Monday, 5 November 2012

ImmunoCellular Therapeutics armed with platform to “effectively eradicate” cancer

ImmunoCellular Therapeutics (AMEX:IMUC) claims it has the technology and approach to potentially eradicate cancer, starting with its ICT-107 vaccine for an aggressive form of brain cancer.
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, says 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.
“The trial is one of the fastest enrolling trials for glioblastoma in North America. This attests to the enthusiasm for the technology, and of the patients themselves,” says Dr. Yu, who was previously chief scientific officer for ImmunoCellular before taking on the role of interim CEO. 
“Despite patients potentially receiving placebo, they are still enthusiastic of the potential for the therapeutic treatment that has some promising phase 1 results.”
Indeed, the phase 1 results showed that the median survival in 16 patients with newly diagnosed glioblastoma multiforme (GBM) – the type of brain cancer – was 38.4 months.
Patients were given three injections of ICT-107, in addition to standard treatment, which includes surgery, radiation and chemotherapy. ImmunoCellular reported a two-year overall survival rate of 80.2% from phase one trial results, compared to 26.5% with standard care alone. 
After four years, 19% of patients remain disease-free. 
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. 
“It is a ubiquitous vaccine for a host of different cancers bearing cancer stem cells.”
The phase 1 trial for ICT-121, which will first target cancer stem cells in patients with recurrent brain tumors, is in the works. “We received the IND from the FDA and are hoping to open and start enrolling patients by the end of the year.” 
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. 
Going forward, Dr. Yu says the vaccine maker is also on track to file an investigational new drug (IND) application for ICT-140, a dendritic cell vaccine targeting ovarian cancer antigens, at the end of this year.
“We are a company with the capability and the platform technology to effectively eradicate cancer. The dendritic cells we use are the most potent stimulatory cells of immune response in the body.”
“Our multiple epitope approach of using several targets is also vastly different from Dendreon’s Provenge for the treatment of hormone refractory prostate cancer, as Provenge just targets one antigen.”
Dr. Yu goes on to say that though many compare Dendreon’s Provenge immunotherapy with ImmunoCellular’s, there are several key differences, including the use of “very mature and activated dendritic cells.”
“Provenge has activated monocytes, which do not have such a potent effect.”
The Provenge product can also not be stored in liquid nitrogen, and has to be given right after production intravenously, which requires more nourishment, whereas ImmunoCellular’s ICT-07 is given intradermally like a flu vaccine. 
“We have important milestones coming up, as well as a three-pronged approach for potent immunotherapy based on a solid science that was validated in the clinic and the lab.”
Indeed, the company’s lead and most advanced product – ICT-107 – is on path for a “significant inflection point” in 2013. 
“Our goal through this process and after the money raise is to become the dominant immunotherapy company in the field,” affirms Dr. Yu. 
 “By using a handful of validated and specific antigens, we are using the most potent type of strategy against cancer,” he concludes, adding that the latest capital raise has given ImmunoCellular the opportunity to establish its technology as a viable means of eradicating cancer. 
The company is also ready to add to its vaccine pipeline as it has a host of proprietary antigen profiles, which can be added on dendritic cells for different indications as a means for treating different cancer types. 
“This is just the crest of a wave of the immunotherapy tsunami that is going to hit the oncology industry as the antibody area did in the 1990s, by using the body’s own mechanisms to effectively kill off cancer.”

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