After losing his wife to colon cancer, a New York man has dedicated his life to fighting the disease and trying to protect other families from the same tragedy.
Roy de Souza, now 54, and his wife, Aisha de Sequeira, had three young children when she was diagnosed with cancer in 2017.
At the time, the family was living in India, where de Souza ran a technology company and his wife headed up an investment banking firm.
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"We had a good life there — and then she was diagnosed," he told Fox News Digital in an interview.
"She was only in her mid-40s."
His wife’s first symptom was stomach pain.
Multiple trips to the doctor yielded nothing, but the pain continued. Finally, a CT scan revealed the shadows of cancer.
"Colon cancer is a tricky one, because it's inside the body — you can’t see it," de Souza said. "It’s a complicated disease."
The family immediately flew to New York, where de Sequeira had surgery and started chemotherapy treatments at Sloan Kettering.
Although de Souza was optimistic at first, the doctors told him that they would not be able to cure his wife, as the cancer had metastasized (spread) throughout her body.
The goal was to prolong her life as much as possible.
"Surgery only works if the cancer has not spread or has not spread too much," de Souza said.
Frustrated by the lack of options, de Souza immersed himself in cancer research.
"My personality is, when I see something broken, I want to fix it," he said.
Traditional treatments use the same approach for every patient, he noted — but they’re not effective for everyone.
"That’s because cancer is different in each patient," de Souza told Fox News Digital.
"The disease is like a tree — there are different branches, and one drug might kill some of those branches, but not all of them."
He added, "I researched all the different options, talked to all the doctors and experts, and decided to create a software to analyze patients’ cancer cells and find the different ‘branches.'"
Leveraging his technology background, de Souza started a company called BreakBio, which aims to develop personalized, targeted therapies geared to each patient’s disease.
Personalization is particularly important for cancer, he noted.
"I don't think you need to personalize all drugs in the world — but for cancer, it’s different from transmissible diseases," he said. "It didn't come from someone else. It grew within you."
The U.S. Food and Drug Administration (FDA) has granted BreakBio approval to start clinical trials for its colorectal therapy later this year.
Even as de Souza’s wife underwent cancer treatment, she was fully supportive of his efforts to launch BreakBio.
"She wanted to be optimistic," he said. "She said, ‘You take care of this disease, you talk to doctors and figure out what can be done.’ That was her way of coping."
The BreakBio team got to work developing a personalized vaccine that is designed to be used along with traditional cancer treatments.
The term "vaccine" can be a bit misleading, de Souza noted, as BreakBio’s therapy attacks the cancer rather than aiming to prevent it.
"We often refer to it as personalized cancer immunotherapy, but unfortunately, the industry uses the word ‘vaccine,’ which can be confusing," he said.
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The software uses machine learning, a type of artificial intelligence, to analyze the outside of the cancer cells, identifying proteins called peptides.
"The machine learning then starts to learn about what kind of peptides are on the outside of the cancer cells, creating patterns for each patient," de Souza said. "You have to repeat that for every patient, because the cancer-related proteins are different for each one."
The personalized vaccine then "trains" the body to create T cells, which are white blood cells that help to fight infection and attack cancer targets, de Souza said.
Initially, de Souza’s wife began receiving some of BreakBio’s therapies in Germany, where the laws were more conducive to experimental treatments.
But when the COVID-19 pandemic hit in March 2020, they were no longer able to travel.
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"She started going downhill, and I realized how much the drugs had been keeping her going," said de Souza.
His wife ultimately lost her battle with cancer in Dec. 2020 — but that didn’t stop de Souza from continuing his own fight.
Outside experts — including Dr. Avital Gaziel, co-founder and chief science officer of Leal Health, a Connecticut-based cancer treatment company — see promise in personalized cancer vaccines like the ones BioBreak is developing.
"Personalized cancer vaccines are a promising and rapidly evolving type of immunotherapy," Gaziel told Fox News Digital.
There are some limitations and challenges associated with these types of therapies, however.
"Tumors are often a mixed bag of cells with varying alterations," he said. "Since the personalized vaccine targets specific entities coming from the patient's own tumor, the immune response might not be strong enough to eliminate the entire tumor."
There may also be manufacturing challenges, Gaziel noted.
"Creating personalized vaccines is a complex process that requires analyzing the patient's tumor and tailoring the vaccine accordingly," he said. "The process is expensive and time-consuming, potentially delaying treatment or making it inaccessible."
Finally, some patients may not be candidates for personalized vaccines, depending on the stage and type of their cancer.
Gaziel is optimistic, though, about the potential of AI-based personalized vaccines.
"AI is revolutionizing the design of cancer vaccines, offering a faster, more targeted approach that is solving or mitigating some of the above-mentioned barriers," he said.
Using a patient's specific tumor attributes, AI can design a vaccine tailored to that person's unique cancer profile, which may lead to more effective vaccines with fewer side effects, Gaziel added.
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There are also some limitations of the AI, however.
"Training effective AI models requires a large amount of data [for] all of the parameters that impact success," he told Fox News Digital.
"Also, it is not always easy to understand how AI models arrive at their predictions. This is crucial for ensuring their accuracy and reliability."
BreakBio’s initial focus is on colorectal cancer — the third-leading cause of cancer-related deaths in men and the fourth leading cause in women, according to the American Cancer Society (ACS).
"It’s an area of urgent medical need, in my opinion," said de Souza. "Colon cancer is hitting patients earlier and earlier, and it's not getting solved."
The plan is to eventually apply the technology to many other types of cancers.
Although de Souza’s journey was sparked by tragedy, he said the experience has been fulfilling.
"For me, it’s a once-in-a-lifetime opportunity to do something that really makes a difference and changes things," he said.
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"If I can get this done, it will be a huge achievement for me personally."
He added that he hopes "it will work for many people."
Looking ahead, de Souza said he is optimistic about the progress being made — particularly with the advent of AI-based approaches.
"Now we have these computer systems that are analyzing and coming up with answers — and that's critical for these personalized therapies."
He told Fox News Digital, "I think technologies have evolved to a point where we can spot and understand the problem, which means the chances of solving it are much higher."
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