Brian Czerniecki, M.D, chair of the Department of Breast Oncology at Moffitt Cancer Center in Tampa, Florida, talks about a vaccine that can possibly wipe out a deadly cancer in women.
Interview conducted by Ivanhoe Broadcast News in February 2017.
Talk to us about the vaccine.
Dr. Czerniecki: The vaccine is a quazi vaccine in that it’s meant to restore an immune response. A vaccine that is the way most people think is that it’s done ahead of time to prevent a disease from occurring. In this case the disease is already beginning and people lose their immune response against breast cancer. We’re restoring that immune response against breast cancer. It’s more akin to the chicken pox vaccine or shingles vaccine where somebody had chicken pox early in life and the virus stays, hides for a long period of time and then it comes out. You’re vaccinating to boost the immune response up in that case to prevent the virus from coming back out as shingles. In this case we’re doing the same thing with cancer. Cancer cells have already started to grow and we’re using this vaccine to restore their immune response to keep the cancer from coming back.
Is it kind of like an immunotherapy?
Dr. Czerniecki: It is an immunotherapy in that it’s made from and personalized for each individual patient in that we actually take their white cells that are responsible for causing the initiation of immune response. We take them out of their body in a process called apheresis where we just take some blood out, almost like going to the blood bank and we take some of those white cells and we activate them out of their body as though they have a virus against the breast cancer. Then we inject them back in so that they will initiate this immune response. It’s personalized for each individual person. It’s a hundred percent biodegradable in that there’s no metals or anything in the typical vaccine that’s being used to try to drive an immune response. We’re telling those cells exactly what to do. We help to program them.
How is it different from a traditional immunotherapy?
Dr. Czerniecki: Traditionally immunotherapy is that we’re giving cells back to someone to drive their immune response. It’s a mix between a vaccine and a traditional immunotherapy in that we’re using it to drive an immune response.
Who would this be for?
Dr. Czerniecki: We originally started to look at this for people who have a specialized form of breast cancer that’s driven by a molecule called Her-2. That accounts for twenty-five to thirty percent of all breast cancers. We designed this immune restoration or this immunotherapy to target that Her2 molecule. But within all stages of breast cancer starting from early, early DCIS all the way to stage four there are various patient populations that could benefit from getting this immune response boosted back up. That includes people before chemotherapy, after chemotherapy if they have residual disease. Even stage 4 patients that have been treated with surgery or radiation that are what we call without evidence of disease right now or at risk to recur another perfect time to vaccinate to boost this immune response against Her2.
They could get it along with something else?
Dr. Czerniecki: Correct, they can get it along with other things, you can get it alone. In the earliest forms of breast cancer we were giving it alone and it showed nice impact in that some people had their disease completely disappear before we operated on them. In other areas we’re trying to rescue those who chemotherapy doesn’t completely eliminate their disease. That immune response stays low, we’re trying to restore that immune response to keep them from getting in to recurrence later on.
How long does it take to start working?
Dr. Czerniecki: It depends on again where you’re starting from. In your early breast cancer it starts working immediately in weeks. Now in people who have had chemotherapy and a lot of other therapies for their breast cancer it starts to work right away but it takes months to see it get the point where it would be considered where a healthy person would be.
For somebody who was just diagnosed would this be that first line of defense? If they fall in to that category.
Dr. Czerniecki: Early breast cancer it may be. We’re testing that out as a potential stand alone for people with DCIS. In people that are Her2 positive we’re beginning to look at trials to boost that immune response before chemotherapy to rescue people who have residual disease after chemotherapy especially if that immune response doesn’t come up. Then we’re also doing it in some late settings. We’re also bringing it in with radiation in early breast cancer. All people who are Her2 positive could potentially benefit from this type of therapy.
How common is HER2?
