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Old 11-11-2014, 11:25 AM   #1
'lizbeth
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YES!!! It is here. Phase II vaccine trial for Her2 3+

Galena Biopharma, Inc.
Nov 11, 2014
Previous Release PDF Add to Briefcase
Galena Biopharma Doses First Patient in Phase 2 Clinical Trial With NeuVax(TM) (nelipepimut-S) in Combination With Herceptin(R) (trastuzumab) to Treat High-Risk HER2 3+ or HER2 Gene-Amplified Breast Cancer Patients


Trial expands the eligible patient population and overall NeuVax clinical trial portfolio
Recent patent allowance provides intellectual property protection for NeuVax in combination with Herceptin in any HER2/neu expressing cancer
PORTLAND, Ore., Nov. 11, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced the dosing of the first patient in a new NeuVax™ (nelipepimut-S) Phase 2 clinical trial to prevent breast cancer recurrence in high risk HER2 3+ and/or HER2 gene-amplified breast cancer patients in combination with Herceptin® (trastuzumab; Genentech/Roche). The patients will be defined as 3+ by immunohistochemistry (IHC) or are HER2 2+ and/or fluorescence in situ hybridization (FISH) > 2.0, also described as gene-amplified. The multi-center, prospective, randomized, single-blinded, placebo-controlled, Phase 2 trial will enroll 100 patients with a diagnosis of HER2 3+ or gene-amplified breast cancer, are HLA A2+ or HLA A3+, and are determined to be at high-risk for recurrence.

"This trial is a significant addition to our portfolio of NeuVax clinical trials that are exploring the potential of the agent to prevent recurrence in a variety of cancer settings," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "Herceptin has shown efficacy in HER2 3+ patients; however, those patients who fall into the high risk category are at much greater risk for a recurrence following standard of care treatment. Based on early studies and pre-clinical data, the combination of NeuVax and Herceptin has shown that the two agents utilize different mechanisms of action to target the same protein, leading to a potentially strong synergistic effect that may provide clinical benefit in this high-risk population. We are excited for the potential to help these high risk patients."

This trial is co-funded via a grant from the Department of Defense through the Congressionally Directed Medical Research Program. The grant comes via a Breast Cancer Research Program Breakthrough Award and was obtained by Elizabeth A. Mittendorf, M.D., Ph.D., Associate Professor, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, who will oversee this investigator-initiated trial.

"The women we are treating in this trial are at a high risk for their disease to recur, particularly because their initial treatment regimen failed to give them a complete response. I believe that NeuVax and Herceptin are complementary to one another and the combination of these agents may provide clinical benefit to these patients," added Dr. Mittendorf.

Eligible breast cancer patients will be randomized to receive NeuVax + GM-CSF (granulocyte macrophage-colony stimulating factor) + trastuzumab or trastuzumab + GM-CSF alone in the adjuvant setting following surgery. The primary endpoint of the study is invasive disease-free survival and enrollment is expected to complete in the second half of 2016, followed by a 3-year follow-up period. There are three categories of high-risk patients that qualify for the trial:

Patients who received neoadjuvant therapy (before surgery) with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy but fail to obtain a pathological complete response (pCR) at surgery, regardless of hormone receptor status.
Patients who undergo surgery as a first intervention and are found to be pathologically node-positive with at least four positive lymph nodes, regardless of hormone receptor status.
Hormone receptor negative breast cancer patients who undergo surgery as a first intervention and are found to have one, two or three positive lymph nodes.
On October 8, 2014, Galena announced the Notice of Allowance of a U.S. patent application covering methods of treating patients having any HER2/neu expressing cancer by administering NeuVax™ (nelipepimut-S) in combination with Herceptin® (trastuzumab; Genentech/Roche).

About NeuVax™ (nelipepimut-S)

NeuVax™ (nelipepimut-S) is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3 molecules on antigen presenting cells (APCs). These activated, specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. NeuVax is currently in an international, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) study under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). Additional information on the PRESENT trial can be found at www.neuvax.com. Two additional Phase 2 trials are ongoing with NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche).

About HER2 3+ Breast Cancer

According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, about 25% are HER2 positive (IHC 3+), which means their breast cancer cells significantly over express the HER2 protein. HER2 is a member of the epidermal growth factor receptor family of receptor tyrosine kinases. Increasing levels of HER2 expression have been shown to be a prognostic indicator for poor outcomes in breast cancer. Patients with HER2 3+ tumors, or HER2 2+ and/or FISH > 2.0 tumors (gene-amplified) may receive trastuzumab, a humanized mAb targeting HER2, as a component of their standard of care therapy. In HER2 3+ breast cancer patients who receive neoadjuvant chemotherapy plus trastuzumab, the 3-year estimate of recurrence free survival are 95.7% for patients that achieve a pCR versus 80.1% for patients that do not achieve a pCR (p=.02). For HER2 3+ or gene-amplified breast cancer patients that undergo surgery as a first intervention and are found to be node-positive, 5-year disease free survival rates are 72% for those with four or more positive lymph nodes and 78% for those with 1, 2 or 3 positive lymph nodes.

About Galena Biopharma

Galena Biopharma, Inc. (Nasdaq:GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company's commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena's clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects. For more information, visit www.galenabiopharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the expected timing of completion of enrollment and the completion of the NeuVax combination HER2 3+ breast cancer clinical trial, the design of the clinical trial and the importance of the results from such trial, if reported to the medical community, the commercialization of Galena's products and development of Galena's product candidates, as well as statements about our expectations, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in Galena's Annual Report on Form 10-K for the year ended December 31, 2013 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.

