TORONTO, ON and REHOVOT, ISRAEL–(Marketwired – March 22, 2017) – VAXIL BIO LTD. (TSX VENTURE: VXL), is pleased to announce a collaboration with “Clalit” Meir Medical Center in Kfar Saba, Israel. This collaboration is yet another expansion of Vaxil’s ongoing R&D program with its lead product ImMucin™ that has received an Orphan Drug designation from both FDA and EMA for treatment of Multiple Myeloma.
As part of the collaboration, Vaxil will receive clinical samples from various cancer patients to further assess the potential of the Company’s immune therapy in combination with other treatment modalities. This collaboration is a part of an ongoing multi-center program in Israel, which Vaxil embarked on during 2016, to strengthen its unique immune therapy modality, and to optimize the treatment method in its upcoming clinical trial.
The collaboration is led by Prof. Michael Lishner, a senior hematologist, head of the Department of Internal Medicine in the hospital and a faculty at the Sackler School of Medicine at the Tel Aviv University. Prof. Lishner is an expert in hematology and cancer during pregnancy. He has graduated from the Sackler School of Medicine, was a fellow at the Princess Margaret Hospital in Toronto and a visiting professor at the University of Toronto. He is the author of over 200 scientific articles and book chapters.
“We are very pleased working with Vaxil’s scientific and management team,” commented Professor Lishner. “I believe Vaxil’s product development strategy fits nicely with existing therapies and contribute considerably to the treatment of those patients which express the antigen. I am a strong believer in immune therapies, and the preliminary success that Vaxil has shown with its vaccine is very encouraging.”
Vaxil has previously announced that it has obtained preliminary positive data with ImMucin™ and other immunotherapy drugs using samples from hematological patients, and that there is now solid evidence to substantiate MUC1-SP as a true neoantigen in humans. The Company is now expanding its efforts to show the importance of MUC1-SP in solid cancers as well. These data will pave the road towards treating more patients with ImMucin.
Vaxil R&D Initiative
As previously reported, the Company will present results from its ongoing research program during the AACR 2017 annual meeting in Washington, DC, next month. The results, obtained using samples from hematological patients received from Hadassah Medical Center and from healthy volunteers, show that not only ImMucin™ is a superior immunogen, compared to other MUC1 derived peptide domains, but that this advantage can be attributed to its neoantigen-like properties. In a series of tests designed to look at the T-cell population after stimulation with various MUC1 derived immunogenic peptides, it was found that those cells stimulated with ImMucin rarely presented the “exhausted” phenotype, typical for T-cells who were long exposed to self-antigens. This exciting finding is in-line with the hypothesis that MUC1-SP is a true neoantigen, for which existing T-cell clones are readily stimulated upon expression on cancer cells, and can mediate an effective anti-tumor response. Dr. Limor Chen, Vaxil’s VP Operation and Clinical Affairs added: “Again we see that our initial assumption as to the mode of action of ImMucin™ is corroborated by robust scientific data. We are excited to expand our understanding about how and why ImMucin may work and this will definitely direct our future selection of treatment scheme and indications.”
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.
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