Dr Alan Taylor, chairman of Clarity Pharmaceuticals, joined us for an extended conversation about Clarity, the competitive landscape, their recent data, and the future of prostate cancer treatment.
Clarity is now up over 575% over the last year, and for good reason. The company announced a series of stunning results in the dose escalation trial of their treatment candidate for prostate cancer, including a complete response in a heavily pretreated patient (see our note from January here).
Alan explained what we can expect from here and considerations for a future Phase III.
We covered the competitive landscape in detail, including which pharmaceutical companies have significant franchises in prostate cancer (and might make potential acquirers of companies like Clarity), the diagnostics offered by Lantheus and Telix, and Novartis’s prostate cancer treatment Pluvicto.
We discussed the new interest in alpha particles, which are larger and more powerful than the beta emitters currently in the market, but perhaps more dangerous too: four patients died in a recent Phase 1 trial conducted by Johnson&Johnson.
And we went through antibody drug conjugates (ADCs), which have interesting parallels to radiopharmaceuticals. Both involve a targeted binder attached to a destructive payload - toxic drugs in the case of ADCs - though the ADC field is far more mature, with 14 approved drugs in the market and many more in development. This was a lucrative space for investors over the last decade, with leading companies like Seagen being acquired for enormous sums (Pfizer acquired them late last year for over US$40 billion).
Alan shared his thoughts on the future of Clarity, the strategic options available to the company, and new avenues of research where they might expand their pipeline.
I’m sure you will find this as interesting as I did!
Michael
Timestamps
0:20 - Dr Alan Taylor introduces radiotherapies and discusses the explosion of interest in targeted radiotherapies in cancer
1:43 - Lutetium and Copper as radioactive payloads
2:00 - The early history of Clarity Pharmaceuticals and the development of the copper cage
4:40 - Novartis’s Pluvicto blockbuster
4:50 - Thoughts on Telix
5:11 - Advantages of Clarity’s copper cage over Lutetium, Gallium and Fluorine alternatives in the market
6:37 - How Clarity is able to dose higher than Pluvicto without dose-limiting toxicities
7:25 - The intellectual property owned by Clarity
9:30 - Eli Lilly’s acquisition of Point Biopharma, and why this trial was likely to fail
11:10 - Eli Lilly’s strategy in radiopharmaceuticals
12:58 - Sensitivity limitations of existing diagnostics from Telix and Lantheus, which beat the prior standard-of-care (bone scans), but still miss far too many metastases.
14:55 - Clarity’s ability to detect lesions down to 2 mm, vs Lantheus at 5 mm. The advantages of Clarity’s second day imaging
18:15 -The pathway to commercialisation of diagnostics after Phase III
18:40 - Supply issues in radiopharma and Clarity’s position
19:30 - Patient centric medicine vs isotope centric
20:00 - Testing for biochemical recurrence (BCR) in prostate cancer
20:33 - Comments on the recent capital raise
21:50 - Big pharma interest in radiopharmaceuticals, and which companies own the existing franchises
22:37 - Typical progression of prostate cancer and treatment pathway
26:25 - Book recommendation: ‘Invasion of the prostate snatchers’
29:30 - Clarity’s Complete Response
29:55 - SECURE trial - the most exciting part of Clarity
33:34 - Discussion of the second cohort data which had a similar dose of radiation to Pluvicto. 3 out of 3 patients had drops in PSA of more than 80%.
34:45 - Discussion of the third cohort data with a higher dose and the sickest patients. Half of the patients had failed prior 6 lines of treatment or more, including Pluvicto and Actinium / alpha particle-based therapies.
36:30 - Discussion of future multiple dose cohorts, dosing regimen of Pluvicto and relevance for Clarity’s trial design
38:00 - Moving radiopharmaceuticals to front-line
40:00 - Clarity’s treatment paradigm
41:50 - Nuclear weapon analogy with JNJ’s alpha particle trial
44:45 - Lead-based alpha emitters
45:00 - Alpha vs beta emitters
45:50 - Clarity’s next targets after prostate cancer?
46:45 - Bombesin as a pan-cancer target, and sartate in neuroendocrine tumors (NETs)
48:00 - More on Lilly, Novartis, and major oncology franchises
49:00 - How is Clarity looking at the big picture strategically?
51:32 - Discussion of Bristol Myers Squibb US$4.1 billion buyout of Rayze Bio, an Actinium alpha-emitter with a generic dotatate linker.
53:44 - Alan’s recent trip to the US and thoughts on conferences attended
58:00 - Antibody Drug Conjugate (ADC) analogy
1:00:57 - Back to SECURE trial, what are the next data readouts and the next steps. Future Phase 3 trial design, head-to-head with Pluvicto vs other standard-of-care
1:02:57 - Clarity’s sartate program
1:07:50 - Clarity’s bombesin target and breast cancer target, detected cancer in 4 out of 4 patients that was undetectable with PSMA-based diagnostics.
1:14:00 - Comments on supply in Europe, Asia, the US.
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