NeuVax is only for Her2+ right?

I'm wondering how this would apply to Her3+ in ILC sub-types....don't know enough about any of it to date.

@Hopeful, which trial are you doing?

Vaccines across all cancer types have struggled in the last few years, especially when compared to the great strides made with immune checkpoint inhibitors and the promise of CAR-T / engineered T-cell receptor approaches. The real payoff will likely be when combining vaccines with these other immunotherapy approaches.
NeuVax is interesting though. I seriously hope it works since breast cancer needs to the lose the "nonimmunogenic" reputation.
With over 700 patients, the "PRESENT" clinical trial is the most significant, since it's a Phase III trial. (first one below)

Here's a short video from March 2016 where Dr. Elizabeth Mittendorf (MD Anderson) discusses NeuVax in relation to finding biomarkers of response.

Here's a simple breakdown of the four NeuVax vaccine clinical trials:

1. Prevention of Recurrence in Early-Stage, Node-Positive patients with Low to Intermediate HER2 Expressions With NeuVax Treatment (PRESENT trial)
Estimated Enrollment: 700
Study Start Date: November 2011
Estimated Study Completion Date: April 2025
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
UPDATE - June 29, 2016: Trial has been cancelled. NeuVax was unable to prevent recurrence in this clinical trial.
Source: Galena website - https://globenewswire.com/news-release/2016/06/29/852251/0/en/Galena-Biopharma-Discontinues-NeuVax-nelipepimut-S-Phase-3-PRESENT-Interim-Analysis-based-on-Independent-Data-Monitoring-Committee-Recommendation.html

2. Phase II Trial of Combination Immunotherapy with Nelipepimut-S + GM-CSF (NeuVax) and Herceptin in High-risk HER2+ Patients
Estimated Enrollment: 100
Study Start Date: October 2014
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

3. Combination Immunotherapy with Herceptin and the HER2 Vaccine E75 in Low and Intermediate HER2-expressing Patients to Prevent Recurrence
Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

* Target population: Node-positive (or Node-negative, if both ER- and PR-) patients with HER2 1+ and 2+ expressing tumors who are disease-free after standard of care therapy

4. Phase II Trial of Nelipepimut-S Peptide Vaccine in women with DCIS (VADIS Trial)
Estimated Enrollment: 108
Study Start Date: March 2016
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)

Breaking news released today.

The NeuVax Phase 3 clinical trial (PRESENT) has been stopped (cancelled). NeuVax was unable to prevent recurrence in this clinical trial.
The Independent Data Monitoring Committee (IDMC) recommended that the PRESENT clinical trial be stopped due to futility.

I'm not sure how this affects the other three trials, but it might be wise to check in with your Oncologist ASAP.

Source: Galena website - https://globenewswire.com/news-release/2016/06/29/852251/0/en/Galena-Biopharma-Discontinues-NeuVax-nelipepimut-S-Phase-3-PRESENT-Interim-Analysis-based-on-Independent-Data-Monitoring-Committee-Recommendation.html

This is a monumental disappointment.

Hi Hopeful, on June 1 Galena posted the news about fast track designation for NeuVax PRESENT Clinical Trial, i.e. the trial that was cancelled today:

Fast Track for NewVax PRESENT Trial

You're absolutely correct, Muska; that is the same trial that was cancelled today. As ErenTo stated, this does not make any sense at all. I'm really curious to hear what our study coordinators come up with. Although they're not involved in this particular NeuVax trial they're pretty well in the loop as far as all of the various NeuVax trials.

muska, I think you're right. I still don't understand how they could get approval from FDA to fast track this before IDMC's analysis and recommendation was finalized. Some people must have made a lot of money with buying and selling Galena shares within the right window...

My search leads me to mostly investment sites who were watching this drug. I came across this one which is not only disappointing, but also scary.

The IDMC, after evaluating interim data from the Phase 3 program (the PRESENT study), determined that the breast cancer vaccine was ineffective at stopping the resurgence of tumors compared to the placebo group. The committee's short letter to Galena in regards to the futility of NeuVax as a cancer treatment actually suggests that the drug might have performed worse than the placebo during the trial.

http://www.economiccalendar.com/2016/06/30/galena-...

Also from the link:

It appeared as though NeuVax did not respond to cancer cells with high expression levels of HER2 – but worked best against those with low-to-intermediate levels of HER2.

I thought PRESENT trial was for low to intermediate HER2 expression? Not sure I'm very clear on this. Granted it's not a scientific writing, I'd be curious what the data looked like.

Interesting stuff. I like to know how their other trials are going, hope they're more promising than this one