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Cellectis and Allogene's cema-cel Shows Positive Clinical Data

Cellectis (CLLS) highlighted the interim futility analysis announced by Allogene Therapeutics (ALLO) from Allogene's sponsored pivotal ALPHA3 trial evaluating cema-cel in first-line consolidation for large B-cell lymphoma. Cema-cel is a product candidate licensed to Servier under the license, development and commercialization agreement signed by and between Servier and Cellectis and sublicensed by Servier to Allogene in certain territories. Allogene announced the futility analysis, which was triggered by the protocol-defined data cutoff of the 24th patient completing Day 45 minimal residual disease assessment, showed that 58.3% of patients in the cema-cel arm achieved MRD negativity compared to 16.7% in the observation arm, representing a 41.6% absolute difference in MRD clearance between the arms. Allogene reported that based on specific benchmark literature, a difference of 25%-30% in the MRD clearance could translate into meaningful clinical benefit at study completion. Allogene further announced that the cema-cel treatment was generally well-tolerated as of the cutoff, with most patients managed in the outpatient setting post-infusion, no cases of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, graft-versus-host disease or treatment-related Serious Adverse Events, and no hospitalizations for treatment-related Adverse Events. Allogene announced that study accrual is anticipated to be complete by the end of 2027 and that it anticipates an interim Event-Free Survival analysis in mid-2027 and the primary EFS analysis in mid-2028. If positive, Allogene announced that these results could support a biologics license application submission. Under the Servier agreement, Cellectis is eligible to receive payments up to $340M in development and sales milestones, as well as low double-digit royalties on net sales of licensed CD19 products, including cema-cel developed in LBCL.

Allogene Therapeutics Wins Arbitration Against Cellectis

Allogene Therapeutics (ALLO) noted the favorable outcome for Servier in its arbitration with Cellectis (CLLS) as it relates to cemacabtagene ansegedleucel. This decisive win reconfirmed Allogene's full development and commercial control of cema-cel in the United States, all EU Member States, and the United Kingdom, while clearing the path to obtain full global commercialization rights from Servier. In particular, the tribunal: Rejected Cellectis's allegations relating to alleged breaches by Servier of its development obligations; Rejected Cellectis's financial claims, finding that milestone payments tied to the pivotal trial are not due until U.S. FDA acceptance of a Biologics License Application; and Ordered only a partial termination of the license strictly limited to the UCART19 V1 product (formerly known as ALLO-501, which was discontinued in 2021 in favor of ALLO-501A/cema-cel) and directed Cellectis to negotiate in good faith a direct license to Allogene on terms substantially similar to the existing agreement, if Allogene elects to pursue it. With this legal matter resolved, Allogene enters 2026 with improved fundamentals. The company is approaching one of the most meaningful catalyst periods in the allogeneic CAR T field, including a 1H 2026 interim futility analysis comparing MRD conversion with cema-cel following standard fludarabine/cyclophosphamide lymphodepletion versus observation in first line patients with large B-cell lymphoma.