Glioblastomas (GBM) are the most aggressive and deadly kind of brain tumors, with less than 7% of patients surviving to 5 years after diagnosis.
The University of Cincinnati is a study site for a new Phase 2b clinical trial, sponsored by biotechnology company Imvax, Inc. that will test a personalized immunotherapy approach designed to work similarly to a vaccine by training the immune system to fight the tumor.
Soma Sengupta, MD, PhD, site principal investigator and a University of Cincinnati Cancer Center physician-researcher, explained the trial will enroll patients newly diagnosed with GBM. Patients will undergo brain tumor neurosurgery at the UC Gardner Neuroscience Institute to remove the tumors, and researchers will create a personalized vaccine from patients’ own brain cancer cells.
From there, the tumor cells will be shipped to Imvax’s facility. The cells are combined with a drug called IMV-001 and incubated in biodiffusion chambers to form a personalized immunotherapy treatment against the patient’s specific cancer cells. The chambers are then implanted into the patient’s abdomen and removed 48 hours later, after the immune system has had a chance to train itself to fight the tumor.
“Your own immune system is then working on that tumor,” said Sengupta, UC associate professor in neurology, director of neuro-oncology clinical trials, associate director of the Brain Tumor Center and a UC Health neuro-oncologist, funded by the Harold C. Schott Endowed Chair in Molecular Therapeutics (Neurosurgery) and the Pam and Tom Mischell Funds. “It’s a state-of-the-art, immune-mediated vaccine from your own body, and it’s personalized medicine at its best.”
Patients in the trial will be randomized to either receive the personalized immunotherapy or a placebo of inactive solution in the biodiffusion chamber. After the chambers are removed, the patients will continue the current standard of care of outpatient chemotherapy and radiation following surgery.
The Phase 1 trials showed the approach was safe, and this phase of the trial will assess progression-free survival and overall survival of patients treated with the Imvax therapy.
“Survival with that standard of care with surgery, radiation and chemotherapy is about two years, and this therapy has the promise of extending survival beyond that,” Sengupta said.
“The commencement of this autologous cell-based immunotherapy Phase 2b trial is a significant milestone for GBM patients,” said David W. Andrews, MD, chief medical officer at Imvax. “Imvax is greatly indebted to academic leaders like Dr. Sengupta and the University of Cincinnati who are participating in this trial for the benefit of these patients. Our hope is that this trial will ultimately provide support for a new and better treatment option for the many patients diagnosed each year with this intractable disease.”
A total of 93 patients across up to 25 trial sites will be enrolled in the trial, with an estimated seven to 14 patients expected to enroll at UC.
Patients must be newly diagnosed with GBM and have not had surgery yet to be eligible for the study. For more information, contact University of Cincinnati Brain Tumor Center Nurse Navigator Jamie Denlinger, RN, at 513-675-9656
