PRX-106 is a plant cell-expressed recombinant anti-TNF fusion protein being developed to potentially address autoimmune indications, including rheumatoid arthritis. The fusion protein consists of the soluble form of the human TNF receptor (TNFR) fused to the Fc component of a human antibody IgG1 domain.
PRX-106 Clinical Status:
In vitro and preclinical studies have demonstrated that PRX-106 binds TNF alpha, thereby inhibiting it from binding to cellular TNF receptors, and preventing its downstream effects, such as TNF-induced apoptosis, in a dose-dependent manner. In a proof-of-concept in vivo study using a well established preclinical arthritis model, PRX-106 significantly improved clinical arthritis parameters, including joint inflammation, swelling and tissue degradation. We intend to conduct additional animal studies to collect additional data to form a basis for a discussion with the FDA to explore the regulatory pathway for our antiTNF program. Patents for Enbrel start to expire as early as 2012, and we expect to use our cost-effective manufacturing platform to facilitate entry into this market upon approval of our pr-antiTNF product, if at all. In December 2011, we held a pre-IND meeting with respect to pr-antiTNF, and we expect to submit an IND around year-end.