ImmunoCellular Therapeutics (OTCBB:IMUC) called 2011 "its strongest year yet" in a letter to shareholders released on Tuesday, as it initiated its phase two study of its lead product candidate, ICT-107, and announced one of the largest financings in the company’s history.
The positive reinforcement led to a 18.18 percent spike in the company's stock, to $1.95 per share, on the OTC Bulletin Board as of 3:47 pm EDT.
In February 2011, ImmunoCellular completed a private placement financing, raising $8.1 million, and welcoming many large life science investors to its shareholder base.
Additionally, it raised another $10.4 million in January 2012 through a public offering underwritten by Cowen & Co, with Summer Street Research Partners acting as co-manager. The company said is now well financed to continue its planned operations through the end of 2013.
Following the completion of these financings, ImmunoCellular has over $16 million in cash reserves to fund its operations, which should be sufficient for the next 24 months, the company said.
While pipeline advancement has increased its research and development expenses, the company said it continues to be conservative in its cash burn rate by maintaining a lean infrastructure, staying focused on product development while outsourcing basic research to leading specialty service providers.
In January 2011, ImmunoCellular announced the FDA’s acceptance of its investigational new drug (NDA) application, leading it to commence a phase two study of ICT-107, the company's lead cell-based vaccine candidate for the treatment of glioblastoma multiforme (GBM), a particularly aggressive form of brain tumour.
To date, ImmunoCellular has initiated the trial in 23 centres. There are currently more than 115 patients enrolled in the study. The company expects to enroll a total of 160 to 200 patients by the second quarter of 2012, in order to enroll 102 subjects in the various immunological subtypes.
Progression-free and overall survival times for GBM patients treated with ICT-107 during the company's phase one trial of the drug continue to be substantially longer than those associated with standard of care (SOC) alone, ImmunoCellular said.
In September 2011, ImmunoCellular reported its three-year data, which indicated an overall survival of 55 percent, compared to 16 percent based on historical SOC.
Of the 16 newly diagnosed patients who received ICT-107, 38 percent continue to show no tumor recurrence after three years, compared to the historic disease-free survival rate of 6 percent with SOC.
Out of these patients, 19 percent remain disease-free after more than four years.
Meanwhile, in October 2011, the company retained the services of Progenitor Cell Therapy (PCT), a cell therapy services and development company and a wholly-owned subsidiary of NeoStem (AMEX:NBS), to serve as the second manufacturing site to produce ICT-107.
As part of this agreement, PCT will transfer and qualify the manufacturing process for ICT-107 at its West Coast facility in Mountain View, California, for use in ImmunoCellular's phase two study, and provide subsequent manufacturing to support future trials and development efforts.
In collaboration with BioWa, ImmunoCellular announced the launch of Caerus Discovery, LLC, a new, privately-owned biotech company based on the Prince William campus of George Mason University.
In this joint venture, BioWa will fund drug-target discovery and antibody development activities using ImmunoCellular's proprietary monoclonal antibody technologies.
Lastly, in 2011, ImmunoCellular received two new patents and was granted allowance on one of the key patents on ICT-107. These patents expand the company’s issued patent portfolio to nine, with more than 18 additional patents pending.
One of the new patents relates to the use of the therapeutic antibody candidate ICT-69 in the treatment and detection of multiple myeloma and ovarian cancer, while one of the others cover the use of dendritic cells for the treatment of brain cancers, when used in combination with chemotherapy.
With encouraging data from its phase one study of ICT-107 in GBM, solid progress in phase two enrollment, a broad intellectual property estate, and a new strategic collaboration related to its antibody therapeutics program, ImmunoCellular said a busy 2012 awaits.