VXL Vaxil Bio Ltd

VAXIL BIO LTD. (“Vaxil” or the “Company”) (TSX VENTURE: VXL), an innovative immunotherapy biotech company specializing in cancer and infectious diseases, announces here on the progress of its various research and development activities including; development of oral formulation for signal peptides ("SPs"), research on the utilization of P-Esbp polymer as a novel anti-cancer drug, and the issuance of U.S. patent No. 11135277 on 5 October, 2021, titled: “Antigen specific multi epitope-based anti-infective vaccines”.

Vaxil is continuing with its mission to bring novel medicines to the public, which includes the utilization of SPs as anti-cancer and anti-microbial vaccines. In order to improve treatment procedures of SP-based vaccines, Vaxil has engaged in efforts to develop a SP-based oral formulation. Vaxil believes that oral delivery of SPs can benefit patients by simplifying administration procedures without compromising the therapeutic efficacy, and it may also simplify manufacturing processes, transportation, and storage conditions.

SP-based oral formulation is being developed independently, as well as in partnership with an established oral delivery company. So far, various potential oral formulations were explored for their ability to solubilize SPs and for their feasibility to be used in in vivo studies against MUC1 and COVID-19 targets. A potentially promising formulation was identified and currently it is being further studied to better define its performance. In parallel, an in vivo study was initiated aimed at testing the ability of the SP-based oral formulation to induce a systemic immune response in mice.

As previously reported Vaxil is making progress in the licensed drug delivery polymer that targets with high affinity E-selectin (P-Esbp), which was invented by Prof. Ayelet David, Head of the Drug Targeting and Nanomedicine Laboratory, Department of Clinical Biochemistry and Pharmacology from Ben-Gurion University of the Negev. E-selectin is an important component in inflammation, metastasis, and tumor growth processes, and Prof. Ayelet David’s previous work demonstrated therapeutic efficacy of P-Esbp conjugated with the anti-cancer drug doxorubicin (P-Esbp-DOX) in prolonging the survival of tumor-bearing mice with both primary (Lewis lung carcinoma) and metastatic tumors (melanoma lung metastasis model).

In order to further explore and establish the potential of P-Esbp-DOX for treating cancer, an in vivo experiment was designed aimed at evaluating the therapeutic efficacy of P-Esbp-DOX in a mouse model of aggressive liver metastasis of colorectal tumors. To this end, P-Esbp was successfully conjugated with DOX, and the maximum tolerated dose of P-Esbp-DOX was determined in the suitable mouse strain. Currently the in vivo treatment study is ongoing, and the results would help Vaxil to strategize the appropriate approach for a clinical program.

In addition, Vaxil announces that it further strengthens its intellectual property assets regarding the treatment of tuberculosis by using SPs, since a patent will be issued in the U.S. (U.S. patent No. 11135277) on 5 October, 2021, titled: “Antigen specific multi epitope-based anti-infective vaccines”, that includes claims relating to various SP-based anti-tuberculosis vaccines.

ABOUT VAXIL

Vaxil is an Israeli immunotherapy biotech company focused on its novel approach to targeting prominent cancer markers and infectious diseases. Its lead product ImMucin™ successfully completed a Phase 1/2 clinical trial in multiple myeloma for which it received orphan drug status from the FDA and EMA. The Company aims to continue to develop ImMucin™, a COVID-19 and a tuberculosis vaccine / treatment that has demonstrated promising preliminary results with further preclinical evaluation planned. Additional indications and mAb candidates are under evaluation as immuno-oncology and infectious disease treatments alone and in combination with other treatments.

Vaxil exploits the unique properties of signal peptide domains on crucial proteins to develop targeted therapies against cancer targets and infectious disease pathogens. These signal peptide domains are identified by VaxHit™, Vaxil’s proprietary bioinformatic approach. These signal peptides induce a robust T- and B-cell response across wide and varied HLA subtypes, while acting as true, universal neoantigens. The peptide platform targets these cells by “educating” or specifically activating the immune system to recognize and attack the affected cells. In addition, Vaxil’s mAb platform directly recognizes the target protein expressed on malignant cells and recruits other elements of the immune system to lyse those cells.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Disclaimer: The Company cautions that COVID-19 Vaccine Development is still under early-stage research and development and is not making any express or implied claims that it has the ability to eliminate the COVID-19 virus at this time. The TSX Venture Exchange Inc. has in no way passed upon the merits of the Company and has neither approved nor disapproved the contents of this press release. This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors - including the availability of funds, the results of financing efforts, the results of exploration activities -- that could cause actual results to differ materially from the Company's expectations are disclosed in the Company's documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This press release does not constitute an offer to sell or a solicitation of an offer to sell any of the securities described herein in the United States or elsewhere. These securities have not been, and will not be, registered in the United States Securities Act of 1933, as amended, or any state securities laws, and may not be offered or sold in the United States or to U.S. persons unless registered or exempt therefrom.

CONTACT INFORMATION

For further information please visit https://vaxil-bio.com/ or contact:

Gadi Levin, CFO — info@vaxil-bio.com, 647-558-5564