“We do believe that, should all the appropriate clinical trials succeed, we can eliminate triple negative breast cancer," says Dr Amit Kumar. Photo / 123RF
A ground-breaking new vaccine being trialled in America could save thousands of women from catching triple negative breast cancer (TNBC).
Imagine having a simple vaccination that could protect you from the disease that affects one in seven women in the UK, and is the leading cause of death for women aged 35-49. It sounds like a futuristic fantasy, but recently a flurry of headlines announced that a breast cancer vaccine could be available as soon as 2030.
Let’s look at the facts: the vaccine in question is specifically for triple negative breast cancer (TNBC), and has so far only been tested on women who have had successful treatment for primary TNBC, but are at high risk of recurrence. This type of breast cancer only accounts for around 10-15 per cent of diagnoses, but it’s particularly aggressive and causes 30 per cent of breast cancer deaths.
Known as “triple negative” because it lacks the three main hormone receptors and proteins usually targeted in treatment, it has long had a bleaker prognosis.
I know this only too well, having been diagnosed with TNBC in January 2021. My treatment wrapped up not with a cheery “all-clear” but with a dark warning to be “extremely vigilant” for signs of recurrence. This leads to all-consuming fear, anxiety and hypervigilance around everything from back pain, to a cough or a headache – all of which can be signs that the cancer is back.
A vaccine that could prevent recurrence sounds too good to be true. Determined to hear it from the horse’s mouth, I arrange a Zoom with Dr Amit Kumar, CEO of Anixa, the company developing the vaccine.
“We do believe that, should all the appropriate clinical trials succeed, we can eliminate triple negative breast cancer, which is the most lethal form of the disease,” he says from his office in California. “Seven years is a tight window but, within that time, we think we can eliminate recurrence in survivors – and could be well into the clinical trials to prevent the onset of TNBC in cancer-free people.”
Of course, there is a cancer vaccination that already exists. The HPV vaccine, now given to all children aged 12 to 13 in the UK, has been shown to reduce cervical cancer rates by almost 90 per cent. But while that vaccine targets a cancer-causing virus, this new one is designed to train the immune system to recognise certain characteristics of TNBC cancer cells, and destroy them before they grow into a tumour. Given by injection in three doses, it works by targeting a protein called alpha-lactalbumin, which is present in 70 per cent of TNBC tumours.
It’s still early days for the research. Phase one of the trial has been small – only 15 women – but it has shown a 100 per cent response, meaning that none of them has seen cancer recurrence. After being approved, the vaccine will initially be given to women like me who have had successful treatment for primary TNBC, to reduce the risk of recurrence.
“These women go through chemotherapy, surgery, radiation; brutal processes for saving their lives,” he says. “And they’re obviously worried that their cancer will come back. If they have an ache in their arm, they wonder if it’s spread to their bones. We’ll be able to alleviate that anxiety by giving them a shot.”
While he thinks this might happen within seven years in the US, here in the UK, NHS approvals take longer. But, he argues, 40 per cent of women treated for primary TNBC get recurrence, incurring enormous costs of ongoing chemo and palliative care. So it’s clear that this vaccine could be cost effective, and he is confident it will be approved for use within the NHS fairly quickly after US approvals.
Eventually, it will be extended to women at high risk of developing the disease, such as those with one of the genetic mutations made famous when Angelina Jolie (who carries the mutation BRCA1) chose to have a preventative double mastectomy. “A lot of [affected] women are doing that now,” says Dr Kumar. “If we can show that this shot prevents cancer from occurring, then those women can avoid painful, disfiguring surgery.”
TNBC is more likely to have a genetic foundation than other types of breast cancer. But despite that, and even though I have a family history of breast cancer, my genetic test came back clear. Would that mean this vaccine wouldn’t be appropriate for my daughter (who is only six at the moment)?
“There are lots of women like yourself, who have family histories but don’t have those mutations,” he says, admitting that this is something not yet fully understood. “There may be other genetic factors that we have not discovered yet. I have two daughters, and we have breast cancer in our family,” says Dr Kumar. “I would love to be able to vaccinate them once we’re approved.”
The vaccine is currently being trialled at the Cleveland Clinic in Ohio. I contact Dr Thaddeus Stappenbeck, the clinic’s chair of inflammation and immunity, whose enthusiasm is more measured. “The seven-year timeline is a substantial overstatement,” he says. “Multiple phases of clinical trials have to be done to show that we are preventing recurrent TNBC and, even once a large study is launched, in order to prove that recurrences are being prevented, we have to wait long enough to see whether they are going to occur.” He believes this will be closer to 10 years.
And, in terms of prevention for women who have never had breast cancer? “That would be a separate set of trials, with patients followed for a significant amount of time, since breast cancer develops over a period of years.”
So it will be some time before a breast cancer vaccine is a reality, which doesn’t help those of us struggling with fear of recurrence right now, but it is extremely promising for the future health of Gen Alpha: my children’s generation.
In the UK, scientists are making great strides in the same direction. Dr Niamh Buckley and Prof Helen McCarthy of Queen’s University Belfast are also working on a TNBC vaccine, thanks to a research grant from Breast Cancer Now. Rather than targeting alpha-lactalbumin, like the Anixa vaccine, this one targets a protein called p53 which is mutated in about 80-90 per cent of TNBC cells.
But getting it to a stage where it is fully tested is some years off. “While associated with the highest risk of death, TNBC is not the most common type of breast cancer,” says Dr Buckley, “so any trial will need to run for longer in order to recruit the number of patients needed for meaningful results to be gained.”
As for a vaccine to prevent all types of breast cancer? Well that’s far more complicated, since different types of breast cancer cells have different characteristics, which need to be targeted on an individual basis. “We’ll either need to look at cocktails of the most common antigens that cover most patients, or the development of biomarker-based tests to work out which vaccine you should get,” says Dr Buckley.
“There is the potential to have a vaccine personalised to your particular cancer. This is something that’s being trialled by companies like BioNTech, although it’s slower and more costly than an off-the-shelf approach.” A recent agreement between the Government and BioNTech is a sign that this may be available in the future. “It’s very exciting,” says Dr Buckley. “A completely patient-specific treatment would be amazing.”
So, while it might not be a case of breast cancer being “eliminated by 2030″, there are many promising developments that make me feel extremely optimistic about the future of treatment and prevention. If not for me, then at least for my daughter.
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