Not for distribution by US newswire or in United States
NESS-ZIONA, ISRAEL – April 13, 2020 – VAXIL BIO LTD. (“Vaxil” or the “Company”) (TSX VENTURE: VXL), an innovative immunotherapy biotech company specializing in cancer and infectious diseases, is pleased to share the results of our first preclinical experiment whose purpose was to test the immune response of our COVID-19 vaccine candidate. These results provide the first pre-clinical validation of our in silico modelling announced a few weeks ago.
By leveraging its platform, Vaxil discovered a potential peptide vaccine against COVID-19 back in February 2020 and then proceeded to manufacture these peptides as well as design the preclinical program to prove effectiveness (the “Program”). Dr. Mordechai Applebaum, PhD, Vaxil’s head of Research and Development, conducted and validated this experiment at the Company’s laboratory in Nes Ziona, Israel, over the last six weeks. The experiments have not been independently verified; this will take place as we advance the Program.
The first experiment in this Program is now complete. As is common in such early preclinical trials/research programs, the first experiment was performed on healthy donor blood cells to validate the immune response in a screening protocol. It was designed to establish that our signal peptides demonstrate a favorable immune response (immunogenicity profile). The results of this test were positive, as proliferation was observed in varying degrees in T cell population (CD3+) as well as in specific subpopulations: cytotoxic T lymphocytes (CD8+) and more prominently in T helper cells (CD4+).
The individual peptides, as well as in combination, all responded in varying degrees, more than unstimulated cells. What was most encouraging was that the most pronounced response was in T helper cells (CD4+). These responses are comparable to those seen for ImMucin, which was used in our Phase 1/2a study for multiple myeloma, published by the Company in 2011 and demonstrated the safety profile of ImMucin.
One of the peptides responded less well (VXL-301), we believe, due to impurities introduced in manufacturing. A purer form has already been ordered and delivered. We are also assessing several large-scale contract manufacturers to develop a scaled GMP process, in the event our preclinical experiments continue to generate positive results.
The response in the combination of all three peptides was less than expected, which we hypothesize may be due to the impurities of the one peptide (as explained above) or it may be as a result of dosage, both of which are being adjusted and analyzed in our current work.
The uniqueness of the platform is that Vaxil’s peptides have the potential distinct benefits of eliciting both a T cell (cellular) and B cell (humoral) immune response. We believe this broader immune response should be more effective as a preventive vaccine.
Vaxil has already begun the next set of experiments in our preclinical program to better understand the immune responses and determine dosing. Vaxil intends to perform additional experiments including assessing patient plasma, in vitro cytotoxicity, in vivo immunogenicity and ex vivo T cell proliferation and cytokine release.
“We are excited to see this early validation of our modelling”, said David Goren, Vaxil’s Chairman and Chief Executive Officer, and continued to say “that given the need to vaccinate billions of people, the world will need multiple vaccination strategies to ensure success and meet the immense demand. We continue to be optimistic that we can play a role in this critical time of need.”
For more detailed results of this first vaccine candidate experiment, please see our presentation on our website vaxil-bio.com/Covid-19.
Dr. Applebaum has read and approved of the scientific disclosure in the news release.
The Company is not making any express or implied claims that it has developed a vaccine to treat COVID-19 (or SARS-CoV-2) at this time.
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 and received orphan drug status from the FDA and EMA. The company continues to develop ImMucintm and is also developing a tuberculosis vaccine / treatment that has demonstrated promising preliminary results with further preclinical evaluation underway at a top US academic and research institution. 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 SPs 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.
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 has neither approved nor disapproved the contents of this press release. 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. 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.