Start of Phase 1 Clinical Trial Planned for the Second Half of This Year
CARLSBAD, CA and SAN DIEGO, CA, USA | Mar 16, 2007 | Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company focused on the development of novel and proprietary antibody-based products for cancer, inflammatory and autoimmune diseases, and TRACON Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on the development of products for cancer treatment, including agents that inhibit angiogenesis, today announced an agreement granting TRACON exclusive worldwide rights to develop and commercialize Micromet’s D93 antibody with a novel mode of action for the treatment of cancer. TRACON Pharmaceuticals was founded in 2005 by Paramount BioSciences, LLC.
"TRACON’s management team, with its specific expertise in the development of antibodies and small molecules that target angiogenesis, is an excellent partner for the development of D93 and we are looking forward to the start of clinical trials planned for the second half of this year," said Christian Itin, PhD, President and Chief Executive Officer of Micromet, Inc.
D93 is a recombinant humanized IgG1 monoclonal antibody that inhibits angiogenesis, tumor cell growth and metastasis by targeting cleaved collagen, which is predominantly produced in the extracellular matrix of tumors. 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. In 2006, Micromet filed an investigational new drug (IND) application with the U.S. Food and Drug Administration for clinical testing of D93 in patients with cancer.
"D93 is a first-in-class humanized antibody that will be developed for the treatment of a variety of cancers to complement other currently available therapies," said Charles P. Theuer MD, PhD, President and Chief Executive Officer of TRACON Pharmaceuticals.
Under the terms of the agreement, TRACON will be responsible for all development and commercial activities. TRACON plans to initiate a phase 1 clinical trial in the second half of this year. Under the terms of the agreement, TRACON will pay Micromet upfront and milestone payments of more than $100 million, if D93 is successfully developed and commercialized. In addition, Micromet will receive royalties on worldwide sales of D93.
About TRACON Pharmaceuticals
TRACON Pharmaceuticals (www.traconpharma.com) is a privately held biopharmaceutical company focused on the development of products for cancer treatment, including agents that inhibit angiogenesis. TRACON addresses unmet needs in this arena with product candidates that will complement existing therapies. The company’s product candidates each target novel disease pathways. TRC105 is an antibody that binds CD105 to inhibit endothelial cell proliferation in the tumor vasculature (IND expected in mid-2007). TRC102 is a small molecule that reverses resistance to chemotherapeutics that is being evaluated in a phase 1 trial and TRC101 is a nanoliposome embedded with ceramide used to improve the activity and delivery of chemotherapeutics. By developing and commercializing novel products in underserved indications, TRACON will maximize patient benefit and enhance shareholder value.
About Paramount BioSciences
Paramount BioSciences, LLC (www.paramountbio.com) is a leading drug development and healthcare investment firm focused on the in-licensing of novel therapeutics, and the formation of new biotechnology companies.
About Micromet, Inc.
Micromet, Inc. (www.micromet-inc.com) is a biopharmaceutical company focusing on the development of novel, proprietary antibody-based products for cancer, inflammatory and autoimmune diseases. Two product candidates are currently in clinical trials. MT103 (MEDI-538), which is the first product candidate based on Micromet’s novel BiTE(R) product development platform, is being evaluated in a phase 1 clinical trial for the treatment of patients with non-Hodgkins lymphoma. The BiTE(R) product development platform is based on a unique, antibody-based format that leverages the cytotoxic potential of T cells, the most powerful ‘killer cells’ of the human immune system. Adecatumumab (MT201), a recombinant human monoclonal antibody which targets EpCAM expressing tumors, has completed two phase 2a clinical trials, one in patients with breast cancer and the other in patients with prostate cancer. In addition, a phase 1b trial evaluating the safety and tolerability of MT201 in combination with docetaxel is currently ongoing in patients with metastatic breast cancer. Micromet has established collaborations with MedImmune and Merck Serono.
Forward-Looking Statements
This release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the intended utilization of product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research, discovery of new product candidates, and clinical trials, and partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, the risks associated with regulatory processes, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for future revenues under the terms of its existing collaboration agreements, and for further pre-clinical and clinical studies, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. These factors and others are more fully discussed in Micromet’s periodic reports and other filings with the SEC, including the "Risk Factors" sections of such reports.
Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. Micromet and TRACON undertake no obligation to publicly update any forward- looking statements, whether as a result of new information, future events or otherwise.
SOURCE Micromet, Inc.
