ImmunoCellular Therapeutics: Targeting Cancer Stem Cells

Written by Mike Havrilla

Wednesday, 01 April 2009 13:29

ImmunoCellular Therapeutics (IMUC.OB) is developing cellular immunotherapies for the treatment of brain cancer and monoclonal antibodies to diagnose and treat several different cancers. The Company is developing a stem cell cancer vaccine (ICT-121) which targets a protein marker called CD133 which is typically expressed only on cancer stem cells and not on normal cells.

Cancer stem cells ("CSC") are responsible for the prolific growth of primary and metastatic tumors and these cells must be eliminated for the complete eradication of a tumor. CSCs are resistant to standard treatments such as chemotherapy and radiation, but numerous bio-markers on these cells have been identified which could be used to target CSCs.

ETF Innovators Global Stem Cell and Regenerative Medicine Index

IMUC uses peptides (the building blocks of proteins comprised of amino acid chains) in combination with another compound called an adjuvant to elicit a targeted immune response by T cells to destroy CSCs. This T cell response targets CSCs with a specific bio-marker (CD133 positive CSCs) that have been identified in a number of cancer types such as gliomas, colon cancer, and pancreatic cancer.

The goal of the Company's cancer vaccine approach is to combine conventional treatment(s) with a vaccine to target the remaining CSCs with the goal of eliminating or significantly delaying the recurrence of tumors. Current treatment brain cancer typically involves a combination of surgery, radiation treatment, and chemotherapy. Such treatments often lead to tumor cell DNA mutations or other changes leading to treatment-resistance and/or tumor recurrence.

IMUC expects to file an IND with the FDA during 3Q09 (after conducting additional preclinical studies specified by the agency) for permission to begin a 15-20 patient Phase 1 human clinical trials of ICT-121 for glioblastoma, which is a deadly type of brain cancer. Preclinical studies indicate that ICT-121 is highly targeted for destroying glioblastoma cancer stem cells. However, ICT-121 could have therapeutic applications beyond brain cancer since CD133 is also over-expressed in colon cancer, breast cancer, liver cancer, prostate cancer, multiple myeloma, and melanoma.

In early 2008, IMUC acquired monoclonal antibody technology from Molecular Discoveries, LLC which includes (1) a platform technology referred to by Molecular Discoveries as DIAAD for the rapid discovery of antigen targets and monoclonal antibodies for the diagnosis and treatment of a wide variety of conditions and (2) certain monoclonal antibody candidates for the potential detection and treatment of multiple myeloma, small cell lung cancer, pancreatic cancer, and ovarian cancer.

Early this year, IMUC completed a strategic review of its cancer vaccine and molecular antibody development programs in order to make the best use of the Company's limited resources in light of the challenging market and economic conditions which make raising capital difficult for many small and micro-cap companies.

IMUC ended 2008 with $3.1M in cash/investments, which the Company believes is sufficient to fund operations through at least mid-2010. IMUC determined that ICT-121 has greater commercial potential as an off-the-shelf cancer stem cell vaccine versus ICT-107, which represents a patient-specific product. Thus, the Company will focus on the continued development of ICT-121 instead of ICT-107, which represents a cancer antigen vaccine which has completed Phase 1 clinical trials.

IMUC has signed an agreement with Formatech, Inc. to develop an optimal formulation for ICT-121 so it can be made available as an off-the-shelf formulation for long-term stability and patient administration via injection under the skin (intra-dermal route). Also, an abstract has been accepted by the American Society of Clinical Oncology (ASCO) for their annual meeting in May 2009, so IMUC is schedule to make a poster presentation of Phase 1 clinical data from its Phase 1 trial of ICT-107 in patients with glioblastoma.

The monoclonal antibodies 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 death of cancer cells while sparing normal cells.

The Company's monoclonal antibody pipeline includes the following: (1) ICT-109 is in preclinical development (with promising preclinical effectiveness data in mice) for treating lung, pancreatic, and colon cancers; (2) ICT-037 is in preclinical development for therapeutic and diagnostic applications for colon cancer, ovarian cancer, and multiple myeloma; (3) ICT-69 is in preclinical development for multiple myeloma and ovarian cancer; and (4) ICT-Diagnostic-SCLC is a diagnostic/prognostic agent in preclinical development for small cell lung cancer.

The President/CEO of IMCU, Manish Singh, Ph.D., is hopeful that a monoclonal antibody deal(s) can be reached with a larger bio-pharma company to provide additional funding beyond the current runway through mid-2010. IMUC also expects to file an IND with the FDA during 3Q09 for lead cancer stem cell vaccine ICT-121 to begin Phase 1 clinical studies in 15-20 patients after completing additional preclinical studies specified by the agency.

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