My next guest has spent more than 35 years developing new treatments in industry and academia. He is an MIT and Tufts Medical School graduate who has authored more than 130 publications. And now he is leading a company taking on late stage breast cancer with a phase three trial that Nature Medicine named one of the top studies to watch in 2026. Joining me is Dr. William Williams, CEO of BriaCell. Doctor Williams, thank you so much for joining us.
Thanks so much for having me.
Talk to us about Bria-IMT. How does it help late stage breast cancer patients who have run out of treatment options?
Bria-IMT is a breast cancer cell line that we have genetically modified to make an immune stimulator. It activates the immune system by multiple different mechanisms. It is an off-the-shelf approach where the cells are grown up, harvested, irradiated so they are growth-arrested, and then frozen down. The patients come in, we ship them the cells overnight, they thaw them out at the clinic, and they inject them into the skin of the thighs and the upper back, in combination with a couple of other treatments to help boost the immune response — with our cycles every three weeks. We have seen excellent data in our phase two study, approximately doubling historical overall survival in patients. And now we are in the midst of our pivotal phase three study, which has been progressing quite well. We are very excited to be nearing the finish line.
How does the technology work and how does Bria-OTS let you treat nearly all patients off the shelf?
It is a cellular approach — an off-the-shelf approach that activates the immune system by both direct and indirect mechanisms, making it a very potent activator. It also has an excellent safety profile, with the main side effect being local irritation at the inoculation sites, which goes away in a few days. We noticed in our study that when the patients match the cells at the HLA type, they have even better clinical benefit. So we have gone back and genetically engineered the cells to express different HLA types — meaning we can match the HLA type of the cells to the patients in over 99% of cases. That is what we call Bria-OTS — off the shelf. Our first patient under the new approach had a lung metastasis, had failed several prior therapy attempts, and with four inoculations every two weeks the lung metastasis completely cleared. She remained on study for a year, getting simple monthly injections. We have gone further and engineered the cells to be even more potent — and we are in the startup process of studies for breast cancer and prostate cancer with this next generation approach.
Talk us through the key goals for the phase three trial.
The phase three trial is designed so that patients with metastatic breast cancer who have failed all approved treatment regimens are randomised to our therapy with an immune checkpoint inhibitor, or to treatment of physician’s choice. At this stage of late stage breast cancer, the only treatments really left are chemotherapy, which certainly have lots of side effects. We have 177 patients in each arm and we are following them for mortality. When we hit 144 mortality events, we can put out our headline data. If we see a 40% reduction in mortality, we can declare victory and file for a licensing application. If we miss the 40%, we can continue through completion — and if we see a 30% reduction, we can also file. In either case, the FDA has agreed this should support full approval — not accelerated approval. Many late stage cancer treatments get accelerated approval and have to do a confirmatory study. This, in principle, supports full approval, so no confirmatory study would be needed. That is extremely important for late stage breast cancer patients who suffer terribly not just from their disease but from their treatments.
Is BriaCell expanding into new cancer types?
We have now developed this into a platform technology where we can genetically modify cancer cell lines to make them into potent stimulators of the immune response against the cancer — and in theory it can be applied to any type. We already have studies in startup for breast cancer and prostate cancer. We are getting very close for lung cancer and melanoma. And we have a laundry list of other types — ovarian cancer and others — that we are planning on getting into the clinic in the near future. We believe this could be transformational for the way cancer is treated. Because it is a simple intradermal injection, it can be done in a physician’s office. In principle, it can even be done by a visiting nurse in somebody’s own home. And we now have shown in our studies that the activated immune cells have immune memory — and what we call serial killer activity. They can kill cancer cells over and over again. The impact on the field of oncology — the sky is the limit for this technology.
Thank you so much Doctor Williams for joining us.
Thank you so much. I really appreciate it.
