$ABVX seems to have (in the last hour or so?) quietly released a new corporate deck with 3 important slides at the end. All, in my opinion, providing strong new information showing that these cancer cases were unrelated to drug and equivalent to expected background noise.
Most important is the slide on the 2 non-nonmelanoma skin cancers. BOTH of these were more indolent, low/intermediate subtypes of their respective cancer (prostate and breast). Not only does this mean that the cancers are less threatening, it also means that THEY ARE SLOWER GROWING CANCERS. Why is this particularly important? Because it means that the development of the cancers very (very) likely PREDATES THEIR ENROLLMENT IN THE TRIAL. Look into the doubling times of grade 2 (Gleason 7) prostate cancer and grade 2 NST breast carcinoma. These are slow-growing tumors that very likely existed before these patients ever even had a dose of obefazimod.
That relates to another key finding on this slide - the prostate cancer case was identified via PSA screening at 8.5 months into the study (remember earlier is better). In the Guggenheim conference they had said it was confirmed at day 367...they must have been referring to the biopsy confirmation of the subtype, not PSA confirmation of the prostate cancer diagnosis. This new information speaks to an earlier diagnosis. The breast cancer patient was diagnosed even earlier than that! Only 6.8 months of Obe exposure.
Also, these new slides give us actual information on the prior drug exposures - before this afternoon we knew that they were on some prior treatments, but we didn't know what...THE PROSTATE CANCER WAS PREVIOUSLY EXPOSED TO ***5*** DRUGS WITH LABELED CANCER WARNINGS BEFORE ENROLLING IN THE STUDY! 3 OF THEM HAD ***BLACK BOX WARNINGS*** FOR CANCER RISK!
-Humira (black box)
-Infliximab (black box)
-Rinvoq (black box)
-Entyvio (warnings and precautions)
-Stelara (warnings and precautions)
We also just got new info on the NMSC cases (which matter far less but which spooked the market anyway).
How you can look at the details of these skin cancer cases and think they are related to the drug is beyond me (but then again, these details just got released - quietly, for some reason).
First of all, ***ALL OF THE 4 50MG CASES OF NMSC OCCURED IN 6 MONTHS OR LESS!!! Again, too rapid to be reasonably assumed drug-related. The fact that they all happened in the first half of this study is actually extremely exculpating evidence for
$ABVX.
Other details:
-4/5 were 60 years old (STRONGLY associated with skin cancer risk)
-3/5 had PRIOR SKIN CANCER ALREADY(!!!!!)
-4/5 had prior exposure to other drugs that are known to increase skin cancer risk.
Finally, they also added a slide discussing that some studies have shown the elevated risks of these cancers for UC patients at baseline.
-~5x higher risk of prostate cancer in IBD patients
-~2x higher risk of breast cancer in IBD patients
Why did
$ABVX add these 3 slides to the corporate deck randomly, silently, on a Friday afternoon? IDK. Legitimately good news in those slides! I'd have pressed released this info as soon as I had it, because the details really help alleviate the (already statistically misguided) concern that these cancers could've been caused by Obefazimod.
Here's the link:
ir.abivax.com/static-files/e…