NeuVax™ is a trademark of Galena Biopharma, Inc. Other trademarks are the property of their respective owners.

CONTACT: Remy Bernarda

VP, Marketing & Communications

(503) 405-8258

rbernarda@galenabiopharma.com
__________________
Diagnosed 2007
Stage IIb Invasive Ductal Carcinoma, Pagets, 3 of 15 positive nodes

Traditional Treatment: Mastectomy and Axillary Node Dissection followed by Taxotere, 6 treatments and 1 year of Herceptin, no radiation
Former Chemo Ninja "Takizi Zukuchiri"

Additional treatments:
GP2 vaccine, San Antonio Med Ctr
Prescriptive Exercise for Cancer Patients
ENERGY Study, UCSD La Jolla

Reconstruction: TRAM flap, partial loss, Revision

The content of my posts are meant for informational purposes only. The medical information is intended for general information only and should not be used in any way to diagnose, treat, cure, or prevent disease
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Old 11-11-2014, 12:14 PM   #2
SusanN
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

YAAYYYY...thanks for posting Mister Sister...hope all is well in your world!!
__________________
10/18/12 Found pea size lump right breast
11/7/12 Biopsy
12/14/12 Lumpectomy
1/4/13 Rexcision, NO CLEAR MARGINS!! :(
2/11/13 Mastectomy with Expander Placed
2/15/13 INFECTION at Mastectomy site...emergency Surgery!!! Expander removed :(
DX: DCIS, IDC, Stage 2a, 2.7cm, 1/5 nodes positive
ER/PR-, HER2+++
3/28/13 Port placed
4/1/13 Begin 6 Cycles TCH Therapy
4/1/14 Finished Herceptin!!
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Old 11-11-2014, 12:19 PM   #3
'lizbeth
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

I am doing great Mister Sister. Life justs gets better and better.

I was just thinking about you this week. How is life for you?
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Old 11-11-2014, 12:32 PM   #4
SusanN
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

That is wonderful to hear...actually...having problems with hypothyroid...TSH was 0.12... blood drawn per PA was 6 mo, then 3 mo...now being referred to an endo...who nows what the next step will be...and throw in a rash, inflammation, ititching on my mastectomy side...had an utrasound, was told it's JUST tissue...so tired of having such thin skin and ending up with nearly just bone from immediate infection after failed reconstruction...going to have a visit with my PS this Friday...LIFE COULD BE SO MUCH WORSE THOUGH...I sure am concerned about Linn...??
__________________
10/18/12 Found pea size lump right breast
11/7/12 Biopsy
12/14/12 Lumpectomy
1/4/13 Rexcision, NO CLEAR MARGINS!! :(
2/11/13 Mastectomy with Expander Placed
2/15/13 INFECTION at Mastectomy site...emergency Surgery!!! Expander removed :(
DX: DCIS, IDC, Stage 2a, 2.7cm, 1/5 nodes positive
ER/PR-, HER2+++
3/28/13 Port placed
4/1/13 Begin 6 Cycles TCH Therapy
4/1/14 Finished Herceptin!!
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Old 11-11-2014, 12:43 PM   #5
'lizbeth
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

I will message you.

I am worried about Linn too. I don't like the radio silence. Let's message her too.

So much progress being made for us, first Prop 303 passes in AZ, and now the Phase II for Neuvax. I AM SO HAPPY!

We should help find 99 more to enroll so that the Phase II finishes quickly. So important to get this done so less have to deal with the agony of progression.
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Old 11-11-2014, 12:43 PM   #6
jaykay
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

Good point, Susan - Linn has been very quiet. Concerned, too
__________________
March, 2000: 48, Post menopausal (5 yrs HRT) Left breast, IDC 3mm/DCIS 1.6cm, ER+/PR-/Her2+++, mod differentiated, MIB low, lumpectomy, node neg via SNB, rads=33 Stage 1a
June, 2000: Tamox 4.5 years,Femara for 5 years (end in Jan. 2010)
Sept, 2012: 61, Via mamm, ultrasound, biopsy, right breast, 2.3cm tumor, ER+/PR-/Her2+++, poorly diff, KI67 60-70%
BRCA 1 and 2 negative
October, 2012: Bi Mast with tissue expanders, port placement
Final Path: IDC 2.8cm, DCIS, 1/4 sentinal nodes positive (@#$%). Stage IIB
Nov 29, 2012: Begin TCH/6x/every 3 wks, H for 1 year/every 3 weeks.
March 14, 2013: Finished chemo
April 9, 2013: Begin radiation 28x
May 22, 2013: Finished rads
June 1st, 2013: Started Aromasin for 5 yrs.
July 15, 2013: Switched to Letrozole (Femara). Probably for the rest of my life
October 16, 2013: Exchange surgery
October 31, 2013: Finished Herceptin
December 5, 2013: Port removed
Glad this year is over!
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Old 11-11-2014, 12:53 PM   #7
SusanN
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

