Tel. +1 508 479 3480
a.sullivan@kiadis.com
Optimum Strategic
Communications:
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 203 950 9144
David Brilleslijper (Amsterdam)
Tel: +31 610 942 514
kiadis@optimumcomms.com
About
ATIR101
ATIR101 is an investigational allodepleted T-cell immunotherapy
product candidate, which is designed to be given after a
haploidentical (genetically half-matched) hematopoietic stem cell
transplantation (HSCT).
Administered as an adjunctive
immunotherapeutic on top of HSCT, ATIR101 provides a single dose
donor lymphocyte infusion (DLI) with functional, mature immune
cells from a haploidentical family member. The T-cells in ATIR101
will help fight infections and remaining tumor cells, until the
immune system has fully re-grown from stem cells in the
transplanted graft.
In ATIR101, T-cells that would
cause GVHD are depleted from the donor lymphocytes, using our
photodepletion technology. At the same time, ATIR101 contains
potential cancer-killing T-cells from the donor that could
eliminate residual cancer cells and help prevent relapse of the
disease.
About Kiadis
Pharma
Founded in 1997, Kiadis Pharma, is a fully integrated
biopharmaceutical company committed to developing innovative
therapies for patients with late-stage blood cancers. With
headquarters in Amsterdam, the Netherlands, Kiadis Pharma is
re-imagining medicine by leveraging the natural strengths of
humanity and our collective immune system to source the best cells
for life.
Kiadis Pharma 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 directors' current expectations
and projections about future events. By their nature,
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release as a result of any change in expectations or any change in
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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 forecasted
developments. You should not place undue reliance on
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Source: Kiadis Pharma N. V. via Globenewswire