Vaccines: Will they become a form of Secondary and Primary Breast Cancer Prevention?

March 14, 2024

Our guest speaker Lee Gravatt Wilke, MD, Senior Medical Director at the University of Wisconsin School of Medicine and Public Health, explains the current state of vaccine clinical trials in breast cancer followed by a review of the STEMVAC trial, design of the vaccine, and the current state of the accrual and next steps.

Key Takeaways from Webinar Viewers:

  • Vaccines are more complex than drugs in their development due to the three components (finding protein, packaging it, and finding the right immuno response) and may take longer to develop.
  • Clinical trials are important and hope patient navigators and advocates can explain the importance of clinical trials and their pros and cons help ease the fears of participation.
  • Vaccines are gender nonspecific and cater to the cancer’s specificity – it would be non-binary.
  • Vaccines are being tested in cancers and look on clinicaltrials.gov if you are interested in this approach.

00:00:00:00 - 00:00:24:03
Unknown
Welcome, everyone. Just going to give it a a few more moments as people are coming in and then we'll get started. Welcome, Welcome.

00:00:24:05 - 00:01:00:11
Unknown
All right. Well, hello. Hello, everyone. Welcome to today's webinar. Vaccines, will they become a form of secondary and primary breast cancer prevention? I'm making clear Chase and I'm Cher's breast cancer program director and the host of our Busy Life podcast. Plus, I'm a seven year invasive lobular survivor. All right, now the chat is open, so feel free to tell us where you're joining from today.

00:01:00:13 - 00:01:39:19
Unknown
Now, before the presentation begins, I'd like to tell you a little bit about Share. We're a national nonprofit that supports, educates and empowers anyone diagnosed with breast or gynecologic cancers and provides outreach to the general public about signs and symptoms. Because no one should have to face breast, ovarian, uterine, cervical or metastatic breast cancer alone. For more information about upcoming webinars, support groups, podcast and our helplines, please visit our website at Scheer Cancer Support dot org.

00:01:39:21 - 00:01:48:12
Unknown
Now we do have a few housekeeping reminders for you.

00:01:48:14 - 00:02:13:13
Unknown
All participants will be needed during the presentation. Now, again, as I mentioned, the chat is enabled, so feel free to write comments and engage with each other. But make sure to select everyone when you're using the chat so that everyone will get a chance to see what you have to say. Now, once our fabulous speaker, Dr. Wilkey, finishes presenting, we'll begin the Q&A discussion.

00:02:13:13 - 00:02:39:18
Unknown
So please submit any questions through the Q&A section at the bottom of your screen. Now, remember, our speaker today is unable to give specific medical advice, so please keep your questions general in nature. We also have closed captioning available. You can enable this feature by clicking the live transcript button on the bottom of the screen and selecting the subtitle option.

00:02:39:19 - 00:03:01:16
Unknown
This webinar is being recorded and we'll share the recording in a few weeks with all the registrants and it'll also be added to our website. So now I'd like to hand it over to our fabulous speaker, Dr. Wilkie, to introduce herself. Dr. Wilkie, this screen is yours. Thank you. My pleasure. Really appreciate it. Hopefully everyone can hear me.

00:03:01:16 - 00:03:32:03
Unknown
Okay. So I am a professor of surgery. I focus now primarily on breast cancer and I'm our senior medical director of clinical cancer services, which means I oversee and of all of the cancer service line here at UW Health Carbon Cancer Center. I am a passionate about clinical trials and also innovation and have actually developed a new technology for breast surgery.

00:03:32:05 - 00:04:06:21
Unknown
And more importantly, I think I'm a mother of two adult sons. I enjoy traveling and I do enjoy getting on the peloton bike in the morning. I am now going to share my screen to start with some slides because everyone's seeing my slides appropriately perfect. Thank you. So I want to start with some disclosures. I am a founder of a company, but I will not be discussing that technology today.

00:04:06:21 - 00:04:34:17
Unknown
And I'm a principal investigator for another company's technology. Again, not going to discuss that technology, but I think it's really important to recognize that I am not a vaccine expert. I am the site principal investigator for the STEM back trial. And I have learned an immense amount from this wonderful individual, Dr. Nora Desus. She's at the University of Washington in Seattle, and she's their cancer Vaccine Institute director.

00:04:34:19 - 00:05:11:05
Unknown
And I will say she is brilliant. And somebody that has is really going to revolutionize how we think about vaccines and cancer. So I always like to start with a little bit of a vignette about what is cancer. We know that our body's cells divide and move through a process of division, activity and then death. But in cancer, we find that that activity becomes uncontrolled and then can lead to uncontrolled growth, whether it's in a breast or a lung or brain.

00:05:11:07 - 00:05:39:06
Unknown
And I'll have to say that I liken cancer's growth to a lot of teenagers and wild kids. They've lost their frontal lobe, don't know where they're supposed to be and are not staying at home in their room. So many factors influence cancerous growth. It is a development from normal cells. It can be influenced by our DNA and our RNA, the process of DNA moving into RNA.

00:05:39:08 - 00:06:16:22
Unknown
It can be influenced by external factors, internal factors, things like virus, radiation and hereditary. And then it can be influenced by changes in the DNA that influence how a cell knows to die or live and grow in an uncontrolled fashion. We're learning a lot in the last 20 to 30 years about what's called the micro environment. The cells that are around the cancer and how they influence them, whether it's blood vessels or lymphatic channels, whether it's the immune cells such as the T cells or the B cells.

