VAXIL BIO LTD. provided an update on the results of in vivo efficacy study for licensed P-Esbp-DOX, a novel anti-cancer drug, first disclosed in 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.