Generex Subsidiary NuGenerex Immuno-Oncology Announces Publication of Positive Results of the AE37 Phase IIb Breast Cancer Tr...
Prospective, randomized, single-blinded, multi-center phase
II trial of two HER2 peptide vaccines, GP2 and AE37, in breast
cancer patients to prevent recurrence
- Conclusion: AE37 Ii-Key peptide vaccine is safe and associated
with DFS in sub-sets of breast cancer survivors after 10-year
- In patients with both advanced stage and HER2 under-expression
(HER2 2+, 1+, triple negative) there was a significant improvement
in Disease Free Survival (DFS) favoring the vaccine group (AE37
83.0% vs Control 62.5%, p = 0.039, HR 0.375)
- Breast Cancer Research & Treatment; article can be found
MIRAMAR, FL -- April 28, 2020 -- InvestorsHub NewsWire --
Generex Biotechnology Corporation (www.generex.com)
is happy to announce that the final results of the Phase IIb
clinical trial of AE37 +/- GM-CSF vaccine for the prevention
of recurrence of breast cancer have been published in the
peer-reviewed journal, Breast Cancer Research & Treatment. In
the AE37 arm of this trial, the investigators* found that patients
with advanced stage, HER2 under-expression, and TNBC may benefit
from AE37 vaccination, and those with both advanced stage and HER2
under expression have a significant clinical benefit to AE37
vaccination, demonstrating earlier DFS plateau that was maintained
for up to the ten years of follow-up. The study showed that AE37
induces CD4+ T helper cell stimulation which is required for the
effective generation of long-term cell-mediated immunity, and
postulates that the AE37 vaccine may have more of an immunoadjuvant
effect to augment a vaccine-induced CD8+ T-Lymphocyte (CTL)
response. Further, AE37 is able to directly stimulate the HLA-DR
alleles with epitopes present in the HER2 protein, increasing
interferon gamma (IFN-γ) and CD4+ T-helper (Th1) cells which in
turn assist in strong in vivo autologous lysing of tumor cells by
CD8+ cells. Thus, the addition of the Ii-Key in AE37 specifically
enhances immune responses via the MHC class I pathway.
Additionally, the study shows that the Ii-Key acts as an immune
system adjuvant, activating both the CD4+ response and the CD8+
response against the HER2 antigenic epitope to which it is
attached. The authors point out the benefit of such a complete
immune response that combines CD8+ and CD4+ activation may not only
induce an immediate cell mediated cytolytic response versus tumor
cells but may also induce T-Helper cell mediated long-term immunity
to protect against tumor recurrence.
Generex President & CEO Joe Moscato Said, “This is fantastic
news for NuGenerex Immuno-Oncology and our AE37 Ii-Key
immunotherapeutic peptide vaccine. The study results confirm that
patients with advanced stage, HER2 under-expression, and TNBC may
benefit from AE37 vaccination, and we now have statistically
significant 10-year disease free survival data that demonstrates
clinical benefit in the most difficult to treat patients with
advanced disease and low HER2 levels, including triple negative
breast cancer. For the last three and a half years, we have worked
diligently to turn around the NuGenerex Immuno-Oncology development
program, and to unlock the true value of the Ii-Key technology.
These positive data confirm our ongoing belief in the power of
Ii-Key platform to modulate the immune system to fight
disease. We will continue to develop AE37 in our ongoing
Phase II clinical trial in combination with pembrolizumab (Merck’s
Keytruda®) for the treatment of triple negative breast cancer, and
we are planning a trial of AE37 in bladder cancer. As we spin out
NGIO as a separate public company, we are excited about the
opportunities for AE37 and our other Ii-Key immunotherapeutic
peptide vaccines GP100 and TYR for melanoma, and we plan to explore
additional tumor associated antigenic epitopes for our Ii-Key
immune system modulating platform.”
Mr. Moscato continued, “In addition to our efforts to develop
Ii-Key peptide vaccines for oncology, the Generex management team
is actively involved in a COVID-19 emergency response effort. We
are advancing discussions with BARDA and have been working hard to
assemble an impressive group of partner organizations to implement
an accelerated, multifaceted development program to commercialize
our Ii-Key-SARS-CoV-2 peptide vaccine in response to the U.S.
government calls for a vaccine solution to the coronavirus crisis.
We are working to secure manufacturing, laboratory, clinical,
regulatory, and expert medical advisory services with world-class
organizations like PPD, Polypeptide Labs, Bachem, Ajinomoto,
Thermo-Fisher, CTL Laboratories, and San Diego Center for AIDS
Research as well as renowned clinical research sites at Tufts
University Medical Center and Wake Forest Baptist Health. Together
we have prepared a full proposal for the end-to-end development of
an Ii-Key-SARS-CoV-2 vaccine. Additionally, we continue discussions
with Canadian health authorities, having held a pre-CTA
teleconference last week, and we plan to finalize our regulatory
strategy in collaboration with Health Canada in the coming weeks.
We will keep our shareholders updated as we progress in our
coronavirus vaccine development program using Ii-Key peptides to
activate the immune system for protection from COVID-19. And to all
of our valued investors, please stay safe and be well.”
*Clinical Investigators and Study Managers: Tommy A. Brown II ·
Elizabeth A. Mittendorf· Diane F. Hale · John W. Myers III ·
Kaitlin M. Peace ·Doreen O. Jackson · Julia M. Greene · Timothy J.
Vreeland · G. Travis Clifton · Alexandros Ardavanis ·Jennifer K.
Litton5· Nathan M. Shumway · J. Symanowski · James L. Murray ·
Sathibalan Ponniah · E. A. Anastasopoulou · N. F. Pistamaltzian ·
Constantin N. Baxevanis · Sonia A. Perez · Michael Papamichail ·
George E. Peoples
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
CD4 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.
EpiVax is a 21-year old privately-held biotechnology company
located in Providence, RI, with a broad portfolio of
projects including vaccines and immunotherapies for
infectious diseases, autoimmunity and cancer. Scientists at EpiVax,
led by co-founders Annie De Groot, MD and Bill Martin, lead the
field in immunogenicity risk assessment. The ISPRI and iVAX toolkits
for therapeutics and vaccines are used by a global roster of
companies. Visit www.epivax.com for more information.
Cautionary Note Regarding Forward-Looking
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 Biotechnology Corporation
1-800-391-6755 Extension 222
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