ImmunoCellular (OTC: IMUC): Roche Pact Validates Pipeline Potential Print E-mail
Wednesday, 09 September 2009 08:55

Live from New York . . . A deal in the bio-med space. On my first day at the Rodman & Renshaw Healthcare conference, a deal was announced before the market open for a company in the cancer immunotherapy space that I had previously featured at


ImmunoCellular Therapeutics, Ltd. (OTC: IMUC.OB) announced today that it has entered 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.



IMUC is an emerging cancer immunotherapy company that is developing therapeutic and diagnostic product candidates taking aim at the root cause of the disease, cancer stem cells (CSCs), based on two distinct technology platforms - active (cancer vaccines) and passive (monoclonal antibodies or mAbs). While this approach is still in the early stages of development, it has the potential to become a disruptive, paradigm-shifting therapeutic approach for the treatment of cancer. CSCs are resistant to standard treatments such as chemotherapy and radiation, but numerous bio-markers on these cells have been identified which can be used to develop targeted mAbs and CSC immunotherapy products.



Although CSCs account for a small proportion of the cells in a given tumor, a growing body of scientific literature suggests CSCs drive the process of tumor growth and recurrence (even after the disease is undetectable and thought to be eradicated). Current therapeutic options such as radiation therapy or chemo target the proliferating cells, which form the bulk of any tumor mass while the CSCs lie dormant and unaffected at the root of the disease. Thus, a non-detectable number of CSCs may persist even after a patient is in remission, leading to the potential for recurrence of the disease.



Upon completion of the evaluation period, Roche has the right to acquire for an option exercise payment a commercial license for ICT-69 from IMUC, which would result in total payments due to the Company of up to $32 million (which is approximately 2X the current market cap) in the event that all developmental milestones are met. Royalties also will be payable to IMUC based on Roche’s worldwide sales of ICT-69 products.



“We are extremely pleased to have generated the interest of such a significant player in the international healthcare market,” remarked Manish Singh, Ph.D., president and chief executive officer of IMUC. “We believe that Roche’s interest serves as a validation of our strong portfolio of antibody therapies designed to diagnose and treat cancers and may increase our ability to attract further partnership activities going forward.”



ICT-69 is one of several monoclonal antibodies currently being developed for multiple cancer indications by IMUC. It was designed using the Company’s DIAAD (Differential Immunization for Antigen and Antibody Discovery) technology with the purpose of targeting human multiple myeloma (MM) and ovarian cancer cells. Preclinical data have demonstrated the ability of ICT-69 to target antigens specific to human MM cells without binding to healthy tissues, making it a strong potential candidate for therapeutic applications associated with MM as it directly targets malignant cells without corresponding damage to healthy cells. IMUC holds four issued patents pertaining to ICT-69 and its ability to act as both a therapeutic antibody as well as a diagnostic tool for MM and ovarian cancer.



In early 2008, IMUC acquired the DIAAD technology platform from Molecular Discoveries, LLC for the rapid discovery of antigen targets to develop mAbs for the diagnosis and treatment of a wide variety of conditions with a focus on the detection and treatment of multiple myeloma, small cell lung cancer, pancreatic cancer, and ovarian cancer. The mAbs that IMUC acquired from Molecular Discoveries have been created to recognize certain bio-markers (antigens) which are highly specific to cancer cells and not expressed on normal cells to allow for the targeted treatment and detection of cancer cells.



The Company's mAb pipeline includes the following: (1) ICT-109 is a humanized mAb in development for the diagnosis of SCLC and pancreatic cancers; (2) ICT-037 is in preclinical development for therapeutic and diagnostic applications for colon cancer, ovarian cancer, and multiple myeloma; and (3) ICT-69 is in preclinical development for multiple myeloma and ovarian cancer. In addition, IMUC is developing an off-the-shelf (i.e. does not require obtaining cells from the patient as part of the manufacturing process) stem cell cancer immunotherapy product candidate (ICT-121) that is expected to begin Phase I/II clinical trials in early 2010 and is looking to partner ICT-107, which is the Company's dendritic cell-based cancer vaccine product candidate for the treatment of GBM for which promising Phase I data was presented at ASCO 2009 (the most common and aggresive type of brain cancer).



The stock research section includes a report for IMUC published by Griffin Securities in April with a buy rating and $2.50 price target (12-month) in addition to the most recent corporate presentation for the Company from mid-August. Click here to read my full overview article on IMUC at from late August, which includes a summary of the Company’s pipeline and expected catalysts before year-end into early 2010. 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.


Disclosure: Long IMUC.OB

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