From the Australian benchtop to the ASX: developing next-generation radiopharmaceuticals for cancer patients

The need

An estimated 10 million people globally die of cancer each year with this figure expected to rise to about 16.3 million deaths per annum by 2040. The large unmet need is undeniable, and cancer care continues to evolve to improve treatment outcomes. Cancer treatment has long been dominated by traditional methods such as chemotherapy, external beam radiation and surgery. While these approaches continue to be critical components of cancer care, new treatment pillars have evolved, focusing on personalisation of treatment and growing beyond the “one-size-fits-all” approach of the traditional cancer therapies.

“Cancer remains one of the leading causes of death globally. What is important to understand is that cancer is often not one disease that can be cured with one treatment, and that is why it is so difficult to combat. There are a myriad of cancer types and each of them differentiates itself in each patient, making it challenging to find and destroy it,” Dr Alan Taylor, Executive Chairperson at Clarity Pharmaceuticals, said.

Radiopharmaceuticals, like the ones Clarity is developing, involve precision therapy called theranostics, a combination of therapy and diagnostics. This approach uses diagnostics to select patients who are likely to respond well to the treatment. The targeted therapies are then injected into the patient and deliver radiation directly to cancer cells, potentially reducing side effects within the body and effectively treating various types of cancers.

“At this point in time, radiopharmaceuticals are in the spotlight of the oncology field, generating a lot of interest in the space. However, there are still very few products in the market, so for Clarity this represents a unique opportunity to further improve patient outcomes using cutting-edge science,” Dr Taylor said.

Dr Alan Taylor, a PhD scientist, finance graduate and former investment banker had taken on the task of heading up the company.

“I worked with many, many different life sciences companies around the world, which gave me amazing experience. But they were overseas companies, and I had an undying passion to translate Australian science. Everyone told me that you can’t do therapies in Australia. I said, that’s nonsense,’ Dr Taylor said. “So, I set about raising Clarity’s first $1 million. We raised that within a few months, brought in investors that understood early life sciences and then started putting together a team and collaborating with some brilliant clinicians to progress our products.”

“Now we are over 60 people working at Clarity in Australia and the US,” Dr Taylor said. “We’ve been able to implement capital raises at the right time and listed on the ASX as the largest initial public offering in biotechnology at the time. And vitally, our products are generating exciting data in late-stage clinical trials, including registrational Phase III trials.”

The impact

To date, over 200 patients with various types of cancer have accessed Clarity products through the completed clinical trials in Australia and the US. Many more are benefiting in the ongoing trials.

“The data we are generating is remarkable,” Dr Taylor said. "And we look forward to progressing our clinical trials through to commercialisation. Our therapy product, ⁶⁷Cu-SAR-bisPSMA, is currently progressing through a Phase I/II clinical trial. We have treated patients with advanced disease that have failed several other therapies and have had very few options left. Even in these difficult cases, we are seeing quite promising preliminary results using ⁶⁷Cu-SAR-bisPSMA, with durable responses observed in some cases and a favourable safety profile.”

“Our lead diagnostic product, ⁶⁴Cu-SAR-bisPSMA, is also showing strong results,” Dr Taylor said. “It has been able to detect more cancer lesions than standard imaging, including current prostate-specific membrane antigen (PSMA) positron emission tomography (PET) agents. Some of those lesions were in the 2-millimetre range. The detection of lesions that are less than 5 mm in size by current PSMA PET agents is challenging, which possibly contributes to the low sensitivity of these agents. We were also able to detect lesions more than 6 months earlier than standard of care PSMA PET agents. The ability of early and accurate detection could make a big difference, helping clinicians to tailor treatment plans to individual patient needs, potentially leading to more effective therapies and fewer side effects. Additionally, earlier and more precise diagnoses can allow for timely intervention, potentially improving prognosis and overall quality of life.”

The future

With continued research, strategic collaborations and planned regulatory submissions, Clarity is well-positioned to lead the next generation of cancer treatment solutions. Professor Donnelly notes that the future is bright for the collaboration with the University.

“My ongoing relationship with Clarity Pharmaceuticals remains strong as ever,” Professor Donnelly said. “What’s really important to me is that Clarity has provided exciting career opportunities for outstanding scientists in Australia.”

He continues, “And the brilliant students that come through, they want to make a difference, and they can see that the opportunities that exist at this intersection of academia and industry; and that translating this important science is the best way to ensure that what we do within the academic community is to the benefit of society.”

As Clarity continues to push the boundaries of medical science, the company is hoping to redefine the future of targeted cancer therapy.

“It took a lot of hard yards, but the academic-industry collaboration means we now have a broad clinical development pipeline with products in Phase III trials, some of which have already improved people’s lives,” Dr Taylor said.