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    Posted: Nov 24 2013 at 8:59pm
Cleveland Clinic Innovations Creates Spin-Off Company to Develop a Vaccine for Preventing Breast Cancer

Cleveland Clinic Innovations has created a spin-off company to develop a preventive breast cancer vaccine based on research from Cleveland Clinic’s Lerner Research Institute.

The new company, Shield Biotech, will complete preclinical development and seek permission from the FDA to test the vaccine as an investigational new drug in proof-of-concept, first-in-human clinical trials. The trials are expected to start within two years and will take about three years to complete.

“The mission of Shield Biotech will be to translate the scientific research on a breast cancer vaccine, led by Vincent Tuohy, Ph.D., at Cleveland Clinic, into a viable preventive alternative for the patients who may benefit,” said Thomas Graham, MD, Cleveland Clinic’s Chief Innovation Officer. “We believe that the vaccine has the potential to stop the more lethal forms of breast cancer, as well as inhibiting the recurrence of triple-negative breast cancer in women after they have recovered from their initial disease.”

Initially, Shield Biotech will extend the development to the clinical stage in which the vaccine will be tested in two Phase I clinical trials as part of the process to obtain FDA approval. These trials are designed to establish the safety of the vaccine in women and to characterize and optimize the immune response.

Researchers at Cleveland Clinic’s Lerner Research Institute found that a single vaccination could prevent breast tumors from occurring in mice genetically bred to develop breast cancer, while also inhibiting the growth of already existing breast tumors. The research was originally published in Nature Medicine in 2010.

Tuohy, the principal investigator on the original vaccine study, and an immunologist in Cleveland Clinic’s Lerner Research Institute, will be Shield Biotech’s chief science officer.

“We have proposed that breast cancer may be effectively controlled by providing healthy cancer-free women with pre-emptive immunity against emerging breast tumors,” said Tuohy. “We propose to provide women with an immune defense or shield that will protect them from developing breast cancer. Our data show that safe and effective immune protection against this disease can be induced by vaccinating against proteins that are no longer expressed in aging breast tissues but are significantly overexpressed in triple-negative breast cancer, the most aggressive and lethal form of this disease. We hope to provide women with a safe, effective and relatively benign alternative to invasive prophylactic mastectomy.”

Triple-negative breast cancer has a higher recurrence rate than other forms of breast cancer and is insensitive to current forms of adjuvant therapy. It’s the predominant form of breast cancer that occurs, for example, in women with BRCA1 mutations.

G. Thomas Budd, M.D., of Cleveland Clinic’s Taussig Cancer Institute, will be on the company’s scientific advisory board charged with the design and execution of the clinical trial protocol.

The first (Phase Ia) trial will involve women with triple-negative breast cancer who have recovered from current standard of care involving chemotherapy, radiation therapy, and/or surgery. This trial will determine the dose and frequency of vaccination needed to provide an optimum immune response. The second (Phase Ib) trial will involve healthy cancer-free women at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomy to lower their risk. This trial will focus on the safety of the vaccine by examining the removed breast tissue for any potential changes.

“We expect these clinical trials to lead to more advanced trials designed to determine the effectiveness of the vaccine in treating triple-negative breast cancer, as well as its potential for immunoprevention,” said Dr. Budd.

http://my.clevelandclinic.org



Edited by 123Donna - Dec 13 2013 at 8:56pm
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 13 2013 at 8:55pm
Cleveland Clinic immunologist presents preventive vaccine research to breast cancer field for 1st time

More than three years after his research on a potential breast cancer vaccine appeared in the scientific journal Nature Medicine, Cleveland Clinic immunologist Vincent Tuohy is finally presenting his work to the scientific breast cancer community.

Back in 2010, the journal published findings made by Tuohy’s lab at the Clinic’s Lerner Research Institute. Tuohy and his research team discovered that a vaccine that targeted a substance called alpha-lactalbumin prevented breast cancer tumors from forming, and halted the growth of existing cancers.

Friday at the San Antonio Breast Cancer Symposium, Tuohy is taking part in the formal poster session, which allows researchers to share and explain their work with conference attendees.

It's the first time he is formally sharing his work at an oncology conference.

“It’s kind of unusual setting for me,” he said earlier this week. “I’ve presented [the research] at immunotherapy meetings, but not at a breast cancer meeting

“I’m an immunologist; I don’t consider myself an expert on breast cancer,” said Tuohy, recruited by the Clinic in 1989 for his research in multiple sclerosis.

Alpha-lactalbumin is a protein found in the breast milk of healthy women. The only other time the protein is present is in the majority of breast cancer tumors. The vaccine would be designed to destroy the protein without damaging healthy breast tissue.

Tuohy’s findings show that the vaccine would provide healthy, adult women with protection from the protein. The vaccine's effectiveness is not affected by a woman’s history of lactation and breastfeeding.

