The Cancer Vaccine Institute is pleased to announce that the Kuni Foundation has funded three grants for our organization as part of their commitment to advancing cancer research.
Their generous gifts are elevating critical areas of CVI’s work, including the development of a vaccine for metastatic triple-negative breast cancer, an ovarian cancer prevention vaccine and a breast cancer nanovaccine. Thanks in part to their support, we believe we will have our first breast cancer vaccine approved by the FDA within the next five to eight years.
The Kuni Foundation is known for their dedication to the people and new ideas that drive cancer research toward a cure. Their substantial commitment to the CVI has propelled our mission of creating vaccines and immunotherapies that ignite the immune system to end cancer.
These are three vaccines in development whose advanced progress would not have been possible without the support of the Kuni Foundation:
A Better Treatment Option for Triple-Negative Breast Cancer: STEMVAC
Dr. Shaveta Vinayak, CVI Director of Clinical Trials, is addressing the unmet medical needs of patients with PD-L1–negative triple-negative metastatic breast cancer.
Triple-negative breast cancer (TNBC) is an aggressive form of breast cancer that has few options for targeted therapies, especially once it has metastasized. It is “triple-negative” because the cancer cells lack the receptors for three particular proteins that other types of breast cancer have (HER2, estrogen receptor and progesterone receptor). These absences make TNBC more difficult to target with current therapy options.
The FDA approved in 2019 an immunotherapy for metastatic TNBC that utilizes immune checkpoint inhibitors, drugs that reactivate the immune system against cancer. However, this breakthrough therapy only benefits a third of all patients with metastatic TNBC — those who express the PD-L1 (programmed death ligand-1) protein. The remaining two-thirds of patients whose tumors lack PD-L1 (termed “PD-L1-negative”) are still mostly dependent on a non-targeted chemotherapy approach, which has been the mainstay for decades and can have many side effects.
Patients with PD-L1-negative metastatic TNBC tend to only respond to single-drug chemotherapy for three to six months, developing a resistance to the therapy that leads to disease progression. Their median survival is 12 to 18 months.
Dr. Vinayak and the CVI team received funding to conduct a clinical trial in patients with PD-L1 negative metastatic TNBC with our STEMVAC vaccine. This muti-antigen, poly-epitope vaccine targets five cancer stem cell proteins that drive resistance to therapy, cancer metastases and disease recurrence. The STEMVAC vaccine would educate the immune system to recognize and eliminate cells that express those five cancer proteins.
In our single-arm Phase II clinical trial, patients with PD-L1 negative TNBC will receive three priming vaccines followed by boosters every three months, concurrently with chemotherapy. Based on previous clinical trials with STEMVAC, we anticipate the vaccine will create an anti-cancer immune response that we hope, in conjunction with chemotherapy, will slow or stop metastatic growth.
We anticipate recruiting our first patients in early 2025.
“Getting Kuni funding to develop this study for a highly aggressive type of breast cancer is so meaningful,” Dr. Vinayak said. “I am hopeful that this targeted vaccine will have an impact on patient’s lives in this study.”
A Vaccine for Ovarian Cancer Prevention
Ovarian cancer is the most lethal gynecologic cancer and is known as a “silent killer” because it is difficult to diagnose in its early stages. Patients with mutations in certain genes, such as BRCA1/2, or who have a strong family history of ovarian cancer are at high risk of the disease. Currently, the only way to prevent ovarian cancer in people at high risk is through surgical removal of the ovaries and fallopian tubes.
Although this operation reduces the risk of ovarian cancer by about 80%, it places women into premature menopause, which greatly increases the risk of heart disease, dementia and osteoporosis.
However, many women at the time of surgery are found to have had evidence of a precancerous lesion called serous tubal intraepithelial carcinoma (STIC) in their fallopian tubes. STIC lesions are believed to be the origin of many ovarian cancers. We hypothesize that if we train the immune system to recognize STIC cells as a threat, we may be able to prevent the development of ovarian and peritoneal cancers.
With the support of the Kuni Foundation, Dr. Denise Cecil, CVI Principal Scientist, is developing a vaccine to do exactly this. The vaccine will target proteins that are found at high levels in STIC and ovarian cancers, helping train the immune system to create an immune response to eliminate them. Vaccination would generate immune cells that develop an “immunologic memory” that can provide disease protection for years.
The Kuni Foundation’s grant will be used to identify vaccine targets and test the vaccine in a mouse model for ovarian cancer. Upon successful completion of preclinical studies in mice, we hope to file an Investigational New Drug application to the FDA and conduct human clinical trials. We hope this vaccine may eventually benefit people with STIC identified at surgery and those who are at high risk for ovarian cancer.
A Nanovaccine to Precisely Target Breast Cancer
Dr. Nora Disis, CVI Director, (left) and Dr. Miqin Zhang, Kyocera Profesor at the University of Washington (right)
CVI Director Dr. Nora Disis is collaborating with Dr. Miqin Zhang, Kyocera Professor of Materials Science & Engineering at the UW Institute of Nano-engineered Systems, to develop an advanced nanovaccine to combat breast cancer.
The nanovaccine aims to improve the delivery of vaccines. The nanovaccine, called IOFCC-PEI-mRNA-ManP, combines an iron core with a fluorinated cationic polymer (FCC-PEI) and a targeting ligand (mannose-6-phosphate, or ManP). This unique combination allows precise delivery of therapeutic mRNA to immune cells, enhancing their response.
As part of this project, Dr. Zhang will develop the vaccine and characterize its ability to deliver protection to cells. We will determine how well it can activate immune cells and train the immune system to recognize cancer cells as dangerous. We will also test the nanovaccine in mouse models of triple-negative breast cancer to evaluate its effectiveness, safety and strength of the immune response.
By improving vaccine delivery, our nanovaccine aims to boost the immune system’s ability to recognize and eliminate breast cancer cells.
The Kuni Foundation also awarded research grants to projects at Fred Hutch Cancer Center.
Thank You, Kuni Foundation
We extend our deepest gratitude to the Kuni Foundation and their visionary team for their transformative support.
“The Kuni Foundation has immensely impacted our research at the Cancer Vaccine Institute by advancing the development of vaccines for breast and ovarian cancers,” Dr. Disis said. "They also have played a major role in accelerating new initiatives, such as our cancer microbiome research. Their generous funding is a testament to their commitment to accelerating cancer research and a beacon of hope for patients and families touched by this disease."
The Cancer Vaccine Institute is grateful for the advancements in cancer vaccine research made possible by our donors.