We have manufactured to the vaccine in the laboratory and are now in the process of performing tests to determine whether the vaccine can undergo “scale up” manufacturing to create enough to conduct a clinical trial and we are determining whether vaccination of specific cell lines produced high enough levels of protein to be able to stimulate an immune response. These studies are part of those required to submit an “Investigational New Drug” application to the US Food and Drug Administration which is one of the first hurdles we need to pass to start a clinical trial.
TARGETING INVASIVE BREAST CANCER WITH A MULTI-ANTIGEN VACCINE
$60,000 in new funds will be used to use the master cell cassette and make the first batch of vaccines for trial.
Researchers at the UW Medicine Cancer Vaccine Institute (CVI) have identified proteins present in breast cancer stem cells that cause invasive breast cancer. The CVI has created a multi-antigen vaccine targeting five of these proteins. Now CVI researchers would like to manufacture a new lot of vaccine and test vaccine in combination with chemotherapy in women with “locally advanced breast cancer”. This is breast cancer that is too big to be taken out by surgery and women must have chemotherapy before the surgery. The Phase II clinical trial would be designed to see if vaccination can increase the number of immune cells in the tumor and whether vaccines will enhance the destruction of the tumor resulting in eradication of the tumor prior to surgery. This study will set the stage for larger trials to see if the vaccine added to chemotherapy is better than chemotherapy alone.
Update (August 2019)
We have begun working on the design of the clinical protocol, the choice of the patient population, and the types of biomarkers we will use in the study proposed. We have recently identified a more efficient method to vaccinate patients with breast cancer using a small electrical impulse to the skin at the time the vaccine is given. This method is called “electroporation” and is particularly well suited to our vaccine which uses DNA to immunize. We are planning on starting a Phase II trial of testing electroporation in patients similar to those we enrolled on our initial study. If this new method is superior in stimulating higher levels of immunity to these breast cancer proteins we will take this method forward into our therapeutic trial-the one designed to generate anti-tumor responses.
During our 3rd Annual Be The Hope walk in July 2021, a $51,485 check was presented to Dr. Nora Disis by Valley Girls and Guys and one of our amazing sponsors and her team, “Sydney’s Salon Services Legacy”. They hit the ground running and raised over fifty thousand dollars to support UW Medicine’s vaccine clinical trial in honor of Sydney and her continued fight against breast cancer.