PR87348

VANCOUVER, B.C., Dec. 21, 2020 /PRNewswire=KYODO JBN/ --

- 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, asvit should

not be a priority to immunize individuals presenting T cell immunityvto 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 medicalvoncology

and cancer immunotherapy. Dr. Berd received his BS from PennsylvaniavState University

and his MD from Jefferson Medical College of Thomas JeffersonvUniversity.

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.