Kiadis Pharma changes strategy to focus solely on development of Natural Killer (NK) Cell therapeutics and terminates develo...
12 Novembre 2019 - 06:00PM
Kiadis Pharma changes strategy to focus solely on development of
Natural Killer (NK) Cell therapeutics and terminates development of
ATIR101
- Kiadis will focus all future investments on
developing off-the-shelf and haplo donor NK-cell therapies for the
treatment of solid and liquid tumors
- Discontinues development of ATIR101, stopping phase 3
trial
- Restructures organization; reducing workforce by
approximately half
Amsterdam, The Netherlands, 12 November 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 completed a strategic portfolio review and has decided to
change its strategy and focus all resources and investments on the
company’s NK-cell therapy platform and product candidates. The
company will discontinue development of ATIR101 and stop its
ongoing phase 3 trial.
Kiadis’ NK-cell program consists of
off-the-shelf and haplo donor cell therapy products for the
treatment of liquid and solid tumors. Kiadis’ proprietary
off-the-shelf NK-cell platform is based on NK-cells from unique
universal donors, expanded and activated ex vivo using our PM21
particle technology. The Kiadis off-the-shelf platform has the
potential to make NK-cell therapy products rapidly and economically
available for a broad patient population across a potentially wide
range of indications.
The company’s pipeline includes:
- K-NK002: A phase 1/2 study will begin in 2020 evaluating
K-NK002 as an adjunctive treatment to the current standard-of-care
haploidentical hematopoietic stem cell transplantation (HSCT) with
post-transplant cyclophosphamide (PTCy). Relapse remains an issue
with the PTCy protocol. The phase 1/2 study was designed based on
promising clinical proof-of-concept data in 25 patients that
demonstrated a reduction of long-term relapse rates from 45% in a
matched contemporaneous control of patients treated with PTCy, to
8% of patients treated with PTCy and K-NK002 (Blood 2017, ASCO
2018). The 63 patient phase 1/2 study will be conducted in
collaboration with the Bone Marrow Transplant Clinical Trial
Network (BMT-CTN), which consists of the premier transplant clinics
in the United States.
- K-NK003: A phase 1/2A study will begin in 2020 evaluating
K-NK003 as a treatment for patients with relapse and refractory
acute myeloid leukemia. The trial is designed based on clinical
proof-of-concept data that showed a 69% complete response rate
(Haplo 2018).
- Pre-clinical programs: Kiadis has multiple preclinical programs
evaluating its K-NK-cell therapies for the treatment of solid
tumors.
Arthur Lahr, CEO of Kiadis
Pharma commented, “We believe that our proprietary NK-cell
therapy platform has broad potential as stand-alone or adjunctive
treatments for patients with both liquid and solid tumors. Our
off-the-shelf NK-cell platform is based on NK-cells from unique
universal donors, expanded and activated with our PM21 particle
technology, to make our NK-cell therapy products rapidly and
economically available for patients across a potentially broad
range of indications. The proof-of-concept trials for our NK
pipeline programs, in which 38 patients have been treated, is very
promising and was the basis for our acquisition of Cytosen
Therapeutics, Inc. earlier this year. To confirm findings from
these trials, we will start two Phase 1/2 clinical trials in 2020.
We believe that investing in our NK platform and rapidly advancing
development of our off-the-shelf and haplo donor derived NK-cell
therapies in solid and liquid tumors will bring value to patients
and our investors.”
Lahr continued, “As part of our strategic
portfolio review, we reviewed progress of our phase 3 study, which
was designed to show superiority of ATIR101 over the PTCy protocol.
We identified that in the phase 3 a higher percentage of patients
than expected dropped out of the study before receiving ATIR101. We
subsequently collected additional recent external data, which show
that outcomes with PTCy have better survival and lower severe GVHD
than literature showed when we designed and started the phase 3
study. Based on these data, we no longer believe that the phase 3
ATIR study as currently designed with 250 patients can demonstrate
superiority over PTCy and at a minimum would require a much larger
trial. In the best interest of patients, we have therefore taken
the decision to discontinue the ATIR101 study with immediate effect
and are proceeding with close down activities.”
RestructuringKiadis is implementing a
restructuring program to refocus the organization on its NK-cell
therapy platform, which will result in a reduction of approximately
half of its workforce, a reduction in external clinical trial costs
associated with the phase 3 study, and a reduced company cash burn.
The company ended the third quarter of 2019 with approximately €47
million of cash.
About Kiadis’ K-NK-Cell Therapies Kiadis’
NK-cell programs consist of off-the-shelf and haplo donor cell
therapy products for the treatment of liquid and solid tumors as
adjunctive and stand-alone therapies.
Our 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 therapy product rapidly and economically
available for a broad patient population across a potentially wide
range of indications.
Administered as an adjunctive immunotherapeutic
on top of HSCT, K-NK002 provides functional, mature and potent
NK-cells from a haploidentical family member. In addition,
Kiadis is developing K-NK003 for the treatment of
relapse/refractory acute myeloid leukemia 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.
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 impact 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 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.