Kiadis to Acquire CytoSen Therapeutics,
Inc.
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Transaction creates leader in
cell-based cancer immunotherapy, with complementary T-cell and
NK-cell platforms focused initially on hematopoietic stem cell transplants (HSCT)
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CytoSen's lead NK-cell therapy
candidate, CSDT002-NK, is expected to enter clinical development in
2020 building on successful clinical proof-of-concept studies in 25
patients at the MD Anderson Cancer Center (MDACC)
-
The Blood and Marrow Transplant
Clinical Trials Network (BMT CTN) to support clinical development
in leading US transplant centers
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Dr. Carl June, a pioneer in the development of CAR T-cell therapy,
to join Kiadis' Scientific Advisory
Board
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Conference call for analysts
and investors today at 3:00pm CEST (9:00am EDT)
Amsterdam, The
Netherlands, April 17, 2019 - Kiadis Pharma N.V. ("Kiadis" or the
"Company") (Euronext Amsterdam and Brussels: KDS), a clinical
stage biopharmaceutical company, today announced that it has
entered a definitive agreement to acquire US-based CytoSen
Therapeutics, Inc. ("CytoSen"), subject to Kiadis' shareholder
approval and customary closing conditions.
Privately held CytoSen has
developed a proprietary natural killer (NK)-cell platform to enable
NK-cell therapy with broad anti-cancer potential. It was founded on
technology exclusively licensed from the University of Central
Florida (UCF) and further developed at Nationwide Children's
Hospital (NCH). The company's founders, including Dean Lee, Stefan
Ciurea and Robert Igarashi, are leading physicians and scientists
at NCH, MDACC and UCF, respectively. Following the transaction, Dr.
Carl June, a pioneer in the development of CAR T-cell therapy and
current scientific advisor to CytoSen, will join Kiadis' Scientific
Advisory Board.
The transaction creates a leader
in cell-based cancer immunotherapy. The combined company has a
complementary development pipeline focused on improving outcomes
for patients undergoing hematopoietic stem cell transplants (HSCT).
Kiadis' lead T-cell product ATIR101 is in EU registration and a
global Phase 3 clinical trial; CytoSen's lead NK-cell product
candidate, CSDT002-NK, building on promising clinical
proof-of-concept studies in 25 patients carried out at MD Anderson
Cancer Center, is expected to enter the clinic in the US in 2020.
The unique combination of proprietary and synergistic NK-cell and
T-cell therapy platforms has the potential to revolutionize HSCT
and enables Kiadis to create a pipeline with novel cancer
treatments.
Arthur Lahr, CEO
of Kiadis commented: "Our vision is to
leverage the strengths of the human immune system to help patients
with life-threatening diseases. With the addition of CytoSen, we
can create cell therapy treatments that combine the innate and
adaptive arms of the immune system. The ATIR T-cell and
CSDT002-NK-cell programs each have the potential to make
transplants safer and more effective. In combination, they have the
potential to revolutionize HSCT, making it suitable for an even
wider group of patients. This transaction will transform Kiadis
into a unique company with two synergistic proprietary cell-based
immunotherapy platforms and the opportunity to create a pipeline of
innovative treatments for cancer patients."
Carl H. June, MD,
Richard W. Vague Professor in Immunotherapy in the Department of
Pathology and Laboratory Medicine at the University of
Pennsylvania, commented: "NK-cell therapy
could significantly advance the field of immuno-oncology. Also, I
believe the fields of NK-cells and T-cells are enormously
synergistic and the combination could potentially help patients
with devastating diseases. I am pleased to be joining the
Scientific Advisory Board of Kiadis."
Dean A. Lee, MD,
PhD, co-founder of CytoSen and director of the Cellular Therapy and
Cancer Immunology Program at Nationwide Children's Hospital (NCH),
commented: "CytoSen has the most advanced
NK-cell technology to enable NK-cell therapy with broad anti-cancer
potential. The strong experience, infrastructure,
and competencies of Kiadis in cell therapy will accelerate our
delivery of NK-cells to patients, and the new opportunities for
exploring NK-cell and T-cell synergies will enable
disruptive innovation in the cell therapy space. I am excited
to collaborate with Kiadis to bring this innovation to
patients."
