18 BioPharm International
®
Emerging Therapies eBook September 2023 www.biopharminternational.com
C
ancer messenger RNA (mRNA) vaccines
have made headlines multiple times in
2023. In February, an mRNA vaccine for
cancer received breakthrough therapy
designation after demonstrating efficacy in a Phase
II trial (1). In May, the National Institutes of Health
announced that in a small clinical trial, a person-
alized mRNA vaccine prevented pancreatic cancer
from recurring for about half of trial participants
(2). These developments were catalyzed in part by
the success of the mRNA vaccine for COVID-19.
Unlike traditional vaccines, the manufacturing
process for mRNA vaccines is cell-free and can be
performed with synthetic enzymes. This allows for
unprecedented speed and scale of mRNA vaccine de-
velopment and manufacturing, which proved to be
pivotal during the COVID-19 pandemic. In turn, the
deployment of mRNA COVID-19 vaccines helped forge
the robust supply chain for mRNA vaccine manufac-
turing that had not previously existed. Despite this
success, clinical and logistical roadblocks to mRNA
cancer vaccine development remain.
This article reviews the therapeutic prospects of
mRNA vaccines and considerations for clinical devel-
opment that could help address present issues with
patient recruitment, regulatory compliance, manu-
facturing, and funding.
Developing therapeutic cancer mRNA vaccines
The mRNA cancer vaccines currently in clinical develop-
ment have been long awaited. For decades, researchers
have tried and failed to develop an effective therapeutic
cancer vaccine (3). However, advancements in clinical
development have made it clear that success is no longer
a question of "if" but "when"—and, critically, "how."
Challenges of cancer vaccine development
To begin to answer the "how," it's helpful to under-
stand why developing a vaccine for cancer has proven
considerably more challenging than developing a
Logistical Considerations
in mRNA Vaccine
Development
Andreas Dreps, PhD,
is SVP, Drug Development
Services at ICON;
Martin Lachs, PhD,
is VP, Project Management
Oncology at ICON.
Despite its success, clinical and logistical
roadblocks to mRNA cancer vaccine development remain.
JUAN
GÄRTNER
-
STOCK.ADOBE.COM
