VXL Vaxil Bio Ltd

VAXIL BIO LTD. (“Vaxil” or the “Company”) (TSX VENTURE: VXL), an innovative immunotherapy biotech company is pleased to provide an update on the results of our in vivo efficacy study for our licensed P-Esbp-DOX, a novel anti-cancer drug, first disclosed in our press release from October 12, 2021.

Vaxil, together with Prof. Ayelet David, Head of the Drug Targeting and Nanomedicine Laboratory, Department of Clinical Biochemistry and Pharmacology from Ben-Gurion University of the Negev ("BGU"), have demonstrated therapeutic success by prolonging the survival of mice treated with P-Esbp-DOX in a mouse model of aggressive liver metastasis of colorectal cancer (CRC). The results of the current in vivo experiment, along with the previous in vivo experiments suggests that P-Esbp-DOX which combines the safe HPMA polymer, the high affinity E-selectin targeting peptide, and the commonly used chemotherapeutic drug doxorubicin, is a promising targeted drug delivery system for the treatment of aggressive metastatic cancer.

P-Esbp-DOX is an HPMA (N-(2-hydroxypropyl methacrylamide)) polymer conjugated with a high-affinity E-selectin-binding peptide and with the cytotoxic drug doxorubicin (DOX). Targeting E-selectin is relevant to diseases with inflammatory component and cancer, since E-selectin is expressed exclusively on inflamed blood vessels and play an important role in the development of inflammation, cancer and supports metastatic spread of cancer. Prof. Ayelet David’s previous work in cancer research demonstrated that a single dose therapy of P-Esbp-DOX is effective in decreasing the rate of tumor growth and prolonging the survival of mice bearing primary Lewis lung carcinoma (3LL) tumors and established melanoma (B16-F10) lung metastases.

In the experiment, four groups of mice were treated, four days post intrasplenic inoculation of CT26 colorectal cancer cells, with a single dose of either P-Esbp-DOX or P-DOX (15 mg/kg DOX equivalence), or free DOX (8 mg/kg), or saline. The findings confirm the significant effectiveness of a single dose of P-Esbp-DOX over other treatments in mice with detected CRC liver metastases: The number of surviving mice at day 85 was: 3/7 (43%) for P-Esbp-DOX, 1/6 (17%) for free DOX, and 0/6 for P-DOX and saline. The survival medians were: 63 days for P-Esbp-DOX, 36.5 days for P-DOX, 30 days for free DOX, and 35 days for saline (p=0.003 for P-Esbp-DOX vs. control P-DOX). P-Esbp-DOX was well-tolerated at the dose administered, with no weight loss observed post treatment.

In summary, this experiment, coupled with previous work, continues to demonstrate the important role this novel therapeutic approach could play in cancer at all stages. Vaxil is pursuing all necessary steps to initiate human clinical trials as soon as possible. 

As previously disclosed in the Company's press release from August 28, 2019, the Company entered into an exclusive worldwide license agreement for the development and commercialization of a targeted cancer therapy with BGN Technologies, the technology transfer company of BGU. To the extent that a successful therapy is developed, the Company will pay BGU a royalty on sales.

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 P-Esbp-DOX, a novel anti-cancer drug is still under early-stage research and development and is not making any express or implied claims that it will become commercial. 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