At the Annual Research & Development day on February 10, biotechnology company Micromet Inc. (MITI) will outline near-term development plans for its lead product candidate for lymphoma and leukemia, Blinatumomab, also known as MT103.
Blinatumomab is an investigational antibody that was developed using the company's proprietary BiTE antibody technology. The BiTE antibodies work by directing the patients' own cell-destroying, T cells against tumor cells. The company also has conventional antibody products in its pipeline.
According to Micromet, its BiTE technology can overcome significant limitations of conventional monoclonal antibodies. In pre-clinical studies, the company's BiTE antibodies have demonstrated strong anti-tumor activity against tumors resistant to colon cancer drugs Erbitux or Vectibix.
Micromet's lead product Blinatumomab is evaluated in a phase II clinical trial for the treatment of acute lymphoblastic leukemia and in a phase I clinical trial for the treatment of non-Hodgkin's lymphoma. The product candidate has orphan drug designation for chronic lymphocytic leukemia and mantle cell lymphoma.
The final data from a phase II study reported late last year confirmed high response rate of Blinatumomab in patients with acute lymphoblastic leukemia. A pivotal trial in minimal residual disease or MRD- positive (detetactable cancer cells in bone marrow) adult patients with acute lymphoblastic leukemia is expected to begin mid of this year. A phase II trial in relapsed acute lymphoblastic leukemia patients is scheduled to begin in the first half of this year.
Micromet regained the rights to Blinatumomab from MedImmune, a wholly owned subsidiary of AstraZeneca plc (AZN) last November by terminating their alliance, which was entered into in 2003.
Apart from Blinatumomab, the company has four other products in clinical development and a number of BiTE antibodies in pre-clinical testing.
The clinical drug candidates include:
- MT201 in phase II trial for colorectal cancer and in phase I study in combination with anticancer agent docetaxel for metastatic breast cancer;
- MT293 and MT110 in phase I studies for solid tumors, and
- MT203 in phase I trial for inflammation with potential indications of rheumatoid arthritis, inflammatory lung diseases, multiple sclerosis and psoriasis.
MT201, MT203 and MT293 are conventional antibodies, while MT110 is a BiTE antibody.
Micromet has research and development agreements with Sanofi-Aventis (SNY), German pharma Bayer Schering, Denmark-based Nycomed A/S, TRACON Pharmaceuticals Inc. and Merck Serono International SA, a division of Germany-based Merck KGaA.
Micromet entered into partnerships with Sanofi-Aventis and Bayer Schering AG last year.
The agreement with Sanofi-Aventis was inked in October 2009 to develop new BiTE antibodies targeting solid tumors. The agreement with Bayer Schering AG to develop a preclinical BiTE antibody for cancer was entered into in January 2009.
MT201, a phase II candidate, is being developed by Micromet in partnership with Merck Serono, while MT203, a phase I candidate, is being developed in partnership with Nycomed. Micromet's research collaboration with TRACON Pharmaceuticals is focused on the development of MT293, which is in phase I stage for solid tumors.
Micromet will also provide an update on its earlier stage BiTE antibodies on February 10.
Shares of Micromet have more than tripled from their yearly low of $2.25 set last March and trade over $7.
The company's President and CEO Christian Itin is scheduled to make a presentation at the 12th Annual BIO CEO & Investor Conference to be held in New York on February 9. Stay tuned...
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