First patient dosed in ProstACT Global Phase 3 (part 2)

Spent a bit of time this morning getting myself more up to speed on this one. It is certainly a company that requires a fair bit of time if you want to stay well-informed. I'm aware that there are others on this forum who are far more across all of the details than I am.

My 2 cents worth:

Currently TLX generates most of its revenue from prostate cancer imaging products - Illuccix and Gozellix. TLX591 uses the same monoclonal antibody as the imaging products, but attaches a radioactive agent (lutetium) that actually treats the cancer, rather than just imaging it. Should this approach be successful, there is a multi-billion dollar market.

Currently Novartis has a competing product , Pluvicto, with contains lutetium bound to a small molecule that targets the prostate. Pluvicto had around $1.4 billion US in sales in 2024, having first been licensed in 2022. TLX591 has a number of potential advantages. In brief, it is better targeted, cheaper, less overall radiation is required, less doses and there is less toxicity to other organs.

The phase 1/2 trials of TLX591 were quite promising, demonstrating safety and a positive dose-response curve

All details are here: https://telixpharma.com/wp-content/uploads/2024/05/2024052-TLX591-Historical-Data-1.pdf

There is a potential catalyst upcoming when TLX release the results from the phase 3 part one trial. This is an unblinded trial, required by the US FDA in order for part 2 to proceed in the US.

Summary of my thoughts: this is a pivotal trial for TLX, the first for a therapeutic agent. If the trial shows positive results, it will be a game changer for the company. Early results look positive. As always in biotech, there is high risk, including the risk that TLX591 fails completely

I am maintaining my small-medium sized position