00:06:17:00 - 00:06:40:16
Unknown
And then how does the immune system interact with cancer? Does it let it grow in an uncontrolled fashion or does it control it and prevent it from growing? I always like to highlight the World Health Organization maps of the incidence age standardized across the world for breast cancer. The most recent map from the World Health Organization is 2020.

00:06:40:18 - 00:07:03:17
Unknown
I do imagine because of the pandemic, we'll see changes in this in the coming years. But I also want to highlight the age standardized mortality rates and nodes that are mortality rates don't match our incidence rates. And it is the reason that we really need to be thinking about diverse populations as we think about our treatments and approaches to cancer.

00:07:03:19 - 00:07:33:03
Unknown
I'll highlighted again from a U.S. and national imperative that the five year relative survival rates by stage, race and ethnicity vary, and we need to be working to try and equalize this across all groups and individuals. I actually like a lot of the slides that present equality and equity, but I prefer a liberation. Let's take down the walls and make it equal for everyone to see, play and participate in the process.

00:07:33:05 - 00:08:00:00
Unknown
I'm going to do a little education around clinical trials and their phases and the development of new cancer treatments. I've highlighted this in a simple way to show that we move from the lab, cellular evaluation in the lab to animal studies, sometimes large animal studies, and not just mice. And then we move into these three phases of clinical trials Phase one, two and three.

00:08:00:02 - 00:08:25:11
Unknown
Phase one includes a very small number of patients, making sure a new treatment is safe and understanding what the dose is appropriate for humans versus mice. Then, looking at efficacy and short term outcomes, can we determine is there a signal, Is this treatment working? And then we get to phase three large populations, comparing the new treatment to the old treatment.

00:08:25:13 - 00:09:01:03
Unknown
Now, because I'm a surgeon, I always like to show the evolution of surgery and clinical trials, especially for sentinel node surgery or axillary node dissection. I started my career doing axillary node dissections and they were morbid and unnecessary and I am so thrilled that we were now through multiple clinical trials getting to the point of central node mapping, just taking the nodes we need to identify to see if the cancers move and then eventually maybe not even looking at lymph nodes because maybe we'll have a blood test to tell whether a cancer has moved.

00:09:01:05 - 00:09:30:11
Unknown
The timeline of drug development and breast cancer has been dramatic. Just look at this. Since the 1970s, we've seen a dramatic change from what's called docs Aruba Center, or the Red Devil through a large number of optional drugs for different types of breast cancer, moving through targeted drugs, immunotherapy and many others are coming down the pike now. My talk today is about vaccines.

00:09:30:12 - 00:10:04:19
Unknown
And so what I want to highlight is the impact vaccines have had on public health. And I'll confess, Dr. de CES gave me a few of these slides, so you'll see that they say the other UW or UW in Seattle and it is dramatic the impact that vaccines have had on diphtheria, measles, polio, smallpox. These diseases have been eradicated because individuals were given a vaccine ahead of them getting the disease.

00:10:04:21 - 00:10:38:17
Unknown
So that we could prevent the disease from happening. So how does the vaccine work? Well, our immune system is dependent on two types of responses a type one response and a type two response. A type one response creates cells to really recognize that disease in a repetitive fashion versus the type two response, which may recognize it and then allow it to be considered normal.

00:10:38:19 - 00:11:05:12
Unknown
That's the type of response that may allow a cancer to grow because it all of a sudden sees it itself, i.e. that or an agent, whether it's a virus, a bacteria or a cancer. So what we really want is a type one response. Now, I put a slide in here to highlight that vaccine development is complicated and I'm going to try and walk us through the pieces of the puzzle.

00:11:05:14 - 00:11:19:00
Unknown
Not unlike relationships. So relationships are complicated, whether it's with spouses or family members or children. And vaccine development is just as complicated.

00:11:19:02 - 00:11:50:10
Unknown
So what are the key components that we need to make a vaccine? And why haven't we done it before now? Because we've had vaccines for smallpox and diphtheria and polio for generations. Well, the key components of a vaccine are three fold. One, we need a protein that is specific to the cancer that will be recognized as foreign by the patient's immune system.

00:11:50:12 - 00:12:14:12
Unknown
Well, a lot of our we need a lot of ourselves. So we don't want to tell the vaccine to hurt all of our normal cells. So we have to find something that's specific to the cancer. Now, one thing I'll highlight about cancers is that they're unique to the person that has them. Unless you're an identical twin, cancers don't look alike in people.

00:12:14:17 - 00:12:44:17
Unknown
They may have similarities, but they definitely have unique features for every individual. So finding that immunogenic protein can sometimes be difficult. Then we need to show the protein to the immune system and convince the immune system that every time they see that protein, they're going to fight it and not consider it normal. And then we need an adjuvant or a booster to augment the immune system when it does see that antigen or protein.

00:12:44:19 - 00:13:17:18
Unknown
So it's complicated. We need three key components. So let's walk through them a little bit more in-depth. So one example of an antigen or a protein that can be used that is being used in vaccine technology is something called her two. It's overexpressed in about 30% of breast cancers. And there was a study done in 2016 of about 100 volunteer women and 100 untreated patients with DCIS and 500 with invasive breast cancer.

00:13:17:20 - 00:13:52:05
Unknown
These individuals were just tested for antibodies against the her two protein. They're individuals who'd never had cancer, were found to have antibodies against her to actually HER2 is normal on some of our cells and it's being discovered in other cancers in an overexpressed way like breast cancer. It was also discovered that in the individuals with DCIS and invasive cancer that a high level of her two specific antibodies was independently associated with recurrence free survival.

