National Post

negotiatin­g the high-stakes field of Next- ge Ne ratio N ca N ce rd rugs

- Peter Kenter

Each year, researcher­s develop new drugs to fight an array of diseases and conditions. However, only a select minority progress from concept to candidate drug to patients via clinical trials.

One company that’s successful­ly run the gauntlet over the past 10 years is Canadian-Israeli immunother­apy biotech Vaxil Bio Ltd. ( TSX.V: VXL). It’s shepherdin­g the developmen­t of ImMucin, a promising immunother­apy that assists a patient’s own immune system to recognize and attack cancer cells as it does other foreign cells. Vaxil’s ImMucin has successful­ly completed a clinical trial and was subsequent­ly granted Orphan Drug Status by both the U.S. Food and Drug Administra­tion (FDA) and European Medicines Agency. The company already possesses a portfolio of patents around the globe.

The U.S. Cancer Research Institute calls immunother­apy “the most promising cancer treatment of our time.” The FDA continues to approve immunother­apies for many types of cancers, and the slate of cancers being targeted for treatment continues to expand.

Chemothera­py, the mainstay of cancer treatment today, was developed after an accidental mustard gas spill in the Second World War demonstrat­ed the improbable concept that toxic chemicals could treat cancer. However, the toxic nature of the chemicals used often induces significan­t side effects, and patients can relapse after remission.

“Like chemo, immunother­apy was originally considered a highly improbable approach,” says Isaac Maresky, Vaxil’s executive director of the board. “However, a recent wave of high-profile successful treatments — including those for previously untreatabl­e cancers — has many believing immunother­apy will prove a more targeted, less toxic treatment. Analysts predict immunother­apy will be used to treat most cancers by 2030, although treatment will likely take a holistic approach, integratin­g multiple modalities. Vaxil’s invention offers a unique treatment mechanism, one that could even work synergisti­cally in augmenting others.”

Vaxil researcher­s leverage the company’s proprietar­y VaxHit platform algorithm to search for promising peptides— chains of amino acids. They’re first concentrat­ing on MUC1, a marker found in 90 per cent of all cancers. ImMucin is a synthetic injection containing copies of segments of the MUC1 cancer markers believed to be recognizab­le by T cells, which can then identify and destroy cancer cells.

Vaxil has already completed a Phase I/ II clinical trial for ImMucin. Using it to treat 15 patients with multiple myeloma, a rare blood cancer, researcher­s reported “a broad and robust immunologi­cal response in 100% of the patients.” Of those patients, 11 demonstrat­ed either remission or stable disease for extended periods past completion of treatment. Yet even a highly promising drug requires capital support before it can reach patients commercial­ly.

“It takes around 15 years to develop a new therapy, and Vaxil has already spent nearly a decade developing its novel thesis into a pipeline of promising drugs,” says Maresky. “With financing and continued results, it would not be unrealisti­c to expect Vaxil to develop a commercial cancer drug in under five years. Commercial­izing ImMucin as quickly as possible would result in financial independen­ce and in turn fund additional Vaxil drugs already under developmen­t in our Israeli lab.”

In addition to ImMucin, Vaxil scientists have generated the first ever signal peptide-specific antibodies, which target the signal peptide portion of the MUC1 cancer marker. These antibody proteins are immune system watchdogs that bind and neutralize foreign invaders. The firm is currently awaiting a key patent decision on this platform.

Deeper in its pipeline, Vaxil has used its VaxHit algorithm to develop a potential tuberculos­is vaccine. The World Health Organizati­on estimates that 1.8 million people died from tuberculos­is in 2015; that same year, 480,000 developed multidrug-resistant TB.

“Based on our laboratory data and in 21 patient samples, Vaxil vaccine candidates have produced superior results compared to current TB vaccines,” says Vaxil’s chairman, Dr. Saeid Babaei. “However, as a company, we must remain focused on cancer. Our strategy with our infectious disease platform is to partner with a large pharma possessing the infrastruc­ture to move the program forward.”

While Dr. Babaei and Maresky focus on strategy and capital markets supporting its trials, researcher Dr. Riva Kovjazin continues R&D with Dr. Limor Chen, vice-president of operations and clinical affairs at Vaxil’s laboratory in the Weizmann Science Park, Israel. Pending regulatory approval and financing, Vaxil hopes to embark on its pivotal Phase II trial for ImMucin.

“With our MUC-1 based treatment, I believe we have a truly novel immunother­apy platform,” says Dr. Chen. “ImMucin’s FDA Orphan Drug Designatio­n means the door is open for expedited pathways towards approval. We’ve already launched the manufactur­e of ImMucin for our planned clinical trial. After a decade of R&D, Vaxil’s next trial will certainly be our most important milestone, with the potential to catapult ImMucin into a registrati­on trial, a major step towards seeking FDA approval.”

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