Indeed...great progress being made...will "stay tuned" to hear from you...miss you!!
__________________
10/18/12 Found pea size lump right breast
11/7/12 Biopsy
12/14/12 Lumpectomy
1/4/13 Rexcision, NO CLEAR MARGINS!! :(
2/11/13 Mastectomy with Expander Placed
2/15/13 INFECTION at Mastectomy site...emergency Surgery!!! Expander removed :(
DX: DCIS, IDC, Stage 2a, 2.7cm, 1/5 nodes positive
ER/PR-, HER2+++
3/28/13 Port placed
4/1/13 Begin 6 Cycles TCH Therapy
4/1/14 Finished Herceptin!!
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Old 11-12-2014, 08:52 PM   #8
waterdreamer
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

It is a pity that it is only for HLA A2 positive or A3 positive ladies. Alas I am none of these, so despite being Her3+ I am ineligible. I also have some stuff to clear out of my lungs first I will pass this on to anyone I know who is HLA A2 positive.
__________________
Breastfeeding when diagnosed with Her2+ May 2008
Oct 2008 Double mastectomy 22/28 lymph nodes positive
Decline chemotherapy (decision I regret)
Nov 2009 Mets to lungs and bones.
Dec 2009 Start Taxotere and Herceptin, T1, T3 heal completely and lungs are clear, T2 and first rib have lytic lesions. First rib becomes sclerotic. Considered stable.
May 2011, Onc calls progression and I cross over from comparison arm of clinical trial to TDM-1
Brain scan in Sept 2011 showed small tumor in right cerebellum, did Novalis radiation.


Feb 2013 < 1cm tumor in left frontal lobe. Did Novalis in March and latest scan shows no sign of brain metastasis.
Aug 2013 did 36th round of TDM-1 Due to TDM-1 side effects, shortness of breath, and difficulty getting my balance when getting out of bed, agreed with my oncologist to stop TDM-1.
Took a six week break, bone scan showed small uptake on left first rib. CT showed hypodensities in liver (too small to biopsy) and small nodule in lungs (mediastinal).
Started Navelbine weekly. Did one round with Herceptin.
Skipped next 2 rounds, due to neutropenia. Next chemo 7th Nov - have had 3 Neupogen shots, so WBC should look better... Did not tolerate Navelbine well.
December 2013 scans show no sign of active cancer.
March 2014 - currently only on Herceptin - brain MRI clear, PET/CT two nodules in right lung show uptake
May 2014 - stop Herceptin.
Sept 22, 2014 Brain MRI clear :) PET/CT Progression in lungs.
Sept 2014, Xeloda, Tykerb and Herceptin.
Nov 2014 - Decide to take a break from all treatment.
May 2015 - Brain met radiated with Novalis
July 2015 - Have progression in right lung.
Sept 2015 - Perjeta and Herceptin alone after a 9 month break from all treatment.
Nov 2015 - Thoracentesis 1500ml removed from right lung.
Dec 2015 - Two tiny 1mm brain mets radiated in right cerebellum.
Feb 2016 - Thoracentesis 2200ml drained from right lung
Feb 2016 - Stopped Perjeta and Herceptin and started back on Kadcyla as I had no previous progression on it. After 1 cycle of Kadcyla markers begin to drop. On second cycle add Keytruda.
March 2016 - Thoracentesis 1650ml drained from right lung.
April 2016 – Thoracentesis 1500 ml drained from right lung.
June 2016 – CT scan shows progression in right lung, as well as moderate pleural effusion requiring Thoracentesis.
June 2016 – Decide to stop Keytruda, and will do chemosensitivity test through Rational Therapeutics. Plan to continue on Kadcyla for next two cycles.
July 2016 - Start weekly Abraxane with Herceptin. WBRT with hippocampal sparing, Taking Namenda. 15 sessions over 3 weeks.
Aug - Dec 2016 - 2 infusions of Navelbine, very hard on my body and still dealing with anasarca (generalized edema) 1 infusion of Havalen
My doctor wants to put me on hospice.
Dec 23rd 2016 - I am granted compassionate use of Neratanib.
May 31st 2017 - still on Neratinib, feeling good.
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Old 11-13-2014, 10:20 PM   #9
'lizbeth
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

Ouch Waterdreamer, don't be so discriminatory. Surely they will let men into the trial too. After all they specify patients, not just ladies. Plus I just told James that perhaps he could make it into the trial.

I've been hoping for cancer treatments based on our own individual cancer characteristics. It is a blessing that a vaccine is in Phase II & Phase III for both HLA A2 or HLA A3 positive. It is my impression this is a fairly large group.

It is a pity that the AE37 vaccine which includes the HLA A2 negatives in only in Phase IIb for lower expressors. It is my impression that taking this vaccine into Phase III is delayed until the funding is available. Perhaps when that happens they will once again include the Her2 3+ as well.
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Old 11-13-2014, 10:39 PM   #10
waterdreamer
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

Ooops, sorry didn't mean to ignore the men amongst us. I just get tired of being called a patient, it feels as if some control has been taken away, so let me rephrase -
It is a pity that it is only for HLA A2 positive or A3 positive ladies and gentlemen.
__________________
Breastfeeding when diagnosed with Her2+ May 2008
Oct 2008 Double mastectomy 22/28 lymph nodes positive
Decline chemotherapy (decision I regret)
Nov 2009 Mets to lungs and bones.
Dec 2009 Start Taxotere and Herceptin, T1, T3 heal completely and lungs are clear, T2 and first rib have lytic lesions. First rib becomes sclerotic. Considered stable.
May 2011, Onc calls progression and I cross over from comparison arm of clinical trial to TDM-1
Brain scan in Sept 2011 showed small tumor in right cerebellum, did Novalis radiation.


