Generex Biotechnology Publishes
Response to Congressional Letter Calling for COVID-19 Challenge
Studies and Alternative Solution to Accelerate Vaccine
Development
- Generex strategy offers ethical and safe solution to rapid
vaccine development with Ii-Key-SARS-CoV-2 peptide vaccine
- SARS-CoV-2 mechanism of infection still largely unknown
- COVID-19 disease progression remains largely undefined
- Risk factors for hospitalization include age, cardiovascular
disease, hypertension, obesity, and other unknown health and
genetic risks
- Risky strategy of viral challenge studies unnecessarily puts
people’s lives in danger
MIRAMAR, FL -- April 27, 2020 -- InvestorsHub NewsWire --
Generex Biotechnology Corporation (www.generex.com) (GNBT)
(http://www.otcmarkets.com/stock/GNBT/quote)
today published a response to the April 20th letter
from Congressional members to HHS Secretary Alex Azar and FDA
Commissioner Stephan Hahn, MD wherein they call for an accelerated
development path for a vaccine to the SARS-CoV-2 coronavirus
pandemic using viral challenge studies. Generex President & CEO
Joseph Moscato presents a corporate response to the idea of
conducting challenge studies with this coronavirus and provides
details of how Generex is responding to this global emergency by
offering a safer solution with the Ii-Key vaccine technology.
An open letter to Generex shareholders, regulatory authorities,
the medical community, legislative leaders, and all concerned
Americans:
Upon reading the letter that was sent last week by Congress to
Secretary Azar and Commissioner Hahn, the Generex management team
and I were sufficiently alarmed to publish this response to the
proposal that vaccine developers intentionally infect healthy young
people with the deadly SARS-CoV-2 coronavirus to speed up vaccine
development.
While we wholeheartedly support the proposition that we
accelerate the vaccine development process, especially in this time
of emergency pandemic response, the idea of conducting a challenge
study using such a new and incompletely understood virus that has
wreaked devastation around the globe is incomprehensible when there
are safer and better ways available to us right now.
Plus, it is not just the virus that is dangerous. There are
serious potential risks of vaccination as well, especially with
whole virus and large subunit vaccines that are known to cause
off-target effects. Anyone who wants to consider volunteering for a
COVID-19 vaccine challenge study should read the article about a
vaccine that was developed for the previous SARS outbreak that was
published in the American Chemical Society Journal of Infectious
Diseases in 2016 (ACS Infect. Dis. 2016, 2, 361−376). That article
reports the results of a viral challenge study in monkeys using an
inactivated SARS-CoV-1 vaccine. When the monkeys were
vaccinated, their immune systems generated antibodies against the
whole virus, a normal immune response to viral infection; then they
infected the monkeys with the SARS virus. While some antibodies
conferred protection from the viral challenge, other antibodies
caused serious lung damage in the monkeys and enhanced COVID
disease resulting in the honeycomb lung that we see in patients who
have died during the current SARS-CoV-2 outbreak. So, anyone who
enrolls in a viral challenge study risks not only a deadly disease,
but also worsening of the disease because the non-specific vaccine
may produce unwanted immune system overreactions.
At Generex, we understand the risks of developing a vaccine for
this coronavirus, because for the last two months the team at
Generex has been working around the clock to advance the
development of a new COVID-19 vaccine using our targeted Ii-Key
vaccine technology to specifically target the immune system against
the SARS-CoV-2 virus. We are moving forward with a rational
scientific approach and a conservative regulatory strategy that
first and foremost ensures the safety of people who volunteer to
participate in our clinical research trials of an Ii-Key-SARS-CoV-2
peptide vaccine.
