Keeping in mind that the phase I trial's objective is to assess...

Keeping in mind that the phase I trial's objective is to assess safety, however any benefit in decreasing/eliminating the solid cancer will send this stock soaring (even in a phase I trial).

One of the main key side-effects of CAR-T treatments have been the body's immune system being over-stimulated when the CAR-T cells are injected into the patient. This is because once CAR-T cells find the cancer antigen to bind to, they multiply like crazy. This releases cytokines, and in some patients the cytokines released overwhelm the body and result in a 'cytokine storm' (sounds familiar? MSB / SR-aGVHD/COVID-19 ARDS). In short, the immune system ends up attacking/damaging the patient's healthy cells and organs.. which can result in long term damage and death.

There are other serious side effects too (brain swelling / seizures etc), but the cytokine storm may be the scariest and most deadly.

I bring this up because we will get a good look in on any 'cytokine storms' or absence of in the dosed patients in March. Whereas other side-effects may occur over an extended period, the cytokine storm usually occurs days after being injected with the CAR-T cells. Immunogenicity is also hard to study in preclinical studies (and I don't think it was looked at by CHM in their mouse studies), and you only really know once you go into the clinic and test it on humans. For this reason, I suspect the CHM team and any potential partners will be keeping a close eye on this, but in fairness - this is why phase I trials are conducted ... they are there to pick up any potential safety issues, including any unwanted immune responses.

In the interviews I've seen so far, the two patients dosed were doing 'fine'... which to me is exactly what you want to hear.

But what they announce in March will be very interesting.. I don't expect it to be very detailed, but so long as no safety concerns are raised.. then it's a great result, and any sign of efficacy is a bonus (and we love those).

But from an efficacy stand-point, CHM is somewhat already de-risked in that CAR-T works and is an approved therapy in the US. CHM is therefore trying to replicate/improve an already proven therapy. CHM's CLTX-CAR-T cells are unique in that they appear to bind to many variants of solid cancers, and they even demonstrated that with subpopulations of GBM (yes, not all GBM cancer cells are alike), so its application can be far reaching... in other words, very very attractive to big pharma.


goodluck all