Allogene Therapeutics are now over 6-months into their phase 2 trial advancing cema-cel, the most likely first-in-class allogeneic CD19 CAR T, for a wide range of hematological cancers including DLBCL. IMU management committed $70M to Precision before commercialisation for a drug they had to re-test to ensure it wasn't going to kill patients.
I encourage those on this forum interested in clinical and commercial strategy for biotechnology products to review how Allogene have positioned cema-cel - it's really quite brilliant. Naturally, allogeneic CAR T drugs would have to compete with autologous CAR T, and despite some advantages, it would be challenging to capture market share. Allogene recognised this and have instead skipped the que and are targeting all patients who are at risk of chemotherapy relapse, which bolsters the advantages of allogeneic CAR T.
This makes sense from both a clinical and commercial perspective, whereby cema-cel can become a backbone addition to front-line therapy in moderate to high risk relapse patients exposing the drug to a wide market share. The clinical risk involved in this approach is lowered because cema-cel is approaching the market before autologous CAR T, using it's efficiency in production to its advantage. Moreover, cema-cel has the opportunity to dominate market capture and steal patients from Autologous CAR T with limited competition due to its manufacturing efficiencies.
https://ashpublications.org/blood/a.../ALPHA3-a-Pivotal-Phase-2-Study-of-First-Line
https://clinicaltrials.gov/study/NC...amp;tab=history&a=6#version-content-panel
From the phase 1 data available, 12 patients received the phase 2 dose with 58% CR and 67% ORR, and a median duration of response of 23.1 months. None of the patients died due to treatment, highlighting the safety and efficacy of this treatment.
https://ascopubs.org/doi/pdf/10.1200/JCO.2023.41.16_suppl.2517
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