We just took a big step toward developing a preventive vaccine for the most
dangerous type of breast
Cleveland Clinic Innovations has started a new company, Shield Biotech, to
develop a vaccine based on our lab research. This research has shown that a
vaccine designed for immune prevention of triple-negative breast cancer (TNBC)
can work to both prevent and treat
We’re going to try to program the immune system to protect against breast
and other cancers — in much the same way childhood vaccinations work to protect
against polio and measles.
Now, after a three-year
journey, raising money from all kinds of sources who believed in our
project, we’ve finally secured the funds to continue development of the
A shield against tumors
Our ultimate goal is to give women a defense or shield against developing
breast cancer with targeted stimulation of the immune system. The best chance
to prevent a tumor is by providing pre-emptive immunity that spots it early and
kills it before it can grow.
Our early investigations were very promising. Our data showed that immune
protection against breast cancer can be provided by vaccinating against
proteins that are no longer expressed in aging breast tissues, but are
overexpressed in TNBC.
Vaccination didn’t just inhibit the growth of preexisting tumors — it
prevented new ones from forming.
Targeting a difficult-to-treat disease
Triple-negative breast cancer is the most aggressive and lethal form of the
disease, the predominant form that occurs in women with BRCA1
mutations. As of now, TNBC has a higher recurrence rate than other forms of
breast cancer and there’s no targeted therapy for it.
Our aim is to provide protection against recurrence for women diagnosed with
the disease. And pre-emptive protection for healthy, cancer-free women against
emerging breast tumors, giving them an effective, safe alternative to invasive
How long to develop the vaccine?
We’re looking at a timeline of around 10 years before the vaccine would be
available for women.
It will take two years to
complete preclinical studies and obtain permission from the FDA to test an
investigational new drug.
Shield Biotech will then initiate
two Phase I clinical trials, to determine dosage and safety, that will
take about three years to complete. We’ll be testing the vaccine in two
groups: women with triple-negative breast cancer who have recovered from
current standard of care; and healthy cancer-free women at high risk for
developing breast cancer who have decided to undergo voluntary bilateral
mastectomy to lower their risk.
If these trials show the
vaccine induces immunity and is safe, advanced Phase II and Phase III
trials will show us how effective the vaccine is. It should take around
five years before these more advanced trials get underway.
Development of a vaccine that will be widely available
to prevent this breast cancer will take some time. But we’re well on our way
toward discovering whether this vaccine will be effective.