(MENAFN- ProactiveInvestors - N.America) Vaxil Bio Ltd's (CVE:VXL) ImMucin treatment teaches the body's immune system to attack cancer cells.
It is the latest of a string of cancer immunotherapies to take the world of medicine - and the press - by storm with claims of being the new 'cancer cure'.
But as vice president, Dr Limor Chen, explains, beyond the hype, Vaxil is aiming to make a very real difference to patients who are most in need.
The science
The treatment is based on Vaxil's work with signal peptides, short sequences present in certain proteins, including cancer markers called antigens. Specifically, Vaxil has developed its Immucin therapy through isolation of a signal peptide found in the MUC1 antigen, a well-known cancer marker present in 90% of all cancers.
The company's platform VaxHit is an algorithm for identifying and isolating signal peptides 'in-silico' as therapeutic products. ImMucin is the first therapy generated from the VaxHit platform. Vaxil believes its ImMucin has demonstrated a unique mechanism for exposing the MUC1 antigen, which has remained elusive to other modes of treatment.
ImMucin completed a Phase-I/II in 15 cancer patients and the results were published in the British Journal of Haematology.
Multiple myeloma
This trial, conducted during 2010-2012, was successful in showing a specific immune response in patients with multiple myeloma, a type of bone marrow cancer. In a follow up study, some patients were still in remission after three years. ImMucin obtained Orphan Drug Status from the FDA and EMA in 2015.
Its work with multiple myeloma may have been to its detriment in the early stages of the company, as many shareholders were led astray by misconceptions that this cancer was its only target.
In reality, multiple myeloma was targeted by the group as it is a notoriously incurable form of hematological cancer, appropriate for demonstrating Vaxil's ability to target MUC1. If Vaxil's therapy could tackle the disease and achieve where others had failed then it would back claims for the therapy's treatment of other cancers.
'ImMucin is being tested in multiple myeloma, a MUC1 positive blood cancer, in order to prove Vaxil's ability to target this critically important cancer marker. But MUC1 is found in a wide range of cancer types including blood cancers like leukaemia and lymphoma all the way to solid cancers like breast, pancreas, prostate, and lung," said executive director Isaac Maresky.
Even more broadly, ImMucin is only the first product, the first offshoot 'branch' from the 'tree' that is our VaxHit platform, if you will. We engineered it to target MUC1, but VaxHit as a platform can also be utilized in the generation of immunotherapy products targeting other cancer targets altogether.'
Targeting MUC1s means that it could be effective in 90% of all cancers; so the potential is impressive.
Compelling story
It's the strong science that attracted chairman Dr Saeid Babaei to the group.
Babaei was recently involved with another successful immunotherapies group, BriaCell. He joined the board of Vaxil, he says, after he was convinced by its 'compelling story'.
'I was very excited in terms of clinical response. The data is clear and the science is very strong,' he said.
With the new additions to its team and what the MUC1 studies are demonstrating, Babaei said the group was poised to do better and fill the gap in its knowledge.
Founded in 2006, it ticked off all the traditional milestones getting its immunotherapy into the clinic.
But investors back home on the Tel Aviv stock exchange became increasingly risk averse, meaning as it progressed through the stages of development, the share price wasn't following.
That was when the group decided it was time to step in and list on TSX Venture to raise funding to push it through recent trials.
In fact, when it listed in Toronto in March, it became the first Israeli biotech firm to do so.
But Maresky notes that in addition to listing in Canada, Vaxil strengthened its team in order to take its cancer treatments to the 'next level'.
He believes the rapidly evolving field of immunotherapy is moving towards more collaborative and holistic approaches when it comes to managing cancer, and that Vaxil is poised to play an important role whether as a standalone treatment or in combination with other therapies emerging in the market.
Crucially, he thinks Vaxil has built a 'differentiated immunotherapy platform', one capable of targeting cancer antigens in an 'altogether novel manner'.
Phase II
Vaxil is now preparing for a continuation of its clinical development under US and EU regulatory standards and hopes to embark on a larger Phase-II next year.
This Phase-IIb study will be pivotal for the company and its cancer therapy program. Vaxil is currently expanding the preclinical evaluation of ImMucin and is in discussions with clinical and regulatory experts to determine the best design of the study, but the upcoming trial could be a large one.
Although the vaccine has the potential to treat many human cancers, Vaxil's team is dedicated to treating those patients who will benefit the most, explained Chen, who is charged with designing the strategy.
For Chen - who joined Vaxil with drug development experience including at Israel's largest pharma company Teva - it's more about building a viable therapy and less about what he considers 'unrealistic' expectations of an all-round cancer cure.
In this sense, the group believes that certain MUC1-positive multiple myeloma and possibly leukaemia patients at their remission phase may be helped by a combined approach to extend their remission state, deepen the response and maybe even achieve cure.
Vaxil is awaiting randomised controlled trials to prove this.
Antibody platform
Perhaps its most under-recognized technology group, Vaxil has also developed quite a unique antibody platform, including the first ever signal peptide specific antibodies. The group thinks its antibodies have potential to effectively target MUC1 positive cancer patients, hence the potential for accurately diagnosing and treating those most likely to benefit from its approach.
Cross-cancer potential
Previous preliminary results in breast cancer patients also indicated the potential of MUC1-SP in eliciting a significant response, with other potential solid cancers such as ovarian, prostate and lung.
Signal peptides are more inclusive as antigens, making them excellent candidates for developing a more broadly applicable immunotherapy efficient in protecting and treating a larger portion of the diverse patient population.
In fact, Vaxil's full immunotherapy platform is also working on treating other fatal diseases using a similar approach to cancer. The group is currently conducting research into using its therapies for AIDS, Malaria and Tuberculosis to name a few.
Vaxil's therapy is also a relatively inexpensive approach, compared to what Chen calls today's "fancy" immune therapies, such as Opdivo, Keytruda, Tecentriq, Yervoy that can cost as much as US$1,000,000 annually.
As a traditional peptide synthetically manufactured in a conventional and efficient 'off-the-shelf' process, ImMucin could potentially be priced lower, while Vaxil's safe and efficient immune-stimulation could make it an attractive therapy in combination with others, explained Chen.
'It is therefore conceivable that payers will be inclined to prefer such a strategy if and when proven efficient.'
US$62bn market
Current share price values the business at a little over C$5mln, whereas the company has raised approximately C$12mln over its 10 year history.
The global cancer immunotherapy market is currently estimated to be around US$62bn and is expected to reach almost US$120bn by 2021.
This new class of immunotherapies is still in its infancy, with Medarex's Nivolumab one of the first to power through FDA approval and brought to the market with Bristol-Myers Squibb.
At C$5mln, Vaxil seems to be a very cheap way of getting into an exciting sector.