Serono signs autoimmune agreement

Serono and NovImmune have signed an exclusive agreement, under which NovImmune has granted Serono exclusive worldwide rights to develop and commercialise two of NovImmune's fully human monoclonal antibodies, NI-0401 and NI-0501, which may have therapeutic potential in a broad range of autoimmune diseases.

NI-0401 targets the CD3 antigen, a key regulator in the activation of T-cells, the proliferation of which is a hallmark of many autoimmune diseases, including insulin-dependent diabetes, Crohn's disease, multiple sclerosis and rheumatoid arthritis, and of organ transplant rejection.

NI-0501 targets interferon-gamma, a key cytokine involved in the regulation of immune and inflammatory responses. It is overexpressed in autoimmune diseases such as systemic lupus erythematosus, Crohn's disease and several forms of vasculitis.

Both are currently in preclinical development, with NI-0401 expected to enter clinical trials later this year.

Under the terms of the agreement, NovImmune is responsible for the development of the two products until the completion of Phase IIa clinical trials. After this Serono takes over further development, paying a license fee of $5m for the two products, making a CHF7.5m equity investment in NovImmune, and lending NovImmune up to CHF7.5m, convertible into shares of NovImmune on certain conditions or repayable with accrued interest at maturity. Based on the successful development and initial registration of the products, NovImmune may receive up to $105m in future milestone payments. Further milestone payments may also be made according to approval of the products for additional indications, along with undisclosed royalties based on eventual net sales.