Finding the cure for cancer - it has become shorthand for solving the world’s problems.
Human civilisation has been striving towards this lofty goal for a long time, and Proactive has covered several biotechs making serious inroads in this space.
The arsenal of diagnostics and therapies to extend the life of people with cancer has grown exponentially in recent decades.
Into the arena steps Radiopharm Theranostics Ltd, which recently listed on the ASX.
The company started earlier this year with seed capital of A$20 million from investors.
Upon listing, the company attracted strong interest from Australian and international sophisticated, institutional and retail investors, raising a total of A$50 million.
As part of its strategy to fast-track the company’s product pipeline, RAD plans to use funds from the IPO for licensing fees, its ongoing clinical trials and to make up for manufacturing costs, milestone fees and other operational use.
RAD’s portfolio is already secured with commercially attractive licence arrangements and each technology has a robust intellectual property with a long patent duration.
It’s no wonder investors are keen - the global market for radiopharmaceuticals is worth US$6.7 billion as of 2020 and is only growing, with expectations that it will reach US$11.5 billion as we near the end of the decade.
RAD enters a market that, unfortunately, won’t be short on demand any time soon.
So why is radiopharmacology such an important part of the race for cancer therapy and diagnostics?
A new pillar in oncology
“If you consider oncology treatments until now, there has been very important progress in the past 20 or 30 years,” says CEO and managing director Riccardo Canevari. “And yet still there is very high unmet medical need.”
“Oncologists usually leverage one or more of four existing therapeutic options – chemotherapy, targeted therapy, immuno-oncology, or cell therapy. These four options, some long-standing, some more innovative, are really the most used.
“What has been happening in the last five to seven years is an interesting growth in the use of therapeutic radiopharmaceuticals. These really are a new pillar in oncology treatment.”
These radiopharmaceutical assets have unlimited potential because they can be used instead of or in combination with other products. They also have a role in diagnosis.
Diagnostic and therapeutic function
These isotopes have a search-and-destroy function – they can pinpoint a tumour and then, using a different level of radiotherapy, they can set about killing it.
“The way this therapy works is that you have a molecule linked to an imaging isotope,” says Canevari. "This molecule can see where the tumour is in your body, whether it’s a large-dimension tumour or small metastases.
“Once you’ve isolated the tumour you can take the same product and change the isotope from an imaging to a treating isotope, which releases a higher level of energy.”
The molecule that was able to see where the tumour aggregation was can now target it by releasing high energy from the isotope to the cancer cell.
“The beauty of this technology is that the treatment is highly selective, so it will only affect the tumour cell while leaving the healthy tissue untouched,” Canevari says.
A strong pipeline of assets
RAD's asset portfolio features four platforms that, combined, target three-quarters of the causes of death from cancer, including treatment for cancers of the lung, breast, head and neck, along with solid tumours like brain metastases and gliomas.
This pipeline is diverse, differentiated and advanced. It's comprised of four assets – only one of which is still in the pre-clinical phase, while the rest have been tested in around 133 patients in Phase 1 and 2 clinical trials.
“The most advanced is a molecule that targets high unmet medical need in brain cancer treatment,” says Canevari. “We have licensed it from Imperial hospital in London in order to continue its development.
“The next asset is a unique family of monoclonal antibodies serving an unmet medical need for oncology patients with lung cancer and those with a type of breast cancer.”
These are high-prevalence diseases with high unmet medical need.
“We were able to add an additional two to these first two assets,” Canevari says. “One is a receptor cell called integrin, a very interesting molecule with high potential, which is already under analysis in some patients.”
Integrin has the potential to bring hope to those battling pancreatic cancer, until now one of the hardest-to-treat cancers in oncology.
“Unfortunately, the current therapeutic solutions offer limited efficacy, so it is very important to try to enter this space," says Canevari. “It’s a game-changer to patients suffering from this disease.”
A who’s who of biotech expertise
The company’s management team and executive board is a who’s-who of industry leaders, including Canevari, a former Novartis CCO whose experience spans many years in oncology and radiopharmaceuticals.
Joining Canevari are former Professor of Nuclear Medicine at Cornell University, Prof David Mozley, as CMO, Dr Thom Tulip - someone who understands the particulars of the biotech supply chain - as CFO, and executive chair Paul Hopper, whose success launching biotech start-ups, such as the very successful ASX-listed Imugene, the company hopes to replicate.
Board member Dr Ian Turner is also a recognised expert in the isotope field.
“We think it’s an exciting time for the segment we’re in – therapeutic radiopharmaceuticals," says Canevari. “In Australia, there is expertise and knowledge in this field and the ASX is an attractive market platform.”
What’s on the horizon?
“We want to accelerate the development plan for our assets as soon as possible," says Canevari. “We still have some milestones in the licensing agreement plan to solve before moving to development.”
The company has a spectrum of development plans, because of the varying phases of clinical development of the assets. “We have one asset in the preclinical stage, but the other three assets are at the stage where patients have been dosed in clinical studies. So, our objective is to accelerate this process and prove safety and efficacy of our assets and continue their development through to commercialisation.”
As anyone who has followed the path of human therapy - for example, vaccines - will know, clinical trials take time. Phase 1 typically takes a year, Phase 2 is around two and a half years and Phases 3 and 4 can take even longer. All up, the path to commercialisation for a therapeutic drug is long, taking about a decade.
"We’re already well into the clinical phases, so we believe we can deliver some significant Phase 1 and Phase 2 data in the next few years,” says Canevari.
“We’ll then be in a pivotal moment for the company where we’ll go for the big investment in Phase 3 when we’ll be in a position to commercialise. So, yes, we have some steps ahead, but we have already proven this technology in some of our patients.”
Radioactive future
Canevari is proud of the strength of the pipeline of offerings already in development.
“We were able to select these four assets from among about 30 we had the opportunity to choose from," he says.
“We chose them based on their reputation as first-to-market and best-in-class. We chose to go with clearly differentiated assets, not ‘me-too products’ and this is what I believe is unique in our company.
“It's very difficult to see another radiopharmaceutical company with a small molecule peptide, a small monoclonal antibody and large monoclonal antibody as we do, and it’s also difficult to see companies able to leverage the multiple types of isotopes that we plan to work with.
"The breadth and depth of the pipeline, its potential to be best in class and first to market I believe is unique in radiopharmacology.”