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Biotech / Medical : MEDX ... anybody following? -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (802)	4/9/2004 4:39:20 PM
From: Icebrg	Respond to of 2240

Celldex's "pipeline". They have a very ambitious research and development program going at Celldex. Which is reflected in their ambition to sell 25 % of the company for 50 mUSD. The current market cap for MEDX stands around 750 mUSD. Erik Our initial product candidates being developed in this area are listed below: HCG-VAC Indications: Colorectal, Pancreatic, Bladder and Breast Cancers Our most advanced product candidate, HCG-VAC, is a cancer vaccine utilizing bhCG. We believe that beta human chorionic gonadotropin (bhCG) is an attractive antigen for cancer immunotherapy. Aside from pregnancy, the expression of this antigen is primarily found only in tumors, including colorectal, pancreatic, bladder and breast cancers. Patients whose tumors express bhCG generally do not fare as well as patients whose tumors do not express this protein. Furthermore, studies have shown that colorectal cancer patients who develop immune responses to bhCG have greater survival rates compared with patients who do not develop such immune responses. We believe that our preclinical studies demonstrate that this vaccine candidate can efficiently deliver its bhCG tumor antigen to DCs, which in turn may drive cell-mediated immune responses against tumor cells expressing this antigen. The purification and manufacture of HCG-VAC uses procedures already established for the production of standard fully human monoclonal antibodies. Clinical grade material has been successfully manufactured. An IND for HCG-VAC became effective in February 2004, and we expect to commence Phase I clinical trials for colorectal, pancreatic and bladder cancers by July 2004. COL-VAC Indications: Colorectal Cancer Carcinoembryonic antigen (CEA) is a protein normally produced primarily by fetal tissues. CEA is also expressed in 90% of colon cancers, 40% of breast cancers and to a lesser degree in a number of other cancers. Due to its selective expression, we believe CEA is an important tumor-associated antigen and an attractive target for our therapeutic vaccines. Preclinical studies have demonstrated that COL-VAC may induce robust immune responses against cancer cells expressing CEA. COL-VAC has been produced on a research scale, and development of the production cell line is nearing completion. Clinical grade material is expected to be available in early 2005. AFP-VAC Indications: Liver Cancer Alpha-fetoprotein (AFP) is a mucin-like glycoprotein that is normally expressed in fetal liver, but is not expressed by normal adult tissues. Serum AFP measurements are important for the diagnosis and monitoring of hepatocellular carcinoma (HCC), a form of liver cancer, testicular cancer, teratocarcinomas and defined and germinal ovarian cancers. The median survival of AFP-negative patients has been reported to be significantly longer than that of AFP-positive patients. Overexpression of AFP has been found in 50% to 70% of HCC patients. Most patients who develop HCC have an underlying form of liver disease. A strong relationship exists between HCC and chronic hepatitis B and chronic hepatitis C infections. These pre-HCC conditions serve as parameters to identify high-risk patients who are susceptible to HCC. Preclinical studies with AFP-VAC have demonstrated robust immune responses against tumor cells expressing AFP. AFP-VAC has been produced on a research scale and the development of the production cell line for AFP-VAC is nearing completion. Clinical grade material is expected to be available in early 2005. MEL-VAC Indications: Melanoma Melanoma is a malignant tumor that originates in melanocytes, the cells that produce the pigment melanin in the skin. Melanoma is the most serious type of skin cancer. There are several melanoma-specific antigens that we are considering for MEL-VAC. Pmel-17/gp100 is a cytoplasmic differentiation antigen expressed by a majority of melanomas. Technical studies with MEL-VAC using pmel-17 have demonstrated efficient induction of cytotoxic T-cells that are effective at killing human melanoma cells. PSA-VAC Indications: Prostate Cancer Prostate cancer is the most common malignant cancer in men and there are few treatment options available after the tumor becomes refractory to hormonal therapies. Prostate specific antigen (PSA) is a secretory glycoprotein that is expressed by epithelial cells of the prostate and is elevated in the serum of men with prostate cancer. PSA serum levels are used to screen for prostate cancer. The selective expression and identification of T-cell-specific epitopes in the PSA protein has suggested that PSA can serve as a target for immunotherapy of established prostate cancer. Preclinical studies with PSA-VAC have demonstrated promising preliminary results in human culture systems. Our APC Targeting Toxin Technology. Our APC targeting toxin technology is designed to treat diseases in which the immune system is the problem rather than the solution. For example, a variety of autoimmune disorders appear to be the result of a misdirected immune response against a patient's own tissues. In some of these diseases, including systemic lupus erythematosus (SLE) and atopic dermatitis, the patient's DCs and Mfs have been implicated in the disease progression. In such cases, we believe that therapies to selectively inactivate or destroy the patient's APCs will lead to effective clinical responses. Our APC targeting toxin technology is composed of a toxin component genetically fused or chemically linked to our proprietary monoclonal antibodies. After gaining entry into a cell, the toxin kills the cell through inhibiting critical cellular functions such as protein synthesis. GVHD is a disease that results from a bone marrow transplant using stem cells from a different individual. Allogeneic stem cell transplantation is a common procedure for leukemia patients and some other hematological malignancies. In GVHD, the donor's T-cells attack the recipient's body. This may damage the patient's organs and tissues, impairing their ability to function and increasing susceptibility to infection. Professional APCs in the patient are critical for GVHD. Recently, investigators at Yale University demonstrated that the disease-causing T-cell responses in GVHD are against "self" antigens initiated on professional APCs such as DCs and Mfs. Their results suggest that depleting or impairing the function of the patient's APCs prior to stem cell transplantation can reduce or eliminate GVHD without the need for prolonged T-cell-targeted immunosuppression. In collaboration with the investigators at Yale University, we are currently completing our proof-of-concept studies in mouse models and initiating development of a product for clinical development. Investigators at Yale have demonstrated that toxins combined with monoclonal antibodies can substantially eliminate the APCs from laboratory animals. In addition, treatment of mice in this manner significantly lessens GVHD induced by allogeneic transplant of T-cells. Our initial product candidate being developed in this area is discussed below: GVHD-TOX Indication: GVHD GVHD-TOX is an APC-specific monoclonal antibody coupled to a toxin that we believe could be used to substantially eliminate the APCs that mediate GVHD. Proof-of concept studies in animal models of GVHD are currently being completed. Our APC Targeting BRM Technology. BRMs are compounds that enhance or suppress the immune system. In some infectious diseases and cancers, the immune response is insufficient or inappropriate to effectively respond to the disease. Our APC targeting BRM technology attaches BRMs to our proprietary monoclonal antibodies in order to activate professional APCs or modify the immune response in a specific manner that we believe will result in a more effective therapy. There are numerous compounds that can be used as BRMs. Some examples include cytokines and Toll-like receptor (TLR) agonists. Cytokines are a unique family of growth factors that activate APCs and stimulate both the humoral and cellular immune responses. TLRs have evolved to specifically recognize and respond to different kinds of pathogens. When the TLRs are activated by an agonist (such as a bacterial protein), the APCs are activated in a specific manner to respond to the perceived infection. Through the use of cytokines, TLR agonists and other APC activating agents, we believe that it may be possible to manipulate the immune system to overcome the deficiencies that exist in various diseases. However, the cytokines and TLRs agonists may have significant side-effects when delivered in large amounts through conventional delivery methods. We believe that our APC targeting BRM technology requires a smaller amount of BRMs, resulting in more effective immune responses with less toxicity. We plan to initiate our research programs for proof-of-concept studies with our APC targeting BRM technology in the second half of 2004. [Source: Scientific overview in the filing. sec.gov ]