MORAb-009 - A Monoclonal Antibody

Monday January 9, 2006

http://www.pharmalive.com/News/index.cfm?articleid=304378&categoryid=56

EXTON, Pa., Jan. 9, 2006 /PRNewswire/ -- Morphotek(R) Inc. announced today the submission of an investigational new drug application (IND) to the U.S. Food & Drug Administration for MORAb-009, a monoclonal antibody targeting mesothelin. Preclinical data indicate that mesothelin is highly over-expressed in tumors of patients with pancreatic adenocarcinoma and other prevalent cancers including non-small lung carcinoma, ovarian carcinoma and mesothelioma and may be associated with disease activity. Research has shown MORAb-009 to inhibit tumor growth by inhibiting mesothelin binding to extracellular substrate and also through antibody dependent cellular cytotoxicity. Morphotek obtained exclusive rights to develop and commercialize this antibody worldwide from the National Cancer Institute where the mesothelin protein and its expression association with various cancer types were discovered.

"This IND submission reflects Morphotek's commitment to the rapid and efficient development of novel therapeutic agents to treat unmet medical needs in the areas of oncology, inflammation and infectious diseases," said Martin Phillips, Senior Vice President of Clinical Development at Morphotek.

"The entry of this antibody into the clinic demonstrates our ability to successfully discover and develop antibodies for clinical benefit. The MORAb- 009 IND is the second we have submitted for an antibody product developed using our proprietary technology and we plan to advance additional antibodies over the next several quarters," said Nicholas C. Nicolaides, President and Chief Executive Officer of Morphotek.

Tuesday January 3, 3:06 pm ET

http://biz.yahoo.com/prnews/060103/phtu030.html?.v=35

EXTON, Pa., Jan. 3 /PRNewswire/ -- Morphotek® Inc. announced today that it has signed an exclusive, worldwide patent license agreement giving it the right to develop and commercialize an antibody for the diagnosis and treatment of mesothelin-expressing cancers. The license was granted by the Public Health Service (PHS) and the NCI. This agreement is a result of an ongoing research collaboration where Morphotek is applying its proprietary antibody technologies to develop and optimize antibodies to cancer-associated proteins identified by researchers at the NCI. One of these antibodies "MORAb-009" is being developed by Morphotek for the treatment of pancreatic, ovarian and lung cancers and mesothelioma.

"This agreement accelerates the evolution of Morphotek's business model from a service-based enterprise to a biopharmaceutical development company. MORAb-009 is one of six therapeutic antibodies we are currently developing. We expect to file the Investigational New Drug Application for this product in early 2006 which will contribute to our corporate goal of leveraging our antibody technologies to file two INDs per year," said Dr. Nicholas C. Nicolaides, President and Chief Executive Officer of Morphotek.

"The treatment of pancreatic cancer and other mesothelin-expressing malignancies is an unmet medical need," said Dr. Martin Phillips, Senior Vice President of Clinical Development. "We believe the mechanism of action and the target makes MORAb-009 an outstanding addition to our pipeline of antibodies for cancer, infectious and inflammatory diseases. We look forward to commencing clinical studies early in 2006."

The first therapeutic indication for investigation will be for the treatment of patients with pancreatic cancer. According to preliminary numbers presented by the American Cancer Society, 32,180 Americans were diagnosed with and 31,800 died of pancreatic cancer in 2005, making this the fourth-leading cause of cancer death overall. A significant opportunity exists for compounds that can help prolong the survival of patients with pancreatic cancer as well as compounds that offer additional clinical benefits such as a lack of side effects and those that can improve quality of life. Ovarian and lung cancers and mesothelioma will be also evaluated for safety and therapeutic efficacy during the MORAb-009 development program.