In a major pivot, Allogene Therapeutics will no longer focus on two of its studies testing blood cancer therapy cema-cel in an effort to extend its financial runway into 2026.
Pictured: Allogene Therapeutics sign on a building, courtesy of Michael Vi/Getty Images
Allogene Therapeutics announced Thursday it will be pivoting some of its pipeline programs as part of a planned restructuring of resources in the first quarter of 2024, including laying off 22% of its workforce.
In Thursday’s announcement, Allogene stated that its 2024 “platform vision” will now be centered around four allogenic Car-T assets and that the pipeline reprioritization “will reduce cash burn” in an effort to extend the company’s financial runway into 2026.
In an SEC filing, Allogene’s board of directors also announced a reduction in its workforce by 22%, which is “in connection” with its “pipeline prioritization and clinical development strategy.” The workforce reduction is slated to be finished by the end of January 2024.
Allogene’s stock price dropped more than 20% in Friday morning trading in response to the news.
The biotech intends to “pivot” its CD19 program, zeroing in on developing cemacabtagene ansegedleucel (cema-cel), previously known as ALL0-501A, for the first line of treatment for newly diagnosed and treated large b-cell lymphoma patients. Allogene stated that the trial, Alpha 3, will use the treatment as a “one-time, off-the-shelf” procedure, which can be administered once the disease is discovered and some treatment has been issued. Ultimately, Allogene would like cema-cel to be part of the “7th cycle” of treatment in the frontline.
Allogene has said that the starting activities for the Alpha 3 trial are underway and will aim to have around 230 participants. The trial will have a primary endpoint of event-free survival as well. While Allogene is focused on the first-line trial, it will now prioritize the enrollment of the third-line Alpha 2 and Expand trials.
For the Alpha 2 trial, which is being investigated for chronic lymphocytic leukemia (CLL), Allogene will have a new Phase I Alpha 2 cohort of 12 patients who will be treated with cema-cel and will aim to have a “higher bar” where patients with CLL will not be reliant on their own T cells’ fitness to benefit from Car-T treatment—the Phase I will begin enrolling patients in the first quarter of 2024.
In June 2023, data showed that the Alpha/Alpha 2 trials of ALLO-501/501a showed seven out of 12 patients in Phase I reached a complete response and five patients maintained a complete response through the sixth month.
“Until now, CAR T development has been defined by how autologous CAR-Ts are made and used. As a management team with extensive experience in both autologous and allogeneic CAR-Ts and the only company with the breadth of data to demonstrate comparability between the two, we are uniquely positioned to potentially redefine the development and trial design of allogeneic CAR-T products that allow us to do what no autologous CAR T has done before,” Allogene CEO David Chang said in a statement.
Chang added that “this entirely new approach to development creates an advantage for our investigational AlloCAR T products now and in the future while providing a clinical framework to generate far more competitive CAR T products and dramatically expand market opportunity.”
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
