immatics granted orphan drug status for therapeutic cancer vaccine IMA901
- Category: Vaccines
- Published on Thursday, 15 March 2007 02:00
- Hits: 2882
Tuebingen, Germany | Mar 14, 2007 | With the consent of the EU Commission, Tuebingen-based biotech company immatics has been granted orphan drug status from the European Medicines Agency (EMEA) for its product candidate IMA901 for the treatment of renal cell cancer. This gives immatics the exclusive rights to market and sell IMA901 in Europe for ten years following its market approval. In addition, classification as an orphan drug also makes it eligible for a centralized approval procedure, thus affording faster approvals in all EU member countries.
“The orphan medicinal product designation for IMA901 will give us another momentum to successfully develop our most promising renal cell cancer vaccine,” notes immatics Chief Medical Officer Dr. Juergen Frisch. According to his assessment, the company had already been able to give its vaccine candidate greater exposure by filing the application with this European authority, and gained additional expertise in questions relating to drug approvals. This gives immatics important advantages in evolving IMA901 into a therapeutic drug and its successful market launch.
Dr. Ulrich Granzer, one of the world’s most renowned experts in the field of drug development and approval and a longstanding close consultant to immatics, accompanied the company in applying for orphan drug status. “I know of only few German biotech companies that are making such fast and focused progress in developing their product candidates as immatics. Consequently, orphan drug status for IMA901 represents a further step in implementing the strategy of this Tuebingen-based company.”
IMA901 is a combination of ten 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. In late September 2006, barely three years after the launch of early preclinical development, immatics successfully concluded an international Phase 1 study on IMA901, and is now in the process of readying Phase 2 (proof of concept).