Feb 2013 < 1cm tumor in left frontal lobe. Did Novalis in March and latest scan shows no sign of brain metastasis.
Aug 2013 did 36th round of TDM-1 Due to TDM-1 side effects, shortness of breath, and difficulty getting my balance when getting out of bed, agreed with my oncologist to stop TDM-1.
Took a six week break, bone scan showed small uptake on left first rib. CT showed hypodensities in liver (too small to biopsy) and small nodule in lungs (mediastinal).
Started Navelbine weekly. Did one round with Herceptin.
Skipped next 2 rounds, due to neutropenia. Next chemo 7th Nov - have had 3 Neupogen shots, so WBC should look better... Did not tolerate Navelbine well.
December 2013 scans show no sign of active cancer.
March 2014 - currently only on Herceptin - brain MRI clear, PET/CT two nodules in right lung show uptake
May 2014 - stop Herceptin.
Sept 22, 2014 Brain MRI clear :) PET/CT Progression in lungs.
Sept 2014, Xeloda, Tykerb and Herceptin.
Nov 2014 - Decide to take a break from all treatment.
May 2015 - Brain met radiated with Novalis
July 2015 - Have progression in right lung.
Sept 2015 - Perjeta and Herceptin alone after a 9 month break from all treatment.
Nov 2015 - Thoracentesis 1500ml removed from right lung.
Dec 2015 - Two tiny 1mm brain mets radiated in right cerebellum.
Feb 2016 - Thoracentesis 2200ml drained from right lung
Feb 2016 - Stopped Perjeta and Herceptin and started back on Kadcyla as I had no previous progression on it. After 1 cycle of Kadcyla markers begin to drop. On second cycle add Keytruda.
March 2016 - Thoracentesis 1650ml drained from right lung.
April 2016 – Thoracentesis 1500 ml drained from right lung.
June 2016 – CT scan shows progression in right lung, as well as moderate pleural effusion requiring Thoracentesis.
June 2016 – Decide to stop Keytruda, and will do chemosensitivity test through Rational Therapeutics. Plan to continue on Kadcyla for next two cycles.
July 2016 - Start weekly Abraxane with Herceptin. WBRT with hippocampal sparing, Taking Namenda. 15 sessions over 3 weeks.
Aug - Dec 2016 - 2 infusions of Navelbine, very hard on my body and still dealing with anasarca (generalized edema) 1 infusion of Havalen
My doctor wants to put me on hospice.
Dec 23rd 2016 - I am granted compassionate use of Neratanib.
May 31st 2017 - still on Neratinib, feeling good.
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Old 11-13-2014, 10:53 PM   #11
StephN
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

Hope this one will be effective for those who can get it.

There was a vaccine here at the U of W Tumor Group that was only for those with HLA A2. I took a specific blood test for that and was negative, so that vaccine was out for me. I know there were others on this board who also had their HLA tested and were also knocked out as they did not come up as HLA A2. I know I was not HLA A3 either.

The vaccine I did get did not hinge on any HLA testing or specific number.
__________________
"When I hear music, I fear no danger. I am invulnerable. I see no foe. I am related to the earliest times, and to the latest." H.D. Thoreau
Live in the moment.

MY STORY SO FAR ~~~~
Found suspicious lump 9/2000
Lumpectomy, then node dissection and port placement
Stage IIB, 8 pos nodes of 18, Grade 3, ER & PR -
Adriamycin 12 weekly, taxotere 4 rounds
36 rads - very little burning
3 mos after rads liver full of tumors, Stage IV Jan 2002, one spot on sternum
Weekly Taxol, Navelbine, Herceptin for 27 rounds to NED!
2003 & 2004 no active disease - 3 weekly Herceptin + Zometa
Jan 2005 two mets to brain - Gamma Knife on Jan 18
All clear until treated cerebellum spot showing activity on Jan 2006 brain MRI & brain PET
Brain surgery on Feb 9, 2006 - no cancer, 100% radiation necrosis - tumor was still dying
Continue as NED while on Herceptin & quarterly Zometa
Fall-2006 - off Zometa - watching one small brain spot (scar?)
2007 - spot/scar in brain stable - finished anticoagulation therapy for clot along my port-a-catheter - 3 angioplasties to unblock vena cava
2008 - Brain and body still NED! Port removed and scans in Dec.
Dec 2008 - stop Herceptin - Vaccine Trial at U of W begun in Oct. of 2011
STILL NED everywhere in Feb 2014 - on wing & prayer
7/14 - Started twice yearly Zometa for my bones
Jan. 2015 checkup still shows NED
2015 Neuropathy in feet - otherwise all OK - still NED.
Same news for 2016 and half of 2017. Boring ...
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Old 11-14-2014, 05:14 AM   #12
jaykay
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

I'm still looking for a vaccine trial that will also address those of us who are currently cancer free (scared to use the NED word).

