What will be IMU’s first approval?
There are a number of possibilities of course, because there are still so many ‘unknowns’ in the IMU story. Any ‘beginner investor’ only needs to skim the latest ‘highlights’ release/statement to see the enormous scope and depth of the IMU programs. It really is staggering, considering the size of the company. Will it be Vaxinia? Azer-cel? onCARlytics? Or the de-prioritised B-Cell programs? Perhaps the next news could even come from ‘left field’.
In saying that, it certainly doesn’t need an approval to set the SP alight. Numerous quality posters have discussed what might provide the SP spark ... well before we have an FDA approval. That of course, is a different discussion, for another time.
So, back to potential approvals ...
I, like many here, believe it will likely be ... azer-cel. Yes, our newbie.
This little allogeneic (off-the-shelf) CAR T cell therapy, with its proven ability to target CD19, is an obvious candidate.
Why?
Several reasons, but particularly its success in patients already, along with the program in place that is looking to have a registrational trial running next year. You see, the current Phase1b trial will effectively act as a ‘regular’ Phase 2 trial, thus, if successful, lead straight into our Phase 2/3, or registrational trial. Team IMU has already held positive talks with the FDA around this format. This shouldn’t surprise you ... we do have an amazing team.
Azer-cel has shown enormous efficacy across a range of non-Hodgkin’s lymphoma (NHL) patients. The Ph1 trial, with 84 patients, also provided great safety. Additionally, this group showed a 58% Overall Response Rate (ORR) and a 41% Complete Response (CR) rate across all doses. So ... it works.
Now, having noted those responses, it is clear that its results with the DLBCL sub-set of patients, is actually the real diamond in this lode.
As Leslie notes: DLBCL is the most common type of NHL,with approximately 80,500 cases per year1 and approximately 30,000 new casesper year in the U.S., and that relapsed/refractory DLBCL has a high unmet medical need; 60-65% of patients treated with autologous CD19 CAR T relapse.
In the Diffuse Large B Cell lymphoma (DLBCL) sub-group, made up of 18 patients, azer-cel achieved 83% ORR, AND 61% (CR) Rate. Yes, Complete Responses !! This is a ‘head-turner’ and, if these levels are maintained in future trials, I would be expecting the FDA to give it the ‘big tick’. Remember, these are patients who have relapsed,following auto CAR T therapy. If azer-cel, an ‘allo’ treatment, can continue to deliver, with no high-grade cytokine release syndrome (CRS), no immune effector cell-associated neurotoxicity syndrome (ICANS), or, dare I say, no graft versus host (gvH) disease ... then here it is ... our first approval. So far, azer-cel is doing all this. Just image what we might do, in the future, when it's in combo with our onCARlytics program.
Anyway, happy to hear counter points, theories and suggestions that it may be another treatment. Remember, this is just the opinion of one poster.
(20min delay)