NK-cells are one of the body's
first lines of immunological defense with an innate ability to
rapidly and selectively destroy abnormal cells, such as cancer or
virally-infected cells. Advancing research into the biology of
NK-cells, as well as emerging early-stage clinical evidence, has
increasingly shown that NK-cell immunotherapy has the potential to
be at the forefront of cancer immunotherapy. CytoSen's patented
nanoparticle processing technology enables improved ex vivo expansion and activation of NK-cells supporting
multiple high dose infusions with potent anti-cancer
cytotoxicity.
CytoSen's lead program, CSTD002-NK
in HSCT, is built on proof-of-concept studies in 25 patients
carried out at MDACC. First results of these studies demonstrated a
relapse rate of 8% and progression-free survival (PFS) of 66%
(published in Blood[1], with
follow up data presented at the American Society of Hematology
(ASH) annual meeting in 2018). The upcoming clinical study with
CSDT002-NK, expected to start in 2020, has been designed with and
will be supported by the Blood and Marrow Transplant Clinical
Trials Network (BMT CTN). The study will enroll high-risk acute
myeloid leukemia (AML) patients undergoing a haploidentical HSCT at
a consortium of leading US transplant centers in the BMT CTN
network. Additionally, CytoSen's NK-cell therapy will be
investigated for other cancer treatments based on an 8-patient
proof-of-concept study conducted at MDACC in refractory AML.
Transaction
Details:
At closing, CytoSen shareholders will receive upfront consideration
of 1.94 million shares of Kiadis stock. The upfront consideration
constitutes approximately 7.4% of Kiadis' shares outstanding after
the transaction. In addition, CytoSen shareholders are eligible to
receive potential future consideration of up to 5.82 million
additional shares of Kiadis stock upon the achievement of six
clinical development and regulatory milestones, with the final
milestone being first FDA approval of an NK-cell product based on
CytoSen's technology. The majority of the Kiadis shares issued to
the CytoSen shareholders, including to its Executive Chairman and
founders, will be subject to a lock-up for a period of two years
from closing. At signing, CytoSen held approximately USD 6 million
in net cash, which will remain in the combined company. Saola
Healthcare Partners acted as financial advisor to Kiadis in the
transaction.
Shareholder Approval:
The transaction is subject to the approval of Kiadis' shareholders.
The Company has called an extraordinary meeting of shareholders
(EGM) to be held on Wednesday, May 29, 2019, at which the proposal
supporting the transaction will be voted upon. Kiadis' two largest
shareholders (funds represented by and/or affiliated with Life
Sciences Partners and Draper Esprit), together representing 31.5%
of Kiadis stock, have executed voting agreements in favor of the
transaction. In the event that the transaction does not complete
because the General Meeting withholds its approval, CytoSen is
entitled to a USD 1 million break fee to be paid in cash or Kiadis
shares.
Kiadis Business Update:
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Kiadis previously submitted a marketing
authorization application (MAA) to the EMA for ATIR101 which is
currently under review. The Company plans to respond to the day 180
outstanding issues by the end of May 2019, allowing for potential
EU approval and launch by the end of 2019.
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The global Phase 3 trial for ATIR101,
CR-AIR-009, will compare ATIR101 to the post-transplant
cyclophosphamide (PTCy) or 'Baltimore' protocol. Completion of
enrollment and an interim analysis of the primary endpoint is
expected in 2021.
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Kiadis' cash position was EUR 60.3 million as of
December 31, 2018 and EUR 49.0 million as of March 31,
2019.
