Ann: Imugene Opens First Australian Site for azer-cel Trial, page-75

In light of news of the first Australian site for azer-cel opening, its appropriate to consider what kind of international bar has been set for success in the allogeneic CAR T space.

Allogene who is developing an investigative allogeneic CAR T platform has just reported phase 1 data on its solid tumor Car T product. So its not apples for apples with the azer-cel trial but its not oranges and apples either. The Allogene Traverse trial demonstrated an overall response rate of 50% and confirmed response rate of 33%. The trial had enrolled 39 patients as of the data cut-off. It was also reported that there were three grade 5 treatment-related adverse events and one case of dose limiting toxicity on top of an earlier DLT in the previous year. Last but certainly not least there were 3 deaths that included the new DLT where the patient died from cardiogenic shock.

I don't know anything about Allogene so I'm simply interested in the corporate press release: is it good, is it disappointing or is it bad.

According to Allogene the results demonstrated the potential of the investigational CAR T for heavily pre-treated patients with advanced renal cell carcinoma. The data was viewed as positive highlighting its potential as the next generation allogeneic platform. An interesting aside is that Allogene is looking to include 20 patients in a phase 1b expansion cohort. In an article by FierceBiotech it was commented that the durability of responses is an outstanding question that will be answered as the data matures.

The press release by Allogene helps me understand the significance of the press release by Imugene of 2 September 2024 in relation to three complete responses in the azer-cel Phase 1b in DLBCL and in particular the significance of Cohort B where patients continue to be enrolled. And, it also most definitely helps me to understand the significance of the safety profile for azer-cel as well as the durability of response.

The next interesting step in understanding the height of the bar would be to assess the scientific community response to the Allogene announcement as well as the market response. The data was presented at SITC and IKCS.