The Neuvax Phase II is only for those with active cancer (if I'm reading it correctly).
__________________
March, 2000: 48, Post menopausal (5 yrs HRT) Left breast, IDC 3mm/DCIS 1.6cm, ER+/PR-/Her2+++, mod differentiated, MIB low, lumpectomy, node neg via SNB, rads=33 Stage 1a
June, 2000: Tamox 4.5 years,Femara for 5 years (end in Jan. 2010)
Sept, 2012: 61, Via mamm, ultrasound, biopsy, right breast, 2.3cm tumor, ER+/PR-/Her2+++, poorly diff, KI67 60-70%
BRCA 1 and 2 negative
October, 2012: Bi Mast with tissue expanders, port placement
Final Path: IDC 2.8cm, DCIS, 1/4 sentinal nodes positive (@#$%). Stage IIB
Nov 29, 2012: Begin TCH/6x/every 3 wks, H for 1 year/every 3 weeks.
March 14, 2013: Finished chemo
April 9, 2013: Begin radiation 28x
May 22, 2013: Finished rads
June 1st, 2013: Started Aromasin for 5 yrs.
July 15, 2013: Switched to Letrozole (Femara). Probably for the rest of my life
October 16, 2013: Exchange surgery
October 31, 2013: Finished Herceptin
December 5, 2013: Port removed
Glad this year is over!
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Old 11-14-2014, 09:46 AM   #13
'lizbeth
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

Quote:
Eligible breast cancer patients will be randomized to receive NeuVax + GM-CSF (granulocyte macrophage-colony stimulating factor) + trastuzumab or trastuzumab + GM-CSF alone in the adjuvant setting following surgery. The primary endpoint of the study is invasive disease-free survival and enrollment is expected to complete in the second half of 2016, followed by a 3-year follow-up period. There are three categories of high-risk patients that qualify for the trial:

Patients who received neoadjuvant therapy (before surgery) with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy but fail to obtain a pathological complete response (pCR) at surgery, regardless of hormone receptor status.
Patients who undergo surgery as a first intervention and are found to be pathologically node-positive with at least four positive lymph nodes, regardless of hormone receptor status.
Hormone receptor negative breast cancer patients who undergo surgery as a first intervention and are found to have one, two or three positive lymph nodes.
Jaykay, The vaccine is for those who are "NED" cancer free after initial treatment, but fall into 3 high risk categories.

Waterdreamer, that is better, funny. I will call you an "Impatient" because you are tired of dealing with cancer. I am HLA A2 positive, so am quite happy about Neuvax
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Old 11-14-2014, 05:59 PM   #14
thinkpositive
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

Jaykay, I'm with you. I wish I could join this vaccine trial. Because I had pathological complete response after responding to neoadjuvant treatment, I don't qualify.
__________________
8/2013 Diagnosed IDC Left Breast ER-/PR-/HER2+ Stage 3C, DCIS ER+/PR+/HER2- Right Breast (54 yr)
8/2013 PET/CT scan shows mass in uterues and suprclavicular nodes
8/20/13 Begin 6 rounds TCH chemo, Perjeta added for rounds 4-6
9/2013 After 1st round of chemo, mass in neck and breast no longer able to feel
11/2013 Hysterectomy, mass from PET/CT scan not cancer (adenomylosis)
12/2013 Finished chemo
1/2014 Double mastectomy with chest expanders
1/2014 Pathology report from surgery and SNB show complete pathological response!
3/2014 Finish IMRT radiation
8/2014 Fat transfer to radiated breast
8/2014 Completed 1 yr of Herceptin
10/2014 exchange surgery expanders removed implants placed
6/2015 3D nipple and areola tattoos
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Old 11-15-2014, 09:23 AM   #15
'lizbeth
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

Thinkpositive, keep working on the positive . . .

We should start another thread about pCR after neoadjuvant treatment and share the latest numbers. Perhaps the data is not out too many years in a large number of patients, but my expectation is that recurrence rates in this subset is extremely rare.
I understand about wanting to throw every treatment option at cancer (but the kitchen sink). There is the law of diminishing returns, and (like flying) the backside of the power curve, where the more you give (such as cancer treatments) the worse the situation becomes. There comes a time to accept good fortune, such as a complete response, and acknowledge the blessing of being one of the lucky ones with a great prognosis.

I personally am ready for vaccines to be approved. I've watched many women suffer through the trauma over a recurrence in the last 7 years since I've been diagnosed. And I've been with those who remained cancer free but suffered through the worry and anxiety about recurrence for years.

I was disappointed about the PRESENT trial only being for low expressors. Yet, I was excited for the ladies (and gentlemen) who got lumped into triple negative standard of care and were excluded from Her2 treatments. With interim data, 1 of 4 progressed within the control arm, and for 48 months no one progressed in the vaccine arm.

I believe we should be very excited when a subset is successfully treated, such as HLA A2 positive. We should be very excited when treatments cross over from breast cancer - to gastric cancer - to prostate cancer. What wonderful progress!

And by dividing and conquering, more and more researchers can focus on helping the subsets of us that need better treatments.

So if you are HLA A2 negative, it is not necessarily a treatment option that should be for the negatives, but find another positive marker that another subset has in common. Focus on treating that.

Another good reason to "Think Positive" . . .

