WHEN THE CHART LOOKS UGLY I look elsewhere for motivation!
When charts look as ugly as ours currently looks, I like to remind myself of the product. What, Why, How?
In this case, just the Near Term Product, 64CU-SAR-bisPSMA, does just fine!
The current main incumbents (products) in this market are;
a) Pylarify, a Fluorine based tracer, marketed by Lantheus. Pylarify is the current Number 1 by market share.
b) Illuccix, a Gallium base tracer (68Ga-PSMA-11) marketed by Telix (TLX). Illuccix is Number 2, and growing.
But why Copper and why now?
From my reading, Copper has long been seen as the ideal radio tracer and radio therapeutic. Its characteristics are said to be perfect for theranostics, and the fact they differ from Fluorine and Gallium should allow a Copper tracer to establish its own use case and provide optionality that patients reqiure. That's what the research says.
A question: if its so good, why wasn't it in use before? Production issues (in sufficient amounts) stood in the way. Those have now been resolved since the discoveries around using cyclotrone to produce the copper isotopes needed for the job (Cu64 and Cu67). Alan has also spoken about issues with developing a suitable cage, and that too is solved.
Chances of FDA approval?
The probability that 64CU-SAR-bisPSMA will gain FDA approval looks to be higher than what is offered by other biotec peoducts;
1) COPPER PRODUCT IN USE: As it turns out, an FDA approved Cu64 based tracer already exists in the market: Its called Detectnet (Cu64-Dotatate), and it was approved in 2020 for use in NETS! The fact that Copper is already being used in humans is really helpful!
2) SUPERIORITY: Even at early stages, superiority of this product, has already been shown. As below:
Findings from the PROPELLER TRIAL
1) 2-3x increase in uptake of 64Cu-SAR-bisPSMA in lesions compared to 68Ga-PSMA-11 (this is the same tracer in Illuccix by Telix)
2) Where imaging with SOC tracers saw nothing;
a) Same day 64Cu-SAR-bisPSMA found lesions in up to 60% of cases!
b) Next day 64Cu-SAR-bisPSMA increased this to 80% of cases!
3) How about 64Cu-SAR-bisPSMA same day versus next day: number of lesions identified almost doubled from same-day (up to 80) to next-day imaging (up to 153).
Note: 64Cu-SAR-bisPSMA will be available for same day, next day, or anything else the doctors find suitable. This will be the most convenient of the currently used tracers.
With this information at hand, I rest easy!
If funds allow, I sure buy the deep!
REFERENCES USED (Outside of Clarity announcements)
1) Hao, G., Mastren, T., Silvers, W. et al. Copper-67 radioimmunotheranostics for simultaneous immunotherapy and immuno-SPECT. Sci Rep 11, 3622 (2021). https://doi.org/10.1038/s41598-021-82812-1
2) Krasnovskaya, O.O.; et al. Recent Advances in 64Cu/67Cu-Based Radiopharmaceuticals. Int. J. Mol. Sci. 2023, 24(11), 9154; https://doi.org/10.3390/ijms24119154
(20min delay)