A relatively new development being shared for the first time in scientific circles: The vaccine may be most effective in preventing the development or recurrence of triple negative breast cancer, one of the most deadly types of breast cancer. 

“We've shown that the protein is in the most aggressive forms of breast cancer, and in 70 percent of triple negative tumors,” Tuohy said.

“We have 11 years of preclinical data, and we've learned a lot more even in the last year.”

Even with his lack of an oncology background, Tuohy said he didn't expect to have been met with the level of resistance and doubting that his work has faced since the Nature Medicine article appeared.

When he wasn’t looking for funding that would allow him to advance his research, Tuohy said he was spending time responding to the handful of what he calls “serious, scientifically addressable” concerns raised by other researchers.

Friday’s presentation is one step in addressing those points, which ranged from questions over the type of mice used in the studies, to doubts that women with a history of lactation wouldn’t respond to the vaccine.

“We’re trying to put these imaginary demons to rest, to exorcise [them] from legitimate concerns,” Tuohy said. Of that initial resistance, “I think it’s softening.”

That hasn’t been the only progress. A few months ago a private donor stepped up to provide funding for two Phase 1 clinical trials.

The funding established Shield Biotech, with Tuohy as its chief science officer. Shield Biotech is a spinoff company created by Cleveland Clinic Innovations, the commercialization arm of the hospital system, to work on getting permission from the Food and Drug Administration to begin the trials. It’s a process that will likely take two years.

Making and testing the vaccine will take several more years and cost more than $7 million.

The trials will test the safety of the vaccine and dosage, toxicity and immune response. Women who have been treated for triple negative breast cancer will be in the first trial. Women who are at high risk for developing breast cancer – including women over age 40 - will be enrolled in the second trial.

“Women, as they age, are defenseless against breast cancer,” said Tuohy, who recently was named to a federal advisory panel that is compiling a report for the U.S. Department of Health and Human Services on how to improve adult vaccinations.

“We need to have a preventive vaccine.”

http://www.cleveland.com/healthfit/index.ssf/2013/12/cleveland_clinic_immunologist.html

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Melissa P. Quote  Post ReplyReply Direct Link To This Post Posted: Dec 29 2013 at 12:30am
Thanks for sharing Donna... I'll keep you posted as I know more.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 15 2017 at 11:11pm

Doctor researching breast cancer vaccine receives grant to continue research



Meet the mastermind behind a medical game-changer that could ultimately eradicate breast cancer, not only here in the U.S., but the world.

Inside a quiet lab in Cleveland Clinic’s Department of Immunology, Vincent Tuohy, Ph.D. has been hard at work since 2002, researching and creating a breast cancer vaccine.

It will soon be in phase one of clinical trials to determine proper dosage and safety.

"It targets a protein that's found in most or vast majority of what are called triple-negative breast cancer. Triple-negative is the most lethal form of breast cancer," Dr. Tuohy said. . . .

. . .More good news: Tuohy just received a $6 million grant from the Department of Defense towards his mission.




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Post Options Post Options   Thanks (0) Thanks(0)   Quote Kellyless Quote  Post ReplyReply Direct Link To This Post Posted: Dec 17 2017 at 10:41am
I volunteer to be a test patient! Can we email this Dr. and tell him we've got a pool of potential volunteers here? Does Steve know this guy?
I live for your scientific update posts Donna, thank you so much
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 17 2017 at 11:07am
Kellyless,

Here's another link on this vaccine discussion from a few years ago.  



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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 17 2017 at 11:08am
Originally posted by Melissa P. Melissa P. wrote:

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 over-expressed 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 prophylactic mastectomy.

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.

http://health.clevelandclinic.org/2013/09/a-step-closer-to-a-breast-cancer-vaccine/

When will clinical trials begin?

Phase I trials are expected to start within two years and will take about three years to complete.

Who will be in the Phase I trial?

The first (Phase Ia) trial will involve women with triple-negative breast cancer who have recovered from current standard of care involving chemotherapy, radiation therapy, and/or surgery. This trial will determine the dose and frequency of vaccination needed to provide an optimum immune response. The second (Phase Ib) trial will involve healthy cancer-free women at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomy to lower their risk. This trial will focus on the safety of the vaccine by examining the removed breast tissue for any potential changes.

What will the Phase I trials tell us?

These trials are designed to establish the safety of the vaccine in women and to characterize and optimize the immune response. How can a patient enroll in the clinical trials?

Patients are not being enrolled yet, and the trials won’t begin until 2015.
http://my.clevelandclinic.org/giving/where-to-give/tuohy_vaccine.aspx?utm_campaign=pinkvaccine-url&utm_medium=offline&utm_source=redirect

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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 17 2017 at 11:09am
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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