Micromet Inc.’s (MITI) pipeline received a boost when the US Food and Drug Administration (FDA) accepted the investigational new drug (IND) application for its candidate MT111 (MEDI-565). MT111 is an antibody generated with the proprietary bispecific T-cell engager (BiTE) antibody platform.
BiTE antibodies direct the body’s cytotoxic (cell-destroying) T cells against cancer cells. The platform represents a novel approach for treating cancers. The candidate is being developed to treat patients suffering from advanced gastrointestinal cancers.
MT111 is being co-developed with MedImmune, a wholly owned subsidiary of AstraZeneca (AZN), in accordance with a deal inked in 2003. Under the terms of the deal, MedImmune is responsible for the development and commercialization of the candidate in the US and outside Europe.
Micromet is responsible for the development and commercialization of the candidate inEurope. MedImmune made a milestone payment to Micromet following the submission of the IND for MT111, which demonstrated anti-tumor growth features in pre-clinical studies. Following the acceptance of the application by the FDA, MT111 is expected to move into human studies in the first half of 2011.
We note that the most promising candidate at Micromet is blinatumomab (MT103), also being co-developed with MedImmune, for the treatment of acute lymphoblastic leukemia (ALL), a type of blood cancer. The candidate is in mid-stage development. Recently, Micromet commenced the European pivotal trial of the candidate in adult ALL patients.
Our Take & Recommendation
We are encouraged to see Micromet’s progress with its pipeline candidates. However, although we believe Micromet’s association with large pharma players will help the company pave its way through the development phase, the early stage status of its pipeline concerns us. Moreover, the heavy dependence on blinatumomab is also a concern – any hiccup in its clinical development programs will weigh heavily on the stock.
Currently, we have a Neutral recommendation on Micromet. The long-term stance emanates from our belief that the risk/reward profile at Micromet is balanced at current levels.