Monday, 12 November 2012

ImmunoCellular Therapeutics posts Q3 results, "sufficient resources" for next steps in immunotherapy

ImmunoCellular Therapeutics (NYSE MKT: IMUC) says that at the end of the quarter, it had around $10 million of cash on hand to fund the development of its clinical programs, not taking into account the near $20 million it raised in an underwritten public offering last month.
The company reported its third quarter results Monday.
“We continue to be pleased with our company’s progress, especially in advancing our development pipeline of cancer vaccines, led by ICT-107, which is anticipated to complete a Phase IIb trial at the end of 2013," said interim CEO, Dr. John S. Yu. 
ICT-107 is a dendritic cell-based vaccine that works by activating a patient's immune system against specific tumor-associated antigens. 
This is done by extracting dendritic cells from a patient, loading them with the tumour-related antigens, and re-injecting them back into the patient's body to trigger an immune response against cancer cells presenting these antigens.
Rather than simply targeting a single tumor-specific antigen, ImmunoCellular's vaccine pursues multiple different antigens found on cancer stem cells (CSCs). Cancer stem cells are thought to be the originators of common tumor cells, and lead to cancer’s re-growth after chemotherapy. 
It is believed that destroying the CSCs will allow for longer survival, without relapse.
CEO Dr. John Yu, who took over from former chief Manish Singh this past summer, recently told Proactive Investors that the phase 2 trial for the vaccine is going “exceedingly well”. The company finished enrollment of 278 patients, and randomized 123 patients at 25 clinical sites in the U.S.
Results from the phase 2, placebo-controlled and double blind trial are expected in the second half of next year. The trial will look at the safety and the efficacy of the vaccine, with the primary goal of overall survival.
The technology behind ICT-107, the company’s most advanced product, has the potential to work for a number of solid tumour cancers. 
Indeed, another vaccine ImmunoCellular is developing is ICT-121 – which is targeting CD133 – a cell surface antigen that has been expressed on a host of different cancer stem cells, from lung cancer to pancreatic cancer. 
"Our plans to initiate the Phase I trial for ICT-121 in recurrent glioblastoma and to file an investigational new drug application (IND) for ICT-140 in ovarian cancer are on track. 
"We are confident that with the additional funding we secured after the close of the third quarter, we have sufficient resources to continue to execute our business plan and prepare for next steps in our promising clinical programs," Dr. Yu said Monday. 
The company recently raised almost $20 million in a public offering, putting it on track to reach all of its near terms goals. The new funds will be used to finish the phase 2 trial of ICT-107, as well as to prepare for the phase 3 trial, and to bring the ICT-121 vaccine into clinic. 
The cash will also go toward the continued development of ImmunoCellular’s platform, and to develop its antigen targets. 
"Our company’s virtual business model is enabling us to operate in an effective and capital-efficient manner, while benefiting from the expertise of talented pharmaceutical executives and the support of our highly engaged board of directors."
For the three months that ended September 30, ImmunoCellular reported a net loss of around $638,000, or 2 cents per basic and diluted share, compared to a small profit a year earlier. 
For the nine months ending in September, it spent $9.2  million to fund its research and development activities, compared to $4.6 million for the same period in the previous year. 
“We believe that our company has the potential to advance the emerging field of cancer immunotherapy, and to change treatment paradigms for some of the most serious and lethal tumor types," said Dr. Yu. 
"Unlike earlier-generation immunotherapeutics, our next-generation approach of targeting both cancer cells and cancer stem cells has demonstrated the potential to eradicate residual disease and significantly prolong survival. 
"We look forward to the prospect of completing our planned clinical trials and potentially generating data that can transform cancer treatment and position our company as a leading immunotherapy innovator.”

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