Gradalis today revealed early details of a study indicating that its personalized cancer vaccine could delay recurrences of ovarian cancer in advanced stage patients by at least a year.
The Dallas-based startup, founded in 2005, presented results of a phase II clinical trial of the vaccine at the annual meeting of the American Society of Gene and Cell Therapy in Salt Lake City.
The vaccine, known as Fang, is designed to harness the power of the patient’s own immune system to fight cancer. It is manufactured from scratch for each individual patient using cells from her tumor, which are genetically modified to activate immune cells and prevent the production of proteins that tumors use to avoid detection by the immune system.
Gradalis said the phase II randomized study has so far enrolled 17 patients with either stages 3c or 4 ovarian cancer, the most advanced stages of the disease, in which the cancer has spread to other organs. A dozen patients received the vaccine along with standard treatment of tumor removal and chemotherapy, while five patients received only the standard course of treatment. Gradalis expects to enroll a total of 60 women by year’s end.
In an interim analysis of data from the study, which is expected to run until January 2016, the mean time between starting treatment and cancer recurring for patients receiving the vaccine was 470 days, versus 193 days for patients receiving standard treatment, according to the company. Gradalis says there were no adverse events associated with the vaccine in study.
“This interim analysis of the phase II study suggests that Fang is very promising as a potential treatment for ovarian cancer and lays the groundwork for a pivotal Phase III study of Fang in this patient population desperately in need of better treatment options,” according to a press release quoting Minal Barve, a physician at Texas Oncology and a principal investigator with the Mary Crowley Medical Research Centers Network at Baylor University Medical Center in Dallas. (Both company founders, CEO Dave Shanahan and John Nemunaitis, chief medical officer, hold positions at the Mary Crowley Centers, and it was while working there that they decided to form Gradalis.)
But Michael Wandell, a biomedical executive and clinical pharmacologist, and an entrepreneur-in-residence at the Houston Area Translational Research Consortium at Rice University, cautions that the study is “small numbers, early data.”
“Do I think it’s important? Yes, it’s important. It really is,” he says. “Do I think it’s a cool type of therapy? Yes, it is.”
In previous research, Gradalis has shown that it can manufacture its vaccine for variety of tumor types, including melanoma, colorectal, breast, ovarian, and hepatocellular cancers.
In January, Gradalis announced it raised $24 million in a Series B round of financing, part of a total of $44 million it has raised from a mix of institutional and private investors focused on the life sciences. The company declined to name specific investors.