Race Oncology Ltd (ASX:RAC, OTC:RAONF) earlier this week announced the launch of two new clinical programs for its lead drug, RC220. The company said the drug will now be trialled in acute myeloid leukemia (AML) and EGFR-mutant lung cancer.
The company told investors that recent findings regarding the composition of matter IP and the mechanism of action of RC220 have significantly increased the potential commercial and clinical value of the asset. It said understanding how the drug works has enabled it to match development programs to the drug’s mechanism of action and increase the probability of clinical success.
Race Oncology said the decision to target EGFR-mutant lung cancer followed a comprehensive analysis of drug combinations and cancer types. The company believes RC220 may help delay or prevent resistance to tyrosine kinase inhibitors, a class of drugs that currently treat the disease but generally fail after 18 months of use.
It highlighted that EGFR-mutant lung cancer is a significant market, estimated to be worth over 10.00 billion US dollars annually.
The non-small cell lung cancer program is at an advanced stage. The company has submitted ethics applications, set up clinical sites, and recruited investigators. It said first patient treatment could begin in the first quarter of next year, pending final approvals and funding. It noted that in-the-money options expiring in May may provide capital to commence the trial.
Race Oncology also confirmed it is advancing a Phase 3 AML program and continuing its cardiac protection study in combination with daunorubicin. The company stated that all trials are open-label and will provide updates throughout their progression.
Proactive: Race Oncology has launched two new clinical programs for its lead drug, RC220, now targeting acute myeloid leukemia and lung cancer. This is quite a development. For more on this, I'm joined by Race Oncology CEO and Managing Director, Dr Daniel Tillett. Daniel, it's good to have you back on here at Proactive. How are you?
Dr Daniel Tillett: Excellent. Excellent. Thank you.
Proactive: It's good to have you back here. This is quite a step forward, not only for RC220 but also for the company. We're now expanding trials into two new types of cancer. That's huge. Walk us through what this really means.
Dr Daniel Tillett: As you mentioned, it’s really a major step forward. It expands the commercial opportunity of our drug. We’ve had discoveries recently around the composition of matter and our IP, which can add a lot of value if we can capture it. Also, we now understand how the drug works. That has allowed us to develop programs that align with the mechanism of action, which improves the probability of success and lets us target markets where we can return the most value to shareholders and patients.
Proactive: How did the mechanism of action for RC220 lead into the lung cancer trial?
Dr Daniel Tillett: Like most things in science, it’s complicated. Once we knew the mechanisms of action, we could systematically review different factors for a clinical program. The mechanism is broad, applicable to many indications and combinations. We worked through an extensive checklist and examined hundreds of drugs, diseases, and combinations. We identified what we think is the best opportunity: EGFR-mutant lung cancer. These cancers are treated with tyrosine kinase inhibitors, which work well but usually only for about 18 months before resistance develops. We believe RC220 can delay or even eliminate this resistance. That makes it an incredibly attractive opportunity.
Proactive: A common investor question would be: why are you running this program?
Dr Daniel Tillett: Our job is to extract value from the drug and the long IP life it now has. That means identifying the most valuable clinical areas. Lung cancer is the most common cancer — a couple of million people are diagnosed each year. EGFR-mutant lung cancer alone is a market worth over 10 billion US dollars annually. We think this is one of the best opportunities. The goal is to collect data that supports the opportunity and, ultimately, either bring a drug to market or pursue partnerships or other paths to success.
Proactive: How advanced is the non-small cell lung cancer trial, and how quickly could you move into clinic?
Dr Daniel Tillett: It’s actually quite advanced. We’ve submitted for ethics approval, set up all the sites, and recruited the clinicians. We're just waiting for the final ethics approval. If that comes through, we could treat the first patient in Q1 next year. The only thing missing is the funding. But we have in-the-money options due mid-May that could provide the funding if converted early. So it’s really in shareholders' hands at the moment.
Proactive: What can investors expect in the next 6 to 12 months?
Dr Daniel Tillett: Alongside our current program in cardiac protection and anti-cancer combination with daunorubicin, we’re adding a Phase 3 program in AML and a Phase 1 in lung cancer. All the trials are open-label, so we’ll have updates along the way, plus preclinical activity as well. There’ll be plenty going on to keep attention on Race.
Proactive: And this will all be highlighted in a webinar you're hosting live tomorrow?
Dr Daniel Tillett: Yes, I’ll be explaining the strategy and why we’ve undertaken these two new programs. There’s a lot of science and interaction between areas, and I’ll walk interested shareholders through that. It's at 1:00 PM tomorrow, Tuesday the 18th. You can register through the link in today’s ASX announcement.
Proactive: Hopefully there’ll be a big turnout. Quite a milestone and quite a few developments happening at Race Oncology. Thanks for your time.
Dr Daniel Tillett: Thank you.