TRACON Pharmaceuticals, Inc. and Micromet, Inc. announced today that TRACON has started the treatment of the first cancer patient in a Phase 1 clinical trial with TRC093
SAN DIEGO, CA, USA and BETHESEDA, MD, USA | July 11, 2007 | TRACON Pharmaceuticals, Inc. (TRACON), a biopharmaceutical company focused on the development of products for oncology and ophthalmology treatment, and Micromet, Inc., (NASDAQ: MITI), a biopharmaceutical company focused on the development of novel, proprietary antibody-based products for cancer, inflammatory and autoimmune diseases, announced today that TRACON has started the treatment of the first cancer patient in a Phase 1 clinical trial with TRC093.
TRC093 is a first-in-class humanized monoclonal antibody that inhibits angiogenesis and tumor cell growth by binding cleaved collagen, a component of the extracellular matrix of tumors that serves as the scaffold for new blood vessel and tumor growth. TRC093 has shown activity, as monotherapy or when combined with chemotherapy, in pre-clinical studies of melanoma, breast and pancreatic cancer.
TRC093 is currently being developed by TRACON in oncology and Age-Related Macular Degeneration (AMD), following execution of a license agreement with Micromet, Inc. in March 2007, granting TRACON worldwide rights to develop and commercialize D93 (now TRC093). TRC093 (D93) was generated and developed by Micromet up to the filing and acceptance of the IND.
“TRACON’s management team is cohesive and focused on execution. These qualities, combined with our excellent working relationship with Micromet and top-notch Phase 1 sites, have allowed us to initiate dosing within four months of execution of the license agreement,” said Charles Theuer, M.D., Ph.D., President and Chief Executive Officer of TRACON Pharmaceuticals, Inc. “Moving a humanized antibody into the clinic, that has the potential to treat multiple solid tumors in combination with chemotherapy and targeted agents, is a major milestone for TRACON in what will be a busy year for the company. We anticipate dosing two additional first-in-class cancer treatments later this year.”
The Phase 1 trial is designed to assess the safety, tolerability and pharmacokinetics, as well as preliminary anti-tumor activity, of TRC093 in patients with advanced cancer.
“We are very pleased to see that TRACON has initiated a broad development program very shortly after receiving the license from us in March of this year. The initiation of the Phase 1 study is an important milestone for the product and we are looking forward to the expansion of the program into age-related macular degeneration,” said Jens Hennecke, Vice President Business Development of Micromet.
About TRACON Pharmaceuticals
TRACON Pharmaceuticals (www.traconpharma.com) is a privately held biopharmaceutical company focused on the development of products for oncology and ophthalmology treatment, including agents that inhibit angiogenesis. TRACON addresses unmet needs in these areas with first-in-class product candidates that will complement existing therapies. TRC093 is a monoclonal antibody that binds to cleaved collagen to inhibit angiogenesis and tumor growth. TRC105 is a monoclonal antibody that binds CD105 to inhibit angiogenesis (IND expected in 2007). TRC102 is a small molecule that reverses resistance to chemotherapeutics that is currently being evaluated in a Phase 1 trial and TRC101 is a nanoliposome embedded with ceramide used to improve the activity and delivery of chemotherapeutics. TRACON Pharmaceuticals was founded by Paramount BioSciences, LLC.
About Paramount BioSciences
Paramount BioSciences, LLC is a global drug development and healthcare investment firm that conceives, nurtures, and supports new biotechnology and life-sciences companies. For additional information about Paramount BioSciences, visit www.paramountbio.com.
About Micromet Inc.
Micromet, Inc. is a biopharmaceutical company focusing on the development of novel, proprietary antibody-based products for cancer, inflammatory and autoimmune diseases. Three 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-Hodgkin’s lymphoma. The BiTE product development platform is based on a unique, antibody-based format that leverages the cytotoxic potential of T cells, widely recognized as 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, which has shown activity in patients with high EpCAM expression, 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, Inc. for MT103/MEDI-538 and Merck Serono for adecatumumab (MT201). Our third clinical stage product candidate is D93, also known as TRC093, a first-in-class humanized monoclonal antibody that inhibits angiogenesis and tumor cell growth by binding cleaved collagen, is being developed by TRACON Pharmaceuticals, Inc. in oncology and Age-Related Macular Degeneration (AMD) pursuant to a license agreement under which we have granted TRACON worldwide rights to develop and commercialize D93/TRC093. In addition, Micromet has established a collaboration with Nycomed for the development and commercialization of MT203, Micromet’s human antibody neutralizing the activity of GM-CSF, which may be important in the treatment of inflammatory diseases, such as rheumatoid arthritis.
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 observation of activity of D93/TRC093 in preclinical studies, and the company’s and TRACON Pharmaceutical Inc.’s current and planned clinical development activities. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that product candidates that appeared promising in early research, preclinical studies or clinical trials do not demonstrate safety and/or efficacy in subsequent clinical trials, the risk that encouraging results from early research, preclinical studies or clinical trials may not be confirmed upon further analysis of the detailed results of such research, preclinical study or clinical trial, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, the risk that we or our collaboration partners will not obtain approval to market our product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaboration partners, including MedImmune, Merck Serono and Nycomed, for the funding or conduct of further development and commercialization activities relating to our product candidates. You are urged to consider statements that include the words "ongoing", "may", "will", "would", "could", "should", "believes", "estimates", "projects", "potential", "expects", “suggests”, "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 our periodic reports and other filings with the SEC. 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, Inc. undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE: TRACON Pharmaceuticals