Last edited by 'lizbeth; 11-15-2014 at 09:24 AM.. Reason: typo, as usual
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Old 11-15-2014, 08:21 PM   #16
jaykay
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

Don't get me wrong, I think it's great that they are expanding the phase 2 trial, but as think said, i don't fall into any of those categories and neither does she. Hope we don't have to wait too long...
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March, 2000: 48, Post menopausal (5 yrs HRT) Left breast, IDC 3mm/DCIS 1.6cm, ER+/PR-/Her2+++, mod differentiated, MIB low, lumpectomy, node neg via SNB, rads=33 Stage 1a
June, 2000: Tamox 4.5 years,Femara for 5 years (end in Jan. 2010)
Sept, 2012: 61, Via mamm, ultrasound, biopsy, right breast, 2.3cm tumor, ER+/PR-/Her2+++, poorly diff, KI67 60-70%
BRCA 1 and 2 negative
October, 2012: Bi Mast with tissue expanders, port placement
Final Path: IDC 2.8cm, DCIS, 1/4 sentinal nodes positive (@#$%). Stage IIB
Nov 29, 2012: Begin TCH/6x/every 3 wks, H for 1 year/every 3 weeks.
March 14, 2013: Finished chemo
April 9, 2013: Begin radiation 28x
May 22, 2013: Finished rads
June 1st, 2013: Started Aromasin for 5 yrs.
July 15, 2013: Switched to Letrozole (Femara). Probably for the rest of my life
October 16, 2013: Exchange surgery
October 31, 2013: Finished Herceptin
December 5, 2013: Port removed
Glad this year is over!
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Old 11-16-2014, 08:23 AM   #17
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

Oh . . . you mean that you two instantly "rained on my parade"?

I had forgotten about the HLA status. What does that mean anyway? So here is what I found on Wiki and I will be keeping an eye out for more information.

Quote:
HLAs serve as the primary link between the immune system and interior of cells. Thus any alteration to the HLA that induces decreased binding to a certain peptide or increased binding to a certain peptide, is expressed as, respectively, increased susceptibility to disease or decreased susceptibility to disease. In other words, certain HLAs may be incapable of binding any of the short peptides produced by proteolysis of pathogenic proteins. If HLAs bind none of the peptides produced by a pathogen, then there is no way for the immune system to tell that a cell is infected. Thus the infection can proliferate largely unchecked. It works the other way too. Some HLAs bind pathogenic peptide fragments with very high affinity. This in essence "supercharges" their immune system in regards to that particular pathogen, allowing them to easily control an infection that might otherwise be devastating.[5]
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Old 11-16-2014, 08:27 AM   #18
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Post Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

More information from Wiki on HLA

Quote:
Human leukocyte antigen
From Wikipedia, the free encyclopedia

HLA region of Chromosome 6
The human leukocyte antigen (HLA) system is the locus of genes that encode for proteins on the surface of cells that are responsible for regulation of the immune system in humans.

This group of genes resides on chromosome 6, and encodes cell-surface antigen-presenting proteins and has many other functions.

The HLA genes are the human versions of the major histocompatibility complex (MHC) genes that are found in most vertebrates (and thus are the most studied of the MHC genes).

The proteins encoded by certain genes are also known as antigens, as a result of their historic discovery as factors in organ transplants. The major HLAs are essential elements for immune function. Different classes have different functions:

HLAs corresponding to MHC class I (A, B, and C) present peptides from inside the cell. For example, if the cell is infected by a virus, the HLA system brings fragments of the virus to the surface of the cell so that the cell can be destroyed by the immune system. These peptides are produced from digested proteins that are broken down in the proteasomes. In general, these particular peptides are small polymers, about 9 amino acids in length.[citation needed] Foreign antigens presented by MHC class I attract killer T-cells (also called CD8 positive- or cytotoxic T-cells) that destroy cells.

HLAs corresponding to MHC class II (DP, DM, DOA, DOB, DQ, and DR) present antigens from outside of the cell to T-lymphocytes. These particular antigens stimulate the multiplication of T-helper cells, which in turn stimulate antibody-producing B-cells to produce antibodies to that specific antigen. Self-antigens are suppressed by regulatory T cells.

HLAs corresponding to MHC class III encode components of the complement system.

HLAs have other roles. They are important in disease defense. They are the major cause of organ transplant rejections. They may protect against or fail to protect (if down-regulated by an infection) against cancers.[1] Mutations in HLA may be linked to autoimmune disease (examples: type I diabetes, coeliac disease). HLA may also be related to people's perception of the odor of other people, and may be involved in mate selection, as at least one study found a lower-than-expected rate of HLA similarity between spouses in an isolated community.[2]

Aside from the genes encoding the 6 major antigen-presenting proteins, there are a large number of other genes, many involved in immune function, located on the HLA complex. Diversity of HLAs in the human population is one aspect of disease defense, and, as a result, the chance of two unrelated individuals with identical HLA molecules on all loci is very low. HLA genes have historically been identified as a result of the ability to successfully transplant organs between HLA-similar individuals.
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Old 11-16-2014, 08:31 AM   #19
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

This article from a couple years ago might explain it better:

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From OncoLog, January 2013, Vol. 58, No. 1
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Emerging Vaccines Take Aim at Preventing Recurrent Breast Cancer

By Joe Munch

Graphic: Disease-free survival
Kaplan-Meier plots depict disease-free survival for patients in the phase I and II trials of the E75 vaccine. Following standard treatment for breast cancer, patients were vaccinated with E75 and granulocyte-macrophage colony-stimulating factor or remained unvaccinated (controls).
Myriad advances have been made in the treatment of breast cancer, and cures are achieved in many patients. However, there are still patients whose cancer recurs, and most of these patients will die of their disease. This indicates a need for other therapies that can be used to prevent recurrent disease. One potential option is breast cancer vaccines.

