Vaxil Launches Manufacturing of ImMucin Immunotherapy for Upcoming Clinical Trials

Vaxil Launches Manufacturing of Immucin

Vaxil Launches Manufacturing of ImMucin Immunotherapy for Upcoming Clinical Trials

Selected to Present at 2017 Biomed Conference

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.

About Vaxil
Vaxil is a cutting edge Israeli-Canadian immuno-oncology biotech with its R&D based in the Weizmann Science Park, in Ness Ziona, Israel and listed on the TSX-V. Vaxil specializes in the development of immunotherapy products for the treatment of cancer and infectious diseases by activating the patient’s immune system. Vaxil immunotherapy products are based on its proprietary VaxHit™ platform algorithm which identifies and isolates signal peptide domains of cancer antigens and their subsequent synthetic production as immunotherapy products.

The first product developed through VaxHit™ is known as ImMucin™, a therapeutic cancer vaccine comprised of the signal peptide domain of the MUC1 antigen. Vaxil has shown that ImMucin™ possesses a high density of T- and B-cell epitopes while preserving MUC1 specificity. Recently, Vaxil has shown that ImMucin™ can potentially elicit a strong anti-tumor activity when used in combination with checkpoint inhibitors. MUC1 is present in many different cancer types, and Vaxil hopes to demonstrate potential applicability to other cancers in the future.

Vaxil has completed a Phase 1/2 clinical trial (n=15) with ImMucin™ demonstrating the vaccine to be safe and highly tolerable in patients with multiple myeloma. A robust immune response was seen in all patients treated with ImMucin™, with the majority of patients achieving stable disease. The company is now in a position to advance toward a larger Phase 2 trial, with Orphan Drug Status granted by both the EMA and FDA.
Vaxil has also developed the first signal-peptide specific antibodies, SPmAbTM with potential to be used as a companion diagnostic. Additionally, Vaxil has utilized its VaxHitTM platform in producing a unique Tuberculosis vaccine known as MTbuVaxTM. Vaxil’s products are protected by a robust patent portfolio.

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, results of clinical 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.

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