TORONTO, ON and REHOVOT, ISRAEL--(Marketwired - July 24, 2017) - VAXIL BIO LTD. (
"We are thrilled to have Dr. Plasse joining Vaxil at this critical juncture, as we are ready to formally advance ImMucin™ toward a Phase I/II clinical trial under US FDA Investigational New Drug (IND)," commented Dr. Saeid Babaei, Vaxil's Chairman. "Dr. Plasse brings a tremendous wealth of knowledge and drug development experience, having led the development of several cancer products through all phases of clinical trials. His skillset is exactly what is needed to advance our lead drug candidate in addition to his guidance for pipeline expansion."
Dr. Terry Plasse commented, "I'm excited to be joining Vaxil which is now well positioned to file for a Phase I/II clinical trial in cancer patients. Subsequent to its prior successful trial in myeloma patients in Israel, Vaxil conducted a robust R&D program, both in terms of ImMucin™'s combination potential as well as its applicability to other cancer types. I am excited about taking all of these data and leading the transition into a larger clinical trial, with an eye toward potentially including several major tumor types. My ultimate goal is to obtain approval to launch the new clinical trial just as our ImMucin™ will be finishing its production."
As recently announced, manufacturing is underway for Vaxil's lead product ImMucin™. The Company maintains its target for completion of manufacturing by late "Q4 2017 to early Q1 2018."
TERRY PLASSE, MD, VAXIL CHIEF MEDICAL OFFICER - BIOGRAPHY
Dr. Terry Plasse began his career as a New York oncologist before entering the biotech world, most recently in Israel. Dr. Plasse was previously North American Director, Oncology Clinical Research, for multi-national Rhone-Poulenc Rorer, which merged with Sanofi, now the world's 5th largest pharma company. There, Dr. Plasse oversaw North American R&D focused on clinical trials for its cancer products, including docetaxel which is marketed worldwide by Sanofi with sales in the billions.
Additionally, Dr. Plasse oversaw a clinical trial for Astra Zeneca's gefitnib, a drug which has been approved for lung cancer. He consulted Merck in relation to vorinostat (Zolinza), approved by FDA for treatment of cancer. Dr. Plasse conducted early analyses for Bristol Myers Squibb for its renowned checkpoint inhibitor ipilimumab, the first approved cancer immune checkpoint inhibitor.
Dr. Plasse also brings experience leading small biotech companies, with leadership positions at Interferon Sciences, UniMed, and Cytokine PharmaSciences. Most recently, Dr. Plasse became Medical Director for Redhill BioPharma, an Israeli biotech which successfully listed on the NASDAQ and just last month announced positive Phase-III results from a clinical trial which he managed. Dr. Plasse completed his medical residency at Beth Israel Hospital and fellowship in medical oncology at Mt Sinai Medical Center, both in New York. He is a graduate of the Washington University School of Medicine, St. Louis, and received his Bachelor's in Chemistry from Brandeis University. Dr. Plasse was also a Lieutenant-Commander (Full Surgeon) in the US National Health Service Corps.
ABOUT VAXIL
Vaxil is an Israeli-Canadian 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 neoantigen. Vaxil is currently advancing toward a Phase-I/II which may include additional solid tumor indications. Vaxil has also developed a proprietary antibody platform known as SPmAb, the first-ever signal peptide specific antibodies.
ABOUT 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.
The Company plans to file an IND application to the FDA, which is a part of Vaxil's strategy to obtain marketing authorization in the US. Approximately 90% of tumor indications express the MUC1 tumor associate antigen, and according to the Company's internal data, certain types are particularly attractive targets for ImMucin™ in terms of potential for evoking an immune response against the MUC1 signal peptide. Vaxil hopes to request its pre-IND meeting with the FDA during this quarter, and will provide updates once progress is made.
Disclaimer: 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. 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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Contact Information:
For further information please visit www.vxlbio.com or contact:
Isaac Maresky
Executive Director
