By Sneha S K
April 13 (Reuters) – Allogene Therapeutics said on Monday that interim data from a mid-stage study showed its experimental off-the-shelf CAR-T therapy reduced the risk of cancer relapse in patients with blood cancer.
Allogene’s shares were up 54% at $4.18 in premarket trading.
The company is testing its allogeneic, or off-the-shelf, CAR-T therapy, cema-cel, in 24 patients with a blood cancer who still had a small number of detectable cancer cells after an initial round of standard treatment.
Interim results showed that 58.3%, or seven of 12 patients, who received cema-cel had no detectable cancer cells on highly sensitive tests, compared with 16.7%, or two of 12 patients, in the observation group.
Allogene set a benchmark of roughly 30 percentage points for success. The company said the interim data support cema-cel’s potential as a novel strategy for treating high-risk patients at the end of first-line treatment.
Cema-cel’s clean safety profile is exceptional and reinforces the potential for the study to transform the treatment paradigm and expand off-the-shelf CAR-T into a community setting, said TD Cowen analyst Tyler Van Buren.
The therapy was well-tolerated as of the data cutoff with no serious adverse events.
The CAR-T therapy, named cema-cel, utilizes white blood cells, specifically T-cells, from healthy donors. These cells are re-engineered to create cancer-fighting immune cells.
Unlike approved CAR-T therapies, which use a patient’s own immune cells and require weeks for collection, modification and reinfusion, cema-cel uses healthy donor T-cells and is pre-manufactured for faster use.
The results “suggest that an off-the-shelf CAR T may be able to intervene during that important window before clinical relapse to eliminate residual disease and make earlier intervention feasible in routine clinical practice,” said Zachary Roberts, Allogene’s chief medical officer.
The ongoing mid-stage study is expected to enroll about 220 patients and be completed by the end of 2027.
(Reporting by Sneha S K in Bengaluru; Editing by Tasim Zahid)
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