SOURCE: Vaxil Bio Ltd.

Vaxil Bio Ltd.

March 01, 2018 08:30 ET

Vaxil Granted First U.S. Patent for Its Cancer Immunotherapy Antibody Platform

Provides Corporate Update on Board Changes and Manufacturing

NESS-ZIONA, ISRAEL--(Marketwired - March 01, 2018) - VAXIL BIO LTD. (TSX VENTURE: VXL), an innovative Israeli cancer research company focused on immunotherapy, is pleased to announce that it has successfully obtained a U.S. Patent for its Signal Peptide Antibody Platform known as SPmAb™.

Vaxil has been granted U.S. Patent # 9,732,153 entitled "Antibodies directed against signal peptides, methods and uses thereof." Within Vaxil's intellectual property portfolio, this marks the Company's 3rd U.S. patent and 8th global patent. The Company has an additional 8 patents pending.

"Although this marks Vaxil's 8th granted patent, we are pleased to finally have the first patent specifically protecting the Company's proprietary antibody platform known as SPmAb™," Vaxil CEO Mr. Isaac Maresky commented. "Our research and development to date has indicated that this family of antibodies possess both therapeutic and diagnostic potential for cancer patients."

Vaxil's latest patent is available publicly online, and includes the following: "This invention relates to diagnostic and therapeutic methods employing antibodies directed against the signal peptide (SP) of disease-related polypeptides, in particular for the diagnosis and treatment of cancer and infectious diseases… In another aspect, the present invention provides a method of treatment of a subject suffering from a disease, the method comprises administering to said subject a therapeutically effective amount of at least one antibody directed against a signal peptide…" This granted patent provides broad patent protection for diagnostic methods of detecting autoantibodies directed against MUC1 signal peptides, MUC1 being a cancer tumor cell marker present in more than 90% of cancer types. In order to bolster this initial antibody platform patent coverage, Vaxil has already filed a U.S. continuation application to pursue additional diagnostic and therapeutic methods using the anti-MUC1 signal peptide monoclonal antibodies.

BOARD CHANGES
Additionally, Vaxil announces that Dr. Saeid Babaei has resigned from his role as Chairman of the Board of Directors. The Company would like to thank Dr. Babaei for his invaluable leadership during the last two years in advancing Vaxil's cancer immunotherapy pipeline and listing on the TSX-Venture Exchange. We wish him well in his future endeavors as he is transitioning over various initiatives to the Company's new board members. Mr. Isaac Maresky has accepted the role of Chairman for the time being.

MANUFACTURING UPDATE
Vaxil is focused on advancing the drug manufacturing processes for its lead cancer immunotherapy product, ImMucin™. While manufacturing of the drug substance has begun, the Company is in discussions with relevant experts pertaining to Chemistry, Manufacturing and Controls (CMC). The Company is working on identifying an optimal CMC process for production of its drug which will in turn allow efficient production via a current Good Manufacturing Practices (cGMP) approved facility. The goal of such an endeavor is to enhance Vaxil's ability to more readily produce larger quantities of high quality product, which would enable the Company to embark upon additional clinical trials. CMC is an important bridge between clinical pilot batches of therapeutic drugs to more commercial-scale batches. The Company hopes to be in a position to report more on the manufacturing process and its CMC direction in the near future.

ABOUT VAXIL
Vaxil is an Israeli immunotherapy biotech focused on its novel approach to targeting prominent cancer markers. Its lead product ImMucin™ is a MUC1 signal peptide derived product, wholly owned by Vaxil and protected by a series of patents in all major territories around the globe, believed to act as a true neoantigen. Vaxil is currently advancing toward a Phase-II which may include additional solid tumor indications. Information about the Company's pipeline is available at www.vxlbio.com

ABOUT VAXIL'S LEAD PRODUCT: IMMUCIN
Vaxil's products, including the actual ImMucin™ peptide, are protected by a series of patents around the globe. The Company successfully completed a Phase- I/II clinical trial in multiple myeloma patients demonstrating encouraging immunological and clinical benefits. ImMucin™ was designated Orphan Drug by both the US FDA and the EMA for use in multiple myeloma. As was recently presented by the company, the mode of action by which ImMucin™ exerts its unique immunological and clinical activity, is believed to be via its distinctive characteristics as a neoantigen. These features enable the robust immune response observed in patients with various hematological malignancies, with potential to be effective in a large population section due to the broad coverage of immune system repertoires. Additionally, it is currently hypothesized that ImMucin™ possesses the ability to overcome cancer's immune-system bypass resistance.

ABOUT VAXIL'S SIGNAL PEPTIDE ANTIBODY PLATFORM
In addition to its lead product, Vaxil has developed the first ever signal peptide specific antibodies, believed to have both treatment and diagnostic potential.

ABOUT VAXIL'S TUBERCULOSIS VACCINE
Vaxil has developed and patented unique Tuberculosis vaccines predicated upon the Company's VaxHit algorithm. In 21 patient samples, Vaxil scientists observed promising potential. Given that this early staged product family is not within the Company's core focus of cancer, Vaxil may seek potential partners for its advancement.

Disclaimer: 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.

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