I wasn't sure if it was going to provide anything additional, but I tried and purchased the journal which cost like A$60 .. turns out you just get a pdf of the abstract, so anyone thinking of doing that, don't bother! just wait for the ASX announcement on Monday and I'm sure follow up presentations/calls will shed further light such as how long disease stabilisation was maintained, survival etc.
In terms of side effects, cerebral edema is when fluid build ups and causes swelling in the brain which is common for tumor patients but may well have been triggered by the CAR-T treatment. The key thing is that there are very effective treatments for this, and if treated the effects are just temporary and will resolve. If untreated it could lead to severe long term damage, but all CAR T patients will be monitored very closely as part of their treatment and these type of side effects can be dealt with easily.
What we don't want are severe life threatening and long term damage side effects such as neurotoxicity (healthy cells being attacked) and cytokine release syndrome (overreaction of the immune system causing damage to healthy tissue/organs). None of these were experienced.
But what we saw in these first four patients dosed with CLTX (low dose) is exactly what I would expect to see if CLTX was going to live up to the high expectations set by the preclinical studies... which were very high (i.e. rivaling the success in the CD-19 CAR T's on blood cancers). There was a big risk that what we saw in the lab, and in mice would not translate into humans... much like taking a leap of faith, many such trials would have leapt and fell...
but what CHM just demonstrated (albeit sample of 4 patients) is that when we took that leap of faith, our right boot landed on something solid... 75% solid... obviously there are many steps to go, but just imagine the 'relief' and 'excitement' the team at CHM would be feeling after that felt that solid ground! Next step, we'll have both feet (ICT and ICV).. lets see if the bridge will take our weight and allow us to get to the other side.
For those who haven't see it, I posted a NEJM journal on a "CLTX-CAR T is a game changer thread' with some brief thoughts on that trial. To those unfamiliar with that, it was an earlier City of Hope CAR-T which demonstrated a complete response in a multiforme GBM patient (more than one tumor). That was big news at the time and was licensed out to Mustang Bio (US listed biotech), which wasn't able to have the same level of success as the case in the journal (Dr Richard Grady), but trials continue. Notably, CLTX, preclinically demonstrated that it binds significantly better to GBM than the target of that earlier CAR-T i.e. IL13Ra2. and we have just seen some human clinical data to suggest that it may hold true as a treatment in humans...
NEJM CAR-T City of Hope IL13Ra2
To put what CHM has achieved thus far, looking at the success of the earlier CAR-T targeting IL13Ra2.. when injecting the same dose level (low dose) into the tumor site.. our CLTX achieved the same outcome i.e. disease stability. A complete response was only achieved through ICV, and after many doses.. which we may see in the second cohort.. where our dose will be doubled, and we'll follow the ICV administration that Richard Grady received... and to keep a lid on things, I'm not going to speculate what our valuation will be if we see a repeat or a better response (or any complete responses).
Goodluck all
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Ann: CHM 1101 data accepted for presentation at SNO meeting, page-44
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