Taking aim at cancer

Merck strikes deal with Cancer Research UK for investigational anti-cancer drug targeting leukemia and lymphoma

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LONDON—Cancer Research UK is taking on early trials of an experimental anti-cancer drug by Germany's Merck KgaA.

The drug, called DI-B4, will become the fourth anti-cancer drug in the charity's clinical development partnerships project, a deal allowing companies to retain the rights to a treatment while the charity carries out early tests.

The program was launched in 2006 to increase the number of potential treatments by taking molecules from drug firms and putting them into clinical trials. The work will be carried out by the charity's development and commercialization arm, Cancer Research Technology (CRT).

Under the terms of the partnership, Cancer Research UK will fund early clinical development and Merck will then have an option to take forward and commercialize the drug in exchange for future payments to the charity.

If Merck KGaA decides not to go any further with the drug, rights to the molecule will be given to CRT, which could then seek to find another commercial partner.

According to Dr. Ian Walker, licensing manager at CRT, after preclinical work on the drug has been completed, it will be taken into a Phase I trial with 20 to 40 patients with advanced B-cell lymphoma—a cancer of the white blood cell—in several British hospitals.

"In an increasingly competitive marketplace, pharmaceutical and biotechnology companies have to focus strategically on certain areas of research and hold back on others. This deal demonstrates how we can work together to progress cancer drugs," says Keith Blundy, chief executive of CRT.

Dr. Nigel Blackburn, director of Cancer Research UK's Drug Development Office (DDO), says the organization is excited to be entering this venture with Merck KGaA.

"Equipped with the knowledge they have gained from creating the antibody, we will use our brand new manufacturing facility to develop it into a potential new treatment for cancer patients," he notes.

DI-B4 is a monoclonal antibody, a highly targeted molecule that binds to a particular protein and is thought to recruit cells from the immune system to attack the tumor. Cancer Research UK says it hopes it may one day help patients with leukemia and lymphoma who do not respond to existing therapies.

According to Walker, the current standard treatment for B-cell lymphoma targets the CD20 protein.

"DI-B4 binds to the CD19 protein, found on B-cells, and is thought to recruit cells from the immune system to attack the tumor," says Walker. "It is hoped that it may help patients with leukemia and lymphoma who do not respond to existing therapies. DI-B4 does have certain differentiating characteristics which we hope will provide a benefit within the clinic."

Dr. Andrew Davies, a Cancer Research UK senior lecturer in medical oncology at the University of Southampton, will run the Phase I trial at Southampton General Hospital.

"Existing treatments which target cancerous cells and draw in the body's immune system can be extremely helpful," Davies says. "But we still need to search for alternative approaches for patients with B-cell cancers which have not responded to existing treatments. We hope that DI-B4 will have the same effects in patients as it has shown in the lab."

The DDO was established in 1982 and during this time has taken more than 100 agents into man. It currently has a portfolio of approximately 40 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials.

Following the first deal in 2008, Walker notes this is the fourth deal signed through the CDP initiative.

"One of these drugs is soon to enter a clinical trial and a further one is at late-stage of preclinical development," he says. "DI-B4 is the first monoclonal antibody to join the scheme. The Clinical Development Partnerships program was launched in 2006 to increase the number of new treatments for cancer patients by taking reprioritized agents from industry and putting them into clinical trials. The success of this program will be judged by the number and quality of agents we are able to advance through this route."

Merck expands biopharma expertise with Avecia Biologics acquisition

WHITEHOUSE STATION N.J.—In an effort to execute its strategy to expand its biopharmaceutical expertise and manufacturing capacity, Merck & Co. Inc. announced Dec. 17 its acquisition of Avecia Investments Ltd., a contract manufacturing organization with specific expertise in microbial-derived biologics. Financial details of the transaction were not disclosed.

The agreement gives Merck all Avecia's assets, including all the company's process development and scale-up, manufacturing, quality and business support operations in Billingham, United Kingdom. In addition to honoring all of Avecia Biologics' contractual commitments, Merck plans to engage in discussions with individual customers relating to their specific ongoing and future biological process development and manufacturing needs after the transaction is closed.

"This transaction follows an initial strategic development and supply relationship with Avecia Biologics and will provide us with an operational facility staffed by an experienced workforce that is highly skilled in a broad portfolio of bioprocess systems," says John T. McCubbins, senior vice president of biologics and therapeutic protein operations for Merck's manufacturing division.

"Over the past 10 years, Avecia Biologics has built and established an enviable reputation for bioprocess development and timely delivery of quality biopharmaceutical ingredients for our customers," says Steve Bagshaw, president of Avecia Biologics. "This acquisition recognizes these successes and now provides the exciting opportunity to focus on advancing Merck's broad early and mid-stage portfolio of biologic candidates."

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