CORRECTION: VAXIL PROVIDES UPDATE ON PRECLINICAL EXPERIMENT
April 13 2020 - 1:58PM
A correction has been issued for the release disseminated at 8:30
AM, April 13th. Some outlets mistakenly replaced the header with
the subheader. The complete and corrected release follows.
VAXIL BIO LTD. (“Vaxil” or the
“Company”) (TSX VENTURE: VXL), an innovative
immunotherapy biotech company specializing in cancer and infectious
diseases, is pleased to share the results of our
first preclinical experiment whose purpose was to test the
immune response of our COVID-19 vaccine candidate. These results
provide the first pre-clinical validation of our in silico
modelling announced a few weeks ago.
By leveraging its platform, Vaxil discovered a
potential peptide vaccine against COVID-19 back in February 2020
and then proceeded to manufacture these peptides as well as design
the preclinical program to prove effectiveness (the
“Program”). Dr. Mordechai Applebaum, PhD, Vaxil’s
head of Research and Development, conducted and validated this
experiment at the Company’s laboratory in Nes Ziona, Israel, over
the last six weeks. The experiments have not been independently
verified; this will take place as we advance the Program.
The first experiment in this Program is now
complete. As is common in such early preclinical trials/research
programs, the first experiment was performed on healthy donor blood
cells to validate the immune response in a screening protocol. It
was designed to establish that our signal peptides demonstrate a
favorable immune response (immunogenicity profile). The results of
this test were positive, as proliferation was observed in varying
degrees in T cell population (CD3+) as well as in specific
subpopulations: cytotoxic T lymphocytes (CD8+) and more prominently
in T helper cells (CD4+).
The individual peptides, as well as in
combination, all responded in varying degrees, more than
unstimulated cells. What was most encouraging was that the most
pronounced response was in T helper cells (CD4+). These responses
are comparable to those seen for ImMucin, which was used in our
Phase 1/2a study for multiple myeloma, published by the Company in
2011 and demonstrated the safety profile of ImMucin.
One of the peptides responded less well
(VXL-301), we believe, due to impurities introduced in
manufacturing. A purer form has already been ordered and delivered.
We are also assessing several large-scale contract manufacturers to
develop a scaled GMP process, in the event our preclinical
experiments continue to generate positive results.
The response in the combination of all three
peptides was less than expected, which we hypothesize may be due to
the impurities of the one peptide (as explained above) or it may be
as a result of dosage, both of which are being adjusted and
analyzed in our current work.
The uniqueness of the platform is that Vaxil’s
peptides have the potential distinct benefits of eliciting both a T
cell (cellular) and B cell (humoral) immune response. We believe
this broader immune response should be more effective as a
preventive vaccine.
Vaxil has already begun the next set of
experiments in our preclinical program to better understand the
immune responses and determine dosing. Vaxil intends to perform
additional experiments including assessing patient plasma, in vitro
cytotoxicity, in vivo immunogenicity and ex vivo T cell
proliferation and cytokine release.
“We are excited to see this early
validation of our modelling”, said David Goren, Vaxil’s Chairman
and Chief Executive Officer, and continued to say “that given the
need to vaccinate billions of people, the world will need multiple
vaccination strategies to ensure success and meet the immense
demand. We continue to be optimistic that we can play a role in
this critical time of need.”
For more detailed results of this first vaccine
candidate experiment, please see our presentation on our website
vaxil-bio.com/Covid-19.
Dr. Applebaum has read and approved of the
scientific disclosure in the news release.
The Company is not making any express or implied
claims that it has developed a vaccine to treat COVID-19 (or
SARS-CoV-2) at this time.
ABOUT VAXIL
Vaxil is an Israeli immunotherapy biotech
company focused on its novel approach to targeting prominent cancer
markers and infectious diseases. Its lead product ImMucin™
successfully completed a Phase 1/2 clinical trial in multiple
myeloma and received orphan drug status from the FDA and EMA. The
company continues to develop ImMucin™ and is also developing a
tuberculosis vaccine / treatment that has demonstrated promising
preliminary results with further preclinical evaluation underway at
a top US academic and research institution. Additional indications
and mAb candidates are under evaluation as immuno-oncology and
infectious disease treatments alone and in combination with other
treatments.
Vaxil exploits the unique properties of signal
peptide domains on crucial proteins to develop targeted therapies
against cancer targets and infectious disease pathogens. These
signal peptide domains are identified by VaxHit™, Vaxil’s
proprietary bioinformatic approach. These SPs induce a robust T-
and B-cell response across wide and varied HLA subtypes, while
acting as true, universal neoantigens. The peptide platform targets
these cells by “educating” or specifically activating the immune
system to recognize and attack the affected cells. In addition,
Vaxil’s mAb platform directly recognizes the target protein
expressed on malignant cells and recruits other elements of the
immune system to lyse those cells.
Disclaimer: The Company cautions that COVID-19
Vaccine Development is still under early stage research and
development and is not making any express or implied claims that it
has the ability to eliminate the COVID-19 virus at this time. The
TSX Venture Exchange Inc. has in no way passed upon the merits of
the Company has neither approved nor disapproved the contents of
this press release. Neither TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release. This news release contains
forward-looking information, which involves known and unknown
risks, uncertainties and other factors that may cause actual events
to differ materially from current expectation. Important factors -
including the availability of funds, the results of financing
efforts, the results of exploration activities -- that could cause
actual results to differ materially from the Company's expectations
are disclosed in the Company's documents filed from time to time on
SEDAR (see www.sedar.com). Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date of this press release. The company disclaims
any intention or obligation, except to the extent required by law,
to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise. This press
release does not constitute an offer to sell or a solicitation of
an offer to sell any of the securities described herein in the
United States or elsewhere. These securities have not been, and
will not be, registered in the United States Securities Act of
1933, as amended, or any state securities laws, and may not be
offered or sold in the United States or to U.S. persons unless
registered or exempt therefrom.
CONTACT INFORMATION
For further information please
visit http://vaxil-bio.com/ or contact: David Goren, CEO
-- david@vaxil-bio.com, +972 (52) 720-6000
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