Philadelphia Medicine Fall 2020 - 15

p h i l a m e d s o c .o rg

LOCAL CONNECTION
TO VACCINE WORK
By Andy Andrews, Editor
Inovio, based in Plymouth Meeting, Pa., and The Wistar Institute in Philadelphia are working together
to develop a COVID-19 vaccine.
Jeff Richardson, spokesman for Inovio, answered several questions about where progress stood as of press time.

What is your role in vaccine development?

What are the steps involved now before the vaccine can be released
We are leveraging our history of developing DNA medicines - to the public? What does the committee do next?
which we have been doing since 2009 - to develop and bring to
INO-4800, our DNA vaccine candidate for COVID-19, is in
market a safe, effective and lasting vaccine for COVID-19.
clinical testing. In its early phases of development, Phase 1 clinical
We were able to apply our extensive work in global health, some data for INO-4800 demonstrated a strong safety profile and robust
with pressing needs such as the Zika, MERS and Ebola outbreaks, immunogenicity, including neutralizing antibodies and/or T-cell
to our work in developing INO-4800, our DNA vaccine candidate immune responses (both CD8 and CD4).

for COVID-19. Our experience in working under pressure to
deliver vaccine candidates in a rapid timeframe prepared us well.
Examples include:

* Vaccine development: Working in parallel instead of in sequence
(the standard approach for vaccine development) enabled Inovio
to perform multiple studies in parallel. Following this approach,
we were able to come together for rapid decisions, all of which
expedited our preclinical development work.
* Manufacturing: Whereas we would have generated a small
batch of DNA to test, analyze and scale up with this situation
we went straight for large scale-up. This was a calculated risk
given the severity of this public health crisis that, while risky,
did shave months off of the process.
* Regulatory: Inovio immediately engaged with the FDA to share
data from the start of our program. This expedited the path to
concurrence and got us into the clinic within 83 days.
What is your criteria for vaccine efficacy and safety?
Inovio's commitment to safety, rigor and diligence has been at
the heart of our R&D efforts, not only for INO-4800, but for all of
our 15 DNA medicines in development that leverage our proprietary
DNA medicines platform. Inovio follows all protocols and comports
with all government/agency requirements as we progress through
the clinical trial process across our platform.

What are the barriers to the release of any vaccine?
We are focused on developing a vaccine that is safe, effective
and lasting. It is important to note, however, that development of
the vaccine is not the end. It needs to be manufactured at scale and
made available to people around the world. Beyond our efforts to
develop our vaccine candidate, INO-4800, we are also working to
build scale through our global manufacturing consortium, composed
of Richter-Helm BioLogics, Thermo Fisher and Ology Bioservices.
Beyond manufacturing at scale, another important consideration
is the appropriate transport of the vaccine to people around the
world. Unlike other COVID-19 vaccine candidates, INO-4800 is
stable at room temperature for more than a year and does not need
to be frozen in transport or storage: vital factors for timely global
distribution.
What is your projected date for public availability?
There are many vaccines in development and they all have different
timelines and considerations for production and distribution. We
are not in a position to know with conviction when a vaccine will
be approved or how quickly production and distribution will occur.
However, we are encouraged - both by the safety profile (side
effects versus peers) as well as the immune response of INO-4800,
and are actively preparing for a Phase 2/3 trial for INO-4800. We
look forward to beginning this trial subject to FDA concurrence *

What is your role, if any, in Operation Warp Speed?
We were selected to be part of the Operation Warp Speed vaccine
pre-clinical efficacy trial evaluating the efficacy of vaccine candidates
to protect non-human primates from COVID-19.
Fall 2020 : Philadelphia Medicine 15

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Philadelphia Medicine Fall 2020

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