00:13:52:07 - 00:14:20:07
Unknown
So here we're seeing that that protein, in addition to a person's immune system, was maybe some booster we don't know about in this study, was able to protect patients from their cancer. So now let's talk about presenting the antigen. How do we present it? Well, lots of different vaccines have been developed, and this is just a summary of the different types.

00:14:20:09 - 00:14:53:08
Unknown
There are something called cell based vaccines. They're expensive and difficult to produce. And you need to control how that protein is presented because they can cause a lot of normal reaction, i.e. your immune system gets revved up to fight your normal cells. Protein or peptide based vaccines have low toxicity. They're easy to produce like that her two peptide, but they don't really rev up the immune system as well.

00:14:53:10 - 00:15:21:00
Unknown
And you have to have a certain feature of your immune system to be eligible to receive certain of these protein or peptide vaccines. Viral or bacterial based. So can we put the protein in a virus, give the virus to the patient, make sure the virus doesn't cause any problems, but then create an immune reaction to that protein. It has a potential of high toxicity and it can cause some undesired infections.

00:15:21:02 - 00:15:42:00
Unknown
Then what about gene based vaccines? We've all learned a lot about an RNA vaccine based approach through COVID. But what about DNA vaccines? They're easier to deliver these RNA or DNA vaccines, but you have to transport them specific. Likely we learned with the COVID vaccine they had to be kept cold. Right, until you gave them to the patient.

00:15:42:02 - 00:16:12:14
Unknown
And they sometimes are poorly immunogenic. They don't do number two, they don't rev up the immune system. So the presentation isn't as effective. Then what about packaging? Boy, this is a confusing diagram on the left, so I'm hoping it seems a little bit easier on the right. But packaging the antigen is very important because you don't want to lose the protein as it goes into the body and you want to make sure that it's shown to the T cells in the correct manner.

00:16:12:14 - 00:16:39:04
Unknown
That type one response versus that type two response. So how you package it with what's called TLR or PRR or sealers is very important to ensure that we're packaging it in the correct way. So the immune system sees it in the right way. We don't cause damage to normal cells and we don't cause infection. So what's been done in this space so far?

00:16:39:06 - 00:17:13:10
Unknown
So there have been three primary therapeutic vaccine trials. I'm sure there are others. These are the main ones that I was able to pull out where protein and or epitope or or the HER2 class one a restricted peptide vaccine were developed. Large numbers of patients have received these, but like most drug trials, they started with patients with metastatic disease.

00:17:13:12 - 00:17:48:07
Unknown
They were randomized to placebo versus the the antigen agent or the vaccine, and some of them had nine injections. Then some, some of them extended the CU 12 week injections. The HER2 based peptide vaccine was given monthly times six, then. Q six months to 36 months. Unfortunately, all three of these showed no difference in overall survival and recurrence free survival, and one of them was stopped early due to futility due to the no difference in disease free survival.

00:17:48:08 - 00:18:17:04
Unknown
The problem was they probably started with more advanced disease and it really is hard to present and rev up your immune system in a really dramatic way to a cancer that's probably morphed into multiple different types as it's become metastatic. So what went wrong and what went right? So the use of single antigens or proteins may not have been immunogenic enough, it may not have revved up the immune system enough.

00:18:17:06 - 00:18:44:03
Unknown
The majority of patients had advanced or metastatic disease and there was minimal long term memory like the immune system didn't stay revved up enough to recognize that antigen again, and potentially they needed to combine treatments. Maybe it should have been a vaccine plus chemo or immunotherapy. What went right, though? There was minimal toxicity, just injection reactions. Like a lot of people get from vaccines.

00:18:44:05 - 00:19:10:03
Unknown
And there was a small signal there was a 9% response rate. When you look at all of these trials, 21 studies and about 28 patients. And so a lot was learned from these early trials. So that leads me to say we're at a tipping point for cancer vaccines. We now know we think we know the type of immune response we need to kill cancer.

00:19:10:05 - 00:19:37:19
Unknown
We know how we need to stimulate the immune system to continue to have it a memory to recognize those proteins. And we think we know how to package it to make it more effective. So I want to highlight that the infectious disease approach is probably the better approach, which is not what we've done in these previous trials, i.e. we've treated people with disease.

00:19:37:21 - 00:20:17:17
Unknown
What about treating them before they get the disease? So as you look at some of the trials of DCIS or ductal carcinoma in situ, which is an early stage form of breast cancer and try and identify patients with HER2 positive disease, not a frequent subtype, but does happen, not something we commonly test for. The first trial was a very intensive trial, injecting in the groin lymph nodes, the dendritic cell primed peptide vaccine, dendritic cells or those tumor microenvironment cells that know how to present antigens.

00:20:17:19 - 00:20:51:05
Unknown
And about 18% of the patients when they had surgery for their DCIS had no residual DCIS said surgery, and 11 of 22 had no detectable HER2 expression, which mean that means the vaccine had a signal. In another trial that was just published this past year, a phase two trial. Looking for that signal. It's determined to be safe. Patients were randomized to a GM CSF, which is like a booster to with the vaccine or gmc's alone.

00:20:51:07 - 00:21:23:04
Unknown
They only got two vaccine doses prior to surgery. And what was interesting is just the booster. The Gmc's said it in addition to the vaccine, seemed to show in the blood a benefit to an anti her to immunologic memory. So the UW Vaccine Institute, led by Dr. Jesus, is developing technologies to allow development of the vaccine that elicits a stronger anti-cancer response.