“Breast tumors are made up of so many different types of cells that we have to use many different drugs and therapies to treat them,” said Jennifer Litton, M.D., an assistant professor in the Department of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center. “Vaccines come at the cancer in a totally different way than our current systemic therapies do.” Vaccines thus may augment the effects of adjuvant treatments currently used to forestall recurrence.

Potential clinical role

Several types of adjuvant therapy are used to prevent breast cancer from returning; the therapy or combination of therapies used depends on the individual patients and their disease. For example, radiation therapy is used for patients who have undergone breast-conserving surgery, and chemotherapy may benefit patients at high risk of recurrence. Hormonal therapy with tamoxifen or an aromatase inhibitor is used in patients with estrogen receptor–positive disease, and immunotherapy with trastuzumab is used in those with tumors that highly express human epidermal growth factor receptor 2 (HER2).

Today, several clinical trials are evaluating the use of breast cancer vaccines—not as an alternative to currently available preventive therapies for recurrent disease but as an additional adjuvant therapy.

“This is a novel approach specifically for people who want another form of therapy to decrease the chance of the cancer coming back,” Dr. Litton said. “People are looking for something extra that may improve their outcome but doesn’t expose them to a lot of extra toxicity.”

Peptide vaccines

Cancer vaccines stimulate patients’ immune systems to recognize and kill tumor cells. The vaccines consist of a tumor-associated antigen that, once introduced into a patient’s body, elicits an immune response. Several systems have been devised to deliver tumor-associated antigens into the body, including whole-cell vaccines, viral vector vaccines, and dendritic cell vaccines, which are custom made from the patient’s own white blood cells. The only therapeutic cancer vaccine currently approved by the U.S. Food and Drug Administration is sipuleucel-T (Provenge), a dendritic cell vaccine used in men with metastatic hormone-refractory prostate cancer.

The breast cancer vaccines being investigated at MD Anderson are of a fourth type, peptide vaccines. Peptide vaccines are made by taking a small amino acid sequence (peptide) from a tumor-associated antigen. The tumor-associated antigen most frequently used in breast cancer vaccines is the HER2 oncoprotein, which promotes tumor growth.

Once taken from the antigen, the peptide is mixed with an immunoadjuvant to help stimulate an immune response. The immunoadjuvant used in the trials being conducted at MD Anderson is granulocyte-macrophage colony-stimulating factor (GM-CSF), which has been used primarily to treat neutropenia in transplant recipients.

When the peptide–GM-CSF combination is injected, GM-CSF stimulates the dendritic cells in the area of injection to take up and process the peptide so that it can be better presented to the immune system. The length of the peptide dictates the type of immune cell it stimulates.

Current clinical studies

Several HER2-derived peptide vaccines are being studied in clinical trials at MD Anderson. Although the vaccines are based on a HER2 peptide, they have the most benefit in the 60% of breast cancer patients with low HER2 expression (1+ or 2+ by immunohistochemistry).

Phase III trial of E75

The E75 vaccine (NeuVax) is the most studied of the HER2-derived peptide vaccines. The 9-amino-acid peptide E75 binds with major histocompatibility complex (MHC) class I molecules to stimulate CD8-positive T cells; when these T cells recognize a target as foreign, they attack it and release cytotoxic enzymes to kill it. Because E75 is an MHC class I peptide, the vaccine works only in patients whose cells are positive for human leukocyte antigen (HLA)-A2 or HLA-A3; only cells with those HLA types will present the peptide on the cell surface to activate T cells.

In May 2012, Elizabeth Mittendorf, M.D., Ph.D., an assistant professor in the Department of Surgical Oncology, and her colleagues published the 24-month landmark analysis of their phase I and II trials of E75. The group’s findings opened the door to the phase III PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study, currently the only phase III trial of a breast cancer vaccine. Dr. Mittendorf is the overall principal investigator of the multinational study.

This randomized, double-blind, placebo-controlled trial will enroll approximately 700 breast cancer patients who were rendered disease free following standard treatment. Patients must be positive for HLA-A2 or HLA-A3 and have had cancers that were scored as HER2 1+ or 2+ by immunohistochemistry. The vaccine will be given once a month for 6 months and then given as a booster inoculation every 6 months thereafter through 3 years. Because GM-CSF causes inflammation at the injection site, it will be given to patients in each study group, serving as the immunoadjuvant for the vaccine group and as an active placebo for the control group. The primary endpoint of the study is 3-year disease-free survival.

Positive results from this trial, researchers hope, would eventually lead to indications for the E75 vaccine in the routine care of breast cancer patients. “We are all cautiously optimistic—and excited—as we wait for the results. If they do show that E75 has significant benefit, it could be an amazing opportunity for our cancer patients,” Dr. Litton said.

Phase II trial of GP2 and AE37

The GP2 vaccine works in much the same way as the E75 vaccine. Like E75, the GP2 peptide is 9 amino acids long and binds to MHC class I molecules to stimulate CD8-positive T cells; thus, the vaccine works only in patients who are positive for HLA-A2 or HLA-A3. In contrast, the AE37 peptide, which is longer than the E75 and GP2 peptides, binds to MHC class II molecules and stimulates CD4-positive T cells, thereby eliciting a more robust immune response. Although MHC class II peptides can be HLA-restricted, AE37 is a promiscuous peptide, meaning that blood cells of almost any HLA type can present it. In addition, the AE37 peptide is paired with the Ii-Key protein, which enhances the presentation of the peptide to the immune system.

