Monday, April 28, 2008

CytImmune teams with UMBI on nanotech product

Rockville biotech to produce cancer treatment at new 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: 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 new 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 has recently approached clinical trials, it has hired a full-time general counsel, a vice president for business development and 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 multi-phase agreement for process development and manufacturing, UMBI’s first 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 service companies with small projects and gain a foothold in the industry. He said CytImmune will retain its current intellectual property in the partnership. However, as UMBI adds development processes, there may be joint patenting possibilities. Kuebbing said UMBI has recently hired six new GMP professionals from industry.

Kuebbing said the signing was for a master services contract for all the legal requirements. The university plans to bill CytImmune for the time and services of each specific process in the GMP facility.