00:21:23:06 - 00:22:04:19
Unknown
We really need to find the proteins that drive the cancer that won't listen to response to normal cells and then package them into a vaccine that's well-tolerated and hopefully doesn't need to be given multiple, multiple times. So for the STEM back study, which is the one where I have been the kind of principal investigator here at UW Madison, what Dr. Jesus has found is a series of stem cell proteins that seem to be immunogenic and seem to have Ms. enlisted immune response.

00:22:04:21 - 00:22:41:14
Unknown
And as I noted, we start in mice. And so when this study was started in mice with five stem cell proteins in a triple negative background, not a HER2 background, it was effective in preventing breast cancer in mice. So not metastatic disease. But again, that pre treatment, infectious disease type approach. So the STEM back vaccine then moved to a phase one trial to figure out what dose should you give in humans not mice.

00:22:41:16 - 00:23:14:15
Unknown
And there were three doses tested most patients had late stage cancer because again you don't want to test something in a large population but you want to see a signal. And so it was tested in the metastatic patients, not anticipating that they would get a significant benefit from it, but to see if they created antibodies to these five stem cell proteins and three vaccines were given one month apart with boosters at three and nine months.

00:23:14:17 - 00:23:43:11
Unknown
And the booster seemed to increase the level of response. And there were very high levels of stem back immunity against those five proteins. So actually now this STEM back type packaging and approach of a DNA vaccine that seems to mount the type one response is being tested in breast cancer patients, as well as non-small cell lung cancer patients.

00:23:43:13 - 00:24:14:13
Unknown
And in you can see in these other cancers, the other potential antigens and proteins that might be able to be targeted to develop into a vaccine approach. So the STEM back trial is a phase two trial. It's overseen and run by the National Cancer Institute, the Division of Cancer Prevention. So here's where that prevention approach is coming in for vaccines.

00:24:14:15 - 00:24:45:11
Unknown
It's a monthly injection times three, then two boosters at six and 12 months. The primary end point. So always important to recognize that in clinical trials, what we're looking for is a signal. What's the immune response to those five antigens? How big is that immune response and how long does it last? So in this clinical trial, the injections are fairly well tolerated.

00:24:45:11 - 00:25:15:06
Unknown
Again, injection site reaction is something that we anticipate, but the main component of the clinical trial is drawing blood. One of the really neat things about clinical vaccine clinical trials is there's minimal toxicity. It's not a new drug. It's not an immunotherapy that can sometimes cause side effects. It's primary the primary focus of these trials is drawing blood.

00:25:15:06 - 00:25:40:19
Unknown
So there is that kind of downside or the risk of having blood drawn, but it doesn't necessarily have any long term side effects. Hopefully the long term side effect is an immune response so that when the patient's body sees that cancer again, it fights it and prevents it from growing. This trial has an accrual goal of about 33 patients.

00:25:40:19 - 00:26:17:00
Unknown
We are considering expanding it because we would like to make sure for triple negative cancers where individuals who identify as black may have and do have a higher incidence of triple negative disease. So we are looking to potentially expand the population to ensure that we have enough individuals from that racial background. Six patients have completed all injections are in and are in follow up and it's being done at three sites UW in Seattle, Johns Hopkins and here at UW in Madison.

00:26:17:01 - 00:26:50:11
Unknown
That gives us the two coasts in the Midwest. I'd now like to take any questions and thank you for your attention, and I'm happy to entertain more discussion around vaccines, their use and prevention in prevention. Thank you so much, Dr. Wilkie. So everyone, we're going to start the Q&A component and you can still sit in any questions via the Q&A button at the bottom of your screen.

00:26:50:11 - 00:27:14:08
Unknown
But we did get a lot of questions submitted with registration and, you know, as you were going through your presentation, I couldn't help but think of the movie World War Z with Brad Pitt and thinking of having to like, you know, this vaccine, like inject yourself with with the, you know, the killer dose and make it so then you'll become invisible to the disease.

00:27:14:08 - 00:27:44:03
Unknown
Right. And so we got a lot of questions around and you did talk about this was once you can go a little bit further and you know, for those that are stage three or stage four metastatic, what can we say to them? As well as can't breast cancer vaccines are, you know, coming to fruition? How do we you know, because a lot of us in the early stage community, we do worry about recurrence.

00:27:44:03 - 00:28:17:13
Unknown
We do worry about eventually, you know, one day becoming metastatic. Where do we fare in the development of breast cancer vaccines? Where can we fit in? Great, great question. So I think about it in three phases. So you have primary prevention. Can we take high risk individuals, identify a series of proteins and vaccinate them and hope that the type of cancer they develop will have that protein feature and they'll create an immune response to it?

00:28:17:14 - 00:28:52:08
Unknown
Then there's what's called secondary prevention, which is what this clinical trial is doing, is taking primary features from stem cells, from triple negative breast cancer, taking individuals who've completed primary therapy, chemotherapy, radiation surgery, radiation if needed, and vaccinating them so that we can prevent recurrence. So that's what I think about is secondary prevention versus primary prevention. And then there's those with late stage disease that already have metastatic.

00:28:52:10 - 00:29:24:00
Unknown
And as we think about that patient population, we probably where the process is going is can we take their cancer, identify the proteins they have, and develop an individualized vaccine. The problem with, you know, most the old the older vaccines that had the inert virus, you know, the smallpox or the inert virus did create more of a of a kind of toxic response at times.

00:29:24:02 - 00:29:55:09
Unknown
And so or use live virus and a lot of cancer patients can't receive, let's say, live virus because then they'll get an they may be immunosuppressed and they can't respond to the virus. So you don't want to package it in a virus and you have to find the right way to package it, their disease, their cancer, that it doesn't get seen as that type two response that it is a So they let it be seen as normal and you have to create an immune response to it.

