The National Breast Cancer Coalition submitted the following statement to the National Vaccine Advisory Committee in advance of its June 13-14, 2024 public meeting.
Founded in 1991, NBCC is a collaboration of activists, survivors, researchers, policymakers, grassroots groups, and national organizations that have come together as disruptive innovators for social change with a mission to end breast cancer.
Breast cancer patients and those at risk of getting the disease must lead and participate in all decision-making affecting breast cancer research, health care, and public policy. NBCC’s comprehensive breast cancer education and training programs equip these advocates, survivors, and others affected by breast cancer with the knowledge they need to confidently participate in their health care, help set scientific priorities, inform research protocols, review science for relevance and merit, and communicate accurate and accessible information to the public.
NBCC’s programs such as the Project LEAD Institute® are considered the highest-quality education and training programs available and serve as models for patient advocacy organizations worldwide.
NBCC’s major research arm is the Artemis Project, a collaboration of advocates and researchers working to develop and implement plans of action in two areas overlooked by traditional funding:
Through Artemis, NBCC has created the infrastructure for collaboration around the advancement of bold and innovative strategies and research that will end breast cancer.
The Artemis Project is an advocate-led, mission-driven research model designed to look at breast cancer in new ways and develop strategic research plans to save lives.
Artemis works because of its advocate leadership, the dedication of visionary scientists, and the strategic, creative approach to achieving its goals. This diverse team of scientists, researchers, advocates, and other stakeholders have expertise ranging from immunology, biophysics, and genetics to molecular biology and clinical oncology. All share a sense of urgency and the goal to end breast cancer.
These volunteer participants meet throughout the year to share information, expand on ideas, build on previous Artemis work, and discuss future visions. An executive committee of Artemis participants meets regularly to provide oversight, set agendas, support critical decisions, and identify and recruit necessary expert team members.
NBCC launched the Artemis Project in 2010 with the bold idea of developing a safe, cost-effective preventive vaccine that targets all three major subsets of breast cancer, reduces the incidence of breast cancer, and prevents death from breast cancer. As part of the strategic plan for vaccine development, initial seed grants were awarded to investigate potential viral-based causes of breast cancer, identify vaccine targets, and begin preclinical work.
Over the past 10 years, a core group of Artemis participants has designed an approach to the preventive vaccine. They chose a team at Mayo Clinic, led by Dr. Keith Knutson, an Artemis participant, as our principal investigator to develop the vaccine construct and the Phase 1 safety trial protocol. Our vaccine targets nonmutated self-antigens (overexpressed tumor-associated antigens) and has a prime-boost strategy.
In 2020, the Artemis vaccine research plan was accepted by the National Cancer Institute’s (NCI) PREVENT program, whose primary goal is to bring new cancer preventive interventions and biomarkers through preclinical development toward clinical trials. Since May 2020, NBCC and Artemis participants, including our partners at Mayo, have collaborated with NCI PREVENT to advance the preventive vaccine work into Phase 1 testing.
In March 2023, NCI PREVENT and its contractor MRI Global awarded a contract to a vaccine manufacturing company to produce both the non-GMP (Good Manufacturing Practices) grade product for the preclinical safety work and the GMP-grade vaccine product for use in humans in the Phase 1 safety trial. We anticipate a 2025 launch for the Phase 1 trial.
NBCC believes that a preventative breast cancer vaccine must be broadly accessible and affordable to all patients. All too often, treatments developed via the traditional industry model fail to meet this critical need. For this reason, we are considering both traditional and non-traditional drug development strategies to ensure the widest possible vaccine accessibility. Without broad accessibility and affordability, we will fail to meet our desired outcome of preventing everyone from receiving a breast cancer diagnosis.
NBCC recommends that the Director of the National Vaccine Program establish a plan to obtain consensus regarding the long-term outcomes that should be measured in both primary and secondary breast cancer prevention vaccine trials.
Furthermore, NBCC recommends that the National Vaccine Program establish a strategic plan that engages broad stakeholder involvement, including patient advocacy organizations to ensure global access to all cancer vaccines under development that prove to be efficacious.
To achieve optimal public health outcomes, this Committee must prioritize making proven interventions accessible and affordable to those in need, regardless of demographics, geography, or socioeconomic status.
