Dive Brief:
- Microcap biotech ImmunoCellular Therapeutics has suspended randomization of patients for the Phase 3 trial of its dendritic cell-based brain cancer therapy, ICT-107, to preserve its shrinking pool of cash and is looking for help to keep itself afloat.
- ImmunoCellular's statement on the news said the company is evaluating both financing and "strategic alternatives," options that could include a potential merger, consolidation, reorganization or sale.
- The Los Angeles-based biotech's share price has tumbled from an all-time high of around $150 in June 2012 down below $1, with a market capitalization under $3 million.
Dive Insight:
However effective its lead candidate ICT-107 is against the hard-to-treat cancer glioblastoma, a brain tumor that has a two-year survival rate of just 30%, ImmunoCellular Therapeutics is finding continued operations to be a financial struggle.
At the end of March, ImmunoCellular said it had working capital of just under $5 million, which it did not expect to be sufficient to fund the business for the next year. Absent additional funding, ImmunoCellular said then, there would be "substantial doubt' about the company's ability to continue as a going concern.
ImmunoCellular was one of a handful of biotechs recently charged by the Securities and Exchange Commission for alleged stock promotion schemes. According to an SEC order, then company CEO Manish Singh commissioned over 50 internet articles and publications promoting ImmunoCellular and ICT-107 on investor websites.
The field of immunotherapy, despite recent successes and explosion of development efforts, has felled other companies before. Patient-specific cell-based cancer vaccines can be a challenge to develop — there is the difficulty and cost of development, manufacturing and distribution, which can up the challenges of creating a feasible business model around a treatment that is individualized, complex and lengthy.
Provenge (sipleucel-T) was the first of the cell-based patient-specific cancer vaccines to reach the market, launched by its developer Dendreon in 2010 to treat prostate cancer. However, reimbursement troubles, manufacturing difficulties and competition from other cancer therapies reaching the market led to the company getting into financial trouble and then filing for bankruptcy in 2012.
More recently, Argos Therapeutics saw its share price fall by two-thirds after a damning evaluation from a data monitoring committee showed its vaccine rocapuldencel-T did not improve overall survival in metastatic renal cell carcinoma.