After withdrawing an initial public offering early last summer, a company employing a two-pronged approach to immunotherapy is raising private capital as it looks toward phase 3 trials of brain and kidney cancer drugs.
A December U.S. Securities and Exchange Commission filing indicates that TVAX Biomedical Inc. had raised $2 million in private financing. The company said in a statement it plans to continue raising up to $10 million. The company had planned for an IPO in early 2012 but withdrew it in May, citing poor market conditions.
TVAX’s approach to immunotherapy is two-fold: vaccinate the patient with a combination of his own cancer cells and a powerful adjuvant, then use the partially activated T cells generated by that vaccine to manufacture high numbers of activated, cancer-killing T cells that are administered intravenously back into the patient.
On their own, both of these approaches have demonstrated therapeutic potential for cancer, the company says, but not enough to make them stand-alone treatments. Together in TVI-Brain-1, the company’s lead candidate for glioblastomas, they improved the median survival of patients by 50 percent in a phase 2 clinical trial.
Currently in an ongoing phase 2 trial, TVI-Brain-1 has been authorized by the U.S. Food and Drug Administration for pivotal phase 3 trials in about 400 patients newly diagnosed with glioblastoma. The company anticipates the trial will begin this year and produce complete data by 2016. It also received FDA authorization to conduct phase 3 trials of the product in kidney cancer.
TVAX boasts that its platform has the potential to be less toxic than radiation and/or chemotherapy. It won’t be cheaper, though. In its corporate fact sheet (PDF), the company estimates prices would be in line with current treatments. A variety of other cancer applications for the platform are included in the company’s pipeline.
The trouble with cancer is that the immune system doesn’t recognize cancerous cells as foreign pathogens the way it does with viruses, etc. Scientists, then, are challenged with the task of training the immune system to eliminate cancer, which has been especially challenging in central nervous system cancers. But, like TVAX, a few other companies are taking cell-based approaches to vaccinations for brain cancer including ImmunoCellular Therapeutics, Innocell Corp., Northwest Biotherapeutics and Oncovir Inc. There are about 135,000 Americans with a history of cancer of the brain or other nervous system, reports to the National Cancer Institute.
TVAX is based in Lenexa, Kansas and was founded in 2004. In addition to the financing, TVAX appointed a new CEO, Philip Haworth. Former CEO Gary Wood has transitioned to the company’s chief science officer.