ImmunoCellular Therapeutics has been forced to suspend a phase 3 trial of its lead cancer vaccine, ICT-107, after failing to raise the funds it needs to complete the study.
The Los Angeles biotech says it is now looking for a commercial partner for the program—or an outright sale—as it looks into "financing and strategic alternatives for its immuno-oncology R&D pipeline and technology platform."
Things were looking precarious after the biotech's available cash reserved dwindled to just over $5 million at the end of the first quarter, given that it has been spending around that amount each quarter on R&D expenses with the bulk going to its ICT-107 program.
ImmunoCellular filed a registration document with the Securities and Exchange Commission for a $4.2 million stock offering on June 12, in the hope of raising the $3.4 million needed to bring the phase 3 ICT-107 trial to a conclusion and advance its early-stage, but the company now says that it is "unable at this time to secure sufficient additional financial resources."
Things have not always gone smoothly with the development of ICT-107, a dendritic cell-based immunotherapy in development for glioblastoma, the most common and deadly form of brain cancer. In 2013, the vaccine failed to show an impact on overall survival in a phase 2 trial, its primary outcome measure, sparking a massive sell-off in ImmunoCellular's shares.
Undeterred—and encouraged by a positive effect on progression-free survival—the biotech pressed ahead with an ambitious phase 3 trial that aimed to recruit more than 500 patients at 120 sites in the U.S., Canada and Europe.
It changed the protocol midway through to accelerate patient enrollment, but on latest estimates reckons it will take until mid-2019 to randomize the required number of patients, putting the trial on course for completion in mid-2021.
"Given our limited financing options, we are considering restructuring our business if a partner or acquirer for ICT-107 is not identified in the near term, said ImmunoCellular in its SEC filing.
The biotech has a series of candidates based on the same platform, which is designed to activate a patient's immune system to target multiple tumor-associated antigens, including CD133-targeting ICT-121 for recurrent glioblastoma and ICT-140 for ovarian cancer, which have not yet entered the clinic.
It also has an early-stage 'stem-to-T-cell' research program which focuses on engineering hematopoietic stem cells to generate cytotoxic T cells.
"While this review is in progress, we also intend to evaluate strategies to refocus and reallocate our available resources on our stem-to-T-cell research programs," it said.