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NESS-ZIONA, ISRAEL – February 17, 2021 – VAXIL BIO LTD. (“Vaxil” or the “Company”) (TSX VENTURE: VXL), an innovative immunotherapy biotech company specializing in cancer and infectious diseases, today reports results of the previously disclosed COVID-19 vaccine candidate challenge experiment and the strategy going forward.
Vaxil established the USAMRIID collaboration (CRADA) based on the global need for a viable COVID-19 vaccine utilizing an alternative technology that demonstrates cellular and humoral responses, both of which are necessary. In this rapidly moving pandemic, variants have become the established infection model, which can be better addressed with Vaxil’s SP approach. Neutralizing antibody technologies may require frequent modifications while Vaxil’s signal peptide (“SP”) technology may provide long-term efficacy as the virus mutates.
The USAMRIID COVID-19 mouse model challenge experiment demonstrated that Vaxil’s SP-based vaccine candidate generated a specific immune response. This was not, however, accompanied by vaccine protection of the animals.
The Company plans to conduct additional analyses and on the basis of the understanding obtained, refine aspects of experiment design, including dosing levels and regimens, and alternate animal models that may allow future investigation of the unique and specific aspects of SP’s as immunogens. In addition, the Company will evaluate alternate peptide delivery approaches, including oral administration. This strategy focuses future efforts on the unique benefits of SP’s to sustain Vaxil’s competitive advantage over the longer term, beyond the current crisis environment, when it can realistically achieve approval for human use.
The Company’s strategy to deliver value over the long-term is based on potentially unique benefits of SPs including their broad and strong immune response, both cellular and humoral, their reduced propensity to genetic mutation and the advantage of efficient manufacturing.
“We were pleased to see the encouraging immune response and are excited to pursue further testing to highlight the unique advantages of SPs as a technology, though we had hoped to be able to demonstrate higher levels of protection in our first challenge experiment. It’s not uncommon to see such results at this early stage. We will work diligently with our international team of experts to further understand the data as COVID-19 is unfortunately going to be around for a long time. Whilst we had hoped to get into the clinic sooner, we believe that our technology could still be very relevant in the fight against COVID-19 and other infectious diseases,” said David Goren, Vaxil’s Chairman and Chief Executive Officer, and continued, “thanks to our relatively strong balance sheet, we have sufficient funds to continue the pre-clinical development of our potential vaccine and our other research programs.”
Dr. Michael Berelowitz, Vaxil’s newly appointed senior advisor the board of directors added: “Vaxil’s innovative approach in targeting the SP domain of clinically meaningful cancer and infectious disease molecules provided the stimulus for joining the company. The demonstration in this study of COVID-19 SP immunogenicity provides support and impetus for the concept. These results, together with those previously seen in multiple myeloma and tuberculosis, provide support for the Vaxil strategy moving forward and their investigative approach toward developing critical new therapeutics.”
The Company is not making any express or implied claims that it has completed developing or will be successful in developing a COVID-19 (or SARS-CoV-2) vaccine at this time.
The company posts periodic updates through videos from the official company’s Youtube channel https://www.youtube.com/channel/UC0M029aN8g6beW09Drgt0dQ
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.
About the U.S. Army Medical Research Institute of Infectious Diseases
For over 50 years, USAMRIID has provided leading edge medical capabilities to deter and defend against current and emerging biological threat agents. The Institute is the only laboratory in the Department of Defense equipped to safely study highly hazardous viruses requiring maximum containment at Biosafety Level 4. Research conducted at USAMRIID leads to medical solutions – vaccines, drugs, diagnostics, information, and training programs – that benefit both military personnel and civilians. Established in 1969, the Institute plays a key role as the lead military medical research laboratory for the Defense Threat Reduction Agency’s Joint Science and Technology Office for Chemical and Biological Defense. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Development Command. For more information, visit http://www.usamriid.army.mil.
[The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.]
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