Amazon Launches Clinical Trials for Development of Personalized Vaccine for Breast and Skin Cancer

The logo of Amazon is seen on the door of an Amazon Books retail store in New York City, on Feb. 14, 2019. (Brendan McDermid/Reuters/File Photo)

Amazon has been developing personalized vaccines for breast and skin cancers in conjunction with the Fred Hutchinson Cancer Center and has been recruiting patients to participate in an FDA-approved clinical trial for the shots, according to a public filing.

A summary of the project was first posted on Clinicaltrials.gov, an online database of clinical studies run by the U.S. National Library of Medicine, in October last year.

The study is titled “Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma or Hormone Receptor-Positive Her2 Negative Metastatic Refractory Breast Cancer.”

According to a brief summary of the study, the Phase 1 clinical trial will look at the “safety of personalized neo-antigen peptide vaccine” in treating patients with melanoma or breast cancer that has spread to other places in the body or does not respond to treatment.

The personalized vaccine will effectively help the body to create tumor-specific antibodies, so attacker T cells can identify and destroy those tumor cells.

An outline of the study states that 20 patients aged 18 years and older will receive poly ICLC, an immunostimulant that is being studied in the treatment of cancer and for its ability to stimulate the immune system, intramuscularly once a week in weeks when no vaccine is given.

Beginning two weeks after starting poly ICLC, participants will receive the “personalized neo-antigen peptide vaccine” once every four weeks and nivolumab, another medication used to treat various types of cancer, every two or four weeks.

‘Collaborator’

The treatment will continue for 25 weeks, so long as the disease does not progress or unacceptable toxicity levels are noted, according to researchers.

“Patients then receive nivolumab every 2 or 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity,” researchers continued. “After completion of study treatment, patients are followed up at 24, 36, and 48 weeks.”

The study of the “U.S. FDA-regulated Drug Product” began on June 9 and the trial has an estimated completion date of November 2023.

Fred Hutchinson is listed as the “sponsor” of the trial, and Amazon is referred to as the “collaborator” of the study.

A spokesperson for Fred Hutchinson confirmed to Business Insider that the details of the clinical trial are accurate.

Meanwhile, a spokesperson for Amazon told the publication that the retail giant is “contributing scientific and machine learning expertise to a partnership with Fred Hutch to explore the development of a personalized treatment for certain forms of cancer.”

They added that things are still in the early stages but that “Fred Hutch recently received permission from the U.S. Food and Drug Administration to proceed with a Phase I clinical trial, and it’s unclear whether it will be successful.”

The spokesperson also hinted that the Jeff Bezos-founded company is looking into potential partnerships with other health care companies to work on similar projects in the future.

‘Long, Multi-Year Process’

“This will be a long, multi-year process—should it progress, we would be open to working with other organizations in health care and life sciences that might also be interested in similar efforts,” the spokesperson added.

The Amazon–Fred Hutchinson Cancer Center trial comes after a study published on June 5 in The New England Journal of Medicine showed that a separate cancer trial had reportedly become the first in the world to completely remove the disease in every patient.

The study was conducted among 12 rectal cancer patients who were given dostarlimab, a monoclonal antibody, every three weeks for six months, and all had a “clinical complete response,” according to the authors.

Those who participated in the trial also continued to show no signs of cancer during follow-ups ranging from 6 months to 25 months and haven’t had to undergo surgery or receive radiation and chemotherapy.

Meanwhile, pharmaceutical giant BioNTech is also working on an mRNA cancer vaccine for the treatment of patients with advanced melanoma, with clinical trials evaluating the efficiency and tolerability of its BNT111 vaccine in combination with Libtayo, an anti-PD-1 monoclonal antibody, which is being co-developed by American biotechnology company Regeneron and French multinational health care firm, Sanofi.