00:29:55:11 - 00:30:26:03
Unknown
It's complicated. The metastatic disease, which is complicated, that's why we're seeing it move into can we think about primary prevention and can we think about more importantly, what everybody's starting with is secondary prevention, preventing a recurrence? Yeah. So how does the vaccine effectiveness change with a weakened immune system? For example, older patients or those who've received prior chemotherapy?

00:30:26:03 - 00:30:58:14
Unknown
And even with your trial, like what was the age range? Yeah, what a fabulous question. What a great directed question it is. One of the reasons for this trial, the patients needed to have completed active therapy and have essentially a normal immune system as much as possible. We had a range of white blood cell counts and function that was allowable.

00:30:58:16 - 00:31:32:09
Unknown
I think there are definitely patients that their immune systems may not be back to normal after chemo, but by basic blood counts, they look rallied. They're within a normal range. The age range for most clinical trials is broad, and this one was just as broad. You could be age 18. We usually don't include pediatric patients and pediatric breast cancer, quote unquote, under the age of 18 is rare and up to 70, 80, sometimes 90.

00:31:32:10 - 00:31:52:04
Unknown
I can't a funny you've asked me that question. I can't remember the exact age range. So please don't quote me. But I know it was at least up to age 70, potentially 80, and I should know the answer to that. I'm going to get in trouble for not knowing that. But you're exactly right. And it's one of the reasons that you give multiple injections.

00:31:52:06 - 00:32:17:07
Unknown
So multiple exposures at different times. All of us know that our bodies are different at different times of the day, different times, different weeks. You know, we may have been exposed to a little cold. We may be feeling fatigued. So we know our immune systems function differently throughout days and weeks. So that's why you want to give the booster at different times, hoping the immune system is functioning.

00:32:17:09 - 00:33:02:12
Unknown
You'd love it to be functioning perfectly every time you gave it, but anticipating that there's variability. So by giving it multiple times, hopefully you're catching it at different functionalities. I hope that made sense. It it also makes me wonder. I'd love to. That question is what happens with this vaccine ideally still work if you develop other comorbidities or you know you now have other illnesses that stem from the the primary cancer, like would it still be affected because wouldn't that also affect your immune system?

00:33:02:14 - 00:33:45:17
Unknown
I think we've learned a lot from infectious vaccines, especially in the last several years, that everybody responds differently and your additional medical conditions can impact that. And so I don't think we know enough about cancer vaccines to know how the additional comorbidities will impact the effectiveness of the vaccines. The hope is that by multiple injections, hopefully not too many, you create enough of immune response and memory of that immune response that it's able to be drawn back up when you need it.

00:33:45:19 - 00:33:59:14
Unknown
But if you happen to need it is a time that you're having, you know, congestive heart failure or COPD or lung failure, will it function the same? We don't know.

00:33:59:16 - 00:34:38:16
Unknown
So I know that because I always want to make sure that people hear that their questions are being asked. And I know you have already discussed this, but can the vaccine help those who already has cancer? And I think it's more of like they have to have been they have to have completed their treatments, correct? Yes. With for this trial, as in other vaccine trials, patients at the early metastatic vaccine trials, patients had to have completed several cycles of treatment for their metastatic disease and have failed those.

00:34:38:18 - 00:35:07:03
Unknown
That's typical of a clinical trial for the vaccine. Trial for this vaccine for STEM back. The patient had to have completed what we would consider standard of care, but there was some wiggle room in that standard of care in that if they hadn't been able to tolerate their chemo and only got through four cycles. But it was because of toxicity, we didn't mandate that they had to have full completion if the reason they stopped was because of toxicity.

00:35:07:03 - 00:35:58:21
Unknown
Does that make sense? And let's say they were treated three years ago and immunotherapy wasn't standard, it wasn't required. We just wanted at the time that they were treated for them to have received the standard of care. Okay. Okay. Let's see. Will the vaccines be of use if you've had inflammatory HER2 positive breast cancer? Great question. Inflammatory breast cancer is such a unique cancer and I think we would all love for it to be responsive to vaccines and it's going to be dependent on finding the right antigen or protein.

00:35:58:23 - 00:36:37:09
Unknown
And so the her two is a really nice protein to be using to develop vaccines. That's why I think the majority didn't do a count. But the majority of vaccines are using her two approach just because it's a unique feature. But not all inflammatory breast cancers are HER2 positive, some are triple negative, some are estrogen positive. And I think you need to find a combination of proteins or antigens that will be targetable, all from an inflammatory standpoint.

00:36:37:11 - 00:37:07:13
Unknown
Now, interestingly enough, inflammatory cancer is an immune response cancer. So, you know, it's it's a cancer in the lymphatics. It's in the spaces that the immune system is living. So you would think maybe that is a good place to be using a vaccine. And I'm sure there is a lot of interest in that approach. But again, developing one that has enough proteins for that cancer to see is going to be the challenge.

00:37:07:15 - 00:37:44:15
Unknown
So, you know, kind of piggybacking off of that of saying if will the vaccine work or eventually work for those who are, you know, HIV positive and HER2 negative or is it only you have to be HER2 positive? So here's here's a great dilemma. It's not a great dilemma. It's a dilemma for primary prevention. If you're trying to prevent someone from getting breast cancer, you're having to predict what cancer they're going to get.

00:37:44:17 - 00:38:06:23
Unknown
And so do we target triple negative? Do we track target estrogen positive? That's more common, but we don't know what type they're going to get. So how do you do primary prevention? And so as we think about primary prevention, I know the way researchers are thinking about it is thinking about individuals who have a BRAC of one or two mutation.

