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ImmunoCellular Therapeutics Announces Data from ICT-121 Phase 1 Trial in Recurrent Glioblastoma at ASCO 2017

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ICT-121 Survival Data Encouraging

LOS ANGELES, June 5, 2017 /PRNewswire/ -- ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today announced the presentation of data from the phase 1 clinical trial of ICT-121 in patients with recurrent glioblastoma. The data from the 20-patient, open-label, multi-center study show that 6 of 20 patients are alive (as of April 2017; survival ranging from 10 to 24 months), and these patients will continue to be followed. As noted in the data presentation, ICT-121 was generally safe and well tolerated. As also noted, although diversity in patient disease severity resulting from a protocol amendment to expand patient eligibility makes interpretation of survival data difficult, the results are encouraging and warrant further investigation. Pending immune response data will provide insight into the potential effectiveness of ICT-121 in inducing the formation of cytotoxic T cells targeting CD133, a cancer stem cell marker. ICT-121 is a dendritic cell-based immunotherapy that specifically targets CD133 which is overexpressed in a wide variety of solid tumors, including glioblastoma as well as non-small cell lung, colon, ovarian, pancreatic and breast cancers.

ImmunoCellular Therapeutics Logo. (PRNewsFoto/ImmunoCellular Therapeutics) (PRNewsFoto/IMMUNOCELLULAR THERAPEUTICS)

The phase 1 data were presented by Jeremy D. Rudnick, MD, a neurologist in the Johnnie L. Cochran, Jr. Brain Tumor Center in the Department of Neurology at Cedars-Sinai, in a poster titled, "Immunological targeting of CD133 in recurrent glioblastoma: A multi-center Phase I translational and clinical study of autologous CD133 dendritic cell immunotherapy." The data were presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago.

"The preliminary findings from this phase 1 trial are encouraging, especially in light of the lethality of recurrent glioblastoma and lack of therapeutic options for patients with this disease," said Dr. Rudnick. "We look forward to continuing to follow the patients in this study, and believe that ICT-121 is a potentially promising cancer immunotherapeutic agent."

The phase 1 multi-center trial of ICT-121 targeting CD133 assesses safety and tolerability (primary endpoint) and monitors overall survival and progression-free survival (secondary endpoints).  ICT-121 is comprised of autologous dendritic cells that are loaded with two HLA-A2 restricted epitopes of the CD133 antigen. After surgical resection, the HLA-A2-positive patients with recurrent glioblastoma were treated with ICT-121 once a week for 4 weeks during the induction phase and then once every 2 months during the maintenance phase until disease progression, death, ICT-121 depletion or discontinuation. In addition to safety and survival data, the phase 1 trial also assesses immune response by using an ELISpot assay and examining cytokine mRNA expression in response ICT-121 treatment.

"We are encouraged by the preliminary phase 1 results of ICT-121, which we believe underscore the potential of our DC-based approach to cancer immunotherapy," said Anthony J. Gringeri, PhD, ImmunoCellular President and Chief Executive Officer. "We are grateful for the time and effort of the patients, investigators, and staff who supported this clinical study."

About Recurrent Glioblastoma and CD-133

A defining characteristic of glioblastoma is the high incidence of tumor recurrence, which is thought to be triggered by cancer stem cells.  These tumorigenic cells tend to be resistant to irradiation and chemotherapeutic agents. The target antigen, CD-133, is overexpressed in glioblastoma tumors and has been identified as a marker for cancer stem cells.  Recent clinical trials suggest that the short survival time for these patients emphasizes the important unmet medical need in this disease requiring additional strategic approaches. Dendritic cell immunotherapies, such as ICT-121, could provide benefit to patients by educating their immune systems to induce the formation of cytotoxic T cells that attack tumor cells bearing the target antigen. In addition to immediate attack on tumor cells present at dosing, a long-term memory response effective against tumor recurrence might be induced. Immunotherapy, such as ICT-121, that targets cancer stem cells could be an important treatment for this disease.

About ImmunoCellular Therapeutics, Ltd.

ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The Company's lead product candidate, ICT-107, is a patient-specific, dendritic cell-based immunotherapy targeting glioblastoma and is currently being studied in an international phase 3 trial. ImmunoCellular's pipeline also includes: ICT-121, a patient-specific, dendritic cell-based immunotherapy targeting CD133 found in recurrent glioblastoma; ICT-140, a patient-specific, dendritic cell-based immunotherapy targeting ovarian cancer; and the Stem-to-T-cell research program which engineers hematopoietic stem cells to generate cytotoxic T cells. To learn more about ImmunoCellular Therapeutics, please visit www.imuc.com.

Forward-Looking Statements for ImmunoCellular Therapeutics
This press release contains certain forward-looking statements, including statements regarding ImmunoCellular's intentions and current expectations concerning, among other things, whether ImmunoCellular will be able to enter into an agreement with a strategic partner or be able to continue its Phase 3 clinical trial of ICT-107, and if it continues development of ICT-107, the timing for enrollment and randomization of patients, the activation of clinical sites, the receipt and announcement of clinical data; the development and commercialization of ICT-107; the likelihood, timing and outcome of ImmunoCellular's evaluation of strategic alternatives, including a partnership or restructuring; ImmunoCellular's ability to defend, and the potential outcome of, the purported securities class action lawsuit; the potential for further development of ICT-121; the availability of financing; and ImmunoCellular's ability to achieve its other clinical, operational, strategic and financial goals. Forward-looking statements are not guarantees of future performance and are subject to a number of risks and uncertainties, including the availability of resources to continue to develop ImmunoCellular's product candidates, the uncertain timing of completion and success of clinical trials, and the risk that ICT-107 can be further successfully developed or commercialized. Additional risks and uncertainties are described under the heading "Risk Factors" in ImmunoCellular's most recently filed quarterly report on Form 10-K for the period ended December 31, 2016. Except as required by law, ImmunoCellular undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

ImmunoCellular Therapeutics, Ltd.
Investor Relations
Jane Green
415.652.4819
jane@jmgcomm.com

 

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SOURCE ImmunoCellular Therapeutics, Ltd.

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