Vaxil BioTherapeutics Release: Company Expands Into Infectious Diseases With First U.S. Patent For MTbuVax

Published: Jan 20, 2017

VAXlL BIO (VXL), a biotech specializing in immunotherapy, announces today that it has received an important Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent providing coverage over Vaxil's derived signal peptides from intracellular pathogens and their use in the vaccination against major infectious diseases. This marks the Company's first US patent for its infectious disease platform, known as MTbuVax™ and its family of signal peptide anti-infective vaccines.

MTbuVax™ has to date demonstrated superior immunity in Tuberculosis patient samples as well as in pre-clinical models. Furthermore, Vaxil's VaxHit™ platform technology has shown the potential to produce effective vaccines against other priority targets such as Malaria, HIV, Prion, Herpes, and more. Like Vaxil's lead orphan designated cancer immunotherapy Immucin™, MTbuVax™ is also derived from the Company's primary proprietary platform VaxHit™. The notice indicates the patentability of claims covering an immunogenic composition comprising tuberculosis derived peptides from four different Tuberculosis antigens, discovered with the company's proprietary VaxHit™ platform, as well as claims reciting methods of treating a pathogenic infection and methods for producing T-cells and anti-tuberculosis antibodies.

Rise of Infectious Diseases and Antibiotic Resistant Super-Bugs

So-called superbugs, antibiotic-resistant strains of infections, have recently made headlines after studies showed that such infections could potentially become the largest threat to global health. The Review on Microbial Resistance stated that "there could be profound health and macroeconomic consequences for the world, especially in emerging economies, if antimicrobial resistance is not tackled" and that super-bugs could even leapfrog cancer as the world's most potent killer as soon as 2050. Last month, the Financial Post mentioned that "Decades of antibiotic overuse have led to an increase in infections from bacteria that have developed a resistance to them, rendering the drugs that have conquered pneumonia, rheumatic fever and tuberculosis powerless."

Dr. Saeid Babaei, Vaxil's chairman added: "This is an exciting milestone forVaxil, as we demonstrate the power of Company's platform, VaxHit™ to produce effective immunotherapy treatment and infectious diseases modalities in the much-needed areas of human diseases. While we continue to focus on immuno-oncology and our orphan designated ImMucin™, we are very pleased to have developed and now patented a highly promising immunotherapy, MTbuVax™, in the rapidly growing field of infectious diseases."

Tuberculosis and Resistance to Treatment

According to the World Health Organization, "Tuberculosis is one of the top 10 causes of death worldwide." According to its report, an estimated 480,000 people developed multi-drug resistance to Tuberculosis, meaning they would not respond to available treatments. There is an acute need for better tools to prevent and treat Tuberculosis.Vaxil believes its MTbuVax™ could possess key advantages with potential for more effective prevention and broader protection, primarily due to its unique signal peptide based immunotherapy mechanism.

MTbuVax™ and Multi-Epitope Anti-Infective Vaccines

Vaxil's primary algorithm platform VaxHit™ has produced multiple peptide immunotherapy candidates derived from the signal peptides of several antigens from intracellular pathogens. The most advanced product under development, MTbuVax™ is a combination of several peptides derived from Mycobacterium tuberculosis, shown to elicit strong responses in samples from healthy and infected individuals. Moreover, the vaccine has a pan-HLA coverage, enabling vaccination of multiple ethnicities and in various geographies, thereby, strengthening the premise of creating a universal vaccine. In addition, the unique characteristics of these sequences may override common immune-escape mechanism used by these pathogens, and confer long-lasting and effective immunity.

"Low protection by the BCG vaccine and existence of drug-resistant strains require better anti-Mycobacterium tuberculosis vaccines with a broad, long-lasting, antigen-specific response. Using bioinformatics tools, we identified five 19- to 40-mer signal peptide domain vaccine candidates derived from M. tuberculosis antigens.Vaxil has demonstrated both in patient samples and in mice results stressing the immunogenic properties of the three top mixtures in inducing a strong and specific cellular response following a short regimen of active vaccination", wrote Dr. Riva Kovjazin when Vaxil first published its findings in a 2013 Clinical & Vaccine Immunology medical journal.

Like its other immunotherapy products derived from the VaxHit platform, Vaxil believes MTbuVax™ potentially contains the following advantages:

• Specificity: MTbuVax™ has higher antigen diversity, derived from four different markers (antigens) in the Tuberculosis pathogen.

• Efficacy: MTbuVax™ is able to induce a very strong and broad* immune response.

• Universal: MTbuVax™ is able to activate the immune system in every patient with no need for personalization/adaptation to their specific immune system.

• TAP: MTbuVax™ can cope with TB pathogen's attempt to hide from the immune system and develop resistance to treatment.

• Therapeutic: MTbuVax™, can potentially be used as a therapeutic vaccine to treat patients already infected with the bacteria.

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