A vaccine aimed at preventing triple negative breast cancer, the most aggressive and deadly form of the disease, has successfully completed a phase I clinical trial on a group of 35 patients with encouraging results.
As presented at the San Antonio Breast Cancer Symposium … (USA) researchers from the Cleveland Clinic, the vaccine produced an immune response in the majority (74%) of participants, in addition to being safe and well tolerated.
The results will inform the subsequent phase 2 study which is expected to begin late next year and last approximately two to three years.
“Triple negative breast cancer remains one of the most difficult forms to treat effectively,” said Thomas Budd of the Cleveland Clinic Cancer Institute and principal investigator of the study. “The results of this trial are promising, suggesting that the investigational vaccine is not only safe and well tolerated, but is also capable of inducing immune responses in more than 70% of participants.”
Aggressive tumor
There is a need for better treatments for triple-negative breast cancer, which does not have biological features that typically respond to hormonal or targeted therapies. Although it accounts for only 10-15% of breast cancer cases, it causes a disproportionate number of breast cancer deaths. This aggressive tumor is twice as common in black women and represents between 70% and 80% of breast tumors in patients with BRCA1 gene mutations.
The study, conducted in collaboration with Anixa Biosciences, Inc., divided the 35 patients into three cohorts: those who completed treatment for early-stage triple-negative breast cancer within the past three years and are tumor-free but remain at high risk of relapse; women without cancer who carry high-risk genetic mutations and who have opted for a preventive mastectomy; and patients with early-stage triple-negative breast cancer who received preoperative chemoimmunotherapy, surgery, and pembrolizumab treatment but have residual cancer in the breast tissue, increasing their risk of recurrence.
The vaccine targets a lactation protein, α-lactalbuminwhich disappears after cessation of breastfeeding in normal and aged breast tissue, but is present in the majority of triple negative breast cancers. It is designed to stimulate the immune system and fight tumors if they develop.
The study is based on research originally published in Nature Medicine by Dr. Vincent Tuohy, which showed that immune system activation against α-lactalbumin was safe and effective to prevent mammary tumors in mice.
“Dr. Tuohy hoped that this vaccine would demonstrate the potential of immunization as a new way to fight breast cancer, and that a similar approach could one day be applied to other types of malignancies,” says Justin Johnson. “Our results, indicating that the majority of participants in all three cohorts demonstrated an immune response to α-lactalbumin, are an encouraging sign for the future of the vaccine.”
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