AMSTERDAM–(BUSINESS WIRE)–Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”)
(Euronext Amsterdam and Brussels: KDS), a clinical stage
biopharmaceutical company developing innovative T-cell immunotherapy
treatments for blood cancers and inherited blood disorders, today
announces that it has entered into a partnership with The Leukemia
Lymphoma Society (LLS) under which LLS will fund the Phase II
development of Kiadis Pharma’s lead product, ATIR101™, through an equity
investment of approximately $1 million.
LLS is investing via its Therapy Acceleration Program (TAP), a strategic
initiative to partner directly with biotechnology companies to help
accelerate the development of promising therapies, and the funds will be
used to finance Kiadis Pharma’s second ongoing Phase II trial in
leukemia patients. The Company intends to continue this trial into a
randomized controlled Phase III pivotal study that is planned to start
later this year. This ongoing Phase II trial is investigating the
repeated dosing of ATIR101™ as an adjunctive treatment to a T-cell
depleted haploidentical hematopoietic stem cell transplantation (HSCT)
(donor cells from a half-matched related donor) in adult patients with
acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL). The
trial (CR-AIR-008; NCT02500550 / EudraCT 2015-002821-20) is conducted
under an IND of the United States Food and Drug Administration and is
set up to enroll patients in the United States as well as other
countries, including Canada, Belgium and the United Kingdom.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma,
commented: “We are pleased to be partnering with the world’s
largest voluntary health agency focused on blood cancers. We see this as
another validation of our innovative product candidate ATIR101™. The
extensive network and expertise of The Leukemia Lymphoma Society will
be extremely valuable to us as we prepare to set up the pivotal Phase
III study later this year. The fact that LLS is investing into Kiadis
Pharma with equity is also a strong sign of confidence in what we do and
our goal remains to be to bring this important product to patients as
quickly as possible.”
Louis J. DeGennaro, Ph.D., LLS’s President and CEO, added: Stem
cell transplantation is one of the most effective curative treatments
for blood cancer patients, but it comes with great risk of
life-threatening infection and graft versus host disease (GVHD). Kiadis
Pharma’s ATIR101™ shows promise in fighting these infections by boosting
the patient’s immune system whilst also reducing GVHD. LLS is
enthusiastic about supporting this program which we hope will improve
outcomes for patients with blood cancers.”
About ATIR101™
For patients suffering from blood cancers, an allogeneic hematopoietic
stem cell transplantation (HSCT) is generally regarded as the most
effective curative approach. During an HSCT treatment, the bone marrow,
harboring the diseased cancer cells, is completely destroyed and
subsequently replaced by stem cells in the graft from a healthy donor.
After an HSCT treatment it usually takes the patient at least six to
twelve months to recover to near-normal blood cell levels and immune
cell functions. During this period, the patient is highly vulnerable to
infections caused by bacteria, viruses and fungi but also to disease
relapse.
ATIR101™ (Allodepleted T-cell ImmunotheRapeutics) provides for a
safe donor lymphocyte infusion (DLI) from a partially matched
(haploidentical) family member without the risk of causing severe
Graft-versus-Host-Disease (GVHD). The T-cells in ATIR101™ will
help fight infections and remaining tumor cells and thereby bridge the
time until the immune system has fully re-grown from stem cells in the
transplanted graft.
In ATIR101™, T-cells that would cause GVHD are eliminated from
the donor lymphocytes using Kiadis Pharma’s photodepletion technology,
minimizing the risk of GVHD and eliminating the need for prophylactic
immune-suppression. 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, known as the
Graft-versus-Leukemia (GVL) effect.
Therefore, ATIR101™, administered as an adjunctive
immuno-therapeutic on top of HSCT, provides the patient with functional,
mature immune cells from a partially matched family donor that can fight
infections and tumor cells but that do not cause GVHD. ATIR101™
thus has the potential to make curative HSCT a viable option to many
more patients.
The Company estimates that approximately 35% of patients who are
eligible and in urgent need of HSCT will not find a matching donor in
time. A partially matched (haploidentical) family donor, however, will
be available to over 95% of patients.
ATIR101™, consisting of donor T-cells that fight infections and
residual tumor cells while not eliciting severe GVHD, is designed to
result in low relapse rates and low rates of death due to infections, in
the absence of severe acute GVHD.
About Kiadis Pharma
Kiadis Pharma is a clinical stage biopharmaceutical company focused on
research, development and future commercialization of cell-based
immunotherapy products for the treatment of blood cancers and inherited
blood disorders. The Company believes that its innovative products have
the potential to address the current risks and limitations connected
with allogeneic hematopoietic stem cell transplantation (HSCT), being
graft-versus-host-disease (GVHD), cancer relapse, opportunistic
infections and limited matched donor availability. HSCT is generally
regarded as the most effective curative approach to blood cancers and
certain inherited blood disorders and the Company expects that HSCT
could become a first-choice treatment for blood cancers and inherited
blood disorders once current risks and limitations are addressed,
thereby meeting a significant unmet medical need with its products.
Currently, the Company’s product ATIR101™ is being tested using a single
dose regimen in an open-label Phase II trial in patients with blood
cancer who have not found a matching donor and where a partially matched
(haploidentical) family member is used as donor for HSCT. Kiadis Pharma
announced full enrolment of this trial in July 2015. The primary
endpoint for the last patient in this trial will be reached at the end
of Q1, 2016, top-line results to follow at the beginning of Q2, 2016.
Very encouraging and positive interim data of this trial was presented
recently at ASH2015.
In addition, the Company is enrolling blood cancer patients in a further
Phase II clinical trial to study the safety and efficacy of
administrating a second dose of ATIR101™ to further improve the HSCT
outcome.
The European Medicines Agency (EMA) has issued an Advanced Therapy
Medicinal Product (ATMP) certificate for manufacturing quality and
non-clinical data to the Company, and to date Kiadis Pharma is one of
only five companies that have received such a certificate
ATIR101™ has been granted Orphan Drug Designations both in the US and
Europe.
ATIR201™ will be developed for inherited blood disorders with an initial
focus on thalassemia, an inherited blood disorder which results in
improper oxygen transport and destruction of red blood cells in a
patient. ATIR201™ is expected to enter clinical development for
thalassemia with a Phase I/II trial in the first quarter of 2016.
Kiadis Pharma is based in Amsterdam, the Netherlands and its shares are
listed on Euronext Amsterdam and Euronext Brussels. Further information
can be found at: www.kiadis.com
About The Leukemia Lymphoma Society
The Leukemia Lymphoma Society® (LLS) is the world’s largest voluntary
health agency dedicated to blood cancer. The LLS mission: Cure leukemia,
lymphoma, multiple myeloma, and improve the quality of life of patients
and their families. LLS funds lifesaving blood cancer research around
the world, provides free information and support services, and is the
voice for all blood cancer patients seeking access to quality,
affordable, coordinated care.
Founded in 1949 and headquartered in White Plains, NY, United States of
America, LLS has chapters throughout the United States and Canada. To
learn more, visit www.LLS.org.
Patients should contact the Information Resource Center at (800)
955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.
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.
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