ImmunoCellular Therapeutics (OTCBB: IMUC) announced today that it has filed its Annual Report with the Securities and Exchange Commission for the period ended December 31, 2009 on Form 10-K.
“During 2009 the company advanced its leading product candidates ICT-107 and ICT-121 through the release of promising data”
"During 2009 the company advanced its leading product candidates ICT-107 and ICT-121 through the release of promising data," said Manish Singh, Ph.D., President and CEO. "We look forward to commencing a Phase II clinical trial for ICT-107 and to enter clinical trials for ICT-121 during the second half of the year."
Some of the fiscal 2009 and recent highlights include:
Financial:
- Unqualified Audit Opinion. ImmunoCellular Therapeutics received an unqualified opinion from its independent auditor that it has sufficient capital to fund its clinical development and other operating activities for at least the next twelve months.
- Research and license option agreement. The company entered into a research and license option agreement regarding its ICT-69 antibody with Roche Group one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics.
- Receipt of $10 million financial commitment. ImmunoCellular Therapeutics entered into a definitive agreement with Socius Life Sciences Capital Group, LLC. ("Socius"), under which Socius committed to purchase from time to time up to $10 million of non-convertible Preferred Stock from the Company.
- Signed key manufacturing and development agreement for ICT-121. The company entered into an agreement with Formatech, Inc. for the manufacture and development of its cancer stem cell vaccine product candidate, ICT-121, for an upcoming clinical trial. The agreement calls for Formatech to develop a formulation for ICT-121 that allows for long-term stability of the vaccine as well as suitability for intradermal injection.
Scientific:
- Promising clinical results from ICT-107 Phase I trials. ICT-107, IMUC's dendritic-cell based cancer vaccine product candidate for the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer, demonstrated the ability to significantly extend the overall survival as well as tumor free survival time compared to the current standard of care.
- Identification of novel peptides to broaden applicability of the company's cancer stem cell vaccine candidate, ICT-121. The identification of these peptides enables the use of IMUC's product candidate in patients with many different HLA types. The company also filed a provisional U.S. patent application related to these findings.
- Provisional patent application. The company filed a patent application related to its ICT-109 monoclonal antibody product candidate. The application relates to what the company believes is a unique glycosidic composition of an antigen found on the surface of small cell lung cancer, colon cancer and pancreatic cancer, and covers methods for detecting, diagnosing, monitoring, staging, imaging and/or treating the cancers.
- Humanization of key antibodies. The company completed humanization of its ICT-37 and ICT-109 antibodies. Humanization is designed to increase acceptance of antibodies by host immune systems. The process was done in collaboration with Antitope, a privately held, UK based biotechnology company.
- Added key personnel. Appointed Colonel George Peoples, M.D., Dr. Constantin Ioannides, and Dr. Cohava Gelber to its Scientific Advisory Board.
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