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Ness Ziona, Israel

Patent
Vaxil Biotherapeutics Ltd. | Date: 2012-09-13

Provided are methods employing antibodies directed against the signal peptide (SP) domain of various disease-associated polypeptides. These anti-SP antibodies detect cell surface expression of these SP domains and are used in methods of diagnosis and/or therapy. Provided is a method for determining the suitability for treatment of a subject suffering from a disease, whereby detection of cell surface expression of a specific SP indicates that the subject would benefit from therapy directed against this SP. Further, provided are methods for diagnosis of diseases based on the detection of endogenously produced anti-SP antibodies.


Patent
Vaxil Biotherapeutics Ltd. | Date: 2010-07-15

Provided are peptide vaccines including the signal peptide domain of selected target antigens of intracellular pathogens. The peptide vaccines of the invention contain multiple class II and class I-restricted epitopes and are recognized and presented by the majority of the vaccinated human population. Further provided, in particular, are anti tuberculosis vaccines. Also further provided are compositions including the vaccines as well as their use to treat or prevent infection.


Carmon L.,Vaxil BioTherapeutics Ltd. | Avivi I.,Rambam Medical Campus | Avivi I.,Technion - Israel Institute of Technology | Kovjazin R.,Vaxil BioTherapeutics Ltd. | And 6 more authors.
British Journal of Haematology | Year: 2015

Summary: ImMucin, a 21-mer cancer vaccine encoding the signal peptide domain of the MUC1 tumour-associated antigen, possesses a high density of T- and B-cell epitopes but preserves MUC1 specificity. This phase I/II study assessed the safety, immunity and clinical response to 6 or 12 bi-weekly intradermal ImMucin vaccines, co-administered with human granulocyte-macrophage colony-stimulating factor to 15 MUC1-positive multiple myeloma (MM) patients, with residual or biochemically progressive disease following autologous stem cell transplantation. Vaccination was well tolerated; all adverse events were temporal grade 1 2 and spontaneously resolved. ImMucin vaccination induced a robust increase in γ-interferon (IFN-γ-producing CD4+ and CD8+ T-cells (≤80-fold), a pronounced population of ImMucin multimer CD8+ T-cells (>2%), a 9·4-fold increase in peripheral blood mononuclear cells proliferation and 6·8-fold increase in anti-ImMucin antibodies, accompanied with T-cell and antibody-dependent cell-mediated cytotoxicity. A significant decrease in soluble MUC1 levels was observed in 9/10 patients. Stable disease or improvement, persisting for 17·5-41·3 months (ongoing) was achieved in 11/15 patients and appeared to be associated with low-intermediate PDL1 (CD274) bone marrow levels pre- and post-vaccination. In summary, ImMucin, a highly tolerable cancerous vaccine, induces robust, diversified T- and B-cell ImMucin-specific immunity in MM patients, across major histocompatibility complex-barrier, resulting in at least disease stabilization in most patients. © 2014 John Wiley & Sons Ltd. Source


Kovjazin R.,Vaxil BioTherapeutics Ltd. | Shitrit D.,Meir Medical Center | Preiss R.,Maccabi Tuberculosis Center | Haim I.,Maccabi Tuberculosis Center | And 8 more authors.
Clinical and Vaccine Immunology | Year: 2013

The low protection by the bacillus Calmette-Guérin (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 (SP) domain vaccine candidates (VCs) derived from M. tuberculosis antigens. All VCs were predicted to have promiscuous binding to major histocompatibility complex (MHC) class I and II alleles in large geographic territories worldwide. Peripheral mononuclear cells (PBMC) from healthy naïve donors and tuberculosis patients exhibited strong proliferation that correlated positively with Th1 cytokine secretion only in healthy naïve donors. Proliferation to SP VCs was superior to that to antigen-matched control peptides with similar length and various MHC class I and II binding properties. Tcell lines induced to SP VCs from healthy naïve donors had increased CD44high/ CD62L+ activation/effector memory markers and gamma interferon (IFN-Υ), but not interleukin-4 (IL-4), production in both CD4+ and CD8+ T-cell subpopulations. T-cell lines from healthy naïve donors and tuberculosis patients also manifested strong, dose-dependent, antigen-specific cytotoxicity against autologous VC-loaded or M. tuberculosis-infected macrophages. Lysis of M. tuberculosis-infected targets was accompanied by high IFN-Υ secretion. Various combinations of these five VCs manifested synergic proliferation of PBMC from selected healthy naïve donors. Immunogenicity of the best three combinations, termed Mix1, Mix2, and Mix3 and consisting of 2 to 5 of the VCs, was then evaluated in mice. Each mixture manifested strong cytotoxicity against M. tuberculosis-infected macrophages, while Mix3 also manifested a VC-specific humoral immune response. Based on these results, we plan to evaluate the protection properties of these combinations as an improved tuberculosis subunit vaccine. © 2013, American Society for Microbiology. Source


Kovjazin R.,Vaxil BioTherapeutics Ltd. | Volovitz I.,The Tel Aviv Sourasky Medical Center | Kundel Y.,Davidoff Cancer Center | Rosenbaum E.,Davidoff Cancer Center | And 6 more authors.
Vaccine | Year: 2011

An optimal cancer vaccine should be able to induce highly potent, long-lasting, tumor-specific responses in the majority of the cancer patient population. One approach for achieving this is to use synthetic peptide vaccines derived from widely expressed tumor-associated antigens, that promiscuously bind multiple MHC class I and class II alleles. MUC1-SP-L (ImMucin, VXL100) is a 21mer peptide encoding the complete signal peptide domain of MUC1, a tumor-associated antigen expressed by over 90% of solid and non-solid tumors. MUC1-SP-L was predicted in silico to bind various MHC class I and MHC class II alleles, covering the majority of the Caucasian population. PBLs obtained from 13 naïve donors all proliferated, with a Stimulation Index (SI = 2), to the MUC1-SP-L peptide, producing mixed CD4 + and CD8 + responses. Similar results were manifested by MUC1-SP-L in PBLs derived from 9 of 10 cancer patients with MUC1 positive tumors. CD4 + and CD8 + T cell populations exhibited CD45RO memory markers and secreted IFN-gamma and IL-2 following stimulation with MUC1-SP-L. These T cells also exhibited proliferation to the MUC1-SP-L inner 9mer epitopes and cytotoxicity against tumor cell lines expressing MUC1 and a concordant MHC class I allele. Cytotoxicity to MUC1-expressing human and murine tumors was shown also in T cells obtained from HLA-A2 transgenic mice and BALB/c syngeneic mice immunized with the MUC1-SP-L and GM-CSF. In an immunotherapy model, BALB/c mice inoculated with metastatic MUC1 transfected murine DA3 mammary tumor cells, exhibited significantly prolonged survival following vaccination with MUC1-SP-L. Our results indicate superior immunological and anti-tumor properties of MUC1-SP-L compared to previously published MUC1-derived epitopes. © 2011 Elsevier Ltd. All rights reserved. Source

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