Post Views: 183
Start of Phase 1 Clinical Trial Planned for the Second Half of This Year
CARLSBAD, CA and SAN DIEGO, CA, USA | Mar 16, 2007 | Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company focused on the development of novel and proprietary antibody-based products for cancer, inflammatory and autoimmune diseases, and TRACON Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on the development of products for cancer treatment, including agents that inhibit angiogenesis, today announced an agreement granting TRACON exclusive worldwide rights to develop and commercialize Micromet’s D93 antibody with a novel mode of action for the treatment of cancer. TRACON Pharmaceuticals was founded in 2005 by Paramount BioSciences, LLC.
"TRACON’s management team, with its specific expertise in the development of antibodies and small molecules that target angiogenesis, is an excellent partner for the development of D93 and we are looking forward to the start of clinical trials planned for the second half of this year," said Christian Itin, PhD, President and Chief Executive Officer of Micromet, Inc.
D93 is a recombinant humanized IgG1 monoclonal antibody that inhibits angiogenesis, tumor cell growth and metastasis by targeting cleaved collagen, which is predominantly produced in the extracellular matrix of tumors. 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. In 2006, Micromet filed an investigational new drug (IND) application with the U.S. Food and Drug Administration for clinical testing of D93 in patients with cancer.
"D93 is a first-in-class humanized antibody that will be developed for the treatment of a variety of cancers to complement other currently available therapies," said Charles P. Theuer MD, PhD, President and Chief Executive Officer of TRACON Pharmaceuticals.
Under the terms of the agreement, TRACON will be responsible for all development and commercial activities. TRACON plans to initiate a phase 1 clinical trial in the second half of this year. Under the terms of the agreement, TRACON will pay Micromet upfront and milestone payments of more than $100 million, if D93 is successfully developed and commercialized. In addition, Micromet will receive royalties on worldwide sales of D93.
About TRACON Pharmaceuticals
TRACON Pharmaceuticals (www.traconpharma.com) is a privately held biopharmaceutical company focused on the development of products for cancer treatment, including agents that inhibit angiogenesis. TRACON addresses unmet needs in this arena with product candidates that will complement existing therapies. The company’s product candidates each target novel disease pathways. TRC105 is an antibody that binds CD105 to inhibit endothelial cell proliferation in the tumor vasculature (IND expected in mid-2007). TRC102 is a small molecule that reverses resistance to chemotherapeutics that is being evaluated in a phase 1 trial and TRC101 is a nanoliposome embedded with ceramide used to improve the activity and delivery of chemotherapeutics. By developing and commercializing novel products in underserved indications, TRACON will maximize patient benefit and enhance shareholder value.
About Paramount BioSciences
Paramount BioSciences, LLC (www.paramountbio.com) is a leading drug development and healthcare investment firm focused on the in-licensing of novel therapeutics, and the formation of new biotechnology companies.
About Micromet, Inc.
Micromet, Inc. (www.micromet-inc.com) is a biopharmaceutical company focusing on the development of novel, proprietary antibody-based products for cancer, inflammatory and autoimmune diseases. Two product candidates are currently in clinical trials. MT103 (MEDI-538), which is the first product candidate based on Micromet’s novel BiTE(R) product development platform, is being evaluated in a phase 1 clinical trial for the treatment of patients with non-Hodgkins lymphoma. The BiTE(R) product development platform is based on a unique, antibody-based format that leverages the cytotoxic potential of T cells, the most powerful ‘killer cells’ of the human immune system. Adecatumumab (MT201), a recombinant human monoclonal antibody which targets EpCAM expressing tumors, has completed two phase 2a clinical trials, one in patients with breast cancer and the other in patients with prostate cancer. In addition, a phase 1b trial evaluating the safety and tolerability of MT201 in combination with docetaxel is currently ongoing in patients with metastatic breast cancer. Micromet has established collaborations with MedImmune and Merck Serono.
Forward-Looking Statements
This release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the intended utilization of product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research, discovery of new product candidates, and clinical trials, and partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, the risks associated with regulatory processes, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for future revenues under the terms of its existing collaboration agreements, and for further pre-clinical and clinical studies, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. These factors and others are more fully discussed in Micromet’s periodic reports and other filings with the SEC, including the "Risk Factors" sections of such reports.
Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. Micromet and TRACON undertake no obligation to publicly update any forward- looking statements, whether as a result of new information, future events or otherwise.
SOURCE Micromet, Inc.
Post Views: 183