Conference Call / Webcast Information:
Kiadis' management will host a webcast / conference call for
analysts and investors today, April 17, 2019 at 3:00pm CEST /
2:00pm BST / 9:00am EDT. To participate in the conference call,
please call one of the following numbers ten minutes prior to
commencement of the call:
Confirmation
Code:
5737097
Participant dial-ins:
Location |
Phone
Number |
|
|
Belgium |
+32 (0)2 400 6926 |
Norway |
+47 2350 0296 |
Finland |
+358 (0)9 7479
0404 |
Sweden |
+46 (0)8 5065
3942 |
France |
+33 (0)1 76 77 22
57 |
Switzerland |
+41 (0)22 567
5750 |
Germany |
+49 (0)69 2222
2018 |
United Kingdom |
+44 (0)330 336
9411 |
Netherlands |
+31 (0)20 703
8261 |
United States |
+1 323-794-2093 |
Webcast:
https://webcasts.eqs.com/osc20190417
A question and answer session will
follow the presentation. The presentation may be accessed by
visiting http://www.kiadis.com/financial-news.
About CytoSen
Therapeutics, Inc.
CytoSen is a private biopharmaceutical company on the front line of
advancing development of next generation NK-cells with the first
scalable, therapeutic platform for high dose, cancer-killing
NK-cells calibrated to each cancer target while reinforcing immune
defenses. Born from the intersection of cellular immunotherapy and
nanotechnology, CytoSen's NK-cell therapy harnesses the power of
the immune system to treat cancer.
About the BMT CTN
The Blood and Marrow Transplant Clinical Trials Network (BMT CTN)
conducts multi-institutional clinical trials of high scientific
merit, focused on improving survival for patients undergoing
hematopoietic cell transplantation (HCT) and/or receiving cellular
therapies. The BMT CTN is funded by the National Heart, Lung, and
Blood Institute and National Cancer Institute at the National
Institutes of Health (NIH) and is a collaborative effort of 20 Core
Transplant Centers/Consortia, The Center for International Blood
and Marrow Transplant Research (CIBMTR), the National Marrow Donor
Program (NMDP)/Be The Match and Emmes, a clinical research
organization. CIBMTR is a research collaboration between the
NMDP/Be The Match and the Medical College of Wisconsin. More
information about the BMT CTN can be found
at www.bmtctn.net.
About Kiadis
Pharma
Kiadis is developing its lead product candidate, ATIR101, for use
in conjunction with haploidentical HSCT for adult blood cancers to
address key limitations of haploidentical HSCT, without
prophylactic immunosuppression and its associated morbidity and
mortality. Based on the positive results from the single dose Phase
II CR-AIR-007 study, the Company submitted a marketing
authorization application to the European Medicines Agency in April
2017 for approval of ATIR101 as an adjunctive treatment in
haploidentical HSCT for high risk adult hematological malignancies.
If the product is conditionally approved, Kiadis intends to launch
ATIR101 in Europe through its own commercial organization
by year end 2019.
In December 2017, Kiadis commenced
an international, multicenter, randomized and controlled Phase III
clinical trial of ATIR101 against the Post-Transplant
Cyclophosphamide, or PTCy protocol, the main protocol used to
perform a haploidentical HSCT. The trial will be performed in 250
patients with acute leukemia and myelodysplastic syndrome at
approximately 50 sites in the United States, Canada, Europe and
certain additional countries. ATIR101 received regenerative
medicine advanced therapy designation from the FDA in September
2017, which provides benefits that are materially equivalent to a
breakthrough designation from the FDA. In addition, ATIR101 has
been granted multiple orphan Drug designations both in the European
Union and the United States.
The Company's shares are listed on
Euronext Amsterdam and Brussels under the ticker KDS.
Kiadis Contacts:
Kiadis:
Amy Sullivan, SVP, Corporate Affairs
a.sullivan@kiadis.com
Maryann Cimino, Manager, Corporate Affairs
Tel. +1 617 710 7305
m.cimino@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 |
Forward Looking
Statements
"Certain
statements, beliefs and opinions in this press release are
forward-looking, which reflect Kiadis' or, as appropriate,
Kiadis' 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, or our ability to
develop and successfully integrate new assets and product programs
into our business, can all 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 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 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 release."
[1] Blood 2017:
blood-2017-05-785659; doi:
https://doi.org/10.1182/blood-2017-05-785659
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