Kiadis Pharma provides regulatory update on ATIR101
17 Octobre 2019 - 5:50PM
Kiadis Pharma provides regulatory update on ATIR101
- Kiadis no longer expects EU
conditional marketing authorization for
ATIR101 in 2020
- Kiadis plans to refile at the
conclusion of the ongoing phase 3 trial
Amsterdam, The Netherlands, 17 October
2019 – Kiadis Pharma N.V.
(“Kiadis Pharma” or the
“Company”) (Euronext Amsterdam and Brussels: KDS), a
clinical-stage biopharmaceutical company, today announced that it
no longer expects to receive EU conditional marketing authorization
for ATIR101 in 2020. The Company expects that European Medicines
Agency’s (EMA) Committee for Medicinal Products for Human Use
(CHMP) will issue a negative opinion and recommend against
conditional marketing authorization at the next CHMP meeting in
November 2019.
Arthur Lahr, CEO of
Kiadis Pharma commented, “Today’s
news is very disappointing, especially for patients who could
benefit from treatment with ATIR101. We filed a marketing
authorization application (MAA) in 2017 with our phase 2 ATIR101
data and historical T-cell deplete haploidentical hematopoietic
stem cell transplant (HSCT) control data based on input from EMA
that these were considered adequate for review. Feedback from the
EMA now indicates that the phase 2 data and historical T-cell
deplete control data do not provide adequate support for a
marketing authorization due to the evolution of the standard of
care with the post-transplant cyclophosphamide (PTCy, aka
Baltimore) protocol.”
Kiadis is currently enrolling a global, 250
patient, randomized phase 3 trial, comparing patients treated with
ATIR101 after a T-cell deplete HSCT to patients treated with a
T-cell replete haploidentical HSCT based on the PTCy protocol.
Completion of enrolment and interim readout of the phase 3 study
are expected in 2021. If positive, the study will be the basis for
filing of a biologics license application (BLA) with the US Food
and Drug Administration (FDA) and a new MAA with the EMA.
Mr. Lahr continued, “The
randomized phase 3 trial, if positive, should address EMA’s
concerns, as it compares ATIR101 to the current standard of care,
the PTCy protocol. HSCT patients are in need of new treatment
options and we will work diligently to advance our HSCT programs,
while also pursuing cancer therapeutics with our NK-cell
platform.”
Scott Holmes, CFO of
Kiadis Pharma added, “We do not
believe that this setback significantly changes the long-term
revenue potential for ATIR or the near-term cash needs of Kiadis.
Revenue expectations in the initial years of European launch were
minimal and would not have provided a positive operating margin.
Importantly, we planned for and are enrolling the phase 3 study
necessary for potential regulatory approval in the United States,
and now the European Union.”
About ATIR101 and KNK002 Kiadis
has two cell-based therapeutics in development for patients with
late-stage blood cancer undergoing a hematopoietic stem cell
transplant: T-cell based ATIR101 and NK-cell based KNK002.
Administered as adjunctive immunotherapeutics on top of HSCT,
ATIR101 and KNK002 provide lymphocyte infusions with functional,
mature and potent immune cells from a haploidentical family member.
The T-cells in ATIR101 and NK-cells in KNK002 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. Our NK-cell
nanoparticle processing technology enables improved ex vivo
expansion and activation of NK-cells supporting multiple high-dose
infusions with potent anti-cancer cytotoxicity.
In addition, Kiadis is developing NK-cell based
therapies for the treatment of relapse/refractory AML and has
pre-clinical programs evaluating NK-cell therapy for the treatment
of solid tumors.
Kiadis Contacts:
Kiadis Pharma:Amy Sullivan, SVP Corporate
AffairsTel: +1 (508) 479-3480a.sullivan@kiadis.com |
Optimum Strategic Communications:Mary Clark,
Supriya Mathur, Hollie VileTel: +44 203 950 9144David Brilleslijper
(Amsterdam)Tel: +31 610 942 514kiadis@optimumcomms.com |
About KiadisFounded in 1997,
Kiadis Pharma, is a fully integrated biopharmaceutical company
committed to developing innovative cell-based therapies for
patients with life-threatening diseases. With headquarters in
Amsterdam, the Netherlands, and offices and activities 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.
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