Key Developments: ImmunoCellular Therapeutics Ltd (IMUC.A)
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17 May 2013
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Latest Key Developments (Source: Significant Developments)
ImmunoCellular Therapeutics Ltd Appoints Andrew Gengos As Chief Executive Officer
ImmunoCellular Therapeutics Ltd announced that the appointment of Andrew Gengos as President and Chief Executive Officer and member of the Board of Directors. Full Article
ImmunoCellular Therapeutics Ltd Announces Proposed Public Offering Of Common Stock And Warrants
ImmunoCellular Therapeutics Ltd announced that it intends to offer shares of its common stock and warrants in an underwritten public offering. The Company also expects to grant the underwriters a 30-day option to purchase additional shares of common stock and warrants to cover over-allotments, if any. Lazard Capital Markets LLC is acting as sole book-running manager for the offering. While the offering is expected to price before 9:30 am EDT on October 18, 2012, the offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Full Article
ImmunoCellular Therapeutics Ltd Appoints John S. Yu, MD, As Interim Chief Executive Officer
ImmunoCellular Therapeutics Ltd announced that the Board of Directors has appointed John S. Yu, MD, as Interim Chief Executive Officer and President, and has accepted the resignation of Manish Singh, PhD, effective immediately, from the CEO, President, and Board positions. Dr. Yu will continue to serve as Chief Scientific Officer and Chairman of the Board. ImmunoCellular has initiated a search for a permanent chief executive officer. Full Article
ImmunoCellular Therapeutics Ltd Announces Clearance Of IND Application For Phase I Study Of Company’s Second Vaccine Product Candidate In Recurrent GBM
ImmunoCellular Therapeutics Ltd announced that the U.S. Food and Drug Administration (FDA) has given clearance to a physician sponsored investigative new drug (IND) application to initiate a Phase I clinical trial of ICT-121, IMUC’s dendritic-cell-based vaccine targeting CD-133, an antigen that is expressed by multiple solid tumors. The trial, which will be conducted at a leading Los Angeles based medical center, will initially test the vaccine in up to 20 patients with recurrent glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. With a Phase II trial of IMUC’s lead product candidate ICT-107 well under way in treating patients with newly diagnosed GBM, ICT-121 is the Company’s second dendritic-cell-based vaccine to enter the clinic. Like ICT-107, ICT-121 targets the cancer stem cells (CSCs) that are widely believed to be the root cause of many cancers. Full Article
ImmunoCellular Therapeutics Ltd Announces Positive Phase I results For Cancer Vaccine Candidate
ImmunoCellular Therapeutics Ltd announced that it will present new data from the previously completed Phase I clinical trial of ICT-107, the Company’s lead cancer vaccine candidate for the treatment of glioblastoma multiforme, at the 2012 Annual Meeting of the American Society of Clinical Oncology in Chicago, IL. The data will show that there is downregulation of both the tumor associated antigens that ICT-107 is targeting as well as CD-133, a cancer stem cell marker, in some of the patients. These observations suggest that targeting antigens expressed by CSCs is a promising strategy for treating patients with GBM. Updated data from the 16 patients in the Phase I trial shows that patients treated with ICT-107 reported overall survival of 50% after four years and 38% of the trial patients are progression free for 48-66 months, compared to historic mean OS of 12.1% after four years and 5.6 % PFS after 48 months with standard of care alone. :theflyonthewall.com Full Article
ImmunoCellular Therapeutics Ltd To Present On Cancer Stem Cell Targeting At The AACR Annual Meeting; Pre-Clinical Data Showing Safety And Immune Response Of ICT-121 In Animal Models
ImmunoCellular Therapeutics Ltd announced that it will deliver a presentation on the identification and characterization of immunogenic epitopes from CD133 and their potential for use to immunologically target cancer stem cells (CSCs) at the Annual Meeting of the American Association for Cancer Research, which will be held from March 31 to April 4, 2012 at McCormick Place in Chicago, Illinois. CD133 is a marker that identifies CSCs on many solid tumors and its expression has been correlated with shortened survival. Potential Cytotoxic T Lymphocytes epitopes were identified by computer algorithms to predict binding to HLA-A2 tissue type on white blood cells. Studies with human cells in vitro demonstrated immunogenicity of two lead peptides and in vivo studies in mice confirmed the safety and immunogenicity of these peptides as a potential vaccine to target CD133 CSCs. It plans to incorporate these peptides into its second product, ICT-121, for recurrent glioblastoma as the initial indication, followed by additional solid tumors. To evaluate the potential for autoimmunity, mouse homolog peptides of the lead epitopes that were shown to have high affinity binding to human HLA-A2 were used to immunize HLA-A2 transgenic mice. Mice were immunized 3 times at 3 week intervals and spleens were harvested and stimulated in vitro for one week with peptide pulsed antigen presentation cells. Interferon Gamma assays showed immune responses to the two lead peptides in 35% and 40% of mice. Full Article
