Is Gilead seriously in play to invest in LL for breast cancer? Some may recall my post shortly after last Monday's TNBC PR in which I opined that Dr Jay clearly has a good reason to invest the time and money to conduct another preclinical study for LL in mTNBC, this time with SMC Labs. I assumed then that CYDY's main focus would be on the Keytruda arm, but noted parenthetically that, because we don't know what we don't know, perhaps the Trodelvy arm might actually be the main focus.
Well, faced with the necessity to muddle through another weekend without football games to watch, I revisited the March, 2023, BioSpace article in which Cyrus had waxed eloquent about the ongoing MD Anderson mouse study involving LL and Keytruda, with his expectation of synergistic results. But no results were ever announced. Unless the study was never completed, I would think that both CYDY and MRK were furnished with the results, suggesting to me that either CYDY or MRK may have invoked a NDA to bury the results. That outcome would have been consistent with ohm's prediction that Keytruda would add nothing to LL. Therefore, no synergistic effect.
So why repeat the LL/Keytruda mouse study 2 years later? Well. unless CYDY believes that the SMC Labs mice are considerably more humanized than the MD Anderson mice, the reason escapes me.
On the other hand, Gilead's Trodelvy, the other leading FDA approved treatment for mTNBC, wasn't involved in the aforementioned MD Anderson study, but was the drug that the FDA cited to deny LL breakthrough designation status when CYDY announced LL's mTNBC phase 2 clinical trial results in August and November, 2021. Back then, LL produced a OS (overall survival) endpoint that although only slightly better than Trodelvy's, was still ongoing because more than half of the 26 women from the trial were still alive.
From last Monday's PR we now know that LL's OS was ultimately many months beyond Trodelvy's. The exact difference will undoubtedly be announced at or before the upcoming conference in Munich. Also, bear in mind that 9 of the 26 women in the trial received only 350 mg doses of LL, and only 3 received the maximum 700 mg doses. Given that the 350 mg doses would not have fully covered the CCR5 cells (thank you ohm), it may well be that the final Leronlimab OS data for the other 17 women (if over half are now deceased) will be particularly provocative compared to Trodelvy.
As I now ponder the above info, it seems much more reasonable to intuit that the LL/Trodelvy arm will be the main focus of attention for both CYDY and Gilead. According to Gilead's recently released annual report, Trodelvy produced revenue of 1.3B in 2024, all of it treating breast cancer. In Merck's annual report, I was not able to isolate Keytruda's breast cancer revenue, but I believe it would compare favorably to or exceed Trodelvy's.
MRK's sp has declined about 30% in the last 12 months, while GILD's sp has increased 70% since last June. GILD had 10B in cash at the end of 2024. And ohm has stated in a recent post that he would not be surprised if LL and Trodelvy were to produce a synergistic effect. If that proves to be true, or even if it doesn't, obtaining the use or ownership of a breast cancer drug arguably far superior to Keytruda or Trodelvy would likely translate to billions in new revenues for GILD, and that's without considering the rest of ohm's list.
Admittedly, however, MRK should also be actively engaged with CYDY concerning LL. With a faltering sp, stagnant revenues, and a Keytruda patent cliff now 2 years closer, MRK has good reason to reconsider LL in light of the newly revised Leronlimab OS that has probably already been communicated to MRK by CYDY. Because, if MRK is no longer interested in CYDY/LL, why is Keytruda still being included in the current mouse trial? And what could be better than 2 BP heavyweights being focused on the major impact that using or owning LL could have for them.
Seems very interesting to me. But bear in mind that I don't know what I don't know. And that's always problematic.
Well, faced with the necessity to muddle through another weekend without football games to watch, I revisited the March, 2023, BioSpace article in which Cyrus had waxed eloquent about the ongoing MD Anderson mouse study involving LL and Keytruda, with his expectation of synergistic results. But no results were ever announced. Unless the study was never completed, I would think that both CYDY and MRK were furnished with the results, suggesting to me that either CYDY or MRK may have invoked a NDA to bury the results. That outcome would have been consistent with ohm's prediction that Keytruda would add nothing to LL. Therefore, no synergistic effect.
So why repeat the LL/Keytruda mouse study 2 years later? Well. unless CYDY believes that the SMC Labs mice are considerably more humanized than the MD Anderson mice, the reason escapes me.
On the other hand, Gilead's Trodelvy, the other leading FDA approved treatment for mTNBC, wasn't involved in the aforementioned MD Anderson study, but was the drug that the FDA cited to deny LL breakthrough designation status when CYDY announced LL's mTNBC phase 2 clinical trial results in August and November, 2021. Back then, LL produced a OS (overall survival) endpoint that although only slightly better than Trodelvy's, was still ongoing because more than half of the 26 women from the trial were still alive.
From last Monday's PR we now know that LL's OS was ultimately many months beyond Trodelvy's. The exact difference will undoubtedly be announced at or before the upcoming conference in Munich. Also, bear in mind that 9 of the 26 women in the trial received only 350 mg doses of LL, and only 3 received the maximum 700 mg doses. Given that the 350 mg doses would not have fully covered the CCR5 cells (thank you ohm), it may well be that the final Leronlimab OS data for the other 17 women (if over half are now deceased) will be particularly provocative compared to Trodelvy.
As I now ponder the above info, it seems much more reasonable to intuit that the LL/Trodelvy arm will be the main focus of attention for both CYDY and Gilead. According to Gilead's recently released annual report, Trodelvy produced revenue of 1.3B in 2024, all of it treating breast cancer. In Merck's annual report, I was not able to isolate Keytruda's breast cancer revenue, but I believe it would compare favorably to or exceed Trodelvy's.
MRK's sp has declined about 30% in the last 12 months, while GILD's sp has increased 70% since last June. GILD had 10B in cash at the end of 2024. And ohm has stated in a recent post that he would not be surprised if LL and Trodelvy were to produce a synergistic effect. If that proves to be true, or even if it doesn't, obtaining the use or ownership of a breast cancer drug arguably far superior to Keytruda or Trodelvy would likely translate to billions in new revenues for GILD, and that's without considering the rest of ohm's list.
Admittedly, however, MRK should also be actively engaged with CYDY concerning LL. With a faltering sp, stagnant revenues, and a Keytruda patent cliff now 2 years closer, MRK has good reason to reconsider LL in light of the newly revised Leronlimab OS that has probably already been communicated to MRK by CYDY. Because, if MRK is no longer interested in CYDY/LL, why is Keytruda still being included in the current mouse trial? And what could be better than 2 BP heavyweights being focused on the major impact that using or owning LL could have for them.
Seems very interesting to me. But bear in mind that I don't know what I don't know. And that's always problematic.
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