Generex Biotechnology Initiates Peptide Manufacturing for Ii-Key- SARS-CoV-2 Peptide Vaccine Against the COVID-19 Pandemic
May 04 2020 - 10:02AM
InvestorsHub NewsWire
- Submitted proposal to BARDA for start-to-finish funding to
develop an approved, commercial Ii-Key peptide vaccine against the
SARS-CoV-2 coronavirus
- SARS-CoV-2 epitope identification and selection completed
- Initiated GLP manufacturing of synthetic Ii-Key-SARS-CoV-2
peptides for screening in “Ex-vivo” human trial in blood samples
from COVID-19 convalescent (recovered) patients
- Obtained letters of support for BARDA Application from
scientific partners, prestigious universities, major contract
manufacturers, and a prominent CRO that will manage the
international regulatory effort and the proposed end-to-end
clinical program
MIRAMAR, FL -- May 4, 2020 -- InvestorsHub NewsWire -- Generex
Biotechnology Corporation (www.generex.com)
(GNBT)
(http://www.otcmarkets.com/stock/GNBT/quote)
today announced that the company has submitted a contract proposal
to BARDA to develop a vaccine against the SARS-CoV-2 coronavirus
using the patented Ii-Key vaccine technology. Following the BARDA
application, and in an effort to rapidly respond to this pandemic
emergency, Generex has now initiated the manufacturing of synthetic
peptides with Ii-Key linked to SARS-CoV-2 epitopes predicted by
computational vaccinology algorithms. These Ii-Key-SARS-CoV-2
peptide epitopes, which contain target amino acid sequences from
the virus, will be screened against blood samples collected from
COVID-19 convalescent (recovered) patients to select those Ii-Key
peptides that activate the immune system to fight the coronavirus
infection. The blood screening program, which is scheduled to begin
to begin shortly, incorporates T Cell Assays, B Cell Assays,
Antibody and Virus Neutralization tests, and a novel in-vitro
“cytokine storm” cellular assay to identify the Ii-Key-SARS-CoV-2
peptides vaccines most likely to stimulate the T-Cell (CD4 and CD8)
response, modulate appropriate immune system responses to minimize
potential for dysregulated cytokine-related inflammation, stimulate
a neutralizing antibody response, and provide a broad-spectrum
coverage for the vast majority of people. This strategy leverages
Ii-Key technology to develop a “Complete Vaccine” that has the
potential to induce the likelihood of protective immunity with
long-lasting immunologic memory against SARS-COV-2 in a highly
specific manner to ensure safety. The most important aspect of this
ex-vivo human trial approach is that we can select the right
peptides for Ii-Key vaccine peptides that will limit the risk of
off-target immune responses that may lead to a cytokine storm, and
we find the answers very early in the development process before we
vaccinate any human volunteers.
Generex CEO, Joseph Moscato said, “We have been working
diligently over the last two months to rapidly respond to the
coronavirus pandemic, because our Ii-Key peptide technology offers
true promise for an effective and safe COVID-19 vaccine.
Highlighting the potential for our Ii-Key-SARS-CoV-2 “Complete
Vaccine”, Generex has obtained letters of support from key,
industry leading partners to provide their expertise, experience,
facilities and infrastructure for the development and manufacturing
of an Ii-Key-SARS-COV-2 vaccine. We have contracted PPD, a
recognized leading CRO to provide comprehensive, turnkey clinical
and regulatory services, including regulatory submissions, site
preparation, clinical testing, data management, protocols and
reports required to maximize the speed and path to licensure.
Additionally, we are planning GMP vaccine production with industry
leaders in GMP peptide synthesis, including Polypeptide
Laboratories (the manufacturers of our AE37 Ii-Key-HER2
immuno-oncology product), Bachem, and Corden Pharma who are on
board to provide clinical trial material and kilogram scale
commercial manufacturing. We also have support from
international leaders, Ajinomoto and Thermo-Fisher for fill/finish
and quality control, ensuring both capacity and redundancy to
deliver on large scale vaccination requirements. Further, we have
obtained a letter of support from 3M to evaluate the use of their
new vaccine adjuvant in the formulation of the Ii-Key peptide
vaccines for the comprehensive clinical program that was outlined
in our proposal.”
Mr. Moscato continued, “Because Generex’ subsidiary NuGenerex
Immuno-Oncology has a long history of developing the Ii-Key peptide
vaccine technology to rapidly respond to potential pandemic
threats, we have been able to rapidly mobilize our efforts to help
respond to the COVID-19 global pandemic. And, as shown in the
recently published positive results from our Phase II trial of AE37
in the prevention of breast cancer recurrence in hard to treat
patients, the Ii-Key activates the T-Cell response against the HER2
antigenic epitope to which it is attached. The authors point out
the benefit of such a complete immune response combining CD8+ and
CD4+ activation may not only induce an immediate cell mediated
cytolytic response versus tumor antigens but may also induce
T-Helper cell mediated long-term immunity to protect against tumor
recurrence. The activation of a complete immune response against
coronavirus antigens modulated by the Ii-Key is what sets us apart
from others in the field and makes us confident in our plans to
deliver a COVID-19 vaccine with our Ii-Key-SARS-CoV-2 peptide
vaccine development program. We will keep our investors informed as
the development progresses.”
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.
NuGenerex Immuno-Oncology (formerly Antigen Express), a
subsidiary of Generex Biotechnology, is a clinical stage oncology
company developing immunotherapeutic peptide vaccines based on the
CD-4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology
(NGIO) is being spun out of Generex as a separate, independent
public company to advance the platform Ii-Key technology,
particularly in combination with the immune checkpoint inhibitors.
NGIO is currently engaged in a Phase II clinical trial of its lead
cancer immunotherapeutic vaccine AE37 in combination with
pembrolizumab (Merck’s Keytruda®) for the treatment of triple
negative breast cancer.
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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