ImmunoCellular (OTC: IMUC.OB) Notches Deal for New Cancer Stem Cell Vaccine Target

Click here to visit the ProActive News Room landing page for IMUC, which includes the most recent corporate presentations, research reports, and an industry report written by Griffin Securities on cancer stem cell development that are also available at the BioMedReports.com research downloads section. In addition, the NIH has a feature from yesterday on the development of multi-drug resistance that may arise due to cancer stem cells.

According to CEO, Manish Singh, IMUC plans to develop an off-the-shelf cancer stem cell vaccine that targets the peptides included in the licensing deal today, which should enter clinical testing in 2011. The Company will conduct preclinical testing to enhance the immune response through the addition of adjuvants and determine the indication(s) that will be studied in Phase I clinical trials - with initial, preclinical data indicating activity against breast and ovarian cancers. After successful Phase I testing, IMUC would seek a development / commercialization partnership in the same manner as ICT-107, which is a personalized brain cancer stem cell vaccine that has completed Phase I testing with promising early-stage efficacy and safety data.

IMUC is also developing an off-the-shelf (i.e. does not require obtaining cells from the patient as part of the manufacturing process) peptide-based, therapeutic cancer stem cell vaccine (ICT-121) that targets a protein marker called CD133 that is over-expressed on cancer stem cells. IND filings for FDA approval to begin human clinical trials for ICT‐121 are expected for brain cancer during 1Q10 and for pancreatic cancer during 3Q10.

While Merck (NYSE: MRK) (MK-0752, Phase I/II) and Roche (OTC: RHHBY.PK) (R4733, Phase I/II) are developing early clinical stage gamma-secretase inhibitors that block Notch signaling, IMUC is targeting cancer stem cells that express aberrant Notch peptides by educating the immune system to recognize and attack these cells. In addition, OncoMed and GlaxoSmithKline (NYSE: GSK) formed a strategic alliance in late 2007 that included a cancer stem cell monoclonal antibody (MAb), OMP-21M18, that is currently in Phase I clinical development which works by blocking a Notch receptor signaling component (DLL4).

Malfunctioning of the Notch pathway is a common phenomenon on several cancers marked by an over-expression of Notch protein on cancer stem cells. The Notch pathway is a signaling mechanism that regulates stem cells and in cases of cancer it acts as an oncogene which promotes the growth of tumors. A number of cancers such as leukemia, lymphoma, breast cancer, lung cancer, and brain cancer are known to have aberrant Notch signaling leading to cells with greater migratory facilities which promotes metastasis.

Click here to follow me on twitter / mikehavrilla and check out the BioMedReports.com FDA Calendar service, which includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter resubmissions to the FDA; and (4) pending clinical trial results.

Disclosure: Long IMUC.OB