ImmunoCellular (OTC: IMUC.OB): After Roche Deal, What’s Next?

Last week, ImmunoCellular Therapeutics, Ltd. (OTC: IMUC.OB) announced a research and license option agreement for its ICT-69 monoclonal antibody (mAb) with Roche Group (SWX: ROG.VX) (OTC: RHHBY.PK).

Under the terms of the agreement, IMUC will license to Roche the rights to investigate the potential of ICT-69 in the diagnosis and treatment of multiple myeloma and ovarian cancer for an upfront payment and up to $32 million in milestone payments based on achieving pre-clinical and clinical development objectives.

While the Roche pact does not allow IMUC to disclose details of the milestone payment schedule; the upfront milestone payment can be calculated by reviewing the 3Q09 SEC 10Q filing for IMUC later this fall and monitoring subsequent filings to determine when cash payments are received for ICT-69 from Roche. The Roche deal validates IMUC’s pipeline potential and is impressive given that ICT-69 is very early in preclinical development and is about two years away from evaluation in clinical trials.

IMUC has already delivered on one of four short-term catalysts expected by early 2010 with the Roche pact. Remaining milestones include (1) the development of clinical data for small cell lung cancer detection in serum samples during 3Q09; (2) an IND filing for a Phase I trial for the Company’s off‐the‐shelf cancer stem cell vaccine (ICT‐121), which is expected during 1Q10; and (3) 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 as per Dr. Singh’s reply to my follow-up question at the Rodman conference on this subject.

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 summarized below.

Seven of the 16 newly-diagnosed patients demonstrated stable disease with median progression-free survival of 64 weeks, and three of these seven patients have progression-free survival (PFS) exceeding two years, compared to the historical median PFS time of newly-diagnosed glioblastoma of just 30 weeks. ICT-107 was well tolerated with no significant adverse events (with no grade 3/4 adverse events and only mild side effects) reported in the study. Nine of the 16 newly-diagnosed patients had progressive disease with a median PFS of 39 weeks and median survival of 56 weeks.

Surasak Phuphanich, M.D., the principal investigator of the trial and a senior author of the ASCO presentation, stated that, "With a historical median PFS time of 6.9 months in GBM, we are encouraged to see a median PFS time of 14.2 months (57.5 weeks) in this newly-diagnosed glioblastoma (16 patients) population, and furthermore, it is exciting to see the correlation between immune response and survival given that the goal of ICT-107 is to elicit a cancer-specific immune response."

Click here for a link to my personal blog site, which includes a YouTube video overview on cancer stem cell research embedded in this article.

The BioMedReports.com stock research section includes a report for IMUC published by Griffin Securities in April with a buy rating and $2.50 price target in addition to the most recent corporate presentation from the Rodman Healthcare conference last week. IMUC is also the top gainer (+237%) among 10 component companies in the Mentor Capital Cancer Immunotherapy (CI) Index, which has posted a gain of about 50% since its inception eight weeks ago. Click here to visit IMUC's page on Facebook to receive updates on the Company.

Disclosure: Long IMUC.OB. See my full disclaimer at MikeHavRx.com at the bottom of any page.

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