Micromet Inc. was formed in May 2006 through the merger of US-based CancerVax Corporation and Micromet AG, a privately held biopharmaceutical company based in Munich, Germany. The company is focused on the research, development using proprietary technology and commercialization of novel antibody-based drug products for the treatment and control of cancer, inflammatory and autoimmune diseases. Micromet Inc.'s North American headquarters is located in Carlsbad, California and its European headquarters in Munich, Germany. Stock in the new company is 67.5% owned by shareholders of Micromet AG, and 32.5% owned by CancerVax shareholders. Revenues generally consist of licensing fees, milestone payments, royalties and fees for research services earned from license agreements or from research and development collaboration agreements.
Prior to the merger, CancerVax was an emerging biotechnology company focused on discovery and development of novel biological products for the treatment and control of cancer, and had been pursuing three distinct product development programs. The most advanced was the company's cell-based polyvalent vaccine Canvaxin, which had been in Phase 3 clinical trials for the treatment of melanoma. On October 3, 2005, CNVX and co-developer Serono announced a joint decision to discontinue the clinical trial of Canvaxin in patients based upon the recommendation of the independent Data and Safety Monitoring Board (DSMB), which found that the data was unlikely to provide significant evidence of an overall survival benefit for patients with melanoma versus placebo. The second drug development program was based on an anti-angiogenic technology, which was obtained via the acquisition of Cell-Matrix, Inc. in January 2002, along with several monoclonal antibody product candidates. CancerVax expanded this program through the in-licensing of several peptides from New York University (NYU). On March 1, 2006, the company filed an IND for D93, its lead anti-angiogenic, humanized, monoclonal antibody with plans to initiate a Phase 1 clinical trial with D93 in patients with solid tumors in 2H06. Preclinical data results to date indicate that D93 inhibits tumor cell growth in several in vivo tumor models, and may be effective in combination with Taxol from studies of human breast cancer models in mice. The third program is based on three human monoclonal antibodies targeting the epidermal growth factor receptor, or EGFR, which is found at abnormally high levels on the surface of many types of cancer cells. The company is currently seeking sublicensing opportunities for these three antibodies.
Prior to the merger, Micromet AG was a privately held German biopharmaceutical company focused on the research, development and commercialization of novel biological products for the treatment and control of cancer, inflammatory, and autoimmune diseases. Micromet's pre-merger product pipeline consisted of two clinical product candidates, adecatumumab, or MT201, MT103, and five preclinical product candidates, which are designated MT110, MT203, MT204, BiTE -I and BiTE -II.
MITI's product pipeline currently consists of the two clinical product candidates, adecatumumab (MT201) and MT103, and six preclinical product candidates, D93, MT110, MT203, MT204, BiTE -I and BiTE -II., not including clinical candidate SAI-EGF and preclinical product candidates SAI-TGF, SAI-EGFR, which the company plans to out-license. Adecatumumab (MT201) is currently being evaluated as a monotherapy in hormone-refractory prostate cancer (Phase 1) and metastatic breast cancer (Phase 2). In addition, adecatumumab (MT201) is being evaluated in a Phase 1 clinical trial in combination with docetaxel in patients with metastatic breast cancer. MT103, a BiTE -compound, is currently in a Phase 1 dose escalation clinical trial in patients with indolent non-Hodgkin's Lymphoma. Currently, MITI has strategic collaborations with Serono and MedImmune to develop therapeutic antibodies in cancer, and an exclusive marketing agreement with Enzon to market and license to third parties the companies' respective single-chain antibody patent estates.
Adecatumumab, or MT201, is being co-developed with Ares Trading, S.A., a wholly-owned subsidiary of Serono International, S.A., for which MITI has received a $10M up-front payment. The collaboration agreement provides for potential future clinical development milestone payments of up to an additional $138M. MITI is developing MT103 in conjunction with MedImmune under an agreement, which provides for potential future milestone payments and ultimate royalty payments based on net sale post launch.
On December 5, 2006, Micromet announced that Merck Serono and Micromet had agreed to amend their collaboration agreement under which the two companies are developing adecatumumab. The companies are planning additional exploratory and clinical activities to identify the optimal dosing regimen, as well as explore additional indications for adecatumumab and initiate a new phase 1 monotherapy study for the treatment of patients with solid tumors, which MITI plans to begin in 2007. Merck Serono will reimburse Micromet for its costs incurred in connection with the development program.
A second agreement with MedImmune for the development of new BiTE product candidates provides for potential future milestone payments and royalty payments based on future sales of the BiTE product candidates currently under development. R&D expenses reflect costs associated with clinical trials and manufacturing process, quality systems and analytical development, and are expensed as they are incurred.
On August 21, 2006, Micromet's collaboration partner MedImmune, Inc. announced the filing of an Investigational New Drug Application with the U.S Food and Drug Administration for MT103 (MEDI-538) for the treatment of patients with B-cell derived non-Hodgkins lymphoma who are not eligible for curative therapy. MT103 is a recombinant single-chain bispecific T-cell engager, or BiTE , molecule. It targets the CD19 antigen, which is uniquely expressed on B cells. MedImmune is currently working with the FDA to finalize the protocol for this clinical trial.
On March 16, 2007, MITI also announced an agreement granting privately held biopharmaceutical company TRACON Pharmaceuticals, Inc. exclusive worldwide rights to develop and commercialize MITI's D93 antibody. In 2006, MITI filed an investigational new drug (IND) application with the U.S. Food and Drug Administration for clinical testing of D93 in patients with cancer. Under the terms of the agreement, TRACON will be responsible for all subsequent development and commercial activities relating to D93. Under the terms of the agreement, TRACON will pay MITI upfront and milestone payments of approximately $100M in addition to royalties on worldwide sales, if D93 is successfully developed and commercialized. Preclinical studies indicate that D93 has the potential to treat different types of cancer as a single agent and in combination with chemotherapeutics. Because of its anti-angiogenic activity, D93 may also provide a new therapeutic approach for other diseases involving neo-vascularization such as wet age-related macular degeneration or proliferative diabetic retinopathy.
On April 23, 2007, MITI announced a milestone in its research collaboration with MedImmune, Inc. for the development of new BiTE(R) molecules targeting carcinoembryonal antigen (CEA), a validated tumor- associated antigen frequently expressed on various human carcinomas, with preclinical data indicating that CEA-BiTE molecules can prevent subcutaneous tumor growth and formation of lung metastases. Management added that achievement of the preclinical proof-of-concept milestone in the CEA-BiTE program triggered an undisclosed payment from collaborative partner MedImmune.