Through a separate process, the EU Committee for Orphan Medicinal Products (COMP) concurrently also granted IMGN901 orphan medicinal product designation for the treatment of MCC.
IMGN901 is an investigational agent designed to kill cancer cells that express CD56, a protein. The TAP compound consists of a CD56-binding antibody with a potent cancer-cell killing agent, DM1, attached to it using an engineered linker. IMGN901 is wholly owned by ImmunoGen.
In a trial, six patients with metastatic MCC had received IMGN901 at the time of the AACR-NCI-EORTC meeting in November 2009.1 Among these, two patients had an objective response – including a patient who has had a sustained complete remission – and a third patient had clinically meaningful stable disease.
In US, the orphan drug designation provides ImmunoGen with seven years of market exclusivity that begins once IMGN901 receives FDA marketing approval for the treatment of MCC. It also provides certain financial incentives that can help support the development of IMGN901 for MCC.
In the EU, orphan medicinal product designation provides ImmunoGen with 10 years of market exclusivity that begins once IMGN901 receives European approval for MCC. It also enables access to certain financial incentives as well as to protocol assistance.
Daniel Junius, president and CEO of ImmunoGen, said: “IMGN901 has shown promising activity among the small number of MCC patients treated to date, suggesting this is a potential registration path for the compound.
“Metastatic MCC is a rare and highly aggressive cancer with no approved treatments today. We are preparing to be ready to initiate pivotal testing of IMGN901 in MCC in 2011 and will make the final decision based on expanded clinical experience and regulatory input. Gaining orphan drug designation for IMGN901 in the US and Europe is an important step in this process.”
ImmunoGen is a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology.