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arGEN-X Starts Phase Ib Expansion Cohorts With ARGX-110, a Novel Anti-CD70 Antibody, in Cancer Patients

January 13, 2014

BREDA, The Netherlands and GHENT, Belgium, January 13, 2014 /PRNewswire/ –

Study supported by a EUR3.5 million IWT grant from the Flemish Government

arGEN-X, a clinical stage human therapeutic antibody company, announces that it has
advanced ARGX-110, a novel anti-CD70 antibody, into the safety and efficacy expansion part
of its Phase Ib study. The objective is to further investigate the safety of ARGX-110 in
CD70-positive cancer patients with either haematological or solid tumors, and to evaluate
efficacy in order to select the indications to be studied in Phase II clinical
development. Top-line results are expected in about 12 months. The study is being
supported by a EUR3.5 million grant from the Flemish Government’s Institute for the
Promotion of Innovation by Science and Technology in Flanders (IWT).

ARGX-110 is a first-in-class monoclonal antibody that potently blocks CD70-induced
tumor proliferation and tumor escape from immune surveillance. In addition, the
POTELLIGENT(R)-enhanced antibody-dependent cellular cytotoxicity (ADCC) of ARGX-110
enables selective destruction of CD70-positive tumor cells. CD70 is overexpressed in the
majority of cancer patients tested to date. Expectations of a favorable therapeutic index
stem from its virtual absence in healthy tissues.

In the first part of the Phase Ib study, announced in December 2013, ARGX-110 showed a
favorable safety profile, exhibited no dose-limiting toxicities and met all translational
development goals (i.e. measures of biological activity such as target engagement,
effector functions, and immune-modulation). The open-label Phase Ib expansion aims to
enrol up to 75 patients at three clinical centers in Belgium (Institut Jules Bordet, UZA,
and UZG) and Institut Gustave Roussy in France.

The expansion phase is part of a broader ‘Transformational Medical Research’ (TGO)
project implemented by arGEN-X in close collaboration with leading Flemish research
organizations and clinical centers and supported by IWT. The project aims to develop and
further the use of innovative, adaptive clinical trial designs that leverage
immunohistochemistry, biomarkers, tissue bank materials as well as clinical data to
improve the chances of success with novel drug candidates. The project also involves
leading academic research on CD70/CD27 signaling for expanding the field of cancer
immunotherapy.

“We are excited to advance ARGX-110 into the expansion phase of the study. The data
generated in the first phase of the study and in preclinical testing are very encouraging
and reinforce our belief in the broad therapeutic potential of ARGX-110 against
CD70-positive haematological and solid tumors,” said Tim Van Hauwermeiren, Chief Executive
Officer. “We are also delighted to receive the IWT grant, which stimulates collaboration
across the Flemish life sciences cluster in search of ground-breaking translational
medicines, and has provided great support for arGEN-X to advance this innovative study
with ARGX-110.”

Katrien Swerts, IWT Advisor and TGO coordinator, added: “On the initiative of Minister
Lieten, the Flemish Government initiated the TGO program in order to stimulate the
development of more effective and affordable medicines. By joining forces with
universities and clinical centers, Flemish companies may be able to accelerate to speed
with which they bring their innovative drugs to patients. For small and medium-sized
companies, the program could have important added value as the financial support will help
them test their innovative products in a faster and more extensive way. By initiating its
Phase Ib expansion cohorts, arGEN-X proves that this approach is working. The company
opted for an adaptive clinical trial design and is now reaping the fruits of this
innovative approach.”

About the ARGX-110 Study

The Phase Ib study (ClinicalTrials.gov Identifier: NCT01813539) consists of a dose
escalation phase followed by adaptive safety and efficacy expansion cohorts conducted in
patients with advanced, refractory cancer. The patient enrichment strategy relies on
individual tumor screening for CD70 utilizing a reproducible immunohistochemistry method.
In addition to traditional clinical and PK/PD endpoints, biomarkers documenting the three
modes of action of ARGX-110 are being evaluated. Patient enrolment is planned at
approximately 90 CD70-positive patients with either haematological or solid tumors. The
study is managed jointly by arGEN-X and a consortium of leading academic institutions in
Belgium.

About arGEN-X

arGEN-X is a clinical stage human therapeutic antibody company that is rapidly
developing a product pipeline using its unique suite of antibody technologies. arGEN-X is
creating first and best in class antibody therapeutics with highly differentiated target
product profiles. Its therapeutic antibody programs, focused on cancer and autoimmune
indications, are designed to deliver tangible benefits to patients with these diseases.

http://www.argen-x.com

About IWT

The agency for Innovation by Science and Technology (abbreviated as IWT) is the
government agency founded in 1991 by the Flemish Government to support technological
innovation projects in Flanders. Each year IWT distributes about EUR 300 million in
subsidies for innovation projects to companies, organizations, research and educational
institutions in Flanders. In addition to financial support, IWT also assists companies by,
for instance helping them find the right information or the right partners at home or
abroad, providing assistance with the preparation of projects for European programmes and
with technology transfer throughout Europe. IWT also has an important coordination mandate
aimed at promoting close cooperation among all the actors involved in technological
innovation in Flanders. IWT Monitoring&Analysis, M&A for short, monitors innovation and
regularly publishes studies. For more information, please visit http://www.iwt.be or
call +32-2-209-09-00.

SOURCE arGEN-X


Source: PR Newswire



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