Kiadis updates status of marketing authorization application for ATIR101
28 Junho 2019 - 01:11PM
Kiadis updates
status of marketing authorization application for ATIR101
Amsterdam, The Netherlands, June 28, 2019 - Kiadis
Pharma N.V. ("Kiadis" or the "Company") (Euronext Amsterdam and
Brussels: KDS), a clinical-stage biopharmaceutical company, today
announced that it has received feedback from the European Medicines
Agency (EMA) related to the marketing authorization application
(MAA) seeking approval of ATIR101 in hematopoietic stem cell
transplant (HSCT). As previously announced, Kiadis submitted
responses to the second Day 180 list of outstanding issues for
ATIR101 to EMA in May 2019.
As part of the review process, EMA today informed
Kiadis that it will convene a Scientific Advisory Group (SAG) in
September, comprising of experts in hematology and HSCT to assist
EMA in arriving at a determination.
"We appreciate the feedback from EMA and look
forward to continuing our interaction with them during the review
of our MAA for ATIR101," said Arthur Lahr, CEO, of Kiadis Pharma.
"With the SAG meeting now preceding the subsequent CAT and CHMP
meetings as part of the EMA approval process, we are changing our
guidance to potential EU conditional approval in 2020."
While initial launch in the EU is delayed, Kiadis
is on track to complete enrollment in the Phase 3 ATIR101 HSCT
study in 2021 to support potential marketing approval in the US.
Additionally, the company is also on track to start the Phase
1/2 studies of CSDT002 in HSCT and relapse and refractory acute
myeloid leukemia in 2020. With a novel cell-based cancer
immunotherapy platform consisting of both T-cell and NK-cell
technologies, Kiadis has the opportunity to potentially
revolutionize transplants and develop novel cancer cell
therapies.
About ATIR101 and
CSDT002
Administered as adjunctive immunotherapeutics on top of HSCT,
ATIR101 and CSDT002 provide lymphocyte infusions with functional,
mature and potent immune cells from a haploidentical family member.
The T-cells in ATIR101 and NK-cells in CSDT002 are intended to help
fight infections and remaining tumor cells, until the immune system
has fully re-grown from stem cells in the transplanted graft. In
addition, CSDT002 has shown promise in the treatment of
relapse/refractory AML.
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.
In CSDT002, nanoparticle processing technology
enables improved ex vivo expansion and
activation of NK-cells supporting multiple high-dose infusions with
potent anti-cancer cytotoxicity.
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, and offices in the US
and across Europe, Kiadis Pharma is 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,
forward-looking statements involve a number of risks, uncertainties
and assumptions that could cause actual results or events to differ
materially from those expressed 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, competition and technology, can
cause actual events, performance or results to differ significantly
from any anticipated 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 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 forecasted
developments. You should not place undue reliance on
forward-looking statements, which speak only as of the date of this
press release.
For more information, please
contact:
Kiadis Pharma:
Amy Sullivan
Sr. Vice President, Corporate Affairs
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 |
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Kiadis Pharma N. V. via Globenewswire