ImmunoCellular Therapeutics (NYSE MKT: IMUC) has seen its shares rise nearly 14% in the last week since announcing the U.S. FDA has allowed the investigational new drug application of ICT-140 - its therapeutic ovarian cancer vaccine.
The news, which came at the end of January, paves the way for conducting a clinical trial.
ICT-140 is a dendritic cell vaccine that targets seven antigens over-expressed in ovarian cancer, as well as cancer stem cells.
ImmunoCellular filed the investigational new drug application with the FDA in the fourth quarter of last year, as planned.
“We continue to make significant progress in advancing our development pipeline of novel cancer immunotherapies, and anticipate that in the second half of this year, we will have three active clinical programs ongoing,” said CEO Andrew Gengos, in the recent statement.
The company's dendritic cell-based vaccine technology 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. Cancer stem cells are thought to be the originators of common tumor cells, and lead to cancer’s re-growth after chemotherapy.
The company already has a phase2b trial ongoing for ICT-107 - its main dendritic cell vaccine candidate targeting glioblastoma, an aggressive type of brain tumour, and cancer stem cells.
It also anticipates the start of an investigator-sponsored phase 1 trial of ICT-121 - its dendritic cell vaccine against recurrent glioblastoma, this year.
The clinical trial of ICT-140, which the company hopes to start in the second half of this year, will be a phase IIa open-label safety study, and is anticipated to enroll around 20 patients with ovarian cancer across 3-4 clinical sites in the US.
“Ovarian cancer remains an unmet medical need, and we believe that our approach of targeting both specific ovarian cancer antigens and cancer stem cells may offer a meaningful therapeutic benefit to patients with this disease," said Gengos.
Shares in ImmunoCellular are up almost 6% today to $2.30 and have gone up around 14% since January 30, a day after it announced its ICT-140 news.
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