Some approved Cancer drugs can cause death but they are still...

Some approved Cancer drugs can cause death but they are still approved and on the market. Autologus Car T's are in that category but are approved because there is nothing left to try for a large proportion of patients. The risk from Allogeneic Car T's which is what IMUGENE is trialling in the Phase 1b study was obviously ACCEPTABLE to the FDA based on the data from the Phase 1 trial across 84 patients otherwise they would not have approved this 1b study. All very simple and easy to understand really.

When there is a high unmet need which is what Imugene is targeting with Azer-cel the reality is that a therapy even with a lower safety profile such as Autologus Car T's gain approval.

(If you have any doubts about this read about the 5-FU therapy and the deaths it has caused since the 1970's but still is approved and continues to be used.)

"ASX Announcement
Azer-cel hits major milestone with first patient dosed in Phase 1b
Allogeneic CAR T Clinical Trial
• First patient in Phase 1b follows successful Phase 1 trial in 84 patients at leading
US Centres
• Azer-cel is currently being studied in an ongoing multi-centre Phase 1b CAR T
clinical trial in patients with blood cancer called non- Hodgkin’s lymphoma (NHL)
• The Phase 1b trial is a precursor to a Phase 2 registrational (subject to FDA
agreement) in 2024
• Strong safety and efficacy signals to date from 84 Phase 1 patients dosed with
azer-cel
• Azer-cel clinical drug supplied from Imugene’s state-of-the-art manufacturing
facility in North Carolina

SYDNEY, Australia, 10 November 2023: Imugene Limited (ASX:IMU), a clinical stage
immuno-oncology company, is pleased to announce dosing of the first patient in a Phase
1b clinical trial using azer-cel (allogeneic off-the-shelf CD19 CAR T, a type of cell
therapy), manufactured and supplied from Imugene’s state-of-the-art facility in North
Carolina.
Following completion of the Phase 1b study there is potential to start a registrational study
in 2024 and become the first approved allogeneic CAR T cell therapy for cancer.
The patient who was dosed at Banner Health (Phoenix Arizona) suffers from a difficult to
treat sub-set of NHL called Diffuse-Large B-cell lymphoma (DLBCL). Dr Paul Woodard,
Imugene’s Chief Medical Officer said, “Patients with DLBCL who have relapsed after
autologous CART therapy have limited therapeutic options and are an unmet medical
need. New and effective therapies are needed for these patients.”

As announced in September 2023, Imugene received positive feedback from the FDA on
the azer-cel manufacturing process to be used in the registrational (to-market) clinical
trial, and potentially for manufacturing of the commercial drug product. Imugene’s
manufacturing facility is a state-of-the-art GMP (Good Manufacturing Process) site
where the proprietary next generation azer-cel process has evolved into a potential firstin-class cell therapy drug.
Imugene MD & CEO, Ms Leslie Chong said, “It is a great credit to our team that the Phase 1b
study has been initiated and the first patient dosed, in under three months since acquiring
the technology.”
The Phase 1b allogeneic (allo) CAR T study is an ongoing multi-centre Phase 1b clinical trial
in patients with non-Hodgkin’s lymphoma (NHL) and B-cell acute lymphocytic leukemia
(ALL). Azer-cel has demonstrated clinically meaningful activity with an acceptable safety
profile, including promising results in DLBCL patients who relapsed following CAR T.
Beyond using azer-cel in blood cancers, in the future it will also be combined with
Imugene’s own onCARlytics for treatment of patients with solid tumours, opening a
potentially large market for azer-cel in the 90% of oncology not beyond blood cancers."

My opinion only DYOR

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