Vaxil BioTherapeutics Launches Manufacturing Of Immucin Immunotherapy For Upcoming Clinical Trials
TORONTO, ON, and NESS ZIONA, ISRAEL--(Marketwired - May 23, 2017) - VAXIL BIO LTD. (TSX VENTURE: VXL), a biopharmaceutical company focused on developing immunotherapies based on signal peptides from known tumor antigens, announced today that it has entered into an agreement for the cGMP manufacturing of its lead product VXL100 (ImMucin®) with BCN Peptides S.A. ("BCN Peptides"). This new batch is intended for use in the Company's upcoming clinical trials including multiple myeloma and/or solid tumor indications. The Company is targeting completion of manufacturing for late Q4 2017 to early Q1 2018.
BCN Peptides, based in Spain, is an expert manufacturer of generic and custom-made peptides in various scales, from R&D all the way to commercial batches. BCN Peptides successfully produced the previous batch of VXL100 for Vaxil utilizing its improved process with high yields, which was effectively utilized in preclinical development.
Dr. Limor Chen, VP Operations and Clinical Development, added: "We are very pleased to launch manufacturing of a new batch of ImMucin™ in collaboration with BCN Peptides, our long-term partner with a proven track record. This is a major step towards our first clinical trial under IND and significantly facilitates our development plan."
Dr. Berta Ponsati, CEO of BCN Peptides, stated: "The technical and pharmaceutical experience of the BCN Peptides team is a real asset, bringing its expertise to manufacture Vaxil's product efficiently, thus helping to make it available to patients faster. BCN Peptides maintains a state-or-the-art manufacturing facility which is routinely inspected by the US and EU regulatory agencies and complies with the highest quality standards."
VAXIL PRESENTATION AT BIOMED 2017 TEL AVIV
Vaxil is also pleased to announce that it has been selected to present at a special Innovation Pavilion within the 2017 Biomed Conference in Tel Aviv this week, with 15 presenting each day of the conference. This unique presentation opportunity is being sponsored by the Israel Innovation Authority of the Ministry of Economics and will take place at the Start-Up Pavilion in the exhibition hall of the conference at the David Intercontinental hotel in Tel Aviv, on May 25.
Vaxil was further selected amongst 10 innovative companies, to present as a part of the annual Start-Up Competition. The Biomed 2017 program notes that "Out of the 45 exhibiting companies, 10 will be selected to give an oral presentation as part of the event's conference and a chance to win the Start-up area Competition." Vaxil's presentation will be taking place today, on May 23rd between the hours of 3:45 - 5:15, local Israel time.
ABOUT VAXIL
VXL100 (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. The actual peptide is protected by patents covering all aspects of the drug substance. Additionally, Vaxil holds patents covering the use of VXL100 in various medical indications.
ImMucin™ was designated Orphan Drug by both the US FDA and the EMA for use in multiple myeloma. It has been previously tested in a phase I/II clinical trial in multiple myeloma patients and showed encouraging immunological and clinical benefits. As was recently announced by the company, the mode of action by which VXL100 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, and have a potential to be effective in large population section due to the broad coverage of immune system repertoires and owing to ability of VXL100 to bypass immune-system resistance often encountered in these diseases.
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.