I've worked in CAR-T/CellTx for many years. If I could all of a sudden snap my fingers and remove the logistical challenges, reduce COGS, minimize residual hospital costs, make it all outpatient, make it so that it can be administered in community hospitals, scale mfg to easily meet demand, and price it competitively with antibody based drugs, I would. Turns out that that isn't possible right now, lol. It's going to be an uphill battle for cell therapy companies in this TA, especially the auto-CAR-T companies.
Insurers are going to make it tough to secure reimbursement and also put them so low on the formulary in order to manage costs. In a world where both CD19xCD3 and auto CD19 CAR-T are approved. You're going to have a way easier time getting CD19xCD3 commercially, even if it ends up falling short of the "one-and-done" bar CAR-T is shooting for.
I agree the bar for commercial success isn’t CART efficacy but investors will likely only give credit to a TCE which can match it because it’s a crowded space. Considering it’s only phase 1 trials the promise of “immune reset matching CAR-T” is much better than “good commercial opportunity”
Good point on the logistics of delivery. Feels like all the novel CART approaches are all overkill instead of simply designing a better TCE
1. My take on management’s comments isn’t as pessimistic… they definitely highlight some nuance. It’s too early to tell anyway. Even if CAR-T ends up yielding the best results, the process required for treatment will be a massive barrier to access and utilization (leukapheresis, lymphodepletion, cell processing, etc). We are already seeing this in MM, where patient preference is bispecifics > CAR-T.
2. Was $IGMS’ invotamab’s failure due to its CD20 target or due its IgM modality? Or due to some issue with CD3 engagement? It’s hard to tell.
3. A private company, Candid Therapeutics, is advancing its CD20 TCE (CND261) and a BCMA TCE (cizutamig) into a Ph1 with RA, SLE, SE, MG and IgAN cohorts. So the story of CD20 TCEs may continue to involve. Interestingly, CGEM picked up a BCMA TCEs after this news.
1. The problem is that investors are comping to the CAR T data and the goal is reaching that type of efficacy like in indolent lymphomas
2. It’s probably a bit of both. I attribute a large part to the target
3. I think BCMA TCE can be used on an ongoing basis to silence the immune system for anti body driven diseases but no chance of a reset. CD19 is where the true market lies imo
Thanks for the read and feedback! Appreciate if you share with anyone who may find it helpful
Great breakdown on TCEs and CAR-T for AID.
I've worked in CAR-T/CellTx for many years. If I could all of a sudden snap my fingers and remove the logistical challenges, reduce COGS, minimize residual hospital costs, make it all outpatient, make it so that it can be administered in community hospitals, scale mfg to easily meet demand, and price it competitively with antibody based drugs, I would. Turns out that that isn't possible right now, lol. It's going to be an uphill battle for cell therapy companies in this TA, especially the auto-CAR-T companies.
Insurers are going to make it tough to secure reimbursement and also put them so low on the formulary in order to manage costs. In a world where both CD19xCD3 and auto CD19 CAR-T are approved. You're going to have a way easier time getting CD19xCD3 commercially, even if it ends up falling short of the "one-and-done" bar CAR-T is shooting for.
I agree the bar for commercial success isn’t CART efficacy but investors will likely only give credit to a TCE which can match it because it’s a crowded space. Considering it’s only phase 1 trials the promise of “immune reset matching CAR-T” is much better than “good commercial opportunity”
Good point on the logistics of delivery. Feels like all the novel CART approaches are all overkill instead of simply designing a better TCE
Great read! A few things:
1. My take on management’s comments isn’t as pessimistic… they definitely highlight some nuance. It’s too early to tell anyway. Even if CAR-T ends up yielding the best results, the process required for treatment will be a massive barrier to access and utilization (leukapheresis, lymphodepletion, cell processing, etc). We are already seeing this in MM, where patient preference is bispecifics > CAR-T.
2. Was $IGMS’ invotamab’s failure due to its CD20 target or due its IgM modality? Or due to some issue with CD3 engagement? It’s hard to tell.
3. A private company, Candid Therapeutics, is advancing its CD20 TCE (CND261) and a BCMA TCE (cizutamig) into a Ph1 with RA, SLE, SE, MG and IgAN cohorts. So the story of CD20 TCEs may continue to involve. Interestingly, CGEM picked up a BCMA TCEs after this news.
1. The problem is that investors are comping to the CAR T data and the goal is reaching that type of efficacy like in indolent lymphomas
2. It’s probably a bit of both. I attribute a large part to the target
3. I think BCMA TCE can be used on an ongoing basis to silence the immune system for anti body driven diseases but no chance of a reset. CD19 is where the true market lies imo
Thanks for the read and feedback! Appreciate if you share with anyone who may find it helpful