00:38:07:01 - 00:38:34:03
Unknown
They're born with a genetic abnormality that can lead to a breast cancer BRCA1 mutation carriers are more likely to get a triple negative breast cancer. So you're just going to have to predict that maybe the type they get to try and do a primary vaccine approach, It's very difficult. Secondary prevention is easier. So secondary prevention, which is preventing a recurrence, means take the type you know, what type of cancer they got.

00:38:34:06 - 00:38:56:07
Unknown
Now, it's not always that you get that type again, but let's go with it in that regard. Take the type they've already gotten and target it. So if someone had a HER2 positive cancer, we're going to target HER2. If they had a HER2 negative cancer estrogen positive, maybe we should target that estrogen positive cancers are hard to target because we have a lot of estrogen in our body.

00:38:56:07 - 00:39:24:09
Unknown
So that one's going to be a little bit more difficult. But maybe at a stem cell approach we can do that. Again. I'm not the vaccine expert for developing and identifying the proteins. And it makes me wonder, because you said with producing estrogen, what if you were, you know, surgically moved into menopause, which greatly reduces your estrogen or you are already in menopausal age?

00:39:24:11 - 00:39:47:10
Unknown
When I got diagnosed. Yeah. And would it be easier to have the vaccine in a postmenopausal versus premenopausal? I would assume the answer is yes, but I don't know definitively from a research standpoint. Right. Right. we're getting flooded. All right. All right. Get ready. So let's see this one. I'm going to just read it as is. Okay.

00:39:47:12 - 00:40:18:20
Unknown
So this person wrote, My cancer seemed to develop and grow. Shortly after receiving the COVID 19 vaccine diagnosed stage 3er negative HER2 positive cancer, it spread to the lymph nodes. Could RNA and protein in vaccine trigger an immune response aiding in cancer growth, or is she way off base? And, you know, if we understood our immune systems perfectly, I could answer that question perfectly.

00:40:18:22 - 00:40:49:18
Unknown
What I can say is the COVID vaccine was developed against the COVID protein. It was packaged in a way so that your body would respond to that protein and wrap up and create antibodies against the COVID antigen so that when you saw it again, you wouldn't get COVID. So it would be unusual that your immune system revved up to fight the COVID protein packaged in that way, and a cancer would develop because of that.

00:40:49:20 - 00:41:12:04
Unknown
So the RNA was a COVID, RNA wasn't a cancer RNA. And so your immune system was revved up to fight COVID in a short period of time. And then remember, the the immune system revs up for a short period of time. Most people with a lot of people with vaccines get a little bit of feel kind of, you know, kind of myalgic for a day or so.

00:41:12:06 - 00:41:34:06
Unknown
But then when you see the COVID again, your immune system should respond to it. I mean, I don't think we know definitively that, you know, it doesn't and what its interaction is with cancer, but I don't think that's a possibility because the RNA was the COVID RNA, not a cancer RNA, if that makes sense. That does make sense.

00:41:34:06 - 00:42:00:17
Unknown
And and I like how you broke that down, like it was very specific to target that specific in it antigen like for COVID only not for the cancer. Yeah. So this definitely looks really promising like what are the the next steps I guess with with this still that trial where are you what can we expect. So great question.

00:42:00:17 - 00:42:21:22
Unknown
So what's exciting is we have six patients already through all the vaccines. It's a year long process because it's human every month, times three, then a six month booster and a 12 month booster and lots of blood draws. But we're hoping in the next year we'll get the next the, you know, the rest of the patients through that one year cycle.

00:42:21:23 - 00:42:41:06
Unknown
And because it's just an analysis of blood now, it requires a lot of work by a team of researchers to analyze all that blood and look for the immune response as well as follow these patients to see how they're doing year after year. My hope is in the next two years we have early signal of how this trial worked.

00:42:41:08 - 00:43:09:15
Unknown
I realize that seems like a long way away, but in the meantime, there's a lot of new vaccines, I think, coming down the pike, making vaccines. It's not easy. Again, finding those proteins, targeting them to patients. But I know there are several open across the country right now, primarily HER2 One way to look for a clinical trial, if you don't know, is to go to clinicaltrials.gov and enter in just breast cancer and vaccine.

00:43:09:17 - 00:43:34:19
Unknown
And that will show you it's about 30 right now. Clinical trials, it's variable. Some are open at multiple sites, some are only open at one or two sites. But that's actually a really good way to be kind of up on what clinical trials are out there based on your cancer type, if that's something you're interested in. And I highly recommend people.

00:43:34:22 - 00:44:00:05
Unknown
I mean, I'm always happy to say that clinical trials are a personal choice. Being involved in research is always a personal choice, but I always think it's really important to be educated around the pros and cons of clinical trials. What's what's the benefit, what's the risk, and recognize that everything we do in cancer or most everything we do is based on clinical trials that were done many, many, many years ago.

00:44:00:07 - 00:44:29:17
Unknown
If women hadn't agreed to a lumpectomy versus mastectomy in the 1960s and seventies, we'd still be doing mastectomies for for everybody. Wow. Again, a personal choice. Yeah. You know, and as we think about clinical trials, as we think about vaccines and again, like I mean, we were consistently hearing with COVID, everyone was just so shocked at how quickly that vaccine was created.

00:44:29:20 - 00:44:57:03
Unknown
Right. And then so now it almost seems like even that term vaccine has it's gotten like a bad the bad name now. And so how you know, in doing this research of a breast cancer vaccine, how do how how can you change, I guess, the way people think about even that term vaccine and that they're fully understanding that this is not set out to harm a person?

