Adicet Bio Inc (NASDAQ:ACET) shared safety and efficacy data from its Phase 1 study of ADI-001 for relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma (NHL). JMP Securities downgraded Adicet Bio to Market Perform from Market Outperform rating.
The Phase 1 trial included patients who had undergone a median of 4 lines of prior therapy, with 50% having previously progressed on autologous CAR T therapy.
Also Read: Adicet Bio’s Cancer Candidate Shows Anti-Tumor Activity In Preclinical Study.
ADI-001 demonstrated a 71% overall response rate (ORR) and 63% complete response (CR) rate across all dose levels.
83% ORR and 67% CR rate were observed in heavily pre-treated patients who had progressed on prior CAR T.
A 6-month CR rate of 25%, and in patients who had progressed following autologous CD19 CAR T therapy, the CR rate was 67% with a 6-month CR rate of 33%.
The company plans to progress the ADI-001 program into a potential pivotal Phase 2 study in post-CAR T large B-cell lymphoma (LBCL) in the first half of 2024.
In addition, an update on efficacy, 6-month CR rate, and safety data from additional post-CAR T LBCL patients is expected in the second half of 2024.
According to Chen Schor, President and CEO of Adicet Bio, the autologous CD19 CAR T market is growing rapidly, exceeding an annual run rate of $2.2 billion.
Despite this, around 60-70% of patients progress, indicating a significant unmet medical need.
Adicet selected the recommended Phase 2 dose (RP2D) as 1 billion CAR-positive cells (dose level 4).
ADI-001 was generally well-tolerated with no dose-limiting toxicities or graft vs. host disease occurrences.
No significant incidences of CRS (cytokine release syndrome) or ICANS (immune effector cell associated neurotoxicity syndrome) were observed.
Price Action: ACET shares are down 10.50% at $4.17 during the premarket session on the last check Tuesday.
