QuoteReplyTopic: Breast Cancer Vaccine Posted: Dec 22 2020 at 7:46am
FDA clears way for Cleveland Clinic’s groundbreaking breast cancer vaccine
But what if breast cancer could be wiped out altogether?
That is the goal of a promising new breast cancer vaccine, 10 years in the making; invented and developed byCleveland Clinicimmunologist Dr. Vincent Tuohy.
“We know enough about the immune system now to try these things. We have the ability, but we’re on snail pace. We need to be on warp speed pace,” Tuohy said.
The clinic partnering with Anixa Biosciences, who has an exclusive worldwide license to the new technology.
This is how it would work. The technology immunizes against a protein that is expressed in the mammary glands of women, during the latter part of gestation and during lactation. That protein, often a precursor to cancer.
Dr. Amit Kumar, President & CEO of Anixa says, “It’s not absolutely clear why, but it starts being made again and we simply have to teach the immune system to destroy the cells making that protein. Because those are cancer cells.”
Pre-clinical trials conducted on animals showed 100% of mice that were not vaccinated and got the placebo, developed breast cancer and died.
The vaccine’s initial focus is triple negative breast cancer, the most lethal … but is expected to eventually prevent other forms of cancer, including ovarian.
“So we envision a 21st century vaccine program here at the Cleveland Clinic that prevents diseases that we confront with age that we think are completely preventable,” Tuohy said. “We think breast cancer, ovarian cancer perhaps prostate cancer are all preventable diseases and that’s why we want to bring our vaccine program up to the 21st century.”
Now, with FDA clearance, human clinical trials for the breast cancer vaccine are expected to begin by Spring 2021.
Thank you so much for posting this important news.
One thing I have noticed in the last 16 years of being a Patient Advocate are the number of Pregnancy Associated Breast Cancer (PABC) cases I have seen. I was told very early on in my work "PABC is very, very rare. You may never see it." That was not my experience in the beginning and I have seen an increase in the number of cases, over the years. To be honest, I have not kept track of the numbers but it definitely has been occurring, more often, anecdotally.
One of the first women I helped from this site was diagnosed while pregnant. I visited her while she was pregnant and she had mastectomies and started chemo while pregnant. Both she and her little girl (now 10) are both healthy. Mom is cancer free and the child did not have cardio issues, that had been anticipated, from receiving the chemo.
PABC is defined as breast cancer that is found while the woman is pregnant or within the first year after given birth. I have helped several dozen women who discovered their masses (which turned out to be malignant) while breast feeding.
How wonderful it would be if the protein, behind this cancer, as suggested by Cleveland Clinic can be stopped from stimulating cancer.
Thanks again, Donna.
warmly,
Steve
I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates
The FDA has approved a triple-negative breast cancer vaccine for use in human clinical trials.
The
vaccine was developed by researchers at the Cleveland Clinic in Ohio
and works by training the immune system to kill cells that express the
protein alpha-lactalbumin.
The technology used to develop the vaccine could be applicable to cancers beyond breast cancer as well.
" . . . The
vaccine, Tuohy tells Verywell, essentially works by nipping tumor
development in the bud. By imbuing immune cells with the ability to
recognize, attack, and kill cancer cells, it prevents them from ever
reaching a size at which they could inflict lethal damage on the body.
Triple-negative breast cancer cells are distinctive because they express
the protein alpha-lactalbumin, a major component of breast milk, even
when their host is not pregnant or breastfeeding.
“Most triple-negative breast cancers express alpha-lactalbumin," Tuohy
says. "It is a mistake that the tumors make because they have no default
inhibition mechanisms through progesterone and estrogen signaling that
would ordinarily prevent the expression of this protein." He describes
the vaccine mechanism as “simply taking advantage of this mistake.”
What This Means For You
It's not currently known when this vaccine may be available to the
general public. If it proves to be effective and approved for use
several years down the line, you will not be eligible to receive the
vaccine if you are breastfeeding or plan to breastfeed in the future. What Happens Next?
The FDA’s approval clears the way for the Cleveland Clinic to start Phase I clinical trials of the vaccine. Set to be helmed by George Thomas Budd, MD,
staff physician at the Cleveland Clinic’s Taussig Cancer Center, the
trials will also include men, who constitute about 1% of all breast
cancer patients, Tuohy reports.3
Ideally, the trials will help doctors determine whether the vaccine can
be safely administered to human beings by providing insight into dose
size, dose number, and immunity duration. But it is hard to know exactly
when the results might arrive.
“My team takes [it] one day at a time," Tuohy says. "We hope to start
the trials by the end of [the second quarter of] 2021, but we have been
wrong so many times with such anticipated timelines. We hope to finish
Phase I trials within two years after starting them." He adds that he
has "no idea” when the vaccine might become widely available.
The preliminary results of several animal studies conducted by the
clinic have been promising. In one study of female mice, every single
one of those that did not receive the vaccine subsequently developed
breast cancer and died.1
The trials will be funded by the U.S. Department of Defense and conducted in people who do not intend to breastfeed, Tuohy says.3
Because the vaccine conditions the immune system to wipe out all
alpha-lactalbumin-expressing cells, it would have adverse effects on
human milk production. . . .
. . .
The Future of Cancer Vaccine Development
Cancer vaccines can be divided into two camps: those designed to prevent
cancer, like Tuohy’s, and those designed to treat it. The only direct
cancer treatment vaccines currently available are sipuleucel-T/Provenge
(for the treatment of advanced prostate cancer) and talimogene
laherparepvec/T-VEC (for the treatment of advanced melanoma, an
aggressive form of skin cancer).4
Many breast cancer treatment vaccines are in development, including
peptide-based vaccines, whole-cell vaccines, gene-based vaccines, and
dendritic cell-based vaccines, but none have yet advanced past Phase II
clinical trials.5
The candidates hail from organizations all around the country, including
the Mayo Clinic in Jacksonville, Florida, the University of Washington
in Seattle, and the University of Texas M.D. Cancer Center in Houston,
according to Pravin Kaumaya, PhD, professor of translational therapeutics at the Ohio State University Comprehensive Cancer Center. . . ."
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