Washington Editor

Compugen Ltd. is moving into the monoclonal antibody business, teaming up with Medarex Inc. in a preclinical deal to create therapeutics for cancer and autoimmune diseases.

Under the agreement, Compugen will work to identify new drug targets, against which Medarex will develop fully human antibodies. The new partners aren't discussing specifics about those targets, but terms of the joint collaboration call for them to share discovery, development and commercialization responsibilities on resulting antibody-based therapeutics down the road, and also share revenues.

"From our perspective, this is a huge move forward as we now have a partner for an actual drug, in the form of Medarex," said Alon Amit, Compugen's vice president of science, technology and commercial operations. "We're extremely excited about this opportunity."

That's understandable, given Medarex's deep roots in developing monoclonal antibodies for cancer and autoimmune diseases through a number of partnerships. And the Princeton, N.J.-based company is looking forward to testing the waters with Compugen's targets.

"You can never have enough pitching," Medarex Chairman Irwin Lerner told BioWorld Today, using a baseball analogy. "If Compugen has high-quality, validated targets that we can add our antibody expertise to, that forms the basis of our collaboration and for our hope for success."

The company, of Tel Aviv, Israel, employs a discovery process that combines mathematical modeling with experimental validation to lead to new therapeutic or diagnostic products: drugs or biomarkers. These discovery engines are based on its LEADS platform, which creates a comprehensive view of predicted genes, mRNA transcripts, splice variants and proteins, along with detailed functional annotation.

Diagnostic breakthroughs surfaced first for Compugen, Amit told BioWorld Today, since such predictive discoveries could be more quickly validated. As a result, the company already has three diagnostic deals in place, and its latest arrangement allows Compugen to independently pursue diagnostic applications involving certain antibodies and targets.

But the therapeutic angle is a new validation for the company, which Lerner praised for its "high potential."

"Having studied our capabilities in this field," Amit said, "Medarex has found it useful to enter into collaboration to develop our targets further."

At the deal's outset, the partners will select targets based on various criteria such as evidence around a particular target and disease attractiveness. There is no limit to the number that could pass muster, so multiple projects could arise from the collaboration. With one or maybe more targets in hand, Medarex will apply its UltiMAb technology to generate antibody candidates with efficacy, specificity and applicability.

Upon selecting the most promising of those, the partners will advance per terms of a 50/50 relationship. To get to that point "is a relatively short time," said Lerner, who also is Medarex's interim president and CEO. But he added that "it always takes too long" for companies operating under high senses of urgency.

"When they come through with targets," Lerner said, "we'll jump right on it and see whether we can come up with really exciting, high-potential antibody products to put into early research phases and go through the various steps on the way to development."

In addition to getting the collaboration under way, Medarex also is looking to other product development milestones this year, mostly related to its cancer drug ipilimumab. Sometime later in the year, the company expects to file a biologics license application for the product, for which it recently completed enrollment in a pivotal metastatic melanoma trial. Other studies of the drug in other cancers also are moving forward.

For Compugen, apart from the new program with Medarex, its portfolio includes therapeutic products that are proteins for cancer, autoimmune diseases and cardiovascular disorders. Amit said the company would like find partners for each of them, all of which remain in preclinical development for now.

On Tuesday, Compugen's stock (NASDAQ:CGEN) gained 20 cents to $2.64, while shares in Medarex (NASDAQ:MEDX) fell 3 cents to $13.26.