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Biotech Innovations
Personalized Cancer Vaccine Approach
Safe in Early Trial
An experimental peptide vaccine personal-
ized for individual patients with different
cancer types was well tolerated in a phase 1
trial, researchers reported at the American
Association for Cancer Research annual
meeting in April. The vaccine is designed to
train the immune system to detect and elimi-
nate so-called micrometastic disease that re-
mains after cancer treatment and can lead
to recurrence.
The trial enrolled 15 patients with mul-
tiple myeloma or solid tumors including non–
small cell lung cancer and cancers of the head
and neck, bladder, and breast. After under-
going a bone marrow transplant or surgery,
11 of the patients received 10 vaccine doses
over 27 weeks, according to researcher
Thomas U. Marron, MD, PhD, of the Icahn
School of Medicine at Mount Sinai. Of the
4 other participants, 1 patient received 9
doses, 1 received 7, and the remaining 2 did
not receive the vaccine.
About a third of the patients who were
vaccinated had mild injection site reactions
and 1 participant developed a fever. An ini-
tial analysis of blood from the first few pa-
tients showed that the vaccine was able to
successfully induce an immune response.
Further blood analysis is underway.
The personalized genomic vaccine,
named PGV-001, is based on patients’ RNA
and DNA sequencing. Genetic mutations in
cancer lead to mutated proteins, Marron
explained. “The goal of the vaccine is to
make synthetic versions of these foreign
proteins and to vaccinate your body against
them,” he said in an email. In the trial, each
patient’s customized vaccine contained the
lab-grown proteins and the adjuvant poly-
ICLC to boost the immune response. Mount
Sinai’s computational pipeline OpenVax
identified the proteins.
Larger trials are needed to determine if
the method eliminates residual cancer cells
after surgery or transplant, Marron said.
iStock.com/nito100
A Next-Generation Rapid, Accurate
SARS-CoV-2 Antibody Test
More than a year into the COVID-19 pan-
demic, SARS-CoV-2 antibody tests are plen-
jama.com
© 2021 American Medical Association. All rights reserved.
tiful, but highly accurate, affordable, point-of-
care versions with quantitative data still don’t
exist. An innovative test from scientists at
the University of California, San Francisco, and
colleagues could change that.
To develop their assay, the researchers
fused fragments of a luminescent enzyme
to SARS-CoV-2 viral protein antigens—
specifically the S-protein receptor bind-
ing domain or the N-protein terminal se-
quence. The engineered antigens glow
when they react with antibodies against
them, resulting in luminescent biosensors
that are compatible with a commercially
available handheld luminometer.
The assay quantifies antibody levels
within 30 minutes. The researchers evalu-
ated it with 159 serum and plasma samples
from 3 COVID-19 cohorts including inpa-
tients, outpatients, and recovering pa-
tients. Its sensitivity was 89% for detecting
anti–S-protein antibodies and 98% for
anti–N-protein antibodies, and its specific-
ity was more than 99% for both. Additional
testing also demonstrated the assay’s
potential for use with whole blood from
simple finger sticks or saliva samples (with
somewhat less accuracy), valuable in low-
resource settings.
The test could be used to track anti-
body responses after infection or vaccina-
tion, to follow vaccine response duration,
(Reprinted) JAMA May 11, 2021 Volume 325, Number 18
and for widespread serosurveillance, the re-
searchers wrote in Nature Biotechnology.
Highly Sensitive Point-of-Care Ebola
Diagnostic In Development
A novel, point-of-care (POC) antigen test in
development at Duke University could
allow for quick and accurate Ebola detec-
tion in decentralized health care facilities
without a laboratory infrastructure. The
World Health Organization has called for such
a test since the 2014-2016 West Africa
Ebola outbreak, which killed more than
11 000 people.
Lateral flow assays (LFAs) for Ebola de-
tection are cheap and provide results in as
little as 15 to 30 minutes. But they can be far
less sensitive than polymerase chain reac-
tion (PCR) tests, which has limited their
adoption. Meanwhile, PCR tests typically re-
quire highly trained laboratory personnel,
and newer POC single-use versions can still
take around 90 minutes to deliver results
and are relatively costly.
The new blood test, called the EBOV D4,
is a low-cost chip that emits a fluorescent sig-
nal in the presence of Ebola virus secreted
glycoprotein (sGP), a decoy molecule pro-
duced by the pathogen in huge amounts
early in infection. A handheld reader de-
tects and quantifies the signal.
In a study published in Science Transla-
tional Medicine, the prototype assay took 60
minutes to detect the biomarker in donor
whole human blood spiked with sGPs from
patients who died in different Ebola out-
breaks and was 1000 times more sensitive
than currently available LFAs. The assay had
comparable sensitivity to PCR tests and de-
tected Ebola a day earlier in an experiment
involving rhesus macaques challenged with
the virus.
The chip’s sensitivity in part comes from
its nonstick surface, which is embedded with
antibodies to which only sGP binds. Before
setting up a clinical trial, the Duke team is
working to develop antibodies with even
greater Ebola virus sGP-binding affinity,
among other improvements, the research-
ers said in an email. − Jennifer Abbasi
Note: Source references are available through
embedded hyperlinks in the article text online.
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