Vaxil Receives Positive Response From European Patent Office for the Allowance of the Immunotherapy Orphan Drug Designated ImMucin(TM)

TORONTO, ON and REHOVOT, ISRAEL–(Marketwired – June 16, 2016) – VAXIL BIO LTD. (TSX VENTURE: VXL), an Israeli biotech specializing in immuno-oncology, reports that it has successfully received a Notice of Allowance to Grant a Patent from the European Patent Office for Patent Application No. 07827143.4 entitled “Antigen Specific Multi Epitope Vaccines”.
“This is a major patent for Vaxil and our team has been working towards this for a long time. Vaxil is very excited about having broad IP protection in the European Union, covering the VaxHit™ platform and all immunotherapy products derived from it. This of course includes Vaxil’s lead, Orphan Drug Designated immunotherapy ImMucin™. Perhaps even more importantly, however, is the protection this patent affords VaxHit™ as a platform with potential to generate additional immunotherapies targeting a range of cancer antigens in the uniquely advantageous manner through which ImMucin™ has targeted MUC1,” commented Vaxil Founder Dr. Lior Carmon.
Vaxil’s VaxHit™ platform technology combines proprietary algorithms which enable in-silico identification of signal peptides domains and their subsequent use as immunotherapeutic products. The VaxHit™ platform is essentially a launchpad for novel and uniquely targeted immunotherapy products. In the case of MUC1, a renowned yet still unsuccessfully targeted cancer antigen, Vaxil utilized its VaxHit™ platform in order to isolate a 21-mer lead product now known as ImMucin™. A Phase-I/II clinical trial with 15 myeloma cancer patients served to validate strong immunotherapeutic potential. The trial also served to endorse VaxHit™’s potential as a platform for generating products with the ability to target renowned cancer antigens in an altogether novel and effective way.
Given Vaxil’s highly novel approach to immunotherapy, the Company believes its VaxHit platform possesses potential perhaps not yet understood or appreciated by the broader market. The Company is therefore utilizing the opportunity to amass a strong and broad intellectual property for ImMucin™ and even more so for VaxHit™ as an extensive platform with potential to generate additional immunotherapies targeting prevalent cancer antigens. Vaxil has already identified tens of possible immunotherapy product candidates utilizing its platform. Most importantly, VaxHit™ derived immunotherapy products (including ImMucin™) all contain the following critical advantages:
1. Broad Immune Response: SP domains have the advantage of being short sequences which induce a broader, stronger and antigen specific immunity via promiscuous activation of multiple T-cell clones both CD4+ and CD8+ T-cells and the production of key cytokines like IFN-g, IL-12 and IL-2.
2. Universal: Vaxil’s immunotherapeutic products are “universal” in the sense that they can induce an efficient response in the majority of the patient population due to their ability to bind multiple HMC molecules. This is critical as every individual expresses different sets of MHC molecules. Unlike many other peptide immunotherapies, Vaxil’s SP domains do not require patients selected based on their MHC repertoire (type).
3. Potent Immune Response: T-cells specific clones against SP domains are less likely to be “exhausted” in cancer patients. They possess a greater likelihood of being more potent at killing cancer tumor cells, when compared with other epitopes (already validated for MUC1, tuberculosis).
4. Overcoming Cancer’s Immune Evasion: Vaxil’s products are able to efficiently overcome difficulties posed by immune evade mechanisms utilized by cancer,, mainly Transporter Associated Antigen Processing (TAP) deficiency, mediated by cancer cells and intracellular pathogens. To the best of our knowledge, Vaxil’s are the only products which currently possess this crucial characteristic.
5. Expression on Cancer Stem Cells: These cells are often responsible for leading to metastasis and chemo-resistance, and can continue doing so when only primary tumor cells are targeted.
