BiQ: Quick Note on KURA ESMO Poster for FIT-001 (KO-2806 w/ Cabozantinib) (KURA)
I received a few emails today from members asking if I was planning to sell KURA after the release of the ESMO poster for KO-2806+Cabozantinib. Apparently, there have been some negative posts on X, with one prominent author selling his shares after reviewing the ESMO poster abstract. Every investor should make their own decision based on their interpretation of the data and personal risk tolerance. However, for my part, the short answer is no, I don't currently have any plans to take any trading actions.
For reference, the poster abstract data can be found here:
https://cslide.ctimeetingtech.com/esmo2025/attendee/confcal_2/presentation/list?q=KO+2806
KO-2806 is a Farnesyltransferase inhibitor which is being trialed in the FIT-001 Phase 1 trial for use as a post-IO therapy in combination with Cabozantinib, which is currently considered the SoC for treatment of RCC in patients refractory to IO therapies. The current standard of care for these 2nd line patients is Cabozantinib monotherapy.
Just looking at the top-line numbers, and putting aside for a moment the fact that this is a cross-trial comparison, ORR and DCR look roughly similar for Cabo 60mg vs. KO-2806+Cabo 40mg in this refractory population:
Efficacy Comparison (Cabo/FIT-001)
ORR: 25-37% / 28%
DCR: 70-75% / 84% (25% cPR, 59% SD)
What's interesting here, however, is that 2/5 responders in the FIT-001 group were Cabo resistant, which indicates that FIT-001 is showing at least some activity as an mTOR inhibitor in overcoming Cabo resistance.
It gets a little more interesting when we look at the safety data:
Safety Comparison (Cabo/FIT-001)
Diarrhea: 74% / 22%
Fatigue: 56% / 30%
Nausea: 50% / 30%
Vomiting: 32% / 22%
> GR3 AEs: 71% / 30% in 3 mg cohort, 57% in 5mg cohort.
There are two things to consider here. First, I don't believe there is much, if any, value for KO-2806 built into KURA's current valuation, so I'm not sure why this data should trigger a sell-off, at least for investors who have a clear understanding of the value proposition in the Menin inhibition space. Second, this is very early data and far from conclusive; however, in my opinion, it still demonstrates that KO-2806 is exhibiting early signs of activity without additional toxicity. At this very early stage, I take this as a positive signal, though still too early to draw any conclusions. A lot more data will be required before we can assign any value to KO-2806.
For me, early data like this has little or no bearing on KURA's current valuation. That doesn't mean shares won't sell off on sentiment, especially since, to be frank, many retail investors often take their trading cues from social media posts. However, I don't like to trade on sentiment or momentum. In my view, the thesis hasn't changed, so I don't feel the need to take any action on this data. I will wait to hear management's presentation of the data on the 18th. Information for the upcoming webcast can be found here:
I hope this is of some help to BiQ members. The single biggest near-term risk factor for KURA is the upcoming PDUFA in November. A CRL will undoubtedly sink the share price. For investors who currently hold KURA and are concerned with the binary risk, there is no harm in taking profits and moving to the sidelines until there is more clarity; however, for myself, I don't plan to take any action at this time based on the early KO-2806 data.
Please refer to the BiQAP Live spreadsheet on the Active Portfolio page for additional information.
KURA share price at time of publication: $ 9.93
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