New Antibody Platform

[RandyW]

New Antibody Platform Leads Genmab Stock To New High

By Nuala Moran

BioWorld International Correspondent

LONDON - Shares in Genmab A/S reached a record high of DKK267 (US$45) after the Danish antibody company unveiled a stripped-down antibody construct, Unibody, and outlined progress in the development of the clinical portfolio at an R&D update meeting held here last week.

With the latest increase, Genmab's share price has gained 111 percent over the past year, pushing the market capitalization to €1.4 billion (US$1.8 billion) and promoting the company to the top league of European biotechs.

Unibody consists of an IgG4 antibody that's had its hinge joint removed. That produces a stable molecule that is small enough to reach targets that previously were inaccessible.

Jan van de Winkel, Genmab's chief scientific officer, said, "It does not activate the immune system, so it may be useful to treat autoimmune disease where the goal is to regulate and preserve the target cells. It also may be effective against certain cancer targets, where it is not expected to cause unwanted cell growth."

CEO Lisa Drakeman said that by overcoming the key problem of the shorter half-life that smaller formats have had to date, Unibody will expand the market for targeted therapy. "It can get to targets that antibodies can't," she said.

In addition, Unibodies can be linked to therapeutic payloads, and the small size means there is a better tissue distribution, for example, in solid tumors.

Drakeman also announced expansion of Copenhagen, Denmark-based Genmab's clinical development program for HuMax-CD20, the lead product, which is being groomed as a competitor for Genentech Inc.'s Rituxan.

A Phase III trial in rheumatoid arthritis will start in 2007, pending the results of an ongoing Phase II study. HuMax-CD20 will be further expanded into a first-line Phase II study in combination with chemotherapy in the treatment of follicular non-Hodgkin's lymphoma, and a first-line Phase II combination study treating chronic lymphocytic leukemia.

The first approval for HuMax-CD20 is expected to be in follicular lymphoma in treating patients who are refractory to Rituxan, an indication for which Genmab believes the drug will be eligible for expedited approval.

Similarly, the company is planning two first-line studies to expand the HuMax-EGFr program, with Phase II trials in combination with chemotherapy in lung cancer and head and neck cancer. New preclinical data for HuMax-EGFr indicated the antibody is more effective against variants of the EGF receptor than other EGFr-directed treatments.

Genmab also expects an expansion to the program for HuMax-CD4, which is partnered with Serono SA, the Swiss firm being acquired by Merck KGaA. The antibody is in Phase III trials in cutaneous T-cell lymphoma, while a Phase II study in non-cutaneous T-cell lymphoma in combination with chemotherapy was expected to start soon.

Drakeman said she would not be dismayed if Merck decided to hand back the antibody once it takes control of Serono. "We would be happy to get the Serono molecule back, because of all that has been spent on development."

For now, Genmab's business development activities are focusing on establishing a partnership for HuMax-CD20. Drakeman said that having invested $100 million on development to date, she would expect to receive a large up-front payment in any deal. "We've got plenty of offers for this antibody," she said.

Published October 25, 2006