Vaxil within Cancer Immunotherapy
Immunotherapy has become the most promising field in the fight against cancer, intended to train and harness the body’s own robust and complex immune system in order to recognize, identify, and target cancer tumors. Work done, mainly with immune check-point inhibitors, engineered T-cells and cancer vaccines validated that immune cells can indeed recognize and effectively kill tumor cells.
However, while check-point inhibitors and engineered T-cells have showed dramatic effects in metastatic patients, they do tend to have moderate to high adverse effects in certain patients and are therefore less applicable as long term maintenance treatments such as for patients with minimal residual disease. Thus, it is anticipated that products like Vaxil’s ImMucin™ have potential to fill the gap for those patients, or possibly in combination with other immunotherapy modalities in more advanced cancer patients. Given that all immunotherapeutic modalities are based on antigens, we believe them to be the most important component in terms of both safety and efficacy. To date, immunotherapy products in development have not fulfilled key requirements, and Vaxil has specifically designed its VaxHit™immunotherapy platform and products to address the 5 requirements noted above.
About Vaxil
Vaxil is an immuno-oncology biotech based in Israel’s Weizmann Science Park, and listed on the TSX-Venture as VXL. Vaxil has developed a proprietary platform called VaxHit™ for the identification and production of signal peptide domains as cancer vaccines, target for superior T-cell based cell therapy and proprietary antibodies.
The Company’s lead product stemming from the VaxHit™ platform, is ImMucin™, which has shown highly promising results in a published Phase-I/II clinical trial which included 15 myeloma cancer patients. ImMucin’s Phase-II clinical trial is currently planned to launch in 2017, and will include up to 60 cancer patients. Meanwhile, Vaxil is developing additional immunotherapy products, leveraging the VaxHit platform in order to generate uniquely targeted products for a range of cancer antigens. Vaxil has already identified tens of possible immunotherapy product candidates utilizing its platform.
About VaxHit™ Platform
Effectively, VaxHit™ enables the identification of sequences (antigens) in a unique domain of the proteins called the signal peptide domain that is capable of triggering a unique and specific reaction, among T -cells and antibodies (B-cells) in the immune system of most patients. Recently, Vaxil has reported that by using the VaxHit™ technology, one can identify epitopes within the same specific signal peptide domain in targets, and thus produce improved recombinant antibodies that can serve to diagnose and potentially treat cancer and infectious diseases. The Company believes there is significant potential to develop additional technologies utilizing VaxHit™. The Company is therefore working to protect its ability to develop and produce such immunotherapies, which includes its lead product, ImMucin™.
About ImMucin™
Vaxil’s lead product, ImMucin™, trains the patient’s immune system to identify and destroy cells which display a short specific 21-mer portion (signal peptide domain) of the cancer-associated (marker) expression of MUC1, which appears on 90% of all cancer cells but not in normal cells or patient blood, a factor which can enhance its potency. Vaxil completed a Phase I/II clinical study with ImMucin™ in multiple myeloma (MM) patients, which showed a high safety profile, strong diversified T/B-cell immunity in all 15 patients across MHC repertoires and initial indications of clinical efficacy; 11 out of the 15 treated patients demonstrated stable disease or clinical improvement which did not require any further treatment. An ongoing follow-up study in patients who responded clinically to ImMucin™ has shown that some patients haven’t required any further treatment for their disease up to five years since ImMucin™ treatment. ImMucin™ was recently granted an Orphan drug designation for MM by both the USA FDA and the European EMA.
Link to film about Vaxil’s Cancer Immunotherapy Platform: Vaxil Video Link
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Forward-looking Statements: This news release contains forward-looking information, which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general that could cause actual results to differ materially from the Company’s current expectations. These risks and uncertainties, including the availability of future financing, the results of future clinical trials, the strength and sufficiency of existing patents and the risk of IP litigation, and the need for further FDA and other regulatory approvals, are more particularly described in the Company’s public filings on SEDAR at www.sedar.com. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only to management’s good faith beliefs 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. 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.
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