ImmunoCellular (OTC: IMUC.OB): Delivering on Key Milestones Print E-mail
Wednesday, 30 September 2009 07:16

On 9/30/09, ImmunoCellular Therapeutics (follow link for the Company’s Facebook page) (OTC: IMUC.OB) announced promising results from a pilot study evaluating the ability of the monoclonal antibody (mAb), ICT-109, to distinguish between inflammatory conditions, cancerous, and non-cancerous tissue among pancreatic and lung cancer samples in the blood.


ICT-109 was able to detect the pancreatic and lung cancer samples by binding to specific regions (glycosylated epitopes) of two common, over-expressed markers (CEA-CAM6 and CEA-CAM5) in a wide range of cancers. In addition, glycosylated CEA is over-expressed in patients with pancreatic / lung cancers and can be used to detect these cancers using a direct blood test.  


IMUC’s President / CEO, Manish Singh, PhD, stated in the PR that the results are encouraging with regard to future development of ICT-109 for the early detection of lung / pancreatic cancer, which is a key factor in positive treatment outcomes for patients. In addition, Dr. Singh provided guidance that IMUC will seek a diagnostic partner to further develop and commercialize ICT-109, including the combination with additional cancer bio-markers with the goal of creating a robust assay for early-stage cancer detection.


Dr. Singh has now delivered on two of the four short-term catalysts for the Company expected to occur by early 2010 with the previously announced Roche pact (OTC: RHHBY.PK) and the announcement today regarding the development of clinical data for small cell lung cancer detection in serum samples. Two key remaining milestones are outlined below, with the addition of a third goal based on the news today.


1.) An IND filing for a Phase I trial for the Company’s offtheshelf cancer stem cell vaccine (ICT121) is expected during 1Q10


2.) updated Phase I clinical data for ICT-107, which is possible during 4Q09 pending follow-up with statisticians for the trial and determining the appropriate venue for releasing the data based on Dr. Singh’s guidance at the Rodman Healthcare conference in early September.


3.) IMUC will seek a diagnostic partner to further develop and commercialize ICT-109, including the combination with additional cancer bio-markers with the goal of creating a robust assay for early-stage lung / pancreatic cancer detection.


IMUC’s ICT-121 is an example of active cancer immunotherapy that is being developed as an off-the-shelf antigen to stimulate the immune system to recognize a nine amino acid epitope of CD133, which is found on many different types of CSCs. IMUC has a patent on this molecule and on its use as a vaccine and expects to begin a Phase I/II clinical trial in early 2010. In addition, IMUC is developing a passive immunization approach to combating cancer through a monoclonal antibody discovery platform and recently signed a deal worth up to $32 million with Roche for ICT-69 in the diagnosis and treatment of multiple myeloma and ovarian cancer.


ICT-107 is the Company's autologous (patient-derived) therapeutic cancer vaccine (in contrast to ICT-121 as an off-the-shelf vaccine) product candidate that consists of dendritic cells (immune system cells also referred to as antigen presenting cells or APCs that present molecules to the immune system to elicit a reaction) which are obtained from the patient's blood and programmed with tumor antigens which in turn provide a target for the immune system. Patients in the Phase I trial received three intradermal injections of ICT-107 at two-week intervals. IMUC is looking to partner ICT-107 and the pending Phase I trial update could be a key factor in this development if it demonstrates improved survival data from the last update at ASCO.


Disclosure: Long IMUC.OB


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