After seeing “tremendous efficacy” in a phase 1 study, a cancer drug firm is preparing for what it thinks will be a phase 2 pivotal study early next year of its virus therapy for brain tumors.
DNAtrix Inc.’s technology is an oncolytic agent, meaning it’s a virus engineered to destroy cancer cells in the body and leave healthy cells unharmed. When implanted directly into a brain tumor, the company’s adenovirus, Delta-24-RGD, invades and self-destructs tumor cells, and spills out to adjacent cells as the virus replicates. “What we think is also happening secondarily is that it destabilizes the tumor and may be initiating an immune response,” said CEO Frank Tufaro.
Initially, the drug is being studied in high-grade gliomas, brain tumors that are rarely curable even with surgery, radiation and chemotherapy.
Tufaro said the company saw “tremendous efficacy” in its phase 1 study conducted at MD Anderson Cancer Center for treatment of malignant gliomas, with one patient in remission posttreatment. The DNAtrix team is now designing what it thinks will be a phase 2 pivotal study that it plans to take to the U.S. Food and Drug Administration and begin early next year, he said.
It’s also doing scalable manufacturing in Houston and has recently raised some capital. Since its founding, the company has raised about $3.8 million in equity, Tufaro said, but was originally supported by dollars from the National Cancer Institute. Venture firm DFJ Mercury and the Texas Emerging Technology Fund have also put money in the company.
Although DNAtrix initially plans to seek orphan drug approval for treatment of recurrent glioblastoma in patients, early study results have suggested that the drug is definitely killing tumors, and there could be other applications in other forms of cancer, Tufaro said. In the future, it may also test the drug in combination with chemotherapy. Tufaro estimates the company’s initial target market at about 20,000 patients a year, but the American Brain Tumor Association estimates there are more than 124,000 people living with malignant brain tumors in the U.S.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Researchers at Ohio State University are also working on oncolytic virus technology for brain cancer, and several companies are developing new brain tumor therapies as well. Roche is testing its cancer drug Avastin in brain cancer, and Northwest Biotherapeutics is enrolling patients in a phase 3 study of its DCVax-L immune therapy for GBM.
Brain cancer treatment is also the target of several medical device companies including NovoCure, which had its noninvasive device approved last year for glioblastoma multiforme, and Monteris Medical, which developed a minimally invasive laser surgery for brain tumors.
Some have hailed oncolytic virus technology as one of most promising new strategies in treating cancer. Last year, Amgen shelled out $1 billion to acquire BioVex and its OncoVEX, a phase 3 oncolytic vaccine that’s being tested in melanoma and head and neck cancers. These kinds of drugs have a long history in cancer research, but many therapies in the past have failed because of safety issues and the inability to only recognize and kill cancer cells, Tufaro said.
Founded by physicians and scientists at UCSF Helen Diller Comprehensive Cancer Center and MD Anderson Cancer Center, DNAtrix is stationed in Houston, Texas.
[Image from DNAtrix Inc.]
