While Kite Pharma was purely a CAR-T company and would be a suitable comparison for CHM moving forward, however, the fact that CHM is targetting solid tumours would suggest that they will not receive the same efficacy rates Gilead's axi-cel had on the blood tumours. At the end of the day, it is these efficacy rates that will drive value growth for any biotech company. It is these Phase 1 efficacy rates that will determine whether a Phase 2 pivotal trial can be deemed sufficient to be used as evidence in a BLA submission. If the Phase 1 results are not eye-popping for CHM 1101, then the FDA will not approve a Phase 2 pivotal trial. Just because the FDA approved it in hematological cancers, it doesn't mean they will do it for GBM.
If CHM started targetting blood tumours with their CAR-NK and posted similar efficacy rates to Kite Pharma's axi-cell, then I think we wouldn't be sitting around these levels. However, the strategy of CHM is to target solid tumours first (which biotech companies are divesting from due to non-statistically significant results in efficacy) and blow the market away by its outstanding results in a field where CAR-T has struggled to work. The odds will be against them, especially with CLTX CAR-T. You may get good news from any of those programs, but CAR-T in solid tumours will deliver more bad news than good so it will be a case of one step forward and 2 steps back. Again, CLTX CAR-T's Phase 1 results as we head to cohorts 3 and 4 could completely prove me wrong, but no CAR-T has ever been successful in solid tumours. Something to think about.
CLTX CAR-T (CHM 1101):
I'm really surprised by Eisai's divestment from 131-I-TM-601(CLTX) when they acquired this product from Morphotek (I would highly suggest researching more about this product because it'll be the closest therapy that's been in the clinic that we can compare CHM 1101 to in GBM). This radiopharmaceutical drug uses CLTX as a biomarker and 131-I as a therapeutic agent (CHM is essentially using CLTX as a biomarker and the CAR-T Cell as a therapeutic agent). If it was that successful, why didn't Eisai continue developing the drug? Again, the two drugs are not quite the same, but they offer a glimpse of how difficult it is to target GBM with a single target despite using a superior biomarker. The use of ICV administration could be a game changer so we'll see.
CDH-17 CAR-T (CHM 2101):
This is a really interesting biomarker that they are using. It's interesting enough that Boehringer Ingelheim is testing it on a Phase 1 trial (BI 905711). If it is successful then this could bode well for this program. They do work differently, but the proposed mechanism of action makes sense. However, one negative to BI 905711 being successful is it would completely make CHM 2101 irrelevant if they post similar efficacy rates. Why go through an expensive and logistically extensive therapy, when you can go through a therapy that is easily manufactured, cheaper, and easily administered? There could be a double-edged sword here.
We do not have any data yet to justify any valuations, but you can dream of 11B. The upcoming Phase 1 CLTX CAR-T trial will determine where we will go in the short term. I am invested in this company, but I know the risks and have invested accordingly.
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