00:44:57:05 - 00:45:15:02
Unknown
I think one thing I'll say about cancer vaccines is, you know, with COVID, we were entering a pandemic. We did not know what was going on. As physicians, I think most of us felt like the sky was falling, I'll confess. And all a lot of us were like, my God, you made this vaccine fast and you're going to put it in me.

00:45:15:02 - 00:45:40:20
Unknown
Okay, okay. I hope it goes okay. Yeah, Yeah, I hope that goes okay. I will say that the technology was there in the background, but just like everything, it was slowly getting developed and introduced and we had to go fast because there was a pandemic. Lots of things were learned during the pandemic, I think. But for cancer vaccines, it's going to be like every you know, we have we don't have time.

00:45:40:20 - 00:46:06:05
Unknown
We'd love to save more patients. So I won't say we have more time, but we have time to put them through the phase of clinical trials appropriately. And we need broad patient representation in these clinical trials to make sure that what we're developing is applicable to a broad group of patients. And but it's going to go through a progression first, you're going to make sure it's safe.

00:46:06:07 - 00:46:31:13
Unknown
Do not give a vaccine that's not safe. And so you're only going to test a few people that are very brave in the beginning, but most vaccines are safe. That's what I was trying to show across thousands of patients. They're relatively safe except for injection reactions. That's the primary response of these cancer vaccines. And as we develop them, will test them through clinical trials.

00:46:31:13 - 00:46:55:07
Unknown
And if we start to develop vaccines that are targeted to a patient's tumor, i.e. you take their tumor or make a vaccine, which I think is really hard to do because that's expensive and you got to make just one for one patient. You might what might end up happening is they might realize that there's a series of proteins that work across a broad group of patients.

00:46:55:07 - 00:47:24:00
Unknown
By doing that, they might learn that. Then you could develop a personalized vaccine for a group of people because you tested individual vaccines. I hope that made sense. Well, you know, as I think about this and with the the questions that were asked, what can we say? Like for many of us, you know, we go for our scans or those who are still in treatment.

00:47:24:00 - 00:47:56:11
Unknown
What kind of questions can we ask our ecologist about breast cancer vaccines? What can we say to them? No, great question. And again, I would use that kind of clinical trials approach where you can always ask your oncologists what's new and available. I get that question all the time. And what's actually funny is the not funny the first patient on this clinical trial is a professor of pharmacology.

00:47:56:11 - 00:48:19:23
Unknown
So she actually understood clinical trials in research. And I she said, So what's new and greatest? I said, Well, funny you mentioned it. There is a clinical trial that we're opening up that is exact. And I showed the picture on the last slide of she and I together is the first time getting the injection. You know, it is a it is a contrived photo.

00:48:19:23 - 00:48:47:16
Unknown
I will say that's but it is asking questions, always being your own advocate and the first person to say, please be your own advocate and say, hey, what's new and different? What am I applicable for? I get asked questions all the time about what should I eat for what, what exercise should I do? And I say, Well, let's look at the let's look at the research.

00:48:47:16 - 00:49:15:17
Unknown
Let's see what's out there for your type of cancer and see if there's anything new or different we should be doing for you. And we, you know, discuss this with our families because, you know, as we think about those who are I'll say in the early stage, stage zero disease to technically stage three, what is it that we can tell our families?

00:49:15:17 - 00:49:41:11
Unknown
Because so many you know, we're worried about that. We're clients, we're worried about trying to stay on top of the latest research. What are things that we could say to our families about this particular program and this breast cancer vaccine? I think always being honest with family members about what you know and asking them to help you ask questions.

00:49:41:12 - 00:50:15:14
Unknown
So family members are always good to get multiple opinions. And so, you know, having family members provide a avenue for critical review, I will say that many times when I presented clinical trials to patients, patients are overwhelmed, especially if they're newly diagnosed and having family members supportive care. It doesn't have to be family members, whoever is your support person or people to be critical reviewers because their blood pressure is not over the moon.

00:50:15:16 - 00:50:41:06
Unknown
They don't have adrenaline running through their veins because they've just been diagnosed with cancer and maybe they can be more critical and say, Hey, this sounds like a good option or no, that may not be something right for you. I will never say that clinical research or new treatments are for everyone. Everyone has to decide how they want to approach their cancer and what they're comfortable with for their treatment approach.

00:50:41:08 - 00:51:20:22
Unknown
And Absolutely, Absolutely. So what is the realistic availability for this vaccine are? Do you envision this being something that you know will be covered? Will it be kind of like the COVID vaccine where it was at? No charge, or will this, you know, welcome patients, I guess, kind of expect as far as price? And yeah, I think we're at point I have I have no knowledge or ability to answer that because we're still in such an early stage of vaccine development.

00:51:20:22 - 00:51:46:17
Unknown
And please understand that on clinical trials, your care is covered by the clinical trial unless it's standard of care. So for example, for this trial, none of it was standard. It's almost none of it was standard of care. And so it's covered by the the the clinical trial. Any time a clinical trial has part standard of care and part new parts of it are covered, parts aren't.

00:51:46:19 - 00:52:15:18
Unknown
But I will say that if vaccines were to become and I think they're going to enter into secondary prevention first before they get into primary prevention, i.e. prevent a recurrence, that it be a much simpler way of treating cancer than our current expensive approaches. So I can't imagine it won't be well supported. So I'm going to ask you this question that came in.

