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BVX-0922 to Target Colorectal Cancer Under Investigator-Sponsored IND

VANCOUVER, BC, March 30, 2022 /PRNewswire/ — BioVaxys Technology Corp. (CSE: BIOV), (FRA: 5LB), (OTCQB: BVAXF) (“BioVaxys” or “Company”), introduced right this moment the enlargement of its most cancers vaccine platform with BVX-0922, its autologous haptenized tumor vaccine for colorectal most cancers (“CRC”).  BioVaxys plans to advance an Investigator-Sponsored Clinical Trial Application (“CTA”) within the EU with the European Medicines Agency (“EMEA”) this yr for BVX-0922.  An Investigator Sponsored CTA is submitted to regulatory authorities by a medical investigator who each initiates and conducts an preliminary medical research of a brand new drug or process, and beneath whose instant route the investigational drug is run. 

CRC is the third most typical malignancy and the second most dangerous most cancers world-wide, with an estimated 1.9 million new CRC circumstances identified and 0.9 million deaths globally in 2020. The incidence of CRC is larger in extremely developed nations, with international new CRC circumstances predicted to succeed in 3.2 million in 2040.   When identified early, the five-year relative survival price for stage I and stage II colon most cancers is 90%; nevertheless, CRC sufferers typically expertise no indicators or signs related to the illness. The 5-year survival price for sufferers identified at Stage IV is just 14% (Journal of Translational Oncology, Global Colorectal Cancer Burden in 2020 And Projections to 2040, Vol 14, Issue 10, October 2021).

A significant good thing about the Company’s autologous haptenized tumor vaccine know-how platform is the fast scalability into a spread of tumor sorts, particularly these the place the usual of take care of these most cancers sufferers sometimes entails surgical excision of tumor tissue.  Access to those tumor cells is important for BioVaxys to fabricate autologous haptenized tumor cell vaccines, equivalent to BVX-0918 for late-stage ovarian most cancers or BVX-0922 for CRC.

The BioVaxys vaccine platform is predicated on the established immunological idea that modifying floor proteins—whether they’re viral or tumor—with haptens makes them extra seen to the immune system. This means of haptenization “teaches” a affected person’s immune system to acknowledge and make goal proteins extra “seen” as overseas, thereby stimulating a T-cell mediated immune response.   BioVaxys’ most cancers vaccines are created by extracting a affected person’s personal (i.e., autologous) most cancers cells, chemically linking with a hapten, and re-injecting them into the affected person to induce an immune response to proteins that are in any other case not immunogenic.

Haptenization is a widely known and well-studied immunotherapeutic strategy in most cancers remedy, and has been evaluated in each regional and disseminated metastatic tumors. BioVaxys has a big benefit over many different corporations taking a look at most cancers therapies in that it already has in depth promising medical information for its most cancers vaccines. 

First-generation single-hapten vaccines invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved constructive immunological and medical ends in his earlier FDA-approved Phase I and Phase II human trials in over 600 sufferers with totally different tumor sorts, in addition to having no noticed toxicity in years of medical research. 

For instance, two research of sufferers with metastatic melanoma have been accomplished and printed. The first trial examined the exercise of the autologous, DNP-modified vaccine in 83 evaluable sufferers with incurable, metastatic melanoma (Berd et al, Int J Cancer 2001; 94: 531-539).  Following vaccine administration there have been 11 responses—2 full, 4 partial, and 5 blended; 2 sufferers have been judged to have secure illness. Both full responses and two of the 4 partial responses occurred in sufferers with lung metastases. Response durations have been as follows: partial responses— 5, 6, 8, and 47+ months; full responses—12, 29 months. In a second trial 214 sufferers with superior stage III melanoma (lymph node metastases) underwent excision of enormous lymph node lots after which have been administered the haptenized vaccine. With a median follow-up time of 5.1 years the 5-year general survival price was 46%, which is significantly larger than survival occasions reported with surgical procedure alone (Berd et al, J. Clin. Oncology, 1997, 15:2359)

A primary era autologous, haptenized vaccine was additionally examined in two medical trials performed by Dr. Berd in ladies with superior ovarian most cancers who had ceased to reply to typical chemotherapy.  In the primary trial 13 evaluable sufferers with cumbersome, chemotherapy-refractory illness have been handled. The sufferers exhibited full regression of a residual peritoneal mass by computed tomography (CT) and a concomitant fall in serum CA-125 (an ovarian most cancers serum marker) from 65 to six. Both the CT and CA-125 responses have been maintained for six months.

In a second research (Taha et al, Gynecol Oncol 2014; 134, Abstract 25: 428-437), 26 topics with recurrent platinum resistant ovarian most cancers have been enrolled. Vaccine was ready for, however not administered to, 25 further topics. In six vaccinated topics, CA125 ranges grew to become regular following surgical procedure plus vaccine and remained regular all through the 9-month period of the protocol. Median general survival by Kaplan–Meier technique after surgical procedure within the vaccinated group was 25.4 months in comparison with 6.5 months within the vaccine ready however not administered group.

