By Molly Fosco

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Personalized immunotherapy is emerging as the latest frontier in cancer treatment.

This OZY series brings to you the Medical Breakthroughs promising to transform healthcare, and our lives.
Judy Perkins, a 52-year-old breast cancer patient, had been in remission for a decade when her cancer returned with a vengeance. She stopped responding to treatment and was grappling with a terminal diagnosis. But then Perkins learned about a National Institutes of Health trial that involved the extraction of immune cells to treat cancer. She enrolled, went for treatment and, within months, her advanced breast cancer was eradicated through the use of immunotherapy tailored to fight her tumors.

She dodged a bullet. A definitive cure for cancer has remained elusive despite years of steady advancements in treatment. Cancer killed 8.8 million people in 2015 worldwide, according to the WHO. But the rise of personalized and precision medicine like Perkins had now promises to transform cancer treatment. Traditional oncology treatment has largely focused on targeting every person’s tumors and cancer cells with the same methods. Yet everybody — and every cancer — is different, and the development of genome sequencing has paved the way toward a new cancer treatment tuned to those unique qualities: personalized immunotherapy.

Researchers have explored immunotherapy as a strategy for fighting cancer for years. The American Association for Cancer Research in 2015 found immunotherapy vaccines to be effective at treating non-small cell lung cancer. But immunotherapy is today leaping toward a level of personalization that scientists didn’t think was possible even just a few years ago.

Beyond breast cancer, personalized immunotherapy can increase survival in brain cancer patients, according to a University of California Los Angeles study released in June. In May last year, the FDA approved a personalized and injectable drug, Keytruda, that helps the immune system destroy cancer cells and has increased survival for patients with skin cancer, Hodgkin lymphoma and bladder cancer, among others. The oncology community’s summits increasingly focus on personalized immunotherapy. This August, Cambridge Healthtech Institute will host its third annual personalized cancer vaccines meeting. There are likely 20 times more companies and research institutions focused on the development of personalized immunotherapy for cancer treatment today, compared to a decade ago, says Keith Knutson, a professor in the department of immunology at the Mayo Clinic in Jacksonville, Florida.

Some companies focus on diagnostics. Mitra Biotech, headquartered in Boston and with labs in Bangalore, for example, has devised a model that feeds a patient’s tumor biopsies into a machine learning algorithm to predict how she will respond to different drugs. BioNTech, based in Mainz, Germany, has developed several methods of immunotherapy treatments for cancer: protein coding and protein therapy, genetically engineered T cells, small molecule therapies, as well as a diagnostics platform that identifies the best treatment option for each patient. These approaches target the specific genome sequence of malignant tumors, and unlike chemo and radiation, they “can specifically kill cancer cells without as many side effects,” says Dr. Ugur Sahin, co-founder of the firm. At the Mayo Clinic in Jacksonville, Knutson’s team is developing breast cancer and ovarian cancer vaccines aimed at stimulating the immune system right after tumors have been removed through surgery. And EpiVax Oncology in Rhode Island is crafting a precision vaccine that leverages the body’s own immune system to attack and destroy cancer cells.

“This is truly revolutionary — something that’s never been done before,” says Gad Berdugo, co-founder of EpiVax Oncology.

At the heart of this explosion of interest in personalized immunotherapy is the rise of genomics. An increase in computer power has allowed genome sequencing to become cheaper and more efficient over the past two decades. In 2001, the cost of sequencing one human-size genome was $100 million. Today, it’s a mere $1,000, according to the National Human Genome Research Institute. This has enabled research involving genomics, like immunotherapy, to ramp up dramatically. As an immunology researcher, Knutson recalls feeling fairly invisible at conferences hosted by organizations like the American Association of Cancer Research in the 1990s. Immunology was “on the fringe because we didn’t understand the immune system that well,” Knutson says. The genomic revolution changed that.

Now increasingly front and center in the field of oncology, personalized immunotherapy is the route Sahin and his team at BioNTech are counting on. The process they’ve devised starts the standard way — with a biopsy. But within a few weeks the doctor receives information about the genome sequence of the tumor. A therapy based on that information is created and injected into the patient, with a maximum of two additional sessions, and the hope, says Sahin, is that it will be enough to completely kill the cancer. Their treatments are still in pre-clinical or clinical trials.

For Berdugo’s team, the process involves sequencing both the normal cells of a patient and their tumors. Then, an algorithm determines which sequence is likely to trigger your specific immune response against cancer. “It’s 100 percent custom,” Berdugo says. The method would be most effective in preventing a recurrence of cancer or preventing the development of the disease in patients who are genetically high-risk. EpiVax is meeting with the FDA at the end of July and, if all goes well, they will soon begin clinical trials. Berdugo believes an EpiVax vaccine could be on the market as soon as 2023.

But it’s not just the private sector that’s making strides; the U.S. government also has increased funding and development of the infrastructure that enables immune-based therapy research, says Knutson.

Still, costs remain high. The EpiVax technology is currently more than $10,000 per vaccine. Berdugo and his team are confident they can get that number below $10,000, but it’s unclear how much lower they’ll be able to go, or how much of the cost insurance companies will cover. As of 2016, Keytruda was priced at about $150,000 per year — prohibitively expensive for most Americans.

But as the research advances, so does hope for patients like Perkins. A cancer diagnosis might remain terrifying. But in the war on tumors, doctors will have a new advantage as they tailor their weapons based on a specific battleground: the patient’s body.

Molly Fosco, Reporter