Promising TNBC Vaccine: Phase 1 Trial Shows Safety and Strong Immune Response
An investigational vaccine for triple-negative breast cancer (TNBC) has shown positive results in a phase 1 trial. Over 70% of participants responded as expected to the vaccine, which is based on α-lactalbumin. The trial presented findings at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting.
The vaccine demonstrated safety and tolerability across three patient groups. The primary side effect was irritation at the injection site. No serious systemic adverse events were reported, even when the vaccine was used with pembrolizumab (Keytruda).
The maximum tolerated dose has been found, but researchers are testing additional doses. A phase 2 trial in patients with newly diagnosed breast cancer is planned to begin in 2025.
Dr. G. Thomas Budd from Cleveland Clinic stated, “Triple-negative breast cancer has the least effective treatments. We hope this vaccine could prevent this aggressive disease in healthy individuals.”
The phase 1 trial was conducted with Cleveland Clinic and funded by the US Department of Defense. It involved three cohorts: women previously treated for TNBC, women at high genetic risk undergoing preventive mastectomies, and patients receiving the vaccine with pembrolizumab.
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Interview with Dr. G. Thomas Budd on the Investigational Vaccine for Triple-Negative Breast Cancer
News Directory 3: Thank you for joining us today, Dr. Budd. We’re excited to hear about the promising results from the phase 1 trial of the breast cancer vaccine. Can you provide an overview of the trial’s findings?
Dr. G. Thomas Budd: Thank you for having me. I’m pleased to discuss our findings. The phase 1 trial evaluated a novel vaccine based on α-lactalbumin aimed at preventing triple-negative breast cancer (TNBC). Over 70% of participants responded well to the vaccine, which is encouraging given the aggressive nature of TNBC. We found the vaccine to be safe and well-tolerated across three patient cohorts, with the primary side effect being mild irritation at the injection site.
News Directory 3: That’s impressive. Could you elaborate on the different cohorts involved in the trial?
Dr. G. Thomas Budd: Certainly. We structured the trial into three cohorts: the first consisted of women previously treated for TNBC, the second included women at high genetic risk who were undergoing preventive mastectomies, and the third involved patients receiving the vaccine alongside pembrolizumab, an immunotherapy drug. The primary goal was to establish the maximum tolerated dose, while our secondary objectives focused on identifying the lowest effective dose.
News Directory 3: How did each cohort respond to the vaccine?
Dr. G. Thomas Budd: Cohort 1a showed strong immune responses along with safety, which is a promising sign. Cohort 1b is still actively enrolling participants and analyzing tissue samples to gather more data. Importantly, cohort 1c reported no significant adverse events, and we confirmed that immune responses were robust in this group as well.
News Directory 3: You mentioned plans for a phase 2 trial. What are the next steps for this research?
Dr. G. Thomas Budd: Yes, we’re eagerly planning a phase 2 trial for patients newly diagnosed with breast cancer, which we anticipate launching in 2025. The positive early findings have definitely motivated us to continue our evaluation.
News Directory 3: This vaccine could potentially change the landscape for treating TNBC. What does this mean for future patients?
Dr. G. Thomas Budd: Indeed, triple-negative breast cancer currently has the least effective treatment options available. We are hopeful that this vaccine could not only act as a preventative measure for high-risk individuals but also improve clinical outcomes for patients diagnosed with this aggressive disease.
News Directory 3: That’s an optimistic outlook. What message do you have for those currently affected by TNBC?
Dr. G. Thomas Budd: I want patients and their families to know that we are committed to advancing research and treatment options for triple-negative breast cancer. The enthusiasm and participation of everyone involved in this trial are crucial for our progress, and we are grateful to all the participants, medical staff, and supporters of this research.
News Directory 3: Thank you, Dr. Budd, for sharing these insights. It’s been a pleasure speaking with you.
Dr. G. Thomas Budd: Thank you for the opportunity. I look forward to sharing more positive developments in the future!
The primary goal was to establish the maximum tolerated dose, while secondary objectives aimed to identify the lowest effective dose of the vaccine. Cohort 1a showed strong immune responses and safety. Cohort 1b is still enrolling and analyzing tissue, while cohort 1c reported no major adverse events and confirmed immune responses.
Due to the positive early findings, experts are keen to continue evaluating the vaccine in a phase 2 study for newly diagnosed breast cancer patients.
Amit Kumar, CEO of Anixa Biosciences, expressed satisfaction with the trial results, stating, “The data continues to exceed our expectations. We are grateful to all participants and the medical staff who supported this study.”
For more information, visit the trial’s page on ClinicalTrials.gov.