Two months after winding down development of its lead candidate for lack of funds, ImmunoCellular Therapeutics says it will cut jobs and facilities in a restructuring designed to lower costs and refocus the company on its program to generate cancer-killing T cells by engineering hematopoietic stem cells.

The company gave no details on how many jobs will be eliminated or which facilities would be jettisoned in a statement yesterday. ImmunoCellular has seven full-time and two part-time employees, according to its Form 10-Q for the second quarter, filed August 14.

“The board and management of ImmunoCellular remain committed to pursuing a viable strategic path forward for the Company, with the goal of realizing the value of our immuno-oncology technology platform and assets,” stated ImmunoCellular president and CEO Anthony J. Gringeri, Ph.D.

To that end, ImmunoCellular said, it will shift its attention to developing its “Stem-to-T-Cell” research program, which could potentially treat both solid and blood tumors. Stem-to-T-Cell uses the immune system to manufacture antigen-specific killer T cells that target and destroy cancer cells, as well as prevent tumor recurrence through long-term immunosurveillance.

Stem-to-T-Cell is expected to achieve two milestones by year’s end: During the third quarter, ImmunoCellular anticipates completion of loading of the T-cell receptor DNA sequence into a viral vector, with transfection of the human hematopoietic stem cells by the loaded viral vector occurring during the fourth quarter. The transfected stem cells are expected ultimately to produce an unlimited supply of killer T cells bearing the desired T-cell receptor.

Once proof-of-concept has been established, ImmunoCellular said, it can advance to studies using preclinical models.

“We are focusing resources on advancing our research-stage Stem-to-T-Cell program in collaboration with leading academic researchers and contract laboratories,” Dr. Gringeri added.

ImmunoCellular is developing Stem-to-T-cell technology through a license granted in 2014 by the California Institute of Technology, where the technology originated in the labs of Nobel Laureate and President Emeritus David Baltimore, Ph.D.  

The company says that Stem-to-T-Cell offers a more gradual and measured release of killer T cells than chimeric antigen receptor T-cell (CAR-T) technologies, thus avoiding the limited response, and even toxicity, associated with some CAR-T treatments. Stem-to-T-Cell could be used in combination cancer immunotherapy approaches, ImmunoCellular says.

“We believe that by inserting DNA that encodes T-cell receptors into hematopoietic stem cells rather than into T cells, the immune response can be transformed into a durable and more potent response that could effectively treat solid tumors,” ImmunoCellular explains in its Form 10-K for 2016, filed March 17.


Exploring Opportunities

Dr. Gringeri added that ImmunoCellular was also continuing to explore opportunities to partner its development-stage programs—starting with lead candidate ICT-107, a patient-specific, dendritic cell-based immunotherapy for patients with newly diagnosed glioblastoma.

In June, ImmunoCellular suspended patient enrollment in a Phase III trial assessing ICT-107 in human leukocyte antigen A2 (HLA-A2) patients, saying it lacked the funding to continue the registrational study. The company added at the time that it was seeking a development partner or buyer for the program.

ImmunoCellular was awarded $19.9 million in funding from the California Institute for Regenerative Medicine (CIRM) in September 2015 to support the trial. David Fractor, vp, finance and principal accounting officer, told analysts yesterday he did not believe any unspent portion of the grant could be used by a partner or buyer, but they could apply for funding to CIRM.

The company’s pipeline also includes ICT-121, a patient-specific, dendritic cell-based immunotherapy designed to target CD133 found in recurrent glioblastoma, and ICT-140, a patient-specific, dendritic cell-based immunotherapy designed to target ovarian cancer.

ImmunoCellular also disclosed that two members of its board of directors, Mark A. Schlossberg and Gregg LaPointe, resigned from the board as of August 15.

The company also said it successfully secured funding that will extend its operating funds “runway.” Last month, ImmunoCellular completed the first tranche of a financing that provided $5 million in gross proceeds from the sale of convertible preferred stock, with the potential to gain an additional $9 million through the exercise of warrants in the financing transaction over the following 12 months.

ImmunoCellular finished the first half of this year with a $9.4 million loss, an improvement over the $11 million loss of January–June 2016. The company has been warned of a possible delisting of its shares from the New York Stock Exchange’s NYSE MKT for failing to maintain stockholders' equity of $6 million or more after reporting losses from continuing operations and/or net losses in its five most recent fiscal years. ImmunoCellular said last week it is awaiting an NYSE to its proposed plan to regain compliance by December 23, 2018.







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