Regulatory News:
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 its Interim Management Statement for the
nine months ended 30 September 2015.
Operational review
Kiadis Pharma continued to make good progress in developing its
lead product ATIR101™ for blood cancer:
- Full enrolment of the ongoing Phase II
clinical study (CR-AIR-007) with ATIR101™ has been accomplished.
The primary endpoint for the last patient in this trial will be
reached at the end of Q1, 2016 and top-line results will follow at
the beginning of Q2, 2016.
- Another study (CR-AIR-008), testing
repeat dose administration of ATIR101™ in parallel with the ongoing
Phase II trial, has been initiated and has enrolled its first
patient.
- Establishing a closed manufacturing
process that allows for automation which is advancing according to
plan.
Interim financial results
In the first nine months of 2015, the Company did not generate
any revenues. The net loss for the nine months ended 30 September
2015 came at a level of €13.1 million. Expenses and net results are
in line with management expectations. The Company ended the first
nine months of 2015 with €31.3 million in cash and cash equivalents
and an equity position of €29.1 million.
Kiadis Pharma listed its shares via an IPO on Euronext Amsterdam
and Brussels on 2 July 2015. The gross proceeds from the IPO came
to a total of €34.7 million and net proceeds came to a total of
€31.2 million.
The financial information in this press release has not been
audited nor reviewed by the external auditor.
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, harbouring 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 tumour
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, minimising 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-Leukaemia (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 tumour 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 tumour 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 commercialisation 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.
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.
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
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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Kiadis PharmaManfred Rüdiger, CEOTel. +31 20 314 02
50communication@kiadis.comorInternational Media and Investor
Contact:Mary-Jane Elliott, Lindsey Neville, Hendrik
ThysConsilium Strategic CommunicationsTel: +44 (0) 203 709
5708kiadis@consilium-comms.com