Navigation Links
Cleveland Clinic's preventive breast cancer vaccine development takes step forward
Date:9/17/2013

Tuesday, Sept. 17, 2013, Cleveland: 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.


'/>"/>

Contact: Joe Milicia
milicij2@ccf.org
216-636-5873
Cleveland Clinic
Source:Eurekalert

Related medicine news :

1. Cleveland Clinic selected to participate in National MDS Clinical Research Consortium
2. Cleveland Clinic researchers discover molecule that may prevent atherosclerosis
3. Cleveland Clinic Florida receives approval for transplant programs at Weston Facilities
4. Cleveland Clinic researchers investigating potential drug for treatment of Alzheimers disease
5. Cleveland Clinic study shows vitamin E may decrease cancer risk in Cowden syndrome patients
6. University Hospitals & Philips Healthcare to showcase imaging technology at Cleveland Medical Mart
7. Cleveland Clinic researcher identifies 2 new genetic mutations associated with Cowden syndrome
8. Redskins Quarterback & Lynx Shreds Athlete Kirk Cousins will Start Today vs. Cleveland Browns for Injured RG3
9. Cleveland Clinic researcher receives grant to fund autism research
10. Cleveland Clinic study shows bariatric surgery restores pancreatic function by targeting belly fat
11. Vein Expert in Winston-Salem, NC Participates in Elite Cleveland Clinic Seminar
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology: