Country for PR: United Kingdom
Contributor: PR Newswire Europe
Tuesday, December 22 2020 - 00:00
AsiaNet
BioVaxys Vaccine Platform Stimulates Robust T-cell Response Against Viral Antigens
VANCOUVER, B.C., Dec. 21, 2020 /PRNewswire-AsiaNet/ --

- BVX-0320 ACTIVATES IMMUNE SYSTEM MEMORY 'HELPER ' CD4+ AND KILLER CD8+ 
T-CELLS AGAINST SARS-COV-2

- POTENTIAL FOR LONGER-TERM VIRAL PROTECTION

BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB, OTC:LMNGF) ("BioVaxys") 
announced today that further analysis of the data from a preclinical animal 
study (also known as the "murine model study") of its haptenized viral protein 
vaccine technology show that BVX-0320, its COVID-19 vaccine candidate based on 
the Company's haptenized viral protein platform, elicits a robust T-cell 
response against SARS-CoV-2.

Using a technique called flow cytometry, the BioVaxys team found that its 
haptenized SARS-CoV-2 s-spike vaccine activated CD4+ helper T cells and CD8+ 
killer T cells that express the activation markers, CD69 and CD25.  This result 
indicates that immunization with BVX-0320 at two different dose levels of 3 
micrograms or 10 micrograms stimulated immune system memory 'helper' T-cells as 
well as killer T cells.  CD4+ T-cells are crucial in achieving a regulated 
effective immune response to viral pathogens, and are central to adaptive 
immune responses. Generated following an immune response, memory 'helper' CD4+ 
T-cells retain information about the virus, which enables them to respond 
rapidly after viral exposure.  CD8+ T cells have the capacity to kill cells 
infected by the virus, thereby stopping viral replication in those cells.

BioVaxys Co-Founder, President and Chief Operating Officer Kenneth Kovan says, 
"This is an exciting development not only in the COVID-19 vaccine field, but 
potentially for other viral vaccines.  Post-vaccination generation of 
antibodies is no doubt critical and garners much attention. However, antibody 
levels can quickly become undetectable after just a few months, leading to the 
conclusion that anti-viral immunity has waned."  He goes on to say that "a 
robust CD4 and CD8 T-cell response, such as that we are seeing, has potential 
to confer much longer protection."  

Recent data from the preclinical study, which began in September 2020 and was 
conducted by leading independent contract research organization ("CRO") Charles 
River Laboratories, Inc. under contract with BioVaxys, evaluated the anti-virus 
immune response elicited by BVX-0320 in a controlled murine model by measuring 
the development of antibodies to the protein that binds the virus to human 
cells.  Following two injections of BVX-0320 together with the immunological 
adjuvant, QS21, to 28 mice at four dosage levels, 96.4% developed positive 
antibody responses detected at week 6.  Co-founder and Chief Medical Officer 
David Berd, MD, says that "Stimulating a 96.4% antibody response is an 
excellent development, but we believe that activation of T-cells is even more 
important. A post-SARS2 infection T cell response appears to be a defining 
characteristic following recovery in COVID-19 patients.  Seeing activation of 
CD4 and CD8 T-cells differentiates our approach from some other COVID-19 
vaccines."   Dr. Berd adds that "a duration of immunity that cannot be 
guaranteed past a few months is really not useful protection.  Activation of a 
T-cell response may be the critical determinant for effective long-term 
protection."  

A separate study sponsored by BioVaxys is underway at The Ohio State University 
Wexner Medical Center, where the mouse sera (collected from the test animals) 
is being tested for the ability to inactivate live SARS-Cov-2 virus. Results 
are anticipated later this month.

James Passin, the CEO of BioVaxys, stated, "The outstanding results from the 
Murine Model Study of BVX-0320, including robust T cell and antibody results 
and an excellent safety and manufacturing profile, evidences the value of our 
haptenized viral protein vaccine technology platform and should support ongoing 
discussions with potential pharmaceutical partners. We are excited to continue 
to leverage this scientific momentum, as well as to continue advancing our 
novel COVID-19 T-cell diagnostic, a low cost and scalable tool which may assist 
public health authorities in the distribution of scarce vaccine resources, as 
it should not be a priority to immunize individuals presenting T cell immunity 
to SARS-CoV-2."

BioVaxys's product pipeline includes BVX-0918A, an IND-stage haptenized cancer 
cell vaccine for treating late-stage ovarian cancer.  In Phase I and Phase II 
clinical studies previously conducted by BioVaxys, co-founder and Chief Medical 
Officer, Dr. David Berd, using an earlier generation of the BioVaxys cancer 
vaccine on nearly 500 patients with melanoma or ovarian cancer, the haptenized 
cell platform showed significant clinical promise. 

BioVaxys has developed its vaccine technology platforms based on the 
established immunological concept that modifying proteins with simple chemicals 
called haptens makes them more visible to the immune system. The process of 
haptenization "teaches" a patient's immune system to recognize and make target 
proteins more 'visible' as foreign, thereby stimulating an immune response.  

For greater certainty, BioVaxys is not making any express or implied claims 
that it has the ability to treat the SAR-CoV-2 virus at this time.

David Berd, M.D. the Chief Medical Officer of BioVaxys, has reviewed and 
approved the scientific disclosure contained in this press release. Dr. Berd is 
a medical oncologist with a lifelong record of clinical research in medical 
oncology and cancer immunotherapy. Dr. Berd received his BS from Pennsylvania 
State University and his MD from Jefferson Medical College of Thomas Jefferson 
University.

About BioVaxys Technology Corp.

Based in Vancouver, BioVaxys Technology Corp. [http://www.biovaxys.com/] is a 
British Columbia-registered, early stage biotechnology company that is 
developing viral and oncology vaccine platforms, as well as 
immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its 
haptenized viral protein technology, and is planning a clinical trial of its 
haptenized autologous cell vaccine used in combination with anti-PD1 and 
anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian 
cancer. Also in development is a diagnostic for evaluating the presence or 
absence of a T cell immune response to SARS-CoV-2, the virus that causes 
COVID-19. BioVaxys has two issued US patents and two patent applications 
related to its cancer vaccine, and pending patent applications for its 
SARS-CoV-2 (COVID-19) vaccine and diagnostic technologies. BioVaxys common 
shares are listed on the CSE under the stock symbol "BIOV" and trade on the 
Frankfurt Bourse (FRA: 5LB) and US OTC: LMNGF.

ON BEHALF OF THE BOARD

Signed "James Passin"
James Passin, CEO
+1-646-452-7054

Media Contacts
Andrea Vuturo
+1-508-301-3774
biovaxys@dittopr.co 

Cautionary Statements Regarding Forward Looking Information 

This press release includes certain "forward-looking information" and 
"forward-looking statements" (collectively "forward-looking statements") within 
the meaning of applicable Canadian and United States securities legislation 
including the United States Private Securities Litigation Reform Act of 1995. 
All statements, other than statements of historical fact, included herein, 
without limitation, statements relating the future operating or financial 
performance of the Company, are forward looking statements. Forward-looking 
statements are frequently, but not always, identified by words such as 
"expects", "anticipates", "believes", "intends", "estimates", "potential", 
"possible", and similar expressions, or statements that events, conditions, or 
results "will", "may", "could", or "should" occur or be achieved. 
Forward-looking statements in this news release relate to, among other things, 
completion of the murine model study, regulatory approval for a Phase I study 
of its BVX-0320 Vaccine Candidate in humans and the overall development of 
BioVaxys' vaccines, including any haptenized SARS-Cov-2 protein vaccine. There 
can be no assurance that such statements will prove to be accurate, and actual 
results and future events could differ materially from those expressed or 
implied in such forward-looking statements. 

These forward-looking statements reflect the beliefs, opinions and projections 
on the date the statements are made and are based upon a number of assumptions 
and estimates, primarily the assumption that BioVaxys will be successful in 
developing and testing vaccines, that, while considered reasonable by the 
Company, are inherently subject to significant business, economic, competitive, 
political and social uncertainties and contingencies including, primarily but 
without limitation, the risk that BioVayxs' vaccines will not prove to be 
effective and/ or will not receive the required regulatory approvals. With 
regards to BioVaxys' business, there are a number of risks that could affect 
the development of its biotechnology products, including, without limitation, 
the need for additional capital to fund clinical trials, its lack of operating 
history, uncertainty about whether its products will complete the long, complex 
and expensive clinical trial and regulatory approval process for approval of 
new drugs necessary for marketing approval, uncertainty about whether its 
autologous cell vaccine immunotherapy can be developed to produce safe and 
effective products and, if so, whether its vaccine products will be 
commercially accepted and profitable, the expenses, delays and uncertainties 
and complications typically encountered by development stage biopharmaceutical 
businesses, financial and development obligations under license arrangements in 
order to protect its rights to its products and technologies, obtaining and 
protecting new intellectual property rights and avoiding infringement to third 
parties and their dependence on manufacturing by third parties.

The Company does not assume any obligation to update the forward-looking 
statements of beliefs, opinions, projections, or other factors, should they 
change, except as required by law.

Source: BioVaxys Technology Corp.
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