Serono and Genmab sign mab agreement

A worldwide agreement to develop and commercialise a fully human monoclonal antibody that could have therapeutic potential in the treatment of T-cell mediated diseases has been agreed between Serono and Genmab.

Genmab has agreed to grant Serono exclusive worldwide rights to develop and market Genmab's HuMax-TAC, a human antibody targeting the TAC antigen also known as CD25, or the interleukin-2 receptor alpha subunit (IL-2Ra) - which is overexpressed by activated T-cells.

Under the terms of the agreement, Genmab will receive an upfront payment of $2 million (€1.6 million) and is entitled to potential milestone payments of up to $38 million (€30 million) and royalties on sales from any eventual commercialisation of the product. Serono will be responsible for all future development costs for HuMax-TAC.

By inhibiting the proliferation of T-cells, HuMax-TAC may have uses in diseases such as autoimmune disorders, inflammatory and hyperproliferative skin disorders, as well as acute transplant rejection. HuMax-TAC is currently in pre-clinical development

Transplantation is now a relatively standard procedure for patients with diseases such as serious kidney, liver or heart disease. Rejection of transplanted organs can be limited by the use of treatments, which inhibit the proliferation of T-lymphocytes.

Unfortunately, many of the present treatment regimens involve drugs that have serious side effects. There is thus a growing need for effective biologics that are tolerated well by the patients.

The collaboration is the result of just over three years of research into the Interleukin-2 receptor and is one of a number of pipeline products that Genmab had identified as a potential antibody for early out-licensing.

This latest collaboration also adds to the number of agreements Genmab have built up regarding its human antibody development programs. In May 2001, the company entered into a collaboration with Roche to develop human antibodies for disease targets identified by the Swiss pharma giants.

In May 1999, Genmab obtained exclusive worldwide rights to Amgen's patent estate relating to antibodies to IL-15, a promising target in the area of inflammation, and the IL-15 receptor, which is found on a number of tumour types. In October 2001, this sub-licensing arrangement was replaced by a direct license from Amgen.

"We are committed to the development of novel therapeutics to fulfill significant unmet medical needs," said Timothy Wells, head of research at Serono. "We believe that HuMax-TAC brings a new dimension to the treatment of many of the key diseases where Serono has a scientific and medical interest."