Dr. Czerniecki: It’s about twenty-five to thirty percent of breast cancers. We have similar vaccines that we’re in the process of developing for other types of breast cancer. Those with triple negative we have similar vaccines ready to go that we could bring in, in the same type of situation and the same thing goes for estrogen positive breast cancers.
What do you think this means in breast cancer?
Dr. Czerniecki: Well I think it’s a potential game changer because we’ve actually shown that people lose this specific immune response early in the process of breast cancer development and if you don’t get it back you’re not going to respond to all the other therapies. One of the critical components is going to be restoring this immune response to make any therapy work in breast cancer. We think it’s going to be a big game changer because it’s going to apply to everyone with breast cancer.
You take the blood cells out, they get their blood drawn but if the cancer has already attacked, then?
Dr. Czerniecki: There’s various time points when we can do that. Again we can take the white blood cells out and we take them away from where the cancer is and activate them out of their body and then we inject them back in. It turns out once you activate them the cancer can’t reprogram it. A lot of vaccines when you inject it you’re depending on the immune response to do what you want it to do but the cancer can influence that. When we’re taking the cells out and doing it away from the cancer the cancer no longer influences that immune response.
What are some of the side effects?
Dr. Czerniecki: Most of the things that people had a mild flu like symptoms and it’s usually self-limited for a few hours after vaccination. For instance, people get fever, they might feel tired just like you might when you have a cold or flu. You might get some headaches, feel a little nauseous all lasting a few hours, anywhere from four to six hours. You feel that way when you have flu for days. This is for a brief period of time. Usually it’s the heaviest with the first vaccinations as we give subsequent vaccinations your body becomes tolerant of them.
How many does that patient need?
Dr. Czerniecki: It depends on what stage they are in breast cancer but we can give anywhere from six to nine vaccinations. We do some very early rapidly in the beginning and then start to spread them out boost stage so we might give them every couple of months instead of every week. In the beginning we sometimes give them weekly to give the big charge to the immune response.
Six to nine in a course of—
Dr. Czerniecki: Of the whole therapy. From one apheresis where we take the blood draw we can make anywhere from six to ten, twelve vaccinations and so we can give those all back over a period of time.
Then does the patient get again?
Dr. Czerniecki: Yeah, so we’re now designing a boost phase because we also have a blood test that can tell us how good this immune response is staying in their blood so we can just draw blood from them and see it. If it starts to fall off we can boost them back up.
People think vaccine against cancer, is that—
Dr. Czerniecki: Again this is a restoring of an immune response but if it turns out that losing your immune response precedes the cancer then we would have an opportunity here for preventive. Because if we boost your immune response if it drops before you ever get cancer it can potentially prevent it. This has the implications long term of being potentially a pure preventive vaccine.
The candidates for that would be if you have a history or__
Dr. Czerniecki: The candidates could be lots of different reasons. For instance, in the Her2 positive patients some of the women are pre-menopausal that develop that and we think some of that is linked to pregnancy. We could be able to in between pregnancies check your blood tests and see and potentially vaccinate you. We have others that would be like for genetic mutation carriers, they know they have a family history. We’re going to be launching one later this year where we’re going to vaccinate them to try to prevent them from developing breast cancer because they have a super high risk. There are various groups who we can identify. Women who’ve never had children are another group that’s at high risk for breast cancer. They walk around with the lowest anti-Her2 immune response of anyone. We can just boost their immune response. We found that women with each pregnancy their immune response naturally against Her2 goes up. It’s always been known that women who have multiple pregnancies have a decreased or incidence of breast cancer as they go. It looks like it’s a self-vaccination process against this Her2 protein.
As far as learning the causes of breast cancer it seems like you’re finding—
Dr. Czerniecki: Well we’re trying and immune—don’t forget there’s the tumor end, what the cancer cells are doing to try to develop, but then there’s the host which consists of immune component and it may explain why some people get early forms of breast cancer that never go on and progress. Others don’t get such a nice warning sign that they can get detected early because their immune system fails very quickly and the tumor is able to grab and go. We’re working on ways to help use this immune test as a test for detection, as a test for determining whether somebody responds to our natural therapies and also use it to fix with our immune restoration.