With our development partners, we have used computational
algorithms to identify specific antigenic peptides from the viral
spike, envelope, and membrane proteins that are highly conserved
across other deadly coronaviruses like SARS-1 and MERS, have no
human sequences that could cause autoimmune reactions, and contain
amino acid sequences most likely to produce a neutralizing
antibodies based on historical data and computational analyses. We
are manufacturing these peptides with the Ii-Key and will be
screening them against blood samples from patients who have
recovered from COVID-19. The blood from previously infected
individuals contains T-Cells and antibodies that have actually
worked to neutralize the coronavirus infection so the patients
could recover from COVID-19. This standard protocol, which
has been developed over the years by the NuGenerex Immuno-Oncology
team, enables us to identify specific coronavirus
peptide epitopes that produce neutralizing, rather than off-target
antibodies, and activate appropriate T-helper cell (TH1) responses
through the Ii-Key rather than the potentially dangerous TH2
responses that are part of the cytokine storm. In this fashion, we
can not only select the proper, specific epitopes for a peptide
vaccine, but we also test the specificity of the immune response
generated by our Ii-Key-SARS-CoV-2 peptide vaccine in a 100% safe
“Ex-Vivo” human clinical trial before we proceed to the clinic.
Generex has had numerous discussions with U.S. government
agencies, including HHS, FDA, and BARDA, the government funding
agency that has requested that we submit a contract proposal to
provide them with details of our Ii-Key-SARS-CoV-2 peptide vaccine
development program. Today, we are submitting that proposal,
written and compiled by the Generex COVID-19 task force with
detailed plans and budgets from our scientific and clinical team,
our contract manufacturing partners, clinical laboratories,
preeminent infectious disease research laboratories, a major
clinical research organization, regulatory consultants, key opinion
leaders in vaccine development and infectious disease, and clinical
research sites to conduct the safety and efficacy trials required
for FDA fast track approval. We have also agreed to partner with a
major corporation that is developing a vaccine adjuvant formulation
that we plan to evaluate in our proposed clinical trials. Again,
our planned clinical trials are 100% focused on patient safety with
interim reviews by an independent data safety monitoring board or
DSMB that will evaluate the data not only for safety but also for
futility if the vaccine does not induce the appropriate immune
responses necessary to kill the virus. With this ongoing review of
clinical safety and futility, our plan de-risks our vaccine
development program for patients, the medical community, the
government, and our investors, with patient safety being of the
utmost importance.
Generex is highly confident in our rapid vaccine development
program and in our plans to scale the manufacturing of Ii-Key-
SARS-CoV-2 peptide vaccines to conduct not only the clinical trials
required to meet the approval standards of global regulatory
authorities, but to meet government expectations for defeating this
pandemic threat.
Over the next weeks, we will continue working to solidify the
development path and government partnerships to implement our
Ii-Key-SARS-CoV-2 “Complete Vaccine” development program. Thanks to
all of our investors for your continued support in these difficult
times, and please stay safe, be well and take care of your families
and friends.
Sincerely,
Joe Moscato
CEO
About Generex Biotechnology Corp.
Generex Biotechnology is an integrated healthcare holding company
with end-to-end solutions for patient centric care from rapid
diagnosis through delivery of personalized therapies. Generex is
building a new kind of healthcare company that extends beyond
traditional models providing support to physicians in an MSO
network, and ongoing relationships with patients to improve the
patient experience and access to optimal care.
Cautionary Note Regarding Forward-Looking
Statements
This release and oral statements made from time to time by
Generex representatives in respect of the same subject matter may
contain "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements
can be identified by introductory words such as "expects," "plan,"
"believes," "will," "achieve," "anticipate," "would," "should,"
"subject to" or words of similar meaning, and by the fact that they
do not relate strictly to historical or current facts.
Forward-looking statements frequently are used in discussing
potential product applications, potential collaborations, product
development activities, clinical studies, regulatory submissions
and approvals, and similar operating matters. Many factors may
cause actual results to differ from forward-looking statements,
including inaccurate assumptions and a broad variety of risks and
uncertainties, some of which are known and others of which are not.
Known risks and uncertainties include those identified from time to
time in the reports filed by Generex with the Securities and
Exchange Commission, which should be considered together with any
forward-looking statement. No forward-looking statement is a
guarantee of future results or events, and one should avoid placing
undue reliance on such statements. Generex undertakes no obligation
to update publicly any forward-looking statements, whether as a
result of new information, future events or otherwise.
Generex claims the protection of the safe harbor for
forward-looking statements that is contained in the Private
Securities Litigation Reform Act.
Generex Contact:
Generex Biotechnology Corporation
Joseph Moscato
646-599-6222
Todd Falls
1-800-391-6755 Extension 222
investor@generex.com
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