As off-the-shelf cell therapies struggle Allogene plays on

Despite Allogene’s upbeat mood after the quick lifting of its US clinical hold, allogeneic cell therapy is in something of a crisis. A key problem is lack of durability, with some projects showing an efficacy in line with autologous therapies that then falls off as patients relapse. Yesterday Allogene confirmed that patients were again being enrolled into its studies, and primed investors for the start of the pivotal stage of ALLO-501A’s Alpha-2 study in mid-2022 and an update on its multiple myeloma work targeting BCMA by the year end. Stifel analysts issued a cautious view to clients, citing looming competition from allogeneic projects at Fate (FT596) and Precision (PBCAR19B). But this ignores competitors’ own problems: it was hard to discern FT596’s durability at Ash as all but two subjects were redosed; Precision is deprioritising PBCAR0191, and the next-generation PBCAR19B has promise but no meaningful data yet; and Crispr’s CTX110 has been slammed with the same patient relapse problems. Response duration will be a key metric in ALLO-501A’s pivotal study, Allogene says. Having spent $223m last year and lost 70% of its value in 12 months Allogene is committed to keeping annual cash burn below $300m; it ended 2021 with $810m.

Allogene's clinical pipeline
Project Trial Indication Status/catalyst
ALLO-501A (anti-CD19 without Rituxan switch) Alpha-2 R/r non-Hodgkin lymphoma Pivotal ph2 part starting mid-2022, using GMP material manufactured at commercial CF1 plant
Enrolment into ph1 part yet to restart
ALLO-501 (anti-CD19 with Rituxan switch) Alpha R/r non-Hodgkin lymphoma Accrual complete, now tracking long-term follow-up
ALLO-715 (anti-BCMA) Universal R/r multiple myeloma Patient enrolment has resumed; update by end 2022
ALLO-316 (anti-CD70) Traverse Renal cell carcinoma Patient enrolment has resumed
ALLO-605 (anti-BCMA with chimaeric cytokine receptor) Ignite R/r multiple myeloma Patient enrolment has resumed; update by end 2022
ALLO-647 (Campath substitute for lymphodepletion) Pivotal trial Unclear, but will aim to show safety Starting mid-2022
Source: company website &

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