Glioblastomas (GBM) are the most aggressive and deadly kind of brain tumours, 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 personalised immunotherapy approach designed to work similarly to a vaccine by training the immune system to fight the tumour. 

Soma Sengupta, MD, PhD, site principal investigator and a University of Cincinnati Cancer Center physician-researcher, explained the trial will enrol patients newly diagnosed with GBM.

Patients will undergo brain tumour neurosurgery at the UC Gardner Neuroscience Institute to remove the tumours, and researchers will create a personalised vaccine from patients’ own brain cancer cells. 

From there, the tumour 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 personalised 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 tumour.

“Your own immune system is then working on that tumour,” said Sengupta, UC associate professor in neurology, director of neuro-oncology clinical trials, associate director of the Brain Tumour 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 personalised medicine at its best.” 

Patients in the trial will be randomised to either receive the personalised 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 enroled in the trial, with an estimated seven to 14 patients expected to enrol at UC.

Source: University of Cincinnati