IMMATICS WINS ORPHAN DRUG STATUS FOR THERAPEUTIC VACCINE

Immatics has reported that the European Medicines Agency has granted orphan drug status to IMA901, the company's product candidate for the treatment of renal cell cancer.

Orphan drug designation would give immatics the exclusive rights to market and sell IMA901 in Europe for 10 years following its market approval. In addition, classification as an orphan drug makes it eligible for a faster centralized approval procedure.

IMA901, a therapeutic vaccine, is a combination of 10 different peptide antigens that can all be found in the majority of renal cell cancer patients. This means that there is a very high probability that these antigens activate the human immune system to combat the tumor, thus mobilizing the body's own self-defense mechanisms, according to the company.

In September 2006 the company successfully concluded an international Phase I study on IMA901, and is now in the process of launching a Phase II proof-of-concept trial.