Eyal Avidov: Interview with David M. Goren ,,Vaxil” CEO & Charmain

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Cutting-edge israeli biotech focused on immunotherapies as innovative treatments

INTERVIEW with David M. Goren

,,Vaxil” CEO & Chairman

Dear David, can you give us some brief about Vaxil activity?

Vaxil Bio Ltd is an Israeli biotech company, publicly listed on the Toronto venture exchange (TSX.V: VXL.V; OTC: VXLLF) that develops innovative patented technologies in the fields of cancer and infectious diseases based on a novel Signal Peptide (“SPs”) discovery and development platform.

The company’s most advanced product, ImMucin™, completed a Phase 1/2a clinical trial in multiple myeloma and received orphan drug status from the FDA and EMA. The company also announced a COVID-19 vaccine candidate in addition to its tuberculosis vaccine/treatment candidate that demonstrated promising preclinical results at a top US academic institution. Additional indications and mAb candidates are under evaluation as immuno-oncology and infectious disease treatments alone and in combination with other treatments.

https://vaxil-bio.com

Vaxil exploits the unique properties of signal peptide domains on crucial proteins to develop targeted therapies against cancer targets and infectious disease pathogens. VaxHit™, Vaxil’s proprietary bioinformatic approach, mines candidate signal peptides with predicted high immunogenicity and wide coverage over varied HLA subtypes. The SPs induce a robust T- and B-cell response. Under normal conditions signal peptides are not presented on the cell surface, thus acting as a neoantigen in tumor cells. Since these neoantigens are not a result of a mutation, but are naturally occurring sequences, these sequences will be identical among most patients providing a unique class of therapeutics – universal neoantigens. The signal peptide platform targets affected cells, either transformed (i.e., cancer) or infected, by “educating” or specifically activating the immune system to recognize and specifically attack these cells, and only these cells. In addition, Vaxil’s mAb platform directly recognizes the target epitopes presented on malignant cancer cells and recruits other elements of the immune system to kill those cells.

Vaxil’s technology provides unique advantages due to the use of signal peptides as the basis for a prophylactic vaccine and therapeutic treatment. Those advantages include:

  1. Induction of a complete adaptive immune response – cellular (T cell) and humoral (antibodies).
  2. Stimulation of a robust immune response elicited by multiple antigens within the SP.
  3. Wide coverage of diverse populations due to epitopes spanning varied HLA class I and class II restrictions.
  4. Increased immune efficiency due to circumventing the viral and tumor immune evasions, such as TAP insufficiency and HLA downregulation.
  5. Excellent safety profile by specifically and only targeting affected cells.
  6. Potential prevention of infectious disease resurgence and a novel universal class of neoantigen in oncology.
  7. Greater susceptibility to adaptive immunity by targeting infected cells rather than the pathogen.

The clinical Phase 1/2a trial demonstrated a good safety profile coupled with signals of biological activity for Vaxil’s SP platform and approach. Vaxil has created effective, scientifically validated platforms to develop targeted immuno-oncology and infectious disease vaccines and treatments from discovery through clinical trials

 

SIGNAL PEPTIDE IN TRANSFORMED CELLS:

 

P-EsBP FOR TARGETED CANCER THERAPY

The Company entered into an exclusive worldwide license agreement last year, for the development and commercialization of a targeted cancer therapy with BGN Technologies, the technology transfer company of Ben-Gurion University (“BGU”) of the Negev, Israel.

Vaxil has found great interest in the P-EsBP polymer-based macromolecule invented by BGU’s Prof. Ayelet David. The technology is protected by a series of worldwide patents, including specifically “P-EsBP” which is designed to target inflamed endothelial cells through recognition of E-selectin for the inhibition of tumor growth and metastasis. E-selectin, a cytokine-inducible cell adhesion molecule (CAM) which belongs to the selectin family, is expressed only on the surface of inflamed blood vessels and mediates the recruitment of leukocyte and cancer cells into inflamed and cancerous tissue thus further promoting cancer metastasis.

The new synthetic P-EsBP polymer targets E-selectin with high affinity for delivering drugs to tumors and metastatic sites, using primary and metastatic models of cancer. This approach showed promising preclinical therapeutic results, enhancing drug accumulation in tumors, significantly decreasing the rate of tumor growth, and dramatically prolonging the survival of mice with melanoma lung metastases.

One of the greatest challenges in developing drugs for the treatment of solid tumors is treating the affected site without damaging healthy cells and organs. This P-EsBP polymer only targets the inflamed blood vessels, thus offering the opportunity to treat selectively without harming healthy tissues.

P-EsBP has been shown to interfere with E-selectin-mediated interactions, thus blocking leukocyte and cancer cell recruitment to inflamed and cancerous tissues which reduced colonization of circulating cancer cells in secondary organs. In addition, it was also shown to inhibit leukocyte recruitment and inflammation in animal models of liver injury and atherosclerosis. These results demonstrate the promising therapeutic potential of P-EsBP therapy for inhibiting inflammation and arresting cancer disease progression as well as other diseases where inflammation plays a role.