ImmunoCellular Therapeutics Ltd Reports Manufacturing Process Data For ICT-107
ImmunoCellular Therapeutics Ltd announced that its method for manufacturing ICT-107, its lead dendritic cell (DC) based vaccine for the treatment of glioblastoma multiforme (GBM), has demonstrated meaningfully enhanced efficiency, consistency and convenience, compared to other methods for producing DC-based immunotherapies. Developed in collaboration with the Company’s partners, the manufacturing method employs a closed-bag system designed to produce highly potent DCs from white blood cells (WBCs) collected from patients, and for subsequently cryopreserving the DCs for future vaccine treatments. The process has also been optimized to produce high levels of certain cytokines that play a key role in initiating immune response. Analysis of manufacturing data indicates that this process can produce up to 30 vials of ICT-107 product and 30 vials of placebo (DCs without tumor-specific antigens) in a single production run. Despite variability in cell compositions collected from various patients, the product consistently met the purity and viability criteria reviewed by the U.S. Food and Drug Administration. The final manufacturing process is not expected to require significant changes prior to eventual commercialization. Full Article
ImmunoCellular Therapeutics Ltd Prices Underwritten Offering
ImmunoCellular Therapeutics Ltd announced the pricing of an underwritten offering of 9,489,436 units, each unit consisting of one share of its common stock and a warrant to purchase one half of a share of its common stock, at a public offering price of $1.10 per unit. ImmunoCellular expects to receive net proceeds of approximately $9.4 million, after deducting the underwriting discount and estimated offering expenses. The warrants will have a five-year term and an exercise price equal to $1.41 per share. The offering is expected to close on January 13, 2012, subject to customary closing conditions. Cowen and Company, LLC is acting as sole book-running manager for the offering. Summer Street Research Partners is serving as a co-manager. The proceeds of this offering will be used to fund the Company’s ongoing ICT-107 Phase II clinical trial and for general corporate purposes, including research and development activities for its other product candidates and any future product candidates that the Company may develop or acquire and for general and administrative costs. ICT-107, the Company’s lead product candidate, is a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma multiforme. ICT-107 is currently in a double-blind, placebo controlled, randomized Phase II clinical trial at over 21 centers in the United States. Full Article
ImmunoCellular Therapeutics Ltd Announces 55% Overall Survival At Three years From Phase I Study In Glioblastoma
ImmunoCellular Therapeutics Ltd announced updated long-term data from a Phase I clinical trial of ICT-107, the Company's lead cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), the common and aggressive form of brain cancer. Three-year overall survival is 55% compared to 16% based on historical standard of care (SOC). The data show that 38% of newly diagnosed patients who received ICT-107 continue to show no tumor recurrence after three years, compared to the historic disease-free survival rate of 6% with SOC. Out of these patients, 19% remain disease-free after more than four years. Additional data from the Phase I trial showed that the 12-month disease-free survival rate from the time of surgery was 75%with ICT-107, compared with the historical control of 26.9%, and the 24 month disease-free survival with ICT-107 was 43.8%, compared with 10.7% historically. The Phase I clinical study was conducted in 16 newly diagnosed glioblastoma patients, who received three injections of ICT-107 in addition to standard treatment with surgery, radiation and chemotherapy. The Company has previously reported a two-year survival rate of 80.2% in study patients, which compares favorably to the historic median two-year survival rate of 26.5% with SOC alone. No serious adverse events have been reported and minor side effects have been limited to fatigue, skin rash and pruritis. Full Article
ImmunoCellular Therapeutics Ltd Announces New Patent For Diagnosis And Treatment Of Ovarian Cancer And Multiple Myeloma
ImmunoCellular Therapeutics Ltd announced the issuance of a patent in France and the United Kingdom relating to the treatment and detection of multiple myeloma and ovarian cancer. Patent Number 1,204,683, entitled 'Ovarian cancer cells and myeloma cell surface glycoproteins, antibodies thereto, and uses thereof', covers aspects of the Company’s monoclonal antibody ICT-69, which targets human multiple myeloma and ovarian cancer cells. ICT-69 is already covered in the United States and this patent expands coverage of Company's issued patent portfolio to nine. Full Article
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