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NESS-ZIONA, ISRAEL – April 28, 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 announce that the Company’s annual financial statements and management discussion and analysis for the year ended December 31, 2019 are now available to download on the Company’s website at www.vaxil-bio.com and on Sedar at www.sedar.com. The following is a summary of the activities of the Company in 2019 and through to the date of this release:
• The Company ended the year with cash on hand of $83 thousand. However, the Company now has approximately $1.3 million in cash, following the completion of a bridge financing in March 2020 and the exercise of an aggregate of 13,880,000 warrants with an exercise price of $0.10 issued in January 2018.
• In February 2020, the Company shifted much of its resources to identifying and developing a potential vaccine for COVID-19 (“Vaccine Candidate”). The Vaccine Candidate is based on unique and patent-protected signal peptide technology and was discovered utilizing Vaxil’s proprietary VaxHit™ bioinformatics platform. The Vaccine Candidate’s design is based on knowledge gained from in vivo experiments including testing Vaxil’s tuberculosis signal peptide vaccine candidate. The current work may also lead to other infectious disease applications.
• In March 2020, the Company applied for two US patents in connection with COVID-19. These are intended to provide broad patent protection for novel vaccines, pharmaceutical compositions and methods of treating and preventing an infectious disease as well as methods for producing a peptide vaccine against coronaviruses.
• During April 2020, we started conducting pre-clinical experiments in our laboratory in Israel. The results of work to date indicate that our Vaccine Candidate shows proliferation in T-cells. As is common in such early preclinical trials/research programs, these experiments were performed on healthy donor blood cells to validate the immune response in a screening protocol. The experiments have not been independently verified; however, this will take place as we advance our research program.
• We are in discussions with medical and academic institutions in order to advance our program.
In addition to our work COVID-19, Vaxil maintains other programs as follows:
• our signal peptide platform comprises ImMucin™ which completed a phase 1/2a clinical trial and can be deployed as an adjunct therapy or combination therapy to synergistically improve the standard of care for solid tumors with high risk of metastasis. Preclinical studies are planned to support future clinical trials.
• Vaxil’s platform has potential as a treatment for various infectious diseases. Over the past year, Vaxil advanced the signal peptide platform in infectious disease, focusing on tuberculosis with MTBuVax™. Preclinical studies confirmed the efficacy of Vaxil’s signal peptides in reducing bacterial load in the lungs in a murine protection model. Further studies will evaluate tuberculosis SPs as a boost to standard of care, in order to (1) increase treatment efficacy, (2) prolong the protective immunity effect and/or (3) expand the treated population. Vaxil has collaborations with world-renowned tuberculosis researchers at a top research university.
• Vaxil’s VaxHit™ has identified additional peptide candidates pertinent to a variety of cancers that can be developed as either SPs or mAbs. VaxHit™ will continue to be employed to identify other candidates for oncological and infectious disease indications.
“Vaxil has been quite active during the last 16 months. In 2019, our focus was primarily in oncology and TB, but that quickly shifted in early 2020 to COVID-19, based on Vaxil’s prior knowledge and expertise.” said Gadi Levin, Vaxil’s Chief Financial Officer, and continued “the cash injection from the exercise of warrants has provided the Company with funds to advance our COVID19 research while we seek additional sources of financing.”
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 aims to continue to develop ImMucin™ 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 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.
For further information please visit https://vaxil-bio.com/ or contact: David Goren, CEO — firstname.lastname@example.org, +972 (52) 720-6000