NEW YORK, Apr. 10, 2021 /PRNewswire-PRWeb/ -- A
personalized cancer vaccine developed with the help of a
Mount Sinai computational platform
raised no safety concerns and showed potential benefit in patients
with different cancers, including lung and bladder, that have a
high risk of recurrence, according to results from an
investigator-initiated phase I clinical trial presented during the
virtual American Association for Cancer Research (AACR) Annual
Meeting 2021, held April 10-15.
"While immunotherapy has revolutionized the treatment of cancer,
the vast majority of patients do not experience a significant
clinical response with such treatments," said study author
Thomas Marron, MD, PhD, Assistant
Director for Early Phase and Immunotherapy Trials at The Tisch
Cancer Institute and Assistant Professor of Medicine (Hematology
and Medical Oncology) at the Icahn School of Medicine at
Mount Sinai. "Cancer vaccines,
which typically combine tumor-specific targets that the immune
system can learn to recognize and attack to prevent recurrence of
cancer. The vaccine also contains an adjuvant that primes the
immune system to maximize the efficacy."
To generate the personalized cancer vaccine, Dr. Marron and
colleagues sequenced each patient's tumor and germline DNA and
tumor RNA. They also identified the patient's tumor-specific target
to help predict whether the patient's immune system would recognize
the vaccine's targets.
The Mount Sinai computational
pipeline, called OpenVax, allows the researchers to identify and
prioritize immunogenic targets to synthesize and incorporate into
the vaccine.
Following any standard cancer treatment such as surgery for
solid tumors or bone marrow transplant for multiple myeloma,
patients received 10 doses of the personalized vaccine over a
six-month period. The vaccine was given with the immunostimulant,
or adjuvant, poly-ICLC, which is "a synthetic, stabilized,
double-stranded RNA capable of activating multiple innate immune
receptors, making it the optimal adjuvant for inducing immune
responses against tumor neoantigens," said study author
Nina Bhardwaj, MD, PhD, Director of
the Immunotherapy Program and the Ward-Coleman Chair in Cancer
Research at The Tisch Cancer Institute at Mount Sinai.
"Most experimental personalized cancer vaccines are administered
in the metastatic setting, but prior research indicates that
immunotherapies tend to be more effective in patients who have less
cancer spread," said Dr. Bhardwaj. "We have therefore developed a
neoantigen vaccine that is administered after standard-of-care
adjuvant therapy, such as surgery in solid tumors and bone marrow
transplant in multiple myeloma, when patients have
minimal—typically microscopic—residual disease. Our results
demonstrate that the OpenVax pipeline is a viable approach to
generate a safe, personalized cancer vaccine, which could
potentially be used to treat a range of tumor types."
Before the vaccine, the trial participants statistically had a
high chance of disease recurrence. Thirteen patients received the
Mount Sinai team's vaccine: 10 had
solid tumor diagnoses and 3 had multiple myeloma.
After a mean follow-up of 880 days, four patients still had no
evidence of cancer, four were receiving subsequent lines of
therapy, four had died, and one chose not to continue the trial.
The vaccine was well tolerated, with roughly one-third of patients
developing minor injection-site reactions.
A phase 1 trial's primary goal is to determine the safety of an
experimental treatment, which was achieved in this trial.
Researchers also saw early potential benefits of the vaccine after
blood tests of one of the patients showed an immune response from
the vaccine, and two other patients had robust response to
immunotherapy afterward, results that are normal after being
exposed to a cancer vaccine.
Since this trial's completion, Mount
Sinai has opened or plans to open five other phase 1 trials
testing OpenVax with other therapies in cancers that include
glioblastoma, bladder cancer, prostate cancer, and
myeloproliferative neoplasms, a blood cancer. This study was
sponsored by the Parker Institute for Cancer Immunotherapy and The
Tisch Cancer Institute.
About the Mount Sinai Health System
The Mount Sinai Health System is New
York City's largest academic medical system, encompassing
eight hospitals, a leading medical school, and a vast network of
ambulatory practices throughout the greater New York region. Mount Sinai is a national and international
source of unrivaled education, translational research and
discovery, and collaborative clinical leadership ensuring that we
deliver the highest quality care—from prevention to treatment of
the most serious and complex human diseases. The Health System
includes more than 7,200 physicians and features a robust and
continually expanding network of multispecialty services, including
more than 400 ambulatory practice locations throughout the five
boroughs of New York City,
Westchester, and Long Island. The Mount Sinai Hospital is
ranked No. 14 on U.S. News & World Report's "Honor Roll" of the
Top 20 Best Hospitals in the country and the Icahn School of
Medicine as one of the Top 20 Best Medical Schools in country.
Mount Sinai Health System hospitals are consistently ranked
regionally by specialty and our physicians in the top 1% of all
physicians nationally by U.S. News & World Report.
For more information, visit https://www.mountsinai.org or find
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Media Contact
Marlene Naanes, Mount Sinai
Health System, 212-241-9200, marlene.naanes@mountsinai.org
Twitter
SOURCE Mount Sinai Health System