Friday, May 2, 2008

CytImmune, UMBI team to produce nano-drug

Rockville biotech to make cancer treatment at University of Maryland’s biomanufacturing facility

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CytImmune Sciences, which is developing a nanotech treatment for cancer, will become the first industry ‘‘customer” to use the biomanufacturing facility at the University of Maryland Biotechnology Institute.

The Rockville facility was built in 2006 specifically to help small companies meet federal quality standards for their products.

CytImmune, with 16 employees, will partner with UMBI’s ‘‘good manufacturing practices” facility to help develop AuriTol, which uses nanotechnology to target cancer, said Lawrence Tamarkin, CEO of the Rockville company.

AuriTol is the second drug that CytImmune is developing. The first, Aurimune, will soon enter phase 2 human clinical trials.

Nanotechnology involves synthesis of materials on a scale of a nanometer, or one-billionth of a meter. A sheet of paper is about 100,000 nanometers thick.

CytImmune has a patented technology of attaching nano-particles of gold to carry specific drugs through the blood stream to very specific cellular targets, such as cancer cells.

The company has tested the technology and will now move it to UMBI to produce the fully formulated nano-medicine at UMBI’s facility. UMBI plans to scale up and tweak the process to make it as efficient as possible for clinical trials.

‘‘The cost of such an endeavor is very significant, but it is not only the cost — it is the time,” Tamarkin said. ‘‘The reason I pushed so hard for this is that I believe that working together with scientists committed to making quality products for the new therapeutic testing will add more intellectual horsepower to us as a small company.”

As CytImmune nears clinical trials, the company has hired a full-time general counsel and a vice president for business development and created a clinical advisory board with three members experienced in nanotechnology, Tamarkin said.

Many large drugmakers have their own good manufacturing practices facilities, but they are not common at universities, said UMBI’s president, Jennie Hunter-Cevera.

On Monday, Hunter-Cevera and Tamarkin signed a multiphase agreement for process development and manufacturing — UMBI’s first agreement related to nano-drugs — in a ceremony at the university’s 140,000-square-foot Center for Advanced Research in Biotechnology in Rockville.

According UMBI’s Daniel Kuebbing, director of the GMP training and biomanufacturing program, the facility is not intended to make money for the university, but to help companies with small projects gain a foothold in the industry. Kuebbing said he has given cost estimates to two other companies that are applying for federal grants to cover the cost of working with UMBI.

UMBI has recently hired six new GMP professionals from industry.

CytImmune will retain its current intellectual property in the partnership with UMBI, Kuebbing said.

‘‘If the company brings the basic invention to us it belongs to them,” he said. ‘‘If we then have some intellectual property like a method for manufacturing a product, and would license it to the company, there may be some co-owning of technology in processing possible.”

‘‘It will be the rare company that comes to us and says just make our product. Typically small companies will have done some work on their process but there may be some fine tuning,” Kuebbing said.

The university plans to bill CytImmune for the time and services of each specific process.

CytImmune made its first nanomedicine, Aurimune, at Ben Venue Laboratories Inc. in Bedford, Ohio, partly because that company is owned by one of CytImmune’s suppliers, Tamarkin said.

‘‘It made sense to work with them,” he said. ‘‘But what we learned was that tech transfer and developmental work was very hard for such a classic GMP manufacturer. They did not have the have scientific expertise. They followed a recipe in effect to develop drugs.”

Tamarkin said CytImmune officials determined that the company’s transitional work is best done when it can assist in close proximity at the UMBI facility in Rockville.