00:52:15:20 - 00:52:43:09
Unknown
Why should we trust this, given the myriad forms of breast cancer and, you know, the the for profit, you know, lies? I mean, we know that form a definitely has a lot of work to do as far as building that trust back with the public. Right. How can we trust this? Why should patients trust this research that's coming along?

00:52:43:10 - 00:53:06:13
Unknown
That's a great question. And I think it is what I always say is the importance of bidirectional communication is talking through your concerns, your fears. I will say as a physician, we were all I won't say we all were, but a lot of us were like, okay, we're going to take this vaccine. Health care workers, okay, we'll go for this.

00:53:06:15 - 00:53:38:15
Unknown
We trust you. The same is going to be true for cancer vaccines, that vaccines are really you can see that they're relatively low risk. We think we know there can be side effects, so there can be side effects and there can be unique, what I call anecdotal responses that we didn't expect. So it will never be perfect. There will be people that may have a bad response to a vaccine.

00:53:38:17 - 00:54:04:08
Unknown
I don't think we can ever promise that won't happen. But will the majority of people have a low risk approach? Yes, But it's why we do clinical trials in phases. It's why we do it in a graded approach. It's why we tested in animals first and in test tubes first, and then go to a small group of people.

00:54:04:10 - 00:54:31:01
Unknown
The problem with the small group of people is it doesn't show the impact in a diverse population, but at least by going through a small group of people in the beginning, we can make sure it's safe. That's how most every new approach is done, whether it's robotic surgery or new drugs or new vaccines. As you start small and say, okay, it didn't cause a lot of problems, we used to do bone marrow transplants for breast cancer.

00:54:31:01 - 00:54:56:07
Unknown
We don't do them anymore because in some of those clinical trials, it didn't prove to be beneficial. And so the things that have gone by the wayside, we kind of don't talk about very often, but it's important those few people that participate in phase one clinical trials are brave and we thank them and there's a lot of conversations with them and we support them as much as we can and say thank you, thank you, thank you.

00:54:56:08 - 00:55:48:20
Unknown
Because then once it gets to phase two, it appears to be safe. And, you know, I want to make sure that I address our LGBTQIA plus community. And so as you've been talking and we've been asking these amazing questions, I, I, I recently spoke to someone he is trans who had breast lash chest cancer. And I wonder with the this breast cancer vaccine, how or how do you envision or how or would there be any differences and someone who was part of that community and they are still taking their hormones, is there any difference or what would you say to the LGBTQ a8+ community about this?

00:55:49:01 - 00:56:22:04
Unknown
It's a great question. As we think about vaccines, they are gender nonspecific and so they cater to the cancer. And no matter the gender background, they should be catered to the cancer and its specificity, whether it's triple negative, HER2 positive. So it would be non binary I guess. Yeah. I don't know if that's the correct terminology for a vaccine.

00:56:22:06 - 00:56:49:00
Unknown
I apologize if I've used something incorrectly, but I don't think it's an it is catered to the cancer and just like it would be catered to a virus. And so we always want to have a balanced discussion with any individual of any background of the pros and cons and interaction with whether it's hormones or other medications should be minimal in vaccines.

00:56:49:00 - 00:57:16:03
Unknown
But obviously there's always a chance that that's why you want to test it in graded groups of patients saying, okay, with these drugs, it looks like there's no side effects for all of our patients on the STEM backed vaccine. We know all the drugs they're on. So we're able to say, is there any interaction? Right. Well, you know, as we wrap up here today, Dr. Wilkie, this has been a really fascinating discussion.

00:57:16:03 - 00:57:57:19
Unknown
And talk about just like in the research field that we're even talking about, breast cancer vaccines is just blowing my mind. What are like the I guess, the top three takeaways that you would like our attendees here to walk away with today, that clinical trials are important and we hope we can help as a health care community and, navigators and patient advocates explain the importance of clinical trials and their pros and cons that vaccines are being tested in cancers.

00:57:57:19 - 00:58:34:22
Unknown
And as you may be interested in them, please about look online clinicaltrials.gov and find vaccines. If you're interested in this approach and understand that vaccines are more complex than drugs in there development due to those three components that we talked about, the finding the protein, packaging it and making sure we hit the right immune response. So they definitely may take longer to develop, as we've seen, because breast cancer treatments have been around a while and we're just now starting to see vaccines.

00:58:35:00 - 00:58:57:16
Unknown
Well, Dr. Wilkie, we cannot thank you enough for taking the time to walk us through this today. I guess. Look at that. Getting some love out there. So again, thank you so much for taking the time and we look forward to following the research and seeing where it goes, maybe having you back once you know it's out there.

00:58:57:16 - 00:59:25:11
Unknown
That'd be amazing. Well, Megan, Claire, thanks immensely for your hosting and mentoring and moderating. It was wonderful and I am happy to answer any questions and follow up and I greatly appreciate the Chair Cancer Support Program for Breast Cancer patients. Thank you so, so much. So everyone, we will have a recording of this program available on our website in about 1 to 2 weeks.

00:59:25:11 - 00:59:52:08
Unknown
So you will get an email about it once it is ready and make sure you share it with the world. And also everyone, please make sure to check out Cher's website for upcoming educational programs, our podcast episodes, our support groups. We've got some new stuff coming up and also, please take a moment to complete the survey at the end of the webinar.

00:59:52:08 - 01:00:15:16
Unknown
As soon as you hop out, it'll pop up. They are completely anonymous. We really look at those. It helps guide our programs and content and again, thank you again, Dr. Wilkey, for your time. Everyone. This concludes our webinar. Have a wonderful day. Thank you.

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