When did you start working on this?
Dr. Czerniecki: We’ve been working on this for probably about ten to fifteen years now. Originally starting back just with the concept that we thought we were vaccinating. As time went on and we investigated this more and more what we realized is that healthy people do have an immune response against Her2 and breast cancer. That’s probably what keeps them from getting a breast cancer. But if they lose that response for whatever reason they’re more susceptible. We can push this immune response back up.
The people that are losing response —can you tell?
Dr. Czerniecki: That’s an area of active investigation because now what we’re trying to do is now that we know this happens and we’ve looked at in early, early phases most people keep some of that immune response but by the time the tumor even becomes Stage-1 invasive they really lose that immune response. We’re trying to figure out now, can we predict people that might lose that immune response before cancer develops and what’s the situation, because if we can identify that then we can target this immune response to help them.
When do you think this will be available to the public?
Dr. Czerniecki: Well so from a preventing recurrence thing I think that’s going to be maybe in the next five to ten years. We’re going to do a Phase II study now where we’re staring a study around the country where we’re going to vaccinate people who have residual disease after they have chemotherapy. If they did their surgery after chemotherapy and if the pathologist still saw some live cancers cells in any of their specimen we’re going to vaccinate them because they are at high rate for recurrence. We’re going to vaccinate them to try to prevent recurrence. That may be the one end where this comes in early. The other end is in the really early people who have a specialized form of breast cancer called DCIS or Ductal Carcinoma In-Situ we’re going to use that as a vaccine to potentially eliminate radiation and to better target those people to prevent recurrence. Because they have an immune response they just need it to boost a little more.
Right now the trial that you’re doing now Phase I—
Dr. Czerniecki: No we’ve actually done some Phase I and Phase II in early breast cancer. Now we’ve done a Phase I in more later breast cancer and now we’re starting a Phase II in the later populations of breast cancer. We have Phase I and twos already completing and we’re going to be going in to the twos and threes next.
If I say the vaccine is preventing it from happening again—
Dr. Czerniecki: Preventing risk of recurrence.
Anything else you think is important for the public to know about this?
Dr. Czerniecki: Yeah I think the fact that it’s fairly safe. It’s costly. Because we have to take the cells, make them and activate them and so it’s not as cheap as a vaccine that you produce, mass produce, off a shelf which has got all the metals and everything else in it. But it does directly activate your immune cells because you’ve programmed the cells that you’re trying to do with these vaccines off the shelf, you’re trying to get them to go that way. Here we’re actually doing it.
It’s customized?
Dr. Czerniecki: It’s customized for each individual patient.
Before it would be offered to the public I imagine it would be.
Dr. Czerniecki: Well that’s why it makes sense to test this out. Originally in people that have the highest risk and those with early cancer or with cancer as opposed to if we just went to the general population and said oh, let’s do this for prevention, because prevention is actually an easier thing to achieve. That’s where most of the vaccines have been successful you give it before somebody gets a disease. You can make an off the shelf one once we know this works. You can make it cheaper and don’t have to take the cells and all that you could mimic that. That would be more akin to a regular vaccine that anyone can get before they have disease. We’re trying to show that first in the people that have the highest risk that have it if this is targeting this immune response is effective for preventing that disease from coming back.
Like the HPV vaccine that’s before.
Dr. Czerniecki: Correct, but that targets a virus that causes cancer. If you eliminate the virus you can eliminate the cancer. Here in breast cancer there is no known pathogens or bacteria or viruses that are known to cause breast cancer. It comes from within and the environment for most people, some people have that genetic inherited susceptibility. But that’s a smaller percentage of people. We’re targeting things that your body has in it that get dis-regulated when they shouldn’t be. We’re trying to keep the immune response to keep watch over that.
END OF INTERVIEW
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