arGEN-X initiates a second pre-clinical development program in under 18 months from start of operations

• ARGX-110 TO TARGET AUTOIMMUNE, INFLAMMATION AND ONCOLOGY INDICATIONS

Rotterdam, the Netherlands and Ghent, Belgium– arGEN-X, a biopharmaceutical company focused on the discovery and development of human monoclonal antibodies from its proprietary SIMPLE Antibody™ platform, announces that it has progressed ARGX-110, its second therapeutic candidate, into formal pre-clinical development in less than 18 months since the Company began its operations.

ARGX-110 is a completely novel, fully human antibody specific for an undisclosed, clinically validated cell surface receptor. The antibody has been shown in a series of pre-clinical models to modulate the function of this target with unrivalled potency. The qualities of ARGX-110 are a strong indicator of its potential in improving the treatment of autoimmune disorders, inflammation and cancer.

ARGX-110 has been selected from over 30 unique, potent, receptor-specific candidates generated from the SIMPLE Antibody™ platform. The ability of every antibody in the original panel to block the receptor highlights an unprecedented degree of intrinsic functionality in these antibodies. Further, every antibody has a different sequence composition, increasing the likelihood of covering every epitope on the target, including previously undiscovered functional epitopes. With such an unprecedented diversity of potent candidates available, arGEN-X intends to progress at least one back-up development candidate for the ARGX-110 program.

ARGX-110 has other important characteristics as a development candidate. Its sequence composition is 99% homologous to human and therefore requires no additional engineering for development as a therapeutic antibody. Further, expression studies indicate that ARGX-110 can be manufactured at consistently high quality and yield.

arGEN-X anticipates filing an IND application for ARGX-110 in 2013.

ARGX-110 is one of five therapeutic programs under development at arGEN-X for the treatment of autoimmune disorders, inflammation and oncology, with two now in formal pre-clinical development. arGEN-X’ most advanced pre-clinical program is ARGX-109, a fully human antibody with unprecedented potency in neutralization of IL-6, an important pro-inflammatory cytokine in autoimmunity, inflammation and cancer.

Commenting on today’s announcement, Tim Van Hauwermeiren, CEO of arGEN-X, said:
We are extremely pleased at the speed with which we have advanced both ARGX-109 and ARGX-110 into pre-clinical development. Our high success rate is due to our unique SIMPLE Antibody™ platform, which consistently generates diverse antibodies with exceptional potency and development potential. The rapid progress in applying our expertise to this transformational technology give us great confidence in meeting the development challenges of the next generation of therapeutic antibodies. Furthermore, the inherent strengths of our approach stand to benefit both our ongoing partnership with Lilly, as well as future programs we undertake in partnership.

arGEN-X’ SIMPLE Antibody™ Platform is based on the active immunization of outbred Camelids to deliver antibodies whose variable regions are virtually identical to those of human antibodies. These variable domains are recombined with human antibody constant domains to generate full size, fully human therapeutic antibodies.

SIMPLE Antibodies exhibit gold-standard potency and manufacturability without the need for additional engineering, making them ideal candidates for development as therapeutic antibodies.