Both the GP2 and AE37 vaccines are being investigated in an ongoing phase II trial to determine whether the individual vaccines can prevent the recurrence of node-positive or high-risk node-negative breast cancer. Patients are sorted into groups depending on their HLA status and then randomly assigned to receive the appropriate vaccine plus GM-CSF or GM-CSF alone (as the control).

The AE37 trial’s planned interim analysis revealed that at a median of 22 months, the recurrence rate in the vaccinated patients was 10.3%, whereas the recurrence rate in the control group receiving only GM-CSF was 18.0%. The difference represents a 43% reduction in recurrence rate.

“These data are encouraging,” Dr. Mittendorf said. “Obviously, we need longer follow-up, and we need to finish accrual in the trial, but the data suggest that it is reasonable to look forward to investigating the AE37 vaccine in a phase III setting.”

The interim results for the GP2 vaccine are not yet available.

Potential benefits

One of the benefits of peptide vaccines such as those being investigated at MD Anderson is that they can be given “off the shelf.” This makes them more convenient and less expensive than the custom-made dendritic cell vaccines.

Dr. Litton, who has referred a number of patients to the breast cancer vaccine trials, said that patients’ enthusiasm about participating in a vaccine trial has been overwhelmingly positive. “Some patients tell me that they feel empowered by using their own bodies, their own immune systems, to fight the cancer,” she said.

But the main reason the trials are so popular with patients is that the vaccines offer a potential anticancer benefit with very little risk of toxicity. Most patients have a grade 1 or 2 local toxic response, which means redness at the injection site; and some patients experience grade 1 or 2 systemic symptoms, mostly in the form of minor flu-like symptoms for 4–6 hours after receiving the vaccine.

“These are people who have gone through chemotherapy, lost their hair, and had terrible gastrointestinal side effects, toxicity in their nails, and all those other things,” Dr. Mittendorf said. “So a treatment that is basically not toxic is very attractive.”

Dr. Litton echoed Dr. Mittendorf’s sentiments. “It has not been a hard trial for people to become interested in. In fact, I’ve had several people come from different parts of the country just to be part of the trial,” Dr. Litton said. “And we really appreciate all the patients who have stepped forward to participate. It’s always important to encourage people to participate in clinical trials; otherwise we could never move forward with therapies such as this.”

These vaccines are not for everyone, however. Earlier clinical trials revealed that the peptide vaccines had limited efficacy in patients with late-stage, metastatic breast cancer.

“There’s a long list of reasons why these vaccines are not set up to be administered to patients who have diffusely metastatic disease,” Dr. Mittendorf said. “It would be difficult, with a peptide vaccine, to mount enough of an immune response to eradicate bulky disease. The microenvironment and immune environment around tumors change as tumors progress, so bulky metastatic tumors also have a less favorable environment for the immune system to function in. And a lot of patients with diffusely metastatic disease have received multiple lines of chemotherapy, which we suspect has a detrimental effect on the immune system.”

Future directions

The future of breast cancer vaccines holds many possibilities. Antigens such as cyclin E and folate-binding protein may be targeted for vaccination. Novel immunoadjuvants are being developed that may elicit an immune response more potent than that elicited by GM-CSF. And new approaches using vaccines and harnessing other aspects of the body’s immune system against recurrent breast cancer may be forthcoming.

“I would like to see some of these vaccines combined with other exciting immunotherapies that are coming on board,” Dr. Mittendorf said. For instance, a vaccine could be paired with a drug that inhibits CTLA-4, a protein that downregulates T cells. “Ipilimumab, an antibody that targets CTLA-4, could be used to take the brakes off the immune system. A vaccine would stimulate the T cells, and the anti–CTLA-4 treatment would allow them to proliferate,” she said.

Eventually, such vaccines could be used to treat patients much earlier in the course of their disease. “I think it would be an exciting route to look forward to in the frontline setting as well,” Dr. Litton said. “We could potentially cure more people up front at the time of diagnosis.”

FURTHER READING

Mittendorf EA, Alatrash G, Xiao H, et al. Breast cancer vaccines: ongoing National Cancer Institute–registered clinical trials. Expert Rev Vaccines 2011;10:755–774.
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Old 11-16-2014, 08:37 AM   #20
'lizbeth
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Re: YES!!! It is here. Phase II vaccine trial for Her2 3+

Oh, so here is the one for you JayKay, and I quote:

Quote:
The GP2 vaccine works in much the same way as the E75 vaccine. Like E75, the GP2 peptide is 9 amino acids long and binds to MHC class I molecules to stimulate CD8-positive T cells; thus, the vaccine works only in patients who are positive for HLA-A2 or HLA-A3. In contrast, the AE37 peptide, which is longer than the E75 and GP2 peptides, binds to MHC class II molecules and stimulates CD4-positive T cells, thereby eliciting a more robust immune response. Although MHC class II peptides can be HLA-restricted, AE37 is a promiscuous peptide, meaning that blood cells of almost any HLA type can present it. In addition, the AE37 peptide is paired with the Ii-Key protein, which enhances the presentation of the peptide to the immune system.
Somehow I find it very amusing that they chose the racy term "promiscuous peptide" for AE37 - for those who are HLA A2 negative. Not only is there something out there for you, and it isn't just your ordinary peptide,
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