Finally, preliminary research of a primary era, autologous, single-hapten vaccine have been carried out in kidney most cancers, non-small cell lung most cancers, breast most cancers, and acute myelogenous leukemia. The outcomes indicated that preparation and administration of vaccine was possible.

BioVaxys has enhanced the first-generation strategy in these earlier research of utilizing a single-hapten to now using two haptens (“bi-haptenization”), which the Company believes will yield superior outcomes. The international colorectal most cancers therapeutics market is projected to succeed in $16.5 billion by 2026 (fortunebusinessinsights.com).

About BioVaxys Technology Corp.

Based in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered, medical stage biotechnology firm that’s creating viral and oncology vaccine platforms, in addition to immuno-diagnostics.  The Company is advancing vaccines for SARS-CoV-2, SARS-CoV-1, and a pan-sarbecovirus vaccine based mostly on its haptenized viral protein know-how, and is planning a medical trial of its haptenized autologous cell vaccine utilized in mixture with anti-PD1 and anti-PDL-1 checkpoint inhibitors that can initially be developed for Stage III/Stage IV ovarian most cancers.  Also in growth is CoviDTH®, 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 a number of US and worldwide patent functions associated to its most cancers vaccines, antiviral vaccines, and diagnostic applied sciences. BioVaxys frequent shares are listed on the CSE beneath the inventory image “BIOV” and commerce on the Frankfurt Bourse (FRA: 5LB) and within the US (OTCQB: BVAXF).

ON BEHALF OF THE BOARD

Signed “James Passin”
James Passin, CEO
+1 646 452 7054

Cautionary Statements Rearding Forward Looking Information 

This press launch contains sure “forward-looking info” and “forward-looking statements” (collectively “forward-looking statements”) inside the that means of relevant Canadian and United States securities laws together with the United States Private Securities Litigation Reform Act of 1995. All statements, apart from statements of historic truth, included herein, with out limitation, statements relating the long run working or monetary efficiency of the Company, are ahead wanting statements. Forward-looking statements are incessantly, however not all the time, recognized by phrases equivalent to “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “doable”, and related expressions, or statements that occasions, circumstances, or outcomes “will”, “could”, “may”, or “ought to” happen or be achieved. Forward-looking statements on this information launch relate to, amongst different issues, completion of the murine mannequin research, regulatory approval for a Phase I research of its BVX-0320 Vaccine Candidate in people and the general growth of BioVaxys’ vaccines, together with any haptenized SARS-Cov-2 protein vaccine. There will be no assurance that such statements will show to be correct, and precise outcomes and future occasions may differ materially from these expressed or implied in such forward-looking statements. 

These forward-looking statements replicate the beliefs, opinions and projections on the date the statements are made and are based mostly upon quite a lot of assumptions and estimates, primarily the belief that BioVaxys will likely be profitable in creating and testing vaccines, that, whereas thought of cheap by the Company, are inherently topic to important enterprise, financial, aggressive, political and social uncertainties and contingencies together with, primarily however with out limitation, the chance that BioVaxys’ vaccines is not going to show to be efficient and/ or is not going to obtain the required regulatory approvals. With regards to BioVaxys’ enterprise, there are a variety of dangers that might have an effect on the event of its biotechnology merchandise, together with, with out limitation, the necessity for added capital to fund medical trials, its lack of working historical past, uncertainty about whether or not its merchandise will full the lengthy, complicated and costly medical trial and regulatory approval course of for approval of latest medication obligatory for advertising and marketing approval, uncertainty about whether or not its autologous cell vaccine immunotherapy will be developed to supply secure and efficient merchandise and, if that’s the case, whether or not its vaccine merchandise will likely be commercially accepted and worthwhile, the bills, delays and uncertainties and issues sometimes encountered by growth stage biopharmaceutical companies, monetary and growth obligations beneath license preparations in an effort to defend its rights to its merchandise and applied sciences, acquiring and defending new mental property rights and avoiding infringement to 3rd events and their dependence on manufacturing by third events.

The Company doesn’t assume any obligation to replace the forward-looking statements of beliefs, opinions, projections, or different components, ought to they alter, besides as required by regulation.

Government & Media Relations

JB&A, Inc. 
Davin Shinedling 
davin@jennibyrne.com  
1 (647) 991-6447

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SOURCE BioVaxys Technology Corp.

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By Seth A. Dunbar

Seth Dunbar leads clinical research study operations and quality & compliance. He is experienced working with teams to help drug sponsors better leverage eSource data. With 10+ years of experience Seth brings expertise developing eClinical services that integrate data and technology to help companies optimise study execution.

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