17 September 2014
Breda, the Netherlands / Ghent, Belgium - arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, is pleased to announce the grant of key patents in the United States relating to its two lead clinical candidates ARGX-110 and ARGX-111.
The US Patent & Trademark Office (USPTO) granted composition-of-matter claims relating to ARGX-110, a novel SIMPLE Antibody(TM) product targeting human CD70. The issued patent (US 8,834,882) was examined by the USPTO's Track 1 Prioritized Examination Program leading to a patent grant within ten months of filing. This grant is in addition to the recent grant of an arGEN-X patent (US 8,637,027) relating to ARGX-111, a proprietary SIMPLE Antibody(TM) targeting human c-Met. Both patent rights are projected to expire in 2031-2032 but are eligible for up to an additional five years of Patent Term Extension for marketing delays caused by necessary clinical trials and FDA regulatory review.
In addition to securing core composition of matter patent rights for its antibody products, arGEN-X is pleased to announce the grant of an additional patent (US 8,835,607) relating to its SIMPLE Antibody(TM) platform technology involving broad patent claims relating to arGEN-X' germlining approach for SIMPLE Antibodies. This granted patent serves to supplement arGEN-X' growing portfolio of issued patents relating to its proprietary SIMPLE Antibody(TM) platform (e.g. US Patents 8,444,976 and 8,524,231). Not only do these platform patents provide exclusive composition-of-matter coverage for the development of SIMPLE antibodies, they provide supplementary patent protection for both ARGX-110, ARGX-111 and other SIMPLE antibodies in arGEN-X' pipeline.
Tim Van Hauwermeiren, CEO of arGEN-X, said: "The grant of these patents in the US is an important milestone for arGEN-X that provides validation for our technology and patent strategy. We believe our pipeline has considerable commercial potential and these patents in the world's largest pharmaceutical market give us confidence that we can generate significant shareholder value from these unique therapeutic antibodies as they advance."
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Notes to Editors
ARGX-110 is a SIMPLE Antibody(TM) targeting CD70, an immune checkpoint target involved in hematological malignancies (lymphomas and leukemias), several solid tumors and severe autoimmune diseases. ARGX-110 works in three ways: i) blocks growth of tumor cells, ii) kills cancer cells and iii) activates the patients' immune system against the tumor. ARGX-110 is currently being evaluated across a range of hematological and solid tumors in a Phase 1b study in Europe and will be developed in a Phase 2 trial in sponsorship with the Leukemia & Lymphoma Society (LLS) for the rare lymphoma Waldenström's macroglobulinemia.
ARGX-111 is a SIMPLE Antibody(TM) targeting c-Met, a receptor involved in cancer spread (metastasis) in both solid and hematological tumors. ARGX-111 binds to a unique site on c-Met resulting in its deactivation, with the aim to prevent the spread of tumor cells. It is equipped to kill tumor cells and is enhanced to increase tissue penetration. ARGX-111 is being evaluated in a European Phase 1b clinical study across a range of hematological and solid tumors.
The Simple Antibody(TM) platform is arGEN-X' principal proprietary technology for producing novel antibody leads and has a particular strength in addressing complex disease targets that are difficult to access using established antibody technology platforms. The SIMPLE Antibody(TM) platform is based on the active immunization of llamas with human disease targets. The resulting panels of antibodies show high human sequence and structural homology in the variable regions of the 4-chain antibodies of this species, which makes this class of antibodies attractive for therapeutic applications. The potent immune system of the llama also produces large panels of different antibodies that bind to many possible epitopes on the target, giving the possibility to identify antibody candidates with differentiated characteristics, such as novel ways of modulating target activity or high binding affinities.
About arGEN-X
arGEN-X is a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases. arGEN-X has generated a pipeline of differentiated clinical and preclinical antibody candidates using its SIMPLE Antibody(TM) discovery platform. SIMPLE Antibody(TM) has a particular strength in addressing novel, complex disease targets that are difficult to access using established antibody technology platforms. Proprietary Fc engineering technologies (NHance® and ABDEG(TM)) and POTELLIGENT® technology (licensed from BioWa, inc.) further enhance the therapeutic properties of SIMPLE Antibody(TM) leads in terms of tissue penetration/residence time in the body, ability to clear disease targets or pathogenic antibodies and cell-killing potency through Antibody-Dependent Cell-mediated Cytotoxicity (ADCC), respectively. arGEN-X has leveraged its suite of antibody technologies in forging strategic collaborations with pharmaceutical and biotechnology companies to provide new approaches to diseases with unmet medical needs.
arGEN-X is listed on the Euronext Brussels exchange under the symbol ARGX.
SIMPLE Antibody(TM), NHance® and ABDEG(TM) are trademarks of arGEN-X NV
POTELLIGENT® is a trademark of BioWa Inc.
For further information, please contact:
Tim Van Hauwermeiren, Chief Executive Officer
Eric Castaldi, Chief Financial Officer
+32 (0)9 243 40 70
info@arGEN-X.com
Mark Swallow/David Dible
Citigate Dewe Rogerson
+44 207 282 2948
arGEN-X@citigatedr.co.uk
Beth DelGiacco (US IR)
Stern Investor Relations
+1 212 362 1200
beth@sternir.com
Forward-looking Statements
The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes", "estimates", "anticipates", "expects", "intends", "may", "will", or "should", and include statements arGEN-X makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. arGEN-X' actual results may differ materially from those predicted by the forward-looking statements. arGEN-X undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.