USA News Group Commentary
Issued on behalf of BioVaxys Technology Corp.

VANCOUVER, BC, July 29, 2024 /PRNewswire/ — USA News Group – How and what we eat is always changing. But for more and more people, the options to eat are drastically being reduced, due to rising amounts of food allergies. According to Food Allergy Research & Education (FARE), food allergy prevalence among children has been surging, up by 50% between 1997 and 2011, and up again by another 50% between 2007 and 2021. Research analysts at Spherical Insights projects strong growth in the Global Allergy Treatment Market, growing at a CAGR of 9.27% to nearly US$14 billion by 2033. Now that food allergies affect more than 7% of American children, researchers are exploring different treatment approaches to tackle this serious and potentially lucrative issue, including BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF), Roche Holding AG (OTCQX: RHHBY), Novartis AG (NYSE: NVS), Neogen Corporation (NASDAQ: NEOG), and Thermo Fisher Scientific Inc. (NYSE: TMO).

Earlier this year, clinical-stage biotech company BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF) made a splash by strategically acquiring a broad clinical development pipeline that included the advanced immunotherapeutics platform technology DPX™. BioVaxys specifically targeted DPX™ as a potential gamechanger in improved mRNA vaccines, multivalent viral vaccines, immune system diseases, and more important to the topic of food allergies, vaccines for desensitizing immune response for peanut allergies.

DPX™ is a proprietary lipid-based delivery platform with no aqueous component that can be formulated with a range of packaged antigens, proteins, peptides, mRNA, or small molecules.  Its unique “no release” mechanism of action allows antigen presenting cells (APCs) to be attracted to the injection site, facilitating a robust and sustained immune response.

Since the acquisition, BioVaxys has moved forward with a successful fundraising, and another recently announced private placement later in July. But now it appears that the vision of where DPX™ is coming into view, with the company signing a binding letter of intent (LOI) to develop DPX™-based vaccines therapy to treat or alleviate the potentially life-threatening risk of certain food allergies, namely those triggered by exposure to peanut/tree nuts or eggs. 

In order to achieve this, BioVaxys is set to partner with AP Visionaires, Inc. of Ontario (APVI), whom they’ll be conducting a study in collaboration with The Schroeder Allergy and Immunology Research Institute (SAIRI) at McMaster University in Ontario—a new institute that consolidates clinicians, scientists, and data specialists in a “one-stop shop” to research the causes of life-threatening allergies and develop new treatments.

Under the terms of the Agreement, BioVaxys will provide funding for the study to APVI, which has a collaboration in place with SAIRI to evaluate in animal models the robustness of DPX™ protection and evaluate whether DPX™ transforms the underlying immunopathology of food allergy. Afterards, BioVaxys will retain all intellectual property rights to any resulting product. 

“Our ability to tackle this unmet medical need is directly attributable to the immune educating capability and highly flexible antigen loading capacity of our DPX™ platform,” said Kenneth Kovan, President & Chief Operating Officer of BioVaxys. “With the DPX™ platform already the backbone of multiple BioVaxys clinical programs in oncology and infectious disease, we see a staggering opportunity for continued expansion into other novel DPX-formulations with polynucleotides, peptides, proteins, virus-like articles, and small molecules.”

The market for peanut allergies seems to be growing quite rapidly. According to Global Market Insights, the Peanut Allergy Treatment Market is anticipated to grow at 12.1% CAGR from 2024 to 2032. Researchers at Grand View Research echo the sentiment, projecting this market to reach US$1.01 billion by 2030, growing at 11.82% CAGR throughout that period.

Earlier this year, the FDA granted approval to Xolair from Roche Holding AG (OTCQX: RHHBY) and  Novartis AG (NYSE: NVS), becoming the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods for people ages 1 year and older.

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While not designed to allow patients to freely eat these foods they’re allergic to, the therapy helps them to avoid severe reactions, such as anaphylaxis—which is a life-threatening reaction that can happen immediately as the immune system releases chemicals that can cause the body to go into shock.

Xolair is specifically approved for people with IgE-mediated food allergies, a classification that includes 160 foods, the most common of which are peanuts, milk, eggs, wheat, soy and tree nuts.

“Many people with food allergies and their loved ones live in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction,” said Reshema Kemps-Polanco, U.S. Chief Commercial Officer for Novartis in a release. “This approval, which comes 20 years after the first approval for this medicine [for allergenic asthma], shows that we never stop innovating to make a meaningful difference for patients living with immunological conditions.”

While treating allergies directly will hopefully save more lives, the importance of detecting allergens in food processing and diagnosing food allergies before a dangerous potential anaphylaxis event occurs.

For example, late last year Neogen Corporation (NASDAQ: NEOG), experts in food safety and processing, announced that it had released its Veratox VIP assay for the detection of walnut, the third assay in its Veratox VIP line of enhanced quantitative ELISA products. The innovative quantitative test demonstrated excellent specificity down to 0.15 ppm walnut protein, one of the lowest detection concentrations for an ELISA kit, and utilizes a best-in-class 30-minute time-to-result and ready-to-use reagents.

“As tree nuts remain one of the most common allergens, it is incredibly important that we are providing solutions that make it easier for producers to detect potential contamination, and strengthen their allergen control plans,” said John Adent, President and CEO of Neogen. “Given the highly sensitive nature of the new Veratox VIP for Walnut assay, producers can be confident in Neogen’s strong commitment to food safety and quality.” 

Last year, Thermo Fisher Scientific Inc. (NYSE: TMO) widened availability of its ImmunoCAP™ Specific IgE tests to patients at all Kroger Health The Little Clinic LLC locations, through a blood draw taken on site.

The ImmunoCAP-specific IgE regional respiratory profiles require only one blood draw analyzed at an offsite clinical laboratory. The tests are not new to the industry and are backed by 50+ years of research and development. According to Future Market Insights the IgE Allergy Blood Tests Market is expected to rise at a 5.2% CAGR to US$50 billion in 2033.

“Discovering the actual cause of allergy-like symptoms is vital to empowering patients to address their condition from a preventative medicine standpoint, allowing a more personalized management plan,” said Gary Falcetano, scientific affairs manager at Thermo Fisher Scientific. “Adding trusted and accurate ImmunoCAP testing to all The Little Clinic locations will enable clinicians to help many more patients get the answers they need to proactively manage their health.”

Since 2019, Thermo Fisher has been promoting a blood test designed to support the diagnosis of peanut allergies, after receiving 510(k) clearance from the FDA in 2018, by developing a range of ImmunoCAP in vitro quantitative assays to help healthcare professionals determine whether patients are allergic to particular components of peanuts or suffer from cross-reactivity.

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Article Source: https://biotech-insider.com/the-phoenix-of-biotech-how-a-6m-junior-just-swooped-into-a-potential-billion-dollar-opportunity/ 

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