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123Donna View Drop Down
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    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 by Cleveland Clinic immunologist 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.

https://fox8.com/news/fda-clears-way-for-cleveland-clinics-groundbreaking-breast-cancer-vaccine


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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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Dec 22 2020 at 6:11pm
Dear Donna, 

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
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Vivian Quote  Post ReplyReply Direct Link To This Post Posted: Dec 22 2020 at 11:44pm
This is such exciting news! Thank you for sharing, Donna! I dream for the day that breast cancer is no more a threat to us.  
Dx 12-27-2019 TN,Stg 1, Grade 3 Ultrasound 1.5cm/MRI 1.8cm, node-,BRAC-.
DD AC x 4, ultrasound cCR;
DD T x 4
Lumpectomy:5-28-2020; 0/2 nodes. pCR.
Radiation: 20x
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 08 2021 at 12:30pm
Key Takeaways
  • 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. . . ."

https://www.verywellhealth.com/breast-cancer-vaccine-greenlit-clinical-trials-5094403




Edited by 123Donna - Jan 08 2021 at 12:30pm
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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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 30 2021 at 7:31pm

FDA clears way for Cleveland Clinic’s groundbreaking breast cancer vaccine

That is the goal of a promising new breast cancer vaccine, 10 years in the making; invented and developed by Cleveland Clinic immunologist 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.

https://fox8.com/news/fda-clears-way-for-cleveland-clinics-groundbreaking-breast-cancer-vaccine

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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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Jan 31 2021 at 10:03am
Dear Donna,

Many thanks for the update.

Praying this will work.

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
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 31 2021 at 11:07am
Hi Steve,

Me too!  It's been a long 10 years in development just to reach human trials this spring.

Donna
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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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 31 2021 at 11:28am

Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer

Brief Summary:
The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer

Condition or disease Intervention/treatment Phase 
Stage IIA Triple Negative Breast CancerTriple Negative Breast CancerBiological: α-lactalbumin vaccineBiological: ZymosanEarly Phase 1

Detailed Description:
This aLA breast cancer vaccine is an investigational (experimental) drug that the study team believes will work by stimulating the immune system to fight the participant's cancer, in a way similar to the way the immune system fights off an infection after a vaccination for that infection. α-lactalbumin Vaccine is experimental because it is not approved by the Food and Drug Administration (FDA).
Study Design
Go to  < ="tr-dropbtn" style="-sizing: border-; margin: 0px; overflow: ; text-trans: none; appearance: ; cursor: pointer; font-weight: bold; font-size: 14px;">sections
Study Type  :Interventional  (Clinical Trial)
Estimated Enrollment  :30 participants
Allocation:N/A
Intervention Model:Single Group Assignment
Masking:None (Open Label)
Primary Purpose:Treatment
Official Title:Phase I Trial of Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Patients With Non-Metastatic Triple-Negative Breast Cancer at High Risk of Recurrence
Estimated Study Start Date  :March 2021
Estimated Primary Completion Date  :October 2021
Estimated Study Completion Date  :December 2021


Inclusion Criteria:

  • Histologically proven invasive breast cancer.
  • Primary tumor must be ER-negative (ER in <1% of cells), PR-negative (PR in <1% of cells), and HER2-negative (0-1+ by IHC or FISH ratio<2.0 with signal number <6/cell). 4.1.3 Patients must be high risk, defined as either:

    • Pathologic stage IIA, IIB, IIIA, IIIB, or IIIC by AJCC 8, or
    • Residual invasive cancer in breast or regional nodes following preoperative chemotherapy.

      • 1 months since last active therapy (chemotherapy, radiation therapy, or surgery) and <36 months since the initiation of treatment for the current cancer, based on the period of highest risk for patients with Stages I-III triple-negative breast cancer
  • Treatment prior to enrollment must be consistent with contemporary NCCN guidelines, found at: https://www.nccn.org/
  • ECOG Performance Status 0-1
  • Adequate major organ function, defined as:

    • WBC > 3,000/mcl,
    • hemoglobin > 10.0 gm/dL,
    • platelets > 100,000/mcL,
    • total bilirubin within normal limits,
    • ALT/AST <3 x upper limits of normal (ULN),
    • serum creatinine < 1.5 x ULN
  • Serum prolactin level must be < upper limits of normal (ULN);
  • Participants must have the ability to understand and the willingness to sign and provide a written informed consent document;
  • Participants must have archival tissue available for potential correlative studies (e.g., assays for α-lactalbumin expression or tumor infiltrating lymphocytes), but tumors will not be required to exhibit overexpression of α-lactalbumin for enrollment.
  • Participants agrees not to use alternative therapies from the time of informed consent through 30 days following the last vaccine injection
Locations
United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44915
Contact: George T Budd, MD    866-223-8100    TaussigResearch@ccf.org   
Principal Investigator: George T Budd, MD   

https://clinicaltrials.gov/ct2/show/NCT04674306

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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Post Options Post Options   Thanks (0) Thanks(0)   Quote Lorene Quote  Post ReplyReply Direct Link To This Post Posted: Feb 02 2021 at 11:23am
Donna,
 What wonderful news on the possibility of a breast cancer vaccine!  Thank you for keeping up with these things And sharing it!

Lorene
dx10/01@age59,IDC TNBC, St.IIB,Gr3,2.5cm,3+nodes, epirubicin,5FU,cytoxan,33Rads,No recurrence, 2018
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