Vaxil plans to combine P-EsBP with signal peptides to progress the science of treating cancer with immunotherapy.

Can you explain Vaxil’s activity in the area of the COVID-19 Vaccine development?  

COVID-19 Vaccine Candidate

In February 2020, the company identified unique sequences in certain proteins of the virus that causes the COVID-19 disease, which are suitable to Vaxil’s unique signal peptide platform. These sequences are the basis for the development of Vaxil’s vaccine, CorVax™, which was announced in February 2020.

Traditional vaccines aim to elicit antibody production, most commonly with a neutralizing antibody that interferes with the viral protein (in this case, spike protein) and the cognate receptor on the target cells. Other vaccines aim to induce production of antibodies that opsonize the virus to facilitate clearance of the pathogen. Vaxil’s vaccine candidate targets the infected cells and includes both the cell-mediated immunity for rapid response and a humoral (antibody) response as a secondary response. Quick recognition and disposal of infected cells interferes with viral replication and halts further infection of additional cells. Consequently, viral load remains low, disease progression is terminated and dissemination of the virus within a population is prevented.

Last month, the company signed a collaboration agreement with The Tel Aviv Medical Center to advance the CorVax™ research program. This agreement provides Vaxil with vital access to Tel Aviv Medical Center’s research capabilities resources including their unique bank of biological samples and its advanced research infrastructure.

Vaxil is advancing its CorVax™ preclinical program to validate effective immune response, including assessing convalescent patient plasma, in vitro cytotoxicity, in vivo immunogenicity and ex vivo T cell proliferation and cytokine release.  We anticipate completing this work in the coming months and if successful, we will prepare for and commence our Phase 1 program once receiving approval to do so.

If we are successful in proving the safety of our COVID-19 Vaccine in Phase 1, we will continue the development of CorVax™ to Phase 2 and 3. Vaxil’s signal peptide platform is more easily and more efficiently scaled up

Can you tell me about Vaxil’s other areas of activity?

Tuberculosis (TB)

In addition to our COVID-19 work, Vaxil’s platform has potential as a vaccine and / or treatment for other infectious diseases. Vaxil has advanced its signal peptide platform in infectious disease, focusing on tuberculosis with MTBuVax™. Preclinical studies have confirmed the efficacy of signal peptides in reducing bacterial load in the lungs in a murine protection model. Further studies will evaluate tuberculosis SPs as a boost to standard of care, in order to (1) increase treatment efficacy, (2) prolong the protective immunity effect and/or (3) expand the treated population. Vaxil has collaborated with world-renowned tuberculosis researchers at a top research university.

Oncology

Following the successful clinical trial of ImMucin™, Vaxil plans to develop our MUC1-SP as an adjunct therapy or combination therapy to synergistically improve the standard of care for solid tumors with high risk of metastasis. Preclinical studies are planned to support forthcoming clinical trials.

Vaxil’s VaxHit™ has identified additional peptide candidates pertinent to a variety of cancers that can be developed as either SPs or mAbs. VaxHit™ will continue to be employed to identify other candidates for oncological and infectious disease indications.

During 2019, Vaxil enhanced its peptide production methodologies to increase yield and purity, improving and allowing future scale-up for prospective clinical trials as well as future commercial manufacturing.

Can you explain to us about Vaxil’s intellectual property?

 Vaxil Intellectual Property

Vaxil’s robust patent portfolio which spans across the platform in both oncology and infectious diseases including 30 granted patents and eight additional applications. These patents can be summarized into the following five patent families:

  1. ImMucin™, a MUC1 signal peptide-based vaccine including patents in US, Europe, Australia, Canada, Israel and India, relating to the ImMucin™ vaccine and methods for using ImMucin™ such as for treating cancer and T-cell enrichment.
  2. Immunogenic composition, specifically against a pathogen (e.g., tuberculosis, malaria, toxoplasma, EBV, HIV, herpes virus, and influenza), in the US, Europe and South Africa.
  3. Antibodies produced by MUC1 signal peptides, and diagnostic and therapeutic methods using these antibodies. This patent family includes a US granted patent and patent applications in Europe, Australia, Canada, Israel and India.
  4. Selective delivery of drugs such as anticancer to endothelial cells using polymer-drug conjugates. This patent family includes granted patents in the US, Europe, and Israel.
  5. COVID-19 immunogenic peptides, such as for use as vaccines. This patent family includes two US provisional applications.

 

By

 

Eyal Avidov-Lt. Col. (Ret.)

CEO

BASTION HLS ® LTD

DEFENSE I VEHICLES I SOLUTIONS

Contributing/Representative of News247WorldPress in Israel

www.bastion-hls.com

 

 

 

 

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