Roche’s US subsidiary Genentech has acquired an exclusive option to commercialise Novimmune's TLR4 antibody NI-0101, the very first personalised approach to treat rheumatoid arthritis. The compound has already proved safety and drugability in a Phase I dose escalation trail.
Under the terms of the agreement, Genentech receives an exclusive option to license, develop and commercialise NI-0101 for the treatment of rheumatoid arthritis (RA) and other autoimmune diseases, provided Novimmune’s immune-dampening anti-TLR4 (Toll-like receptor 4) antibody succeeds in early proof-of-concept Phase IIa studies. In Phase I studies, including 80 healthy volunteers the antibody, which blocks downstream IL-6 and TNF signalling, showed favourable safety, pharmakokinetics and pharmacodynamics.
If Genentech exercises the option of licensing the antibody, the pharma company will take over responsibility for further clinical development and commercialisation and pay Novimmune a milestone fee. In addition, Novimmune would be eligible to receive milestone payments upon achievement of certain predetermined clinical, regulatory and commercial milestones, as well as royalties on worldwide net sales resulting from the license agreement. Details about the upfront payment, milestones and royalties were not disclosed.
Why is the programme so interesting for Genentech? Excessive TLR4 signaling provokes various acute inflammatory conditions and has been implicated in a wide range of chronic inflammatory diseases including, arthritis, atherosclerosis, asthma, lupus, osteoporosis, transplant rejection, or contact dermatitis. Novimmune's NI-0101 potently suppresses inflammatory reactions by blocking TLR4 signaling. The Swiss company has also developed an assay to select patients based on their blood levels of anti-citrullinated protein antibodies (ACPA), which are thought to be key triggers for TLR activation in RA. Thus, the combination of assay and antibody could become the very first personalised RA therapy that identifies potential responders prior to treatment.
The companies have been partners before. A first agreement between the two companies was inked in July 2010, Novimmune and Genentech entered into an exclusive licensing agreement to discover and develop antibodies that target the IL-17 signaling pathway for the treatment of autoimmune diseases. “We are excited to have now signed a second agreement with Genentech to develop a medicine for rheumatoid arthritis, where there is significant unmet need and the potential to become the first personalised medicine in rheumatoid arthritis” said Novimmune Chairman and Chief Executive Officer, Eduard Holdener.
