RE:RE:RE:RE:RE:Full report from Doug LoeGood point. I think your approach is right. In case someone doesn't have that old R& D day presentation, here's the slide. I actually don't recall if this is the level of overexpression of Sortilin or is the percent of tumors in these cancers that overexpress Sortilin at what they consider a "high" level. Maybe JFM can recall what they mean here.
Treatment of Sortilin Positive Cancers
Sortilin expression in cancers
• Associated with ovarian and breast cancers aggressiveness:
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90-100% of ovarian cancers
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79% of invasive ductal breast cancer (60% in TNBC)
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Increased expression as a function tumor grade (I to IV)
• Other cancers expressing Sortilin:
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Endometrial (90%)
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Lung (65%)
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Melanoma (90-100%)
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Urothelial (70%)
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Colorectal (30%)
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Pancreatic (30%)
jfm1330 wrote: According to their Investor Day presentation, only 30% of pancreatic and colorectal cancers are overexpressing the Sortilin receptor. In my view they cannot go in phase II in these without a screening tool. Biopsies and histology tests would do that job, but it is hard to imagine biopsies being done on advanced cancer patients just to participate in a clinical trial. That with just 30% of chances to be eligible for the trial upon results. In phase I, given the small number of patients, maybe they will be able to find patients that already had biopsies made and do the histologiocal testing on frozen tumor parts. I don't know. With 30% prevalence of receptor overexpression, they cannot avoid screening. When prevalence is 80-100%, like in ovarian, endometrial cancers and melanomas, maybe they can treat without it, but not at 30%.
Wino115 wrote: Right, and I would assume TNBC is lead but that they would rank pancreatic and ovarian pretty close behind based on large population of unmet need. I suppose you could say the same for colorectal, but like you say, they can't do it all in the first trial. They can clearly tackle them quickly thereafter and will be trialing TH1904 at some point. I guess you go for the ones where the response rate is over a certain hurdle of response.
I am guessing the strategy is to go for the most prevalent but hardest to treat with unmet need so that you get all the accelerated approvals and breakthrough therapy designations. Then do the others right in the background until those are completed. That's where you could partner an indication out if you want someone else to run with it and it's a relatively smaller indication.