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-   -   new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING (https://her2support.org/vbulletin/showthread.php?t=62249)

Lani 12-01-2014 12:21 AM

new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING
 
BASED ON DIRECTING IMMUNE SYSTEM AGAINST MAMMOGLOBIN A , WHICH VAST MAJORITY OF BCs have (in contrast to her2, which a small --but very important-- minority have amplified)

1-Dec-2014
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Contact: Diane Duke Williams
williamsdia@wustl.edu
314-286-0111
Washington University School of Medicine
@WUSTLmed
Breast cancer vaccine shows promise in small clinical trial





IMAGE: A breast cancer vaccine designed by researchers at Washington University School of Medicine in St. Louis is safe in patients with metastatic breast cancer. Preliminary evidence from the small clinical...
Click here for more information.



A breast cancer vaccine developed at Washington University School of Medicine in St. Louis is safe in patients with metastatic breast cancer, results of an early clinical trial indicate. Preliminary evidence also suggests that the vaccine primed the patients' immune systems to attack tumor cells and helped slow the cancer's progression.

The study appears Dec. 1 in Clinical Cancer Research.

The new vaccine causes the body's immune system to home in on a protein called mammaglobin-A, found almost exclusively in breast tissue. The protein's role in healthy tissue is unclear, but breast tumors express it at abnormally high levels, past research has shown.

"Being able to target mammaglobin is exciting because it is expressed broadly in up to 80 percent of breast cancers, but not at meaningful levels in other tissues," said breast cancer surgeon and senior author William E. Gillanders, MD, professor of surgery. "In theory, this means we could treat a large number of breast cancer patients with potentially fewer side effects.

"It's also exciting to see this work progress from identifying the importance of mammaglobin-A, to designing a therapeutic agent, manufacturing it and giving it to patients, all by investigators at Washington University," he added.

The vaccine primes a type of white blood cell, part of the body's adaptive immune system, to seek out and destroy cells with the mammaglobin-A protein. In the smaller proportion of breast cancer patients whose tumors do not produce mammaglobin-A, this vaccine would not be effective.

In the new study, 14 patients with metastatic breast cancer that expressed mammaglobin-A were vaccinated. The Phase 1 trial was designed mainly to assess the vaccine's safety. According to the authors, patients experienced few side effects, reporting eight events classified as mild or moderate, including rash, tenderness at the vaccination site and mild flu-like symptoms. No severe or life-threatening side effects occurred.

Although the trial was designed to test vaccine safety, preliminary evidence indicated the vaccine slowed the cancer's progression, even in patients who tend to have less potent immune systems because of their advanced disease and exposure to chemotherapy.

"Despite the weakened immune systems in these patients, we did observe a biologic response to the vaccine while analyzing immune cells in their blood samples," said Gillanders, who treats patients at Siteman Cancer Center at Barnes-Jewish Hospital and Washington University. "That's very encouraging. We also saw preliminary evidence of improved outcome, with modestly longer progression-free survival."

Of the 14 patients who received the vaccine, about half showed no progression of their cancer one year after receiving the vaccine. In a similar control group of 12 patients who were not vaccinated, about one-fifth showed no cancer progression at the one-year follow-up. Despite the small sample size, this difference is statistically significant.

Based on results of this study, Gillanders and his colleagues are planning a larger clinical trial to test the vaccine in newly diagnosed breast cancer patients, who, in theory, should have more robust immune systems than patients who already have undergone extensive cancer therapy.

"If we give the vaccine to patients at the beginning of treatment, the immune systems should not be compromised like in patients with metastatic disease," Gillanders said. "We also will be able to do more informative immune monitoring than we did in this preliminary trial. Now that we have good evidence that the vaccine is safe, we think testing it in newly diagnosed patients will give us a better idea of the effectiveness of the therapy."

###

This work was supported by the Breast Cancer Research Program (BCRP) of the Department of Defense Congressionally Directed Medical Research Programs (DOD/CDMRP), grant number W81XWH-61-0677; Gateway for Cancer Research, P-06-016; The Foundation for Barnes-Jewish Hospital; the National Cancer Institute (NCI) of the National Institutes of Health (NIH), T32 CA009621; the NCI Cancer Center Support Grant, P30 CA91842; and George and Diana Holway.

Tiriveedhi V, Tucker N, Herndon J, Li L, Sturmoski M, Ellis M, Ma C, Naughton M, Lockhart AC, Gao F, Fleming T, Goedegebuure P, Mohanakumar T, Gillanders WE. Safety and preliminary evidence of biological efficacy of a mammaglobin-A DNA vaccine in patients with stable metastatic breast cancer. Clinical Cancer Research. Dec. 1, 2014.

Washington University School of Medicine's 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine is one of the leading medical research, teaching and patient-care institutions in the nation, currently ranked sixth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children's hospitals, the School of Medicine is linked to BJC HealthCare.

URL: https://news.wustl.edu/news/Pages/27732.aspx

KathyT 12-01-2014 07:22 PM

Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING
 
Thanks for sharing!

'lizbeth 12-02-2014 11:22 AM

Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING
 
Oh Lani - that is very encouraging, and for Metastatic Breast Cancer even.

Are they currently enrolling for a Phase II?

Carol Ann 12-02-2014 11:49 AM

Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING
 
I saw a post about Phase II on Facebook, 'Lizbeth ... they are enrolling early stage women who have been just diagnosed; they want to see how women with better immune systems handle it. Unfortunately that leaves out metastatic women. :( I saw where some were going to call the University to ask more questions as to why they were being cut and to hopefully still be included.

Carol Ann

'lizbeth 12-02-2014 12:04 PM

Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING
 
Early stage? Yes, I understand the disappointment. I felt the same way when many vaccines were switching from studying high HER2 expressors to lower expressors.

Asking is good, and keep asking. I will look for the study information. I believe they can study both early and advanced. It is just a matter of bringing all the right people together.

'lizbeth 12-02-2014 12:10 PM

Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING
 
NCT02204098 and it is a Phase 1B trial, not Phase II.

Interesting study. Did you see the exclusions? Not yet enrolling. This is an interesting one to watch. If you notice that it starts enrolling please post the information.

Carol Ann 12-02-2014 12:19 PM

Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING
 
Will do!

CA

Rolepaul 12-02-2014 08:43 PM

Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING
 
It will be interesting to see how the next phase of the study works out. I am working on getting more info and will post what is not proprietary.

'lizbeth 12-03-2014 12:23 PM

Re: new bc vaccine from Washington Univ (not UNIV OF WASHINGTON) PROMISING
 
Rolepaul, they are dramatically changing cancer management if they can get patients to treat with vaccines before surgery.

This seems to have such a huge perception obstacle. Patients are so convinced they will die because they have been diagnosed with cancer. Convincing them to do a treatment before surgery or neoadjuvant treatment could be a challenge. Educating the public on the survivability of a cancer diagnosis for the vast majority of people is key. Too many patients get sucked into the current system and are pushed into standard of care with fear tactics. Changing the system will be critical over the next 2 decades. I hope you are up to the challenge!


I've been thinking of you and Prop 303 in AZ. Can you follow up in a separate post. What has been the change created by this proposition? Have